PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

U.K. Drug Developer Opens First U.S. Base in Metro Boston

RxCelerate now has U.K. headquarters on the Babraham Research Campus in Cambridge, U.K. and U.S. headquarters at One Broadway, Cambridge, Mass.

RxCelerate, an outsourced drug discovery and development firm based in Cambridge, U.K., has opened its first U.S. location in Cambridge, Mass. and hired Laura Hamilton as executive VP to lead the new operation.

Hamilton previously served as the director of business development at the Massachusetts Biotechnology Council (MassBio), a not-for-profit organization founded in 1985 that represents and provides services and support for members in the Massachusetts life sciences cluster.

RxCelerate offers integrated discovery and development services ranging from medicinal chemistry, antibody discovery, preclinical safety and efficacy, through to clinical proof of concept.

In a press statement, David Grainger, executive chairman at RxCelerate, differentiated the company from typical Contract Research Organizations. "RxCelerate is different," he said. "We are architects of drug discovery and development, rather than builders. Our clients need provide nothing more than the target they are interested in, and RxCelerate will deliver a pharma-grade product candidate and progress it into the clinic."

Founded in 2012 in the U.K., RxCelerate reports that its clients range from start-ups through to three of the top 15 global pharmaceutical companies, and that it already serves clients in the U.S.

The U.K.'s Department for International Trade, a government department responsible for striking trade agreements between the U.K. and non-EU states, served as advisers in development of the firm's international trade strategy during the past two years leading up to the opening of the Massachusetts office.

The company specializes in in vivo pharmacology, offering proprietary models of a range of human diseases, as well as complex cell-based assays. Its chemistry team provides medicinal chemistry, including in silico screening, and synthesis that integrates with in vitro testing capability to deliver pharma-grade drug product candidates "at a fraction of the cost of traditional approaches," according to RxCelerate.

Metrics Contract Services At New Oral Solid-Dose Commercial Manufacturing Facility

Metrics is the contract development and manufacturing division of Mayne Pharma.

With the added capacity of this new 126,000-square-foot facility, Metrics Contract Services will offer development clients “concept to commercialization” solutions in one contiguous location under one site registration.

Construction of Mayne Pharma’s new oral solid-dose commercial manufacturing facility in Greenville, N.C., is complete, with production beginning in January. This $80-million, 126,000-square-foot facility quadruples the company’s U.S. manufacturing capacity.

The facility positions Metrics Contract Services to offer development clients a comprehensive “concept to commercialization” solution in one contiguous location under one site registration — delivering larger scale and increased capabilities for seamless scale-up, and reducing the technical and regulatory complexity of site transfers.

A key highlight of this expansion is Mayne Pharma’s commercial-scale, solvent-based, fluid-bed processing and film coating — a first for its operations in the United States. With the commissioning of this facility, Mayne Pharma will triple its worldwide fluid-bed processing capacity.

While commercial manufacturing will be a new offering for development clients, it is not a new capability for the Mayne Pharma team or the Greenville site, which has successfully tested, manufactured and packaged commercial products for more than 10 years. Space constraints in the current manufacturing facility precluded Metrics from offering commercial manufacturing broadly to its clients.

Here are some “fast facts” about the new commercial manufacturing facility:

Construction began in August 2015

First production scheduled for January 2018

$80 million invested in new construction, new equipment and renovation

Facility is 126,000 square feet in size

Engineered from ground up to maximize flexible space and segregate flows of people, equipment and materials

13 new production suites, each featuring 100-percent HEPA-filtered outside air plus multiple airlocks to support potent handling and mitigate cross-contamination

Annual production will increase to 1 billion+ doses

Offers clients full “concept to commercialization”— from first-time-in-man to commercial manufacturing at one contiguous location under one FDA site registration

Key pieces of equipment include:

Solvent-capable Glatt GPCG Pro 120 fluid-bed dryer with integrated high-sheer granulator

Glatt VG Pro 440 high-speed mixer for wet granulation

Solvent-capable Thomas Flex 500 batch tablet coater

IMA Adapta 100 high-speed capsule filler with 100-percent inline weight checking

Sejong SM-300 high-speed mixer and wet granulator

Fette 3090i and Fette 2200i tablet presses

Bosch 1500S capsule filler and Qualicaps CWI-80 capsule checkweigher

Fitzpatrick Chilsonator L-83 roller compactor

O’Hara Technologies DD400 tray dryer

Metrics is a full-service contract development and manufacturing organization that has delivered scientific and operational excellence for oral dosage forms to clients worldwide for more than 20 years.

Biostem Technologies Expands API Site in Florida

Quality Pharma Ingredients – a subsidiary of BioStem Technologies – is expanding its API facility in Oakland Park, Florida, US.

The expansion will add environmentally controlled warehouse space for storage of the company’s active pharmaceutical ingredients (APIs), and a pack-out area for order fulfillment.

The company has also added a storage cage to handle US Drug Enforcement Administration (DEA) controlled substances with low to moderate potential for abuse.

BioStem Technologies COO Andrew Van Vurst said it is in the process of applying to the Administration for Schedule III-V holding status, which will enable Quality Pharma Ingredients (QPI) to add DEA regulated products to its portfolio.

Van Vurst said he expects the expansion to be completed by the first quarter of 2018, and will create between five and eight new jobs across the quality, processing and warehouse sectors.

Emerson Lands Automation Fit Out At Novo Nordisk Insulin Plant

Novo Nordisk has selected Emerson Automation Solutions to equip a diabetes API manufacturing plant in Clayton, North Carolina.

The US-headquartered service provider landed the contract – valued at $40m (€34m) – at Novo Nordisk’s new $2bn, 825,000 square-foot facility where it will manufacture diabetes treatments.

Emerson will equip the Dutch pharmaceutical firm’s facility with its DeltaV distributed control system (DCS) and Syncade manufacturing execution system (MES), as well as automated valves and measurement technologies.

“Emerson’s DeltaV distributed control system will be the central nervous system that operates their Clayton facility and will utilize various Emerson and third-party instrumentation and final control elements to control unit applications,” said Emerson’s president of global life sciences industry Tom Snead.

Its Syncade manufacturing execution system (MES), along with its OSI PI historical data management technologies will provide “material management, electronic batch records, operational dashboarding, and release-by-exception operational management consistent with regulatory record compliance that is always critical to pharmaceutical operations,” he added.

Emerson said its technology will help Novo Nordisk develop diabetes treatments.

“This alignment will ensure Emerson is able to utilize DeltaV and Syncade to provide a solution that allows for production of their diabetes drugs to meet clinical standards in a safe and efficient manner,” he said.

Further, providing an integrated solution across levels one to three of the ISA-95 model – an international standard from the International Society of Automation – is the ‘new normal’ for pharmaceutical manufacturing said Snead.

“The integration between DeltaV and the Syncade MES helps automate many manual processes, eliminating roadblocks that can delay compliance and project launch,” .

Snead said Emerson’s technology will help reduce Novo Nordisk’s costs in both the project and operating phase.

“During the project phase, Emerson technology for electronic marshalling, virtualization, smart commissioning, class object based configuration of DeltaV and Syncade, and tight integration between DeltaV and Syncade will reduce overall capital project engineering and start-up,” he said.

“Once the facility is in operation, leveraging electronic batch records and a release-by-exception management operational philosophy will help Novo Nordisk reduce inventory costs and improve overall facility throughput.”

The Clayton facility will focus on finished active pharmaceutical ingredient (API) production and oral diabetes candidates, and is due to be operational by 2020.

In related news, Emerson expressed written interest last week in acquiring Rockwell Automation for $225 per share, for a stock transaction valued at $29bn.

Avista Doubles API Mfg. Capacity at Colorado Facility

Avista Pharma Solutions has completed facility upgrades that double the company’s active pharmaceutical ingredient (API) manufacturing capacity at its Longmont, CO site. During this expansion, the site’s three existing GMP drug substance manufacturing suites were upgraded, and a fourth GMP suite was added. The facility’s non-GMP capacity was also doubled with the addition of two large-scale development suites.

Among the new equipment installations were four walk-in hoods, three 50-gallon glass-lined reactors, three Hastelloy agitated filter dryers, and various small-scale reactors and mixing vessels. The new, state-of-the-art equipment will provide additional scale and enable processing of complex and potent categories of chemical compounds.

Safety and containment controls were also upgraded during the expansion, giving Avista Pharma the ability to manufacture materials rated up to occupational exposure bands of 3A and 3B by SafeBridge.

“Our investments in suite upgrades and capacity expansion in Longmont have transformed the site into a world-class API manufacturing facility,” said Ken Domagalski, general manager of the Avista Pharma Longmont facility. “Our team of experienced scientists prides itself in finding the most efficient path to success for our clients, further demonstrating our facility as a CMC center of excellence.”

The API facility expansion is one of several major investments at the Longmont site during 2017. Avista Pharma is also in the process of expanding its drug product manufacturing capacity and analytical capacity, as well as adding walk-in stability storage chambers into the additional 20,000-square-foot expansion announced last year.

Emergent Wins Approval to Bring Smallpox Vaccine Manufacturing To US

Emergent will transfer the upstream process for a former-Sanofi smallpox vaccine from a site in Austria to Massachusetts following US FDA approval.

In July, Emergent BioSolutions paid $97.5m upfront for Sanofi’s ACAM2000, a vaccinia-based smallpox vaccine that was approved by the US Food and Drug Administration (FDA) in 2007. The acquisition included a 10-year supply contract with the US Government, along with a Sanofi manufacturing facility in Canton, Massachusetts which was being set up to produce the vaccine.

And now Emergent announced the Canton facility has received FDA approval for the bulk manufacture of ACAM2000 at the Massachusetts site.

“The Canton site was already previously licensed for the ACAM2000 downstream production. The tech transfer for which we received FDA approval involved the upstream portion of the ACAM2000 process,” said Emergent spokesperson Miko Neri.

Emergent also added a leased fill and finish facility in Rockville, Maryland for the bulk vaccine product. Therefore “transferring the upstream portion previously done in Austria to Canton allows for the full manufacturing process to be done domestically,” the company state.

The Canton site is equipped with large-scale bioreactors for cell culture propagation and viral infection for the production of the vaccine.

“The ACAM2000 cell harvest production is based on the expansion of vero cells through static and dynamic cell culture. Following viral infection of the expanded cell culture, the cells are separated from microcarriers using a vibrating screen, mixed, centrifuged and aliquoted,” Neri said.

“Downstream processing involves purification of the cell harvest material using high pressure to disrupt the cells, clarification, concentration and diafiltration, followed by formulation with the addition of excipients, mixing, and aliquoting.”

The production volume of ACAM2000 at the facility is based on the US Centers for Disease Control and Prevention (CDC) contract to supply nine million doses of the vaccine annually. However, it has capacity to quickly increase this to 39 million doses if required.

Emergent Biosolutions Strengthens Manufacturing Infrastructure with FDA-Licensure

The US Food and Drug Administration (FDA) has approved Emergent BioSolutions’ supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, the only FDA-licensed smallpox vaccine, as the company looks to expand its CMO services.

The life sciences company and contract manufacturing organization (CMO) acquired the ACAM2000 business from Sanofi last month.

As part of the transaction, the company also acquired a cGMP live viral bulk manufacturing facility in Canton, MA, and a live viral fill/finish manufacturing facility in Rockville, MD.

The company has also assumed a 10-year Centers for Disease Control and Prevention (CDC) contract originally valued at $425m to establish warm base manufacturing of ACAM2000 in the US and deliver doses of ACAM2000 to the Strategic National Stockpile (SNS).

Completed deliveries are expected in 2019, Sean Kirk, SVP manufacturing operations and CMO business unit head at Emergent BioSolutions related.

“Receiving FDA-licensure of the Canton facility for the upstream portion of the ACAM2000 process meets our current commitment under our existing contract with the CDC to maintain domestic capabilities to manufacture a licensed smallpox vaccine,” Kirk said.

The facility was previously licensed for the downstream portion of the ACAM2000 process, he explained. The most recent licensure “strengthens Emergent’s manufacturing infrastructure and competencies with the addition of bulk viral capability to address public health threats,” Kirk added.

In addition to manufacturing the smallpox vaccine, the Canton facility also serves as a CMO. Kirk said the facility currently has an existing customer.

“Emergent is looking to expand its clientele and offerings, with live viral vaccine manufacturing capabilities, as part of our CMO services and infrastructure,” he added.

Avantor’s Life Sciences Research Centre, New Jersey

Avantor Performance Materials’ new life sciences research center at the New Jersey Center of Excellence campus was opened in Bridgewater, NJ, July 2017.

The new research center will provide gene synthesis services.

The facility will assess pharmaceutical companies in protein purification process development.

The center will provide contract research capabilities, including gene synthesis, protein expression, final formulation, and drug delivery.

The innovation center employs research specialists including chemists and innovation associates to collaborate with biopharmaceutical and pharmaceutical companies to address their drug manufacturing processing objectives.

The facility was leased in June by Avantor from The Garibaldi Group/CORFAC International, a provider of real estate services based in the US.

Incorporating multiple pharmaceutical research platforms, the new center will serve as a rapid response research hub for biopharmaceutical, biologic, and small molecule markets. It is expected to strengthen the company’s innovation capabilities in the pharmaceutical and life-sciences sector, as well as other advanced technologies.

The Bridgewater Innovation Center has a floor area of 26,769ft² and houses a variety of tools required to help pharmaceutical companies with a range of upstream and downstream bioprocesses in the fields of biopharma, analytical science, drug formulation, and drug delivery.

Pharmaceutical research tools available include multiple mass spectrometers, cleanroom facilities, particle size analyzers, and specially constructed bioreactors.

The biopharmaceutical focus areas include facilitation of recombinant protein engineering, mid-scale bioreactor production, protein purification process development, protein expression, custom chromatography resins, host organism expression, and biophysical characterization.

“The new center will serve as a rapid response research hub for biopharmaceutical, biologic, and small molecule markets.”

For analytical science applications, the facility will perform characterization and quantitation of products, spectroscopic data for structure elucidation, microbial and endotoxin tests, profiling of organic impurities and elemental impurities down to 0.5 parts per billion (ppb), surface and particle characterization and identification, and chromatographic characterization of organic impurities.

Drug formulation and delivery activities at Avantor’s innovation center consist of compatibility assessment of active pharmaceutical ingredients (API) or advanced current good manufacturing practice (cGMP) materials, a selection of excipients, control drug release profiles, loading of API in the drug formulation, and prototyping of drug device combinations.

Location details

Avantor’s new life-sciences research center is located within the JR1 building of the New Jersey Center of Excellence life-sciences campus, which is situated on a 110-acre site in Bridgewater Township, New Jersey.

Situated on the US Highway 202/206 in the middle of the Boston-Washington wealth corridor, the site is well connected to major transportation routes. It is surrounded by approximately 3,000 life-sciences companies and is located close to top universities.

The research and development (R&D) campus was launched in April 2013 and is owned and managed by Advance Realty and investment firm CrossHarbor Capital Partners.

Headquartered in Pennsylvania, Avantor Performance Materials is engaged in supplying ultra-high-purity materials and solutions. It was originally founded as J.T.Baker Chemical Company in 1904 and serves roughly 7,900 customers globally with more than 30,000 products.

The company’s solutions are used for the research and production needs across various industries including pharmaceutical, bio materials, medical device, diagnostics, biotechnology, semiconductor, and aerospace.

Avantor’s products are marketed under brands including J.T.Baker®, Puritan Products™, Rankem™, BeneSphera™, POCH™, Macron Fine Chemicals™, CareSil, and NuSil™.

Alewife Research Centre (ARC), Cambridge, MA

The construction of Alewife Research Centre is expected to be completed by summer 2018.

The research center will have a floor space of 223,000ft².

The research center will feature Class-A lab space for life science and pharmaceutical companies. The construction of Alewife Research Centre is expected to be completed by summer 2018.

The Davis Companies (TDC) has developed a new research center in West Cambridge, Massachusetts.

The Alewife Research Centre (ARC) will be located at 35 Cambridge Park Drive. Initiated in February 2017, it will provide laboratory space for life science and pharmaceutical companies.

Scheduled to be completed by mid-2018, the center will enable more companies to contribute to Cambridge’s reputation as a prime center for research and development (R&D).

Alewife Research Centre is being constructed next to Alewife subway station, which is nearby Kendall Square and Harvard Square. The area can be accessed via the MBTA Red Line subway and the Metro West suburbs via Route 2.

The ARC will be situated in a five-story building with a total floor space of 223,000ft². It will feature flexible lab and R&D spaces, an employee lounge, conference and meeting areas, a fitness workout area with showers and lockers, and a bike room with secure storage.

In addition, the building will include a 29,000ft² penthouse to support the tenant roof-top equipment.

A grand lobby with a two-story atrium and gathering spaces will be provided, as well as a service elevator with a capacity of 5,000lb running between the first floor main lobby and the penthouse.

The center will also include a loading dock area with dock levers and feature concrete slab floors with a live load capacity up to 100 per ft². It will have a floor-to-floor height of 11ft on the first floor and 14ft 6in on the other floors. The column bay spacing will be 22ft 6in x 22ft 6in for the first floor and 22ft 6in x 45ft for floors two to five.

The laboratory in the ARC will feature air-handling units with pre-filters, final filters, and chilled and hot water coils. It will have a paring at a ratio of 1.5 spaces per 1,000ft².

Spagnolo Gisness & Associates (SGA) was awarded a contract to design the core, shell, and lobby elements of the research building. McNamara Salvia, VHB, and AHA Consulting Engineers were awarded the structural engineering services contract.

John Moriarty & Associates was awarded the general construction contract for the research facility. Ipswitch Bay Glass (IBG) was contracted to provide curtainwalls and windows for lab building.

Headquartered in Boston, The Davis Companies (TDC) is a real estate investment, development, and management firm. The company has invested more than $4bn in gross asset value through real estate equity, debt and fixed-income securities. It owns real estate portfolio of approximately 12 million ft² across the Eastern US.

GE Healthcare Facility Expansion and Automation

GE Healthcare’s life sciences business has announced a $7m expansion project at its single-use technology manufacturing facility in Westborough, US.

The expanded site will manufacture a range of single-use products, including cell growth bags, based on a newly developed film platform resulting from GE’s strategic alliance with Sealed Air.

With global demand predicted to exceed $3bn by 2020, single-use bioprocessing technologies are playing an increasingly vital role to biologic producers, helping them accelerate capacity expansion and improve productivity to support faster delivery of targeted therapies to patient populations.

GE’s tripling of production-dedicated cleanroom capacity at Westborough and upskilling of more than 300 personnel will enable the business to confidently meet increasing market demand well into the future. In addition, the installation of automated production lines will drive manufacturing efficiency and improved process controls to ensure product quality and consistency.

Developed in collaboration with Sealed Air expressly for biomanufacturing, the new film platform supports exceptional cell growth and application robustness. It will be used in the manufacture of all single-use products at the Westborough site.

In parallel, GE Healthcare Life Sciences has established an enlarged extractables and leachables (E&L) analytical laboratory in Uppsala to support in-depth characterization of the potential impact of E&L compounds across all production processes and future novel single-use technology materials.

General Manager of bioprocess at GE Healthcare’s life sciences business Jan Makela said: “Biopharmaceuticals are complex to make, requiring a dependable, consistent supply of high-quality manufacturing technologies. Single-use is top of mind for our customers, for its ability to flex production to meet market needs.

“The launch of our new film with Sealed Air, the investment in single-use manufacturing in Westborough, and the enlarged E&L capabilities in Sweden confirm our on-going commitment to minimizing risk and assuring security of supply for our customers around the globe.

“Our enhanced position in single-use bioprocessing ensures we are fully prepared to support the industry’s rapid growth.”

Lonza US Plant and Capsugel Integration on Track

Lonza has reaffirmed its full-year sales and earnings forecast and updated its US operations and the integration of Capsugel.

The Swiss life sciences supplier confirmed its 2017 prediction, explaining it expects full year revenue to grow in the high single digits and core EBITDA to be over CHF1bn. In 2016, sales were CHF4.13bn and EBITDA was CHF918m.

Lonza made the comments in a third quarter business update, which also touched on the performance of its segments - Pharma&Biotech and Specialty Ingredients – but did not provide specific revenue and earnings figures.

“Pharma&Biotech continued its momentum in Q3 2017; however, results are compared with an exceptionally strong Q3 2016” according to the firm, adding that its mammalian cell culture based and chemical manufacturing activities had been performance drivers.

Similarly, Lonza said its specialty ingredients business – which makes products for the consumer care, agro, coatings, composites and water treatment industries – “experienced a solid Q3 2017 and performed as expected.”

Lonza has more specific about its manufacturing facilities.

It made clear that “hurricanes in the US Southeast had no material impact on the company's overall performance as operational issues were resolved thanks to the efforts of the managers and employees in these regions.”

It also confirmed the cell and gene therapy facility it is building in Pearland in Houston, Texas is on track to become operational early next year.

Lonza was positive about the future performance of it pharma&biotech business, although again it did not provide figures.

The firm said its new Ibex offering – which has seen it set up dedicated manufacturing capacity for Sanofi and Portola at its facility in Visp, Switzerland – and recent acquisition Capsugel will drive growth.

“In Q3 2017 Capsugel performed in line with expectations with particularly strong results in Consumer Health and Nutrition,” Lonza said.

The University of Chicago Medicine Center for Care and Discovery Adds 203 New beds

Strict infection control and life safety measures were implemented to protect patients on other floors as work proceeded.

Gilbane Building Company and Albert Kahn Associates completed the 204,000-sf buildout of two vacant floors at The University of Chicago Medicine Center for Care and Discovery, adding 203 new beds. Through the use of six-week, look-ahead planning, adherence to Lean construction principles, Gilbane’s own Quality in Construction program, and prefabrication (for headwalls, dialysis boxes, soffits, and ductwork and plumbing assemblies), the team was able to bring the job in two months ahead of schedule.

The trades used on-site monitors to access documents via Bluebeam Studio. UPC coding and BIM 360 also greased the flow of documents. Mockups of various rooms (med-surg, isolation, observation, ICU) gave medical staff the opportunity to offer input on headwall layouts, tile colors, soffit details, and flooring types.

Existing critical exhaust hoods in 24/7 support spaces were found to be inadequately sized for anticipated airflow. One option—to change the motors and sheaves on the exhaust fans—was ruled out as too disruptive to the operations of clinical departments. Instead, the team incorporated readily obtainable new fans into the existing exhaust system so that the original fans could be removed and modified. The solution saved the hospital considerable operational impacts.

Strict infection control risk assessment (ICRA) and interim life safety measures were put in place to meet the demands of eight separate hospital departments. Halfway through the project, the hospital required that all differential pressure monitors have remote monitoring capability. Gilbane engaged Primex Wireless, which tied a web-based reporting system into the hospital’s existing wireless network. This assured that any possible ICRA breach would be addressed instantaneously.

Union construction crews put in 460,000 man-hours on the buildout of two patient floors at the University of Chicago Medicine Center for Care and Discovery without a lost-time incident. Nearly half (48%) of all trades workers were minorities, females, or both.

The project is a Silver Award Winner.

Building Team: Gilbane Building Company (submitting firm CM) Albert Kahn Associates (architect, SE, M/E engineer).

Details: 204,000 sf. Total cost: $98.3 million. Construction time: February 2015 to August 2016.

SCA Pharmaceuticals Opens Production Facility

SCA Pharmaceuticals celebrated the official opening of its 90,000 square foot manufacturing facility on November 27th, 2017. The private pharmaceutical company specializing in providing high quality sterile admixtures and prefilled syringes to hospitals and surgery centers, is located on Rainbow Road in Windsor, CT.

This new facility "helps us prove the economics of production in Connecticut," Gov. Malloy said. "I think this is a great investment for the state [and] as they prove their success here, we're hoping other companies will follow suit."

SCA partners with hospitals as an extension of their own pharmacy to provide safe medications for patients.

"We are very excited. Our new facility is another milestone in the rapid expansion of our company," stated CEO Milton Boyer. "The Connecticut location allows us to tap into the wealth of pharmaceutical talent in the state as well as position our company strategically to service our east coast clients. We appreciate the tremendous support we have received from the State of Connecticut. They have been an invaluable partner."

Located just north of Hartford, this facility features state of the art cGMP cleanrooms and GLP Quality Control Laboratories to meet FDA quality regulations.

The company employs more than 360 employees with over 140 in Connecticut. As the Windsor facility expands over the next 3 years, SCA plans to add over 200 additional full-time positions.

Rutgers and NJII to Set Up Continuous Manufacturing Institute

The New Jersey Innovation Institute and Rutgers University have teamed up to establish an institute to promote the development of continuous manufacturing technologies for drug production.

The New Jersey Continuous Manufacturing Institute (NJCMI) will let pharma firms develop processes and production technologies in collaboration with NJII and Rutgers experts. The center will also house a training center.

Rutgers has a history of working with drug companies on manufacturing.

The organization helped Janssen develop the continuous production method for the HIV treatment Prezista (darunavir). The US Food and Drug Administration (FDA) approved the process in 2016.

Donald H. Sebastian, president of NJII said, “This partnership with Rutgers builds on over a decade of leading edge R&D, and deep faculty expertise that NJCMI can leverage to make available pilot-scale technologies that meet pharmaceutical industry demands for higher production volume, greater efficiency and reduced cost.

He added that, “I expect the center will be a strong magnet attracting all the links of the pharmaceutical value chain to make New Jersey a place of business.”

Continuous manufacturing

Regulators in the US and Europe have been encouraging drug firms to use continuous processes to make the products for the past few years.

Douglas Hausner from Rutgers University-based Centre for Structured Organic Particulate Systems’ (C-SOPS) underlined this point at the Oral Solid Dosage (OSD) Continuous Manufacturing in the Current Regulatory Landscape summit in Malta in June.

He told delegates ““Currently the FDA is strongly advocating for the adoption of the technology.

“They have created specific offices to facilitate this technology, funded work at universities, re-aligned internally, and hired a significant number of engineers all within the last 2-3 years,” adding “In my opinion, they really could not be encouraging this more than they are already.”

Novum Upgrades Clinical Facility in Las Vegas

Novum Pharmaceutical Research Services has completed several upgrades at its Las Vegas, Nevada clinical facility, which opened in 2004.

The Pittsburgh PA-headquartered contract research organization (CRO) previously expanded at its Houston, TX-based facility and its acquisition of a clinic unit in Fargo, ND in 2013.

According to the CRO, the investment includes refurbished study clinics, screening areas, and outpatient returns at the 196-bed, 34,000 square foot facility. Additionally, the company has added a new administrative wing adjacent to the clinic.

The facility was opened in Las Vegas in 2004, since which time Novum has paid more than $20m to residents for clinical trial participation. More than 100 staff members are employed at the location.

“Over the last several years Novum has adapted to the ever-evolving pharma landscape,” said Andrea Atencio, marketing coordinator at Novum Pharmaceutical Research Services.

“With a modernized facility, we can continue to foster a positive environment for our study participants, and ensure successful recruitment for a wide variety of studies.”

The multi-year expansion and upgrade includes a remodel of screening department to “improve efficiency while making the screening process more ‘participant friendly,’” added Atencio.

Quad Technologies Expands After New HQ, Lab Move

Quad Technologies, 3F Gill St, Woburn, MA 01801, a provider of cell and gene therapy bioprocessing reagents, has opened a new, larger headquarters and laboratory in order to expand manufacturing capabilities and offer clients quality reagents for gene-modified cell therapy bioprocesses.

“We are delivering a service and product that no other company currently offers: a unique T-cell activation reagent using patented QuickGel that ensures optimal efficiency and effectiveness. By moving into this larger office and laboratory space with ISO 8 and ISO 7 cleanrooms, we are poised for immediate expansion that benefits the biotechnology industry,” said Quad Technologies co-founder and chief executive officer, Sean Kevlahan.

According to the company, along with the facility expansion, their staff is expected to grow up to 70 percent over the next year.

Fresenius Kabi Expands Pharma Mfg. in North Carolina

Fresenius Kabi unveiled plans to expand its manufacturing operations in Wilson County, NC. The expansion project will bring hundreds of new jobs and more than $100 million in investment to Wilson, where the company currently employs more than 100 people.

Fresenius Kabi’s plans in North Carolina include expansion of its current pharmaceutical production facility in Wilson and the construction of a new manufacturing facility, also in Wilson. Both sites will be dedicated to manufacturing products used in hospitals and clinics throughout the U.S. and Canada. Fresenius Kabi has owned its Wilson site, which specializes in the production of ready-to-administer syringes, since January 2016.

“Our strategy is to produce in the U.S. and to invest in products and operations that meet important customer needs while helping make health care more accessible for patients. We’re pleased to continue this approach at our site in North Carolina,” said Steven Nowicki, senior vice president, global operations, Fresenius Kabi North America.

Fresenius Kabi will add a variety of job functions with this expansion, including production specialists, engineers, scientists and managers.

“Manufacturing represents 22% of our state’s economic output and we’re one of the country’s largest centers for biotechnology,” said North Carolina Commerce Secretary Anthony Copeland. “We congratulate Fresenius Kabi for this decision, which helps North Carolina maintain its leadership in manufacturing and the life sciences.”

Fresenius Kabi recently broke ground on a $250 million expansion at its pharmaceutical manufacturing site in Melrose Park, IL. In total, the company employs more than 3,000 people in the U.S. and its U.S. headquarters is in Lake Zurich, IL.

Recipharm Equips Three More Facilities for U.S. Serialization

Facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, have been equipped to supply serialized products to the U.S.

Recipharm has equipped three more of its facilities with serialization capabilities in line with the U.S. regulatory requirements and today's introduction of the Drug Supply Chain Security Act (DSCSA).

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, have been equipped to supply serialized products to the U.S., bringing the total number of facilities offering serialization capabilities to nine. The company invested €40 million in a company-wide implementation program in 2016.

Staffan Widengren, director of Corporate Projects at Recipharm and head of the global steering committee for Recipharm’s serialization project said, “We’ve taken a very proactive approach to tackling serialization as we understand the critical role that contract manufacturers must play in ensuring continuous supply of vital medicines in key markets. In addition to equipping nine of our sites ahead of the EU deadline and the new U.S. enforcement date, we’ve also introduced a serialization task force to ensure a consistent roll out of our standard solution across all of our facilities.”

“While the FDA has announced a grace period ahead of the DSCSA deadline, companies can still be penalized for failing to meet the mandate by the 27th November 2017. With this in mind, it was important to ensure we could offer serialization capabilities by the original US deadline to avoid potential problems for our customers.”

The next facilities to be equipped will be the company’s facility in Bengaluru, India, which will supply serialized products for the U.S.

Cambrex Adds Large Scale Manufacturing Capacity at Iowa Facility

Cambrex Corporation, a manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), announced the completion of an expansion to its large scale production capacity at its Charles City, Iowa plant. The investment included the installation of 1,000 and 4,000 gallon glass lined reactors in addition to ancillary equipment.

The new reactors have been installed in the 7,500 sq. ft. multi-purpose manufacturing facility which opened at the site in 2016. This brings the cGMP reactor capacity in this newest facility to 23,000 gallons, with the total capacity at the Charles City facility now approximately 107,000 gallons.

“Cambrex continues to experience strong demand for large scale small molecule API manufacturing,” commented Shawn Cavanagh, COO of Cambrex. He added, “Charles City is a key strategic site within our global manufacturing network and this additional capacity enables us to take on new customer projects, as well as offering the flexibility for projects to be transferred in from other Cambrex sites as needed.”

This latest expansion follows the announcement of the construction of a $24M, 4,500 sq. ft. highly potent API (HPAPI) manufacturing facility at the Charles City facility, which is due to open in 2019.

Cambrex’s Charles City, Iowa facility is located on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of only a limited number authorized by the U.S. DEA to import narcotic raw materials at commercial scale.

Lilly Announces Investment in Diabetes Manufacturing In Indianapolis

Eli Lilly and Company announced plans to invest $72 million in an insulin manufacturing project at one of its Indianapolis facilities. The investment will be used to replace an existing insulin vial filling line and allow Lilly to meet growing demand for its insulins — including Humalog (insulin lispro) and Humulin (human insulin) — while upgrading to state-of-the-art technology and preparing for its insulin pipeline.

"This new project is part of $850 million in anticipated U.S. capital investments which Lilly announced in March of this year. It reinforces our ongoing commitment to the U.S. market and in Indianapolis specifically," said David A. Ricks, Lilly's chairman and chief executive officer. "Our company is poised for continued growth, and diabetes represents one of our key therapeutic areas. Investments such as this are vital to ensuring we continue meeting the needs of people who use our medicines."

Insulin is a core element of Lilly's diabetes business, and its U.S. manufacturing operations are an integral part of insulin supply. Lilly has a nine-decade legacy of researching and producing insulin, and the Indianapolis manufacturing facility plays a significant role in the process. Replacing the existing line will allow for the installation of a new insulin vial filling line that aligns with modern design expectations and utilizes state-of-the-art technology.

"As technology and science continually advance, it is important that our manufacturing facilities are recapitalized and modernized regularly to ensure we can continue to provide a reliable supply of safe and high-quality medicines to people around the world," said Maria Crowe, president of Lilly Global Manufacturing Operations.

Lilly has invested more than $1.2 billion since 2012 to boost its U.S. diabetes product manufacturing operations. More broadly, the company has invested $5 billion in its U.S. facilities over the last decade. Continued U.S. investment can be expected, particularly if favorable tax reform measures are enacted.

"The current U.S. tax reform proposal, developed by the White House and congressional Republicans, would cut the corporate tax rate to 20 percent, put in place a territorial system, and maintain tax credits for research and development. If enacted, these proposed reforms would go a long way toward leveling the playing field for American workers and businesses competing against their foreign peers," said Ricks.

CordenPharma Acquires API Manufacturing Site, Colorado US

Brian McCudden, President and CEO of Corden Pharma and talked about CordenPharma’s recent acquisition of a high containment API manufacturing site in Colorado, US.

CordenPharma recently acquired a highly potent API site in Boulder, US, which was previously owned by Pfizer. The new facility will be renamed CordenPharma Boulder.

The site will add significant capacity to CordenPharma, adding five GMP highly potent manufacturing process trains.

The site will also offer considerable additional process and analytical development capacity and around 110 staff will join the CordenPharma team.

CordenPharma started to discuss the acquisition with Pfizer, a year ago and the agreement to acquire the site was reached in October 2017.

McCudden commented that the acquisition represented a good strategic fit for CordenPharma and will allow the company to significantly expand its capacity and capability in manufacturing highly potent APIs, also enhancing its efficiency.

McCudden said: “CordenPharma Boulder has demonstrated capability in developing and manufacturing highly potent APIs with supply to all regulated markets, with a specialty capability for normal and reverse-phase GMP chromatography.”

The site has an exceptional highly potent quality control lab, containing very advanced analytical tools and the ability to ensure containment at a very low level (< 10 ng/m3).

McCudden stated that the focus for 2018 for the company, will be integrating CordenPharma Boulder into the network of cGMP CordenPharma facilities across Europe and the US, as quickly as possible, so the company can begin providing immediate value to its customer base.

McCudden believes the acquisition will allow for rapid, reliable and high quality services when outsourcing with CordenPharma for highly potent APIs, which will facilitate faster and more affordable access to innovative medicines to the health care system.

CordenPharma / Pfizer Details

CordenPharma, a contract development and manufacturing organization (CDMO), has entered into definite agreements to acquire the former Hospira Boulder (Colorado) high containment API site from Pfizer, Inc. The closing of the transaction is anticipated to occur in November 2017.

Located in proximity to the existing CordenPharma Colorado facility, Hospira Boulder produces active pharmaceutical ingredients (APIs) and intermediate products with specialized capabilities in small to medium scale highly potent and cytotoxic API manufacturing. Previously owned by Pfizer/Hospira, the 54,000 square foot facility with more than 100 employees has API production capabilities ranging from very small scale up to 3,000 liters.

CordenPharma will also enter into a multi-year supply arrangement with Pfizer, with the expectation that the agreement will help defray costs associated with running the site for the next few years while it adds new client work into the facility.

CordenPharma represents the global pharmaceutical manufacturing and service platform of International Chemical Investors Group (ICIG). “The acquisition will augment CordenPharma’s highly potent and oncology platform and integrated supply service offering in association with its drug product manufacturing expertise in the area of solid dosage and sterile injectables in CordenPharma Plankstadt (DE) and CordenPharma Latina (IT) respectively,” said Achim Riemann, managing director, ICIG.

The company said this acquisition represents a further key milestone in CordenPharma’s targeted acquisition strategy implemented over the last several years. As part of this strategy, CordenPharma continuously acquired API and drug product manufacturing capabilities over the last decade, including peptide and small molecules API plants as well as highly potent drug product sites in Italy, Germany and Belgium.

In addition, CordenPharma Colorado completed the construction of a new API process bay in 2016, equipped to handle highly potent compounds up to OEB Level 4, to accommodate increasing customer demand in this segment. “With this new acquisition, CordenPharma is uniquely positioned to provide pharma customers with the most comprehensive highly potent and oncology service in the industry, spanning the entire API and drug product supply chain at any stage from development to commercialization,” said Michael Quirmbach, vice president, global marketing and sales, CordenPharma International.

Hospira Boulder, to be renamed CordenPharma Boulder, will be managed by Brian McCudden, the current chief executive officer of CordenPharma Colorado who was responsible for Hospira Boulder during one of his previous assignments as an employee of Hospira.

Gritstone Opens US Site to Make Personalized Cancer Meds

Gritstone Oncology has opened a manufacturing plant in California to make personalized cancer immunotherapies.

The firm said it will use the 43,000 square-foot facility – which houses good manufacturing practice (GMP) cleanrooms – to identify neoantigens for certain cancer indications.

“The company’s initial goal is to leverage deep learning to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung and gastric cancer,” the firm said in a statement.

Gritstone will also use its antigen discovery platform to identify targets for shared antigen immunotherapies, it added.

“We plan to initially focus on tumor types with the highest mutational burden including, but not limited to, non-small cell lung, gastric and bladder cancers,” the firm said.

Gritstone is focusing on a series of tumor-specific neoantigens which it believes are a new class of immune targets for advancing cancer immunotherapy. After identifying the appropriate anti-tumor immune response neoantigens, the firm places them in its proprietary delivery vehicle and administers them to a patient to generate tumor-specific T-cell responses against the neoantigen to destroy the tumor.

Gritstone expects the first candidate to be manufactured at the facility for clinical trials by mid-next year.

The company said it would “ramp up” its headcount at the facility over the next six months.

Gritstone is currently advertising for positions in quality assurance, regulatory affairs, and manufacturing at the Pleasanton, California-based site.

Alcami’s Analytical Testing Facility, Missouri

Alcami has relocated its existing analytical testing facility in Missouri to the Cortex Innovation Center in Central West End, St. Louis.

The old facility has been operational since 1992, with approximately 80 employees. The workforce is expected to reach 125 by 2021.

Alcami announced an investment of $10.7m for the facility’s relocation in February 2017, and construction began in September. Located at 4260 Forest Park Avenue, the new site provides easy access to the company’s domestic and international business partners. It also offers 30% more laboratory space and 14% more stability space.

The new laboratory is intended to perform microbial and chemical analysis, covering raw material and antibiotic testing, drug product release, stability testing, water testing, in-process evaluations, and environmental monitoring for both sterile and non-sterile drugs.

Featuring advanced equipment, the facility will strengthen Alcami’s ability to expand customized services and client-centric innovations for pharmaceutical and biotechnology markets.

In addition to the existing equipment, a wide range of technologies have been installed at Alcami’s new state-of-the-art facility to support development and analytical testing for the drug manufacturing and packaging sectors.

The site incorporates a lab for handling photo-sensitive materials, a low-humidity room for testing and handling hygroscopic materials, pharmaceutical isolators for sterility testing, and ultra performance liquid chromatography (UPLC) equipment for the analysis of drugs.

“The facility will strengthen Alcami’s ability to expand customized services and client-centric innovations for pharmaceutical and biotechnology markets.”

The laboratory is also equipped with inductively coupled plasma mass spectrometry (ICP-MS) analytical equipment, which allows pharmaceutical companies in their transitions from USP wet chemistry heavy metals.

Alcami’s new analytical testing laboratory occupies the top two floors of a 59,976 sq. ft. (5,574m²) three-story building in the Cortex Innovation Community complex. This

8,708,832 sq. ft.) 809,371m² innovation center promotes bioscience and technology research and development (R&D).

The second floor of the building accommodates a conference room, a large multi-purpose room, 497.5m² of cubicles and office spaces, and a reception area.

The third floor houses sample storage room, a locker room, separate laboratories for chemical and microbiological analysis, lab supervisors, glassware wash and storage areas, and a cleanroom with specialty laboratory areas.

Alcami plans to replace the cleanroom testing equipment with sterility test isolators to reduce the laboratory space.

Headquartered in North Carolina, US, Alcami is engaged in providing customizable services to pharmaceutical and biotechnology companies. With an employee base of 1,000, the company operates seven facilities worldwide.

Alcami offers various technologies for applications including analytical development and testing services, active pharmaceutical ingredients (API) development and manufacturing, formulation development, packaging, solid-state chemistry, and clinical and commercial finished dosage form manufacturing.

Alcami owns two other analytical testing centers in the US, including one in Wilmington, North Carolina, and the other at Edison Township in New Jersey.

Juno Therapeutics Headquarters and R&D Facility, Washington

Juno Therapeutics has inaugurated a new research and development (R&D) facility with an investment of $232m.

The biopharmaceutical company is engaged in developing innovative cellular immunotherapy drugs for the treatment of cancer.

Covering 90,000ft², the new headquarters is located in a 375,000ft² lab and office building situated at 400 Dexter Avenue North, South Lake Union, and Seattle.

Juno filed an application with the US Securities and Exchange Commission to lease the top four floors of the 12-storey building for a period of seven years beginning February 2017. The agreement includes three five-year options, which allow Juno to lease three more floors covering an area of 71,000ft².

The company will pay a base rent of $48 per square foot for the first year and will increase it by up to 2.5% a year.

Opened in September, the facility will allow researchers and scientists to collaborate on the R&D of immunotherapy treatments and will contribute to the long-term growth of the biotechnology sector in Seattle.

The state-of-the-art biotech facility features research laboratories and office spaces to accommodate the company’s researchers, scientists, technical professionals, and administrative staff, who were previously located at three separate sites.

The building features 269,700ft² of laboratory and office space, a 13,800ft² retail area on the first floor, and a 128,000ft² carpark with 457 below-grade parking spaces. The third level is dedicated to a complete mechanical room to serve the needs of the occupants.

The building is constructed with steel frames, while the exterior comprises glass and masonry structures. Open space is provided towards south and rooftop deck.

Design work on the on Juno Therapeutics’ headquarters and R&D facility was completed in February 2015. A ground-breaking ceremony was held in June 2015 and construction was commenced in January 2016.

Salvaged site materials were used in the construction, helping to gain Leadership in Energy and Environmental Design (LEED) Gold environmental standard certification.

The life sciences building at 400 Dexter was designed by architect CollinsWoerman and is owned by Alexandria Real Estate Equities.

BNBuilders was contacted by Alexandria Real Estate Equities to carry out the construction. Costigan Integrated provided design and construction management, owner’s representation, and cost estimation services under a subcontract from Alexandria Real Estate Equities.

PSF Mechanical was selected as the design-build mechanical contractor for the building.

Juno Therapeutics awarded a contract worth $43m to Skanska in October 2016 to complete the 155,000ft², seven-floor tenant improvement works at the building.

Other contractors involved with the project are Weisman Design Group, Hart Crowser, and KPFF Consulting Engineers.

Established in 2013, Juno Therapeutics aims to develop new product candidates using its cell-based platform to treat a wide range of cancers and other human diseases.

With more than 500 employees, the company develops cancer immunotherapies using chimeric antigen receptor (CAR) and high-affinity T cell receptor (TCR) technologies to genetically engineer patient’s own immune cells to treat cancer.

The company is currently developing multiple cell-based product candidates for the treatment of B-cell malignancies, solid tumors, and myeloma.

Cold Spring Harbor Laboratory Center for Therapeutics Research, New York

In October, Cold Spring Harbor Laboratory (CSHL) broke ground on its new Center for Therapeutics Research (CTR) facility in New York, US.

To be built with a $75m investment, the laboratory will support CSHL in research activities for developing novel therapeutics for genetic diseases.

The new research facility will generate 30 new scientific jobs upon completion in 2018. The project will generate 99 full-time positions in construction and 58 full-time-equivalent indirect jobs.

Details of the CSHL Center for Therapeutics Research project

The CTR project will renovate the existing Demerec Laboratory, which was built in 1953. This laboratory is already home to four of the eight CSHL Nobel Prize winners.

Spread over a 26,000ft² area, the building will be equipped with state-of-the-art facilities and equipment.

Financing

The New York State is providing a $25m construction and equipment fund for the project, which will be used to modernize the Demerec Laboratory and house the CTR.

The funding is being provided under a state initiative, which aims to create a research corridor on Long Island.

The National Institute of Health is providing the remaining $50m needed to develop the project. This funding will cover recruitment, lab start-up costs, and CTR operations.

Research activities and benefits of CTR

The CTR will establish partnerships with academic institutions such as Stony Brook University, the Brookhaven National Laboratory, and Northwell Health to carry out both lab-based and clinical research.

It will enable newly developed compounds to be refined by world-leading chemists to develop next-generation therapies. This research will form a basis for collaboration with private foundations and pharmaceutical companies, while advancing the development of new drugs.

In addition, the center will support ongoing research activities aimed to develop therapeutics for breast cancer, leukemia, autism, obesity, diabetes, and lung cancer. The primary goal of such research activities will include the development of advanced drug compounds targeting underlying biological pathways.

Development of the new facility will further, drive the local economy through the creation of additional jobs, spin-offs and new investment.

Details of Cold Spring Harbor Laboratory

Cold Spring Harbor Laboratory is a private non-profit organization established in 1890. The research laboratory focuses on a range of programs in the areas cancer, neuroscience, plant biology, and quantitative biology.

The institute has more than 1,100 employees including scientists and technicians. It has an education arm, which conducts programs for high school students and teachers, as well as includes a publishing house and a graduate school.

Apart from the new CTR, the institute also operates the CSHL Cancer Center, which is a basic research facility conducting research on a broad range of cancers. Other facilities include Genome Research Center, Uplands Farm Field Research Center, the Banbury Center, and the Dolan DNA Learning Center.

Boehringer Ingelheim’s Fremont Manufacturing Facility Expansion, California

Boehringer Ingelheim has broken ground on a $217m expansion of its Fremont facility in California, US.

The facility manufactures monoclonal antibody therapies and other proteins based on mammalian cell culture technology in the areas of immunology, rheumatology, and oncology.

The expansion is expected to increase the facility’s manufacturing capacity by one-third upon completion by 2018. It will generate 300 new high-wage and highly-skilled jobs in the region.

The Fermont facility is located in the San Francisco Bay area, which is one of the world’s biggest biotechnology clusters.

Boehringer Ingelheim invests 20% of its net sales into research and development (R&D). Its latest investment in the Fremont facility will further strengthen the Bay area’s research activities and enable patients to access high-quality medicines.

The expansion project will add a 12,000l bioreactor and a 3,000l media feed tank to the Fremont facility. State-of-the-art equipment and gene expression biotechnology will be used to produce both biologics and biosimilars at the plant.

The products produced at the facility will be used for manufacturing other pharmaceutical products by various biopharmaceutical manufacturers.

Production of biologics and biosimilars will begin by growing cells for a specified period of time. The cells are then fermented in a large container and specific media is added to enable the cells to grow and secrete the desired protein or antibody.

The cells are purified using filters and resins, which remove various impurities including viruses, cell debris, and other undesirable elements. The purification process provides a product suitable for human use.

The State Treasurer’s Office has provided two tax credits worth $25.5m in total for the project.

The Fremont facility was acquired by Boehringer Ingelheim from Amgen in January 2011. Originally spanning 100,000ft², the facility has eventually been expanded to 300,000ft².

The design of the facility features extensive use of glass, which provides visibility into production suites and symbolizes open and transparent collaboration between the customer and the company.

The facility can produce multiple products simultaneously as each production line is a separate operation having its own purification facilities. It also includes development labs, QC labs and a good manufacturing practice (GMP) compliant pilot plant.

The plant is equipped with development-stage stainless steel bioreactors in 2l and 5l capacities and pilot-scale stainless steel bioreactors in 30l and 100l capacities. Single-use bioreactors in non-GMP and GMP scales are also available in 100l, 500l, and 1,000l capacities.

GMP-scale stainless steel bioreactors are available in 2,000l and 15,000l capacities. In addition, the facility is equipped with cell banking, cell culture, harvest, and purification facilities, column and membrane chromatography technologies and filtration technologies.

Boehringer Ingelheim’s Fremont facility provides services such as evaluation and optimization of cell culture processes and can also develop disposable cell cultures. Comparability and stability studies and GMP cell banking can also be carried out at the facility.

The plant is equipped with small-scale to commercial-scale production capabilities. Products in the clinical-stage or hundreds of kilograms a year of approved products can be produced at the plant.

The facility also has fill/finish, packaging and medical device assembly capabilities.

Bluebird Buys NC Manufacturing Site

Bluebird bio has acquired a North Carolina manufacturing facility to produce lentiviral vectors for its cell and gene therapy candidates.

The acquisition sees bluebird bio add a 125,000 square foot manufacturing facility in Durham, North Carolina in its pursuit to bring production of its T-cell and gene therapy candidates in-house.

“The North Carolina manufacturing site will complement our important external manufacturing partnerships,”chief manufacturing and technology officer Derek Adams said in a statement.

“By simultaneously establishing multiple lentiviral vector manufacturing partnerships and pursuing in-house manufacturing, bluebird is uniquely positioned to adeptly, robustly, and reliably provide our current gene and cell therapy products in development, as well as future pipeline therapies to patients in need.”

The Masachusetts-headquartered firm has a number of gene therapies in clinical stage development including Lenti-D for the treatment of cerebral adrenoleukodystrophy, and LentiGlobin BB305 for the treatment of transfusion-dependent β-thalassemia.

Currently the firm has been relying on third-party manufacturers. Specifically: Brammer Bio, Novasep, and MilliporeSigma for the production of lentiviral vector across all its programs, and Lonza and apceth Biopharma for the production of Lenti-D and LentiGlobin drug product.

The in-house site will not disrupt these multi-year contracts, the firm said, but rather increase its manufacturing footprint as it advances multiple products into late-stage development and potential commercial launch.

“Expanding in-house expertise, creating an extensive manufacturing network, and increasing manufacturing capacity ensures that bluebird can deliver on the promise of these product candidates,”the firm said.

Brammer Bio Late-Stage Trials Raise Capacity Concerns, Spurs Investment

Brammer Bio has completed renovations at its gene therapy manufacturing facility in Cambridge, MA amid industrywide capacity concerns as more biologics enter late-stage clinical trials.

The cell and gene therapy contract development and manufacturing organization (CDMO) has completed renovations at its late-stage clinical capacity and commercial-ready cGMP manufacturing site for gene therapy products in Cambridge, MA.

“There is an industry-wide concern regarding the capacity for producing these highly complex biologics,” said Mark Bamforth, president and CEO of Brammer Bio.

In order to meet this demand, Brammer Bio invested more than $50m in 2017 to increase its capacity, he said.

“Brammer has supported early clinical stage products for over a decade at its Florida facility and continues to experience strong demand for process and analytical development and clinical supply,” Bamforth added, noting that some of these products are now maturing to late-stage clinical trials.

“These products, and new ones coming to Brammer from clients with late-stage manufacturing needs, require scale-up, process robustness, and characterization studies to support filing for product licensure,” he explained.

Now, with renovations completed at its Cambridge, MA facility, Bamforth said the company can support clients in Phase III, through licensure, and with commercial supply, including process scale up and qualification for drug substance and drug product production.

The renovation involved “a complete rebuild” of cleanroom areas to support the standards needed for vector product manufacturing and the segregation of products, Bamforth explained. The utility generation systems were also repurposed with new distribution systems.

Additionally, single-use process equipment was installed for manufacturing of viral vector drug substance and drug product filling for gene therapy products, Bamforth added. Quality control laboratories and technical support laboratories were also installed.

The 66,000 square-foot facility, acquired from Biogen in January 2017, was previously licensed to manufacture four commercial protein therapeutic products. In conjunction with the facility purchase, Brammer also took on a team of 100 employees, which it has since expanded to 150.

The most recent investment follows in a series of announcements.

In 2016 at BIO International, Bamforth said“we are now entering the year of personalized medicine,” as the company announced a new 50,000 square foot cell and gene therapy manufacturing facility in Lexington, MA.

In the year following, the company invested in a commercial-scale gene therapy manufacturing facilityin Cambridge, MA and doubled its early phase clinical manufacturing capacityat its site in Alachua, FL.

Orchard Expands Californian In-House Gene Therapy Capabilities

Orchard Therapeutics has opened a second facility in California to support the manufacture of its ex-vivo lentiviral gene therapy products.

The opening of a second facility at its site in Menlo Park, California will support Orchard’s pipeline, which includes lead candidate OTL-101, a gene therapy for adenosine deaminase severe combined immunodeficiency (ADA-SCID) – a rare inherited disorder of the immune system.

“As an extension of our current Foster City operation, the Menlo Park facility will house the cell therapy and analytical operations groups developing and validating the processes and controls used for manufacture of our ex vivo lentiviral gene therapy products,” spokesperson Sylvie Blanchier stated.

The firm’s tech platform revolves around genetically correcting stem cells taken from the patient using a lentiviral vector carrying a functioning copy of the faulty gene, and then transplanting them back into the body by IV infusion.

In November last year, Orchard inked an alliance with gene and cell therapy firm Oxford BioMedica for process development services and cGMP-grade manufacture of lentiviral vectors.

The firm has also contracted PharmaCell – since acquired by Lonza – in January, and fellow contract manufacturing organization (CMO) PCT Cell Therapy Services in July to carry out manufacturing services for OTL-101 and its other gene therapy candidates.

The expansion of its in-house capabilities will not affect Orchard’s ongoing partnerships with these firms, Blanchier confirmed.

“Our CMO partnerships with PCT Cell Therapy Services and Lonza – for drug product manufacturing – and Oxford Biomedica continue under the existing collaboration agreements.”

Orchard hopes to file a Biological License Applicationfor OTL-101 with the US Food and Drug Administration (FDA) in 2018.

New Florida Hospital for Women at Orlando Campus

Growing research demonstrates that patients recover faster and better from illness or surgery in settings that offer abundant daylight and views to the outdoors.

The new award-winning Florida Hospital for Women, Orlando Campus will eventually have 336 licensed beds in the patient bed tower and represents the pinnacle of women’s healthcare while overlooking calming and lushly landscaped gardens and grounds while serving women’s health needs through all stages of their lives.

The new bed tower is flowing, elegant, and playful, seemingly rising from an adjacent pool of water at the center of the health village campus—in welcome contrast to angular and conventional construction of the main hospital tower. For those seeking healing and respite, it will be distinguished as a beacon of hope, light, and wellness.

Goals

Growing research demonstrates that patients recover faster and better from illness or surgery in settings that offer abundant daylight and views to the outdoors. Architectural design that provides these features is proven to correlate with reduced medication intake and shorter recovery periods, thereby improving patient outcomes and quickening room turnaround times.

The design team, including HKS Architects and interior design firm Stantec, took this knowledge into consideration when selecting window treatments for the patient rooms and common areas.

Solutions

MechoSystems provided motorized DoubleShades® for patient rooms, along with ThermoVeil® shadecloth for advanced solar heat control and Classic Blackout shadecloth for improved rest, privacy, and room-darkening at any time of day. The system can be easily operated by patients with a pillow switch, similar to adjusting the overhead light or TV volume, or calling for assistance. Wall controls in the family zone allow visitors and staff the ability to adjust the motorized shades. MechoSystems also has the capability for providing control of motorized shades via an automated shading control system that allows for staff override at the nurse’s stations or connection to building automation systems. Automation ensures effective daylighting integration, management of glare, and control of solar radiation via predictive modeling and real-time sky monitoring.

Common areas of the Florida Hospital for Women at Orlando Campus use manual solar shades to provide ample natural light while minimizing heat gain, thereby ensuring visitor comfort while reducing energy costs in the waiting areas/lounges.

Results

For this project, Window Interiors, a MechoSystems dealer and associate, won Florida’s regional Associated Builders and Contractors Eagle Award in 2016, also a testament to the work of the architects, designers, installers, and MechoSystems in the successful window treatments used at the Florida Hospital for Women at Orlando Campus.

MechoSystems’ 10-year non-depreciating warranty—along with the antimicrobial shadecloth’s 20-year lifespan—will ensure the Florida Hospital for Women in Orlando will serve patients, promote healing solutions, and gain energy savings far into the future.

Rest of World

Stiplastics Opens a New Factory in Saint-Marcellin, France

Stiplastics is a specialist designer, developer and producer of plastic solutions for the pharmaceutical, healthcare and e-health sectors.

A total of €8.6 million has been invested in this site, enabling the company to pool all its operations and meet its customers' various requirements, especially in terms of the increasing demand for connected health.

The 107,600 sq. ft. (10,000 m2) site in Saint-Marcellin in the French department of Isère includes the company's administrative headquarters, design office and production workshops (injection, assembly, storage) where manufacturing is based on lean management principles.

The site includes:

A dedicated injection workshop with 23 electric injection molding machines weighing

30 to 300 T.

An automated assembly area (camera inspections, robot stations) and storage area

A test center with a dedicated injection molding machine

In response to the rise of e-health, Stiplastics has also set up a new electronics workshop equipped with special tools including test benches. This 11,614 sq. ft. (150 m2) space is protected from ESD (Electro Static Discharge) by a controlled environment essential for handling electronic components.

The increasing prominence of connected care has also prompted the company to set up IoC [Internet of Care]. This unit is dedicated to designing, developing and producing e-health medical devices, with the main aim of significantly improving treatment and patient comfort.

Stiplastics is therefore now able to design and manufacture medical devices, add electronic components, test them and then pack them ready-to-use for delivery.

”In 2013, we drew up a development plan forecasting almost doubled sales in 5 years. This investment will enable us to meet our targets since we are still on track for turnover of €23 million by the end of 2018,” said Jérôme Empereur, CEO of Stiplastics.

Recipharm Equips Three More Facilities for U.S. Serialization

Facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, have been equipped to supply serialized products to the U.S.

The next facilities to be equipped will be the company’s facility in Bengaluru, India, which will supply serialized products for the U.S.

Imaging Centre of Excellence, University of Glasgow, Scotland

The Imaging Centre of Excellence (ICE) at the Queen Elizabeth University Hospital (QEUH) in Scotland was inaugurated in March 2017.

The facility was developed by NHS Greater Glasgow and Clyde (NHSGGC) and the University of Glasgow at a cost of £32m ($39.85m). It has supporting research facilities for clinical and academic experts to carry out research for precision medicine.

The research facility is expected to provide employment opportunities to 396 people, and contribute £88m ($1.09bn) to the local economy.

Details of the Imaging Centre of Excellence

The ICE at QEUH is a five-story building with a total floor space of 11,000ft². It added another 11,000ft² to the existing clinical innovation zone (CIZ) of the university, located at Queen Elizabeth Teaching and Learning Centre.

The ground floor of the facility houses a 17.5t 7 Tesla clinical magnetic resonance imaging (MRI) scanner, which helps academic imaging specialists carry out research. It gives researchers an opportunity to know more about brain conditions including stroke, dementia, brain tumors, Parkinson’s, epilepsy, and multiple sclerosis.

The facility also includes 320 slice / large detector computed tomography (CT) scanners. Level one of the ICE building accommodates four neurosurgery theatres.

The ICE was constructed to achieve ‘very good’ rating using the Building Research Establishment Environmental Assessment Method (BREEAM).

The ICE building is connected to the Stratified Medicine Scotland Innovation Centre (SMS-IC), the UK Catapult for precision medicine, and clinical research facilities for better clinical collaboration.

The facility offers sophisticated research laboratories for clinical academics, medical physicists, engineers, and neuroscientists. It also provides direct employment opportunities for 260 people, including 40 clinical staff, 100 researchers, and a further 120 industry positions.

The ground-breaking ceremony for construction was held in October 2015. The project involved dismantling the former clinical building.

“The facility offers sophisticated research laboratories for clinical academics, medical physicists, engineers, and neuroscientists.”

The topping out ceremony of the building took place in July 2016, while the Tesla MRI scanner was delivered in November 2016.

BMJ Architects was selected to design the ICE building, while BAM Construction was hired as construction contractor for the facility.

SCS Construction was sub-contracted to complete the interior fitting of the building and BHC was selected as the structural steel work contractor.

Currie & Brown Manager acted as the project manager, Building 3 as cost consultant, and New Acoustics as acoustician.

Arup and Arup Fire provided civil and structural services respectively, while Hulley & Kirkwood offered building services.

Midland Lead supplied radiation shielding including lead-lined plasterboard and plywood pattress panels for the facility.

CMS Window Systems was contracted to provide glazing and facade for the facility in April 2017.

The imaging facility was completed with an investment of £32m ($39.85m). The UK Government contributed £16m ($19.92m) for construction.

The installed MRI and CT scanners at the facility were installed with a contribution of £10m ($12.45m) from the UK Research Partnership Investment Fund (UKRPIF), £3.5m ($4.35m) from the Sackler Trust and the Dr Mortimer and Theresa Sackler Foundation, £2.3m ($2.86m) from the European Regional Development Funding (ERDF), and £800,000 ($996,272) from the Wolfson Foundation.

Pall Partners Swiss Training Firm For Continuous Biomanufacturing

Pall Life Sciences will equip a training facility in Fribourg, Switzerland., with its continuous bioprocessing equipment.

Located in Fribourg, Switzerland, the BioFactory Competence Center (BCC) offers theoretical and practical training to biomanufacturers, and is set to launch a series of in-house courses next year focused on advances in continuous bioprocessing.

As such, the firm has selected Pall Life Sciences Cadence platform technologies for the hands-on training, as well as to equip a planned dedicated continuous bioprocessing training facility at the site.

“Pall and the BCC both have operations in Fribourg, and consequently, Pall have had a close collaboration since BCC commenced operations in January 2016,” said Peter Levison, senior marketing director of downstream processing at Pall.

“We also share a common vision related to the importance of comprehensive technical training with a strong practical element that illustrates ‘real’ issues in bioprocessing.”

Continuous biomanufacturing

Pall is not the exclusive supplier of bioprocessing technologies, but the BCC will use its range of continuous production tech – including Pall’s Cadence Acoustic Separator for continuous clarification and separation, the Cadence BioSMB PD system for multi-column chromatography, and the Cadence Inline Concentrator for continuous concentration at various process steps – at the center.

According to Levison, Pall is at the forefront of continuous bioprocessing through the development of its portfolio of continuous technologies, which covers all steps from harvest to formulation of the bulk mAb.

“Pall believes continuous bioprocessing philosophy will make a significant impact on the future of bioprocessing, so [is] investing in continuous ready technology and supporting associated education around continuous bioprocessing.”

He added: “Pall is looking to help facilitate the evolution of this paradigm. We certainly aim to keep ahead, but as you know this market does not stand still.”

Fishers Laundry Group Acquired by Canada-based K-Bro

The commercial laundry and textile rental provider in Scotland and the North East of England, has agreed to a deal with K-Bro Linen of Canada.

K-Bro Linen Inc. has agreed to acquire 100% of Fishers’ parent company, Fishers Topco Ltd, from its major shareholder, the private equity firm, Caird Capital, and a number of individual minority shareholders for a consideration of £35 million, in addition to an earn-out consideration based upon full year EBITDA. The transaction is expected to complete on 27th November, 2017.

Michael Jones, Managing Director of Fishers, said: “This is great news for Fishers as it brings a new owner for the business with the resources, experience and ambition to take Fishers to the next level. I am confident that, as part of K-Bro, Fishers will thrive and I look forward to drawing on K-Bro’s experience, particularly in the Canadian healthcare sector, to help us grow the Fishers business further here in the UK.”

Linda McCurdy, President and Chief Executive Officer of K-Bro, said: "We are very excited to add the Fishers platform as K-Bro's first acquisition outside of Canada. The UK linen hospitality market is mature, but still highly fragmented, and we expect to leverage Fishers' leading market position, experienced local management team, entrenched customer relationships and proven track record of stable and profitable operations to take advantage of the significant organic growth and consolidation opportunities available to us, similar to what we have achieved in Canada."

K-Bro plans to use its acquisition of Fishers as a platform from which to build its presence in the UK commercial laundry and textile rental market by taking advantage of organic growth and consolidation opportunities.

Fishers will operate as a standalone, wholly owned subsidiary of K-Bro and will retain its headquarters in Cupar, Fife. The Fishers management team will remain with the business and there are no headcount reductions planned as part of the acquisition.

Fishers employs 800 staff across seven sites in Scotland and the North East of England and provides commercial laundry and textile rental services principally to the hospitality sector but also to a range of other sectors including healthcare, pharmaceutical and manufacturing.

Fishers has also developed the innovative ZHEN luxury linen range incorporating radio frequency identification (RFID) tags in the linen, allowing customers and Fishers to track linen effectively, enabling operational and stock control efficiencies.

Headquartered in Edmonton, Alberta, K-Bro is listed on the Toronto Stock Exchange and employs over 1,600 people in nine processing facilities and two distribution centers in 10 cities across Canada. 75% of its business comes from long-term healthcare contracts with the remainder of its revenues coming from the hotel sector and other commercial contracts.

Quotient Sciences Expands UK Footprint Acquires UK-based CDMO Pharmaterials

Drug development services organization Quotient Sciences has acquired Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, UK. The acquisition strengthens and expands Quotient’s formulation and manufacturing services footprint in the UK, and further supports the growth of Quotient’s Translational Pharmaceutics platform, following the acquisitions of SeaView Research and QS Pharma in February 2017.

Pharmaterials has a significant track record in supporting the development of small molecule drug products for oral and inhaled delivery. The company’s portfolio of services spans the characterization and optimization of drug substance physical forms, the development of preclinical and clinical formulations, through to clinical trial manufacturing and subsequent global drug product supply. The business was founded in 2000 and is located in a 48,000-square feet facility that houses 13 GMP manufacturing suites, with space for future expansion.

“The acquisition of Pharmaterials strengthens Quotient’s service portfolio from preclinical formulation development through to commercial manufacturing,” said Mark Egerton, chief executive officer, Quotient Sciences. “The addition expands Quotient’s global CDMO services with added capacity and capabilities to better serve our clients’ needs.”

Eurofins Amatsigroup Doubles Clinical Trial Supply Capacity

Eurofins Amatsigroup, a European CDMO, has doubled its clinical trial supply activities and capacities after major investments in its Saint Gely du Fesc, site, which specializes in packaging and logistics for human and veterinary drug products.

The new building has been designed to expedite the flow of drug products from reception to the distribution area, particularly for those sensitive to temperature. The facility will house seven packaging suites, and two secondary packaging rooms will be connected to a temperature-controlled storage area (2-8°C) to allow products to remain at the appropriate temperature during all processes. This enables products to be directly picked up in the cold chamber for shipment.

With these new capacities, the Saint Gely du Fesc building will be able to manage the demand for primary packaging. Their capabilities offered include blistering for capsules, tablets, vials, syringes, and bottles.

“With the new capacities of storage, Eurofins Amatsigroup is positioned as a partner for depot activities, including project management, importation, storage, packaging, labeling and worldwide distribution to clinical sites,” said Stéphane Bronner, site director of Saint Gély du Fesc.

Non-Animal Testing Lab Opens in China

A Chinese regulatory institute has opened a non-animal testing laboratory – a model for regulatory bodies to show that implementing alternative methods into government laboratories is achievable, says IIVS president.

The Zhejiang Institute for Food and Drug Control (ZJIFDC) is responsible for the regulatory review of food, drugs, and cosmetics produced in Zhejiang province in China.

The institute, based near Shanghai, opened the laboratory following collaboration with the Institute for In Vitro Sciences (IIVS), a non-profit organization dedicated to promoting non-animal test methods.

According to the release from the IIVS, the ZJIFDC decided to open the laboratory in 2013 to “keep in line with China's increased interest in alternatives to animal testing.”

The ZJIFDC alternatives laboratory is currently open and will provide services to domestic and international companies including several non-animal tests for skin corrosion, skin irritation, sensitization and eye irritation, though these tests are not currently accepted by the China Food and Drug Administration (CFDA).

“In addition to providing high-quality testing services, ZJIFDC serves as a model to CFDA that implementation of non-animal methods into government laboratories is achievable,” said Erin Hill, IIVS president.

Services also include the first CFDA-approved non-animal method to determine a cosmetics product's potential to cause harm after exposure to light.

“Cosmetics are lower hanging fruit for making changes since most of the products are non- or minimally-irritating,” said Hill.

Hill explained that as in other parts of the world, adoption of non-animal testing methods in the cosmetics sector will pave the way for adoption in other areas, such as drug development.

“There are a staggering number of drugs that fail in development due to toxicology problems,” she added. “So the earlier a pharma company can implement human-relevant endpoints

the better.”

Prior to opening the ZJIFDC alternatives laboratory, the institute partnered with IIVS to receive technical training in the implementation, execution, data interpretation, and quality practices associated with a non-animal testing laboratory.

“IIVS provided training at the laboratory in Zhejiang and also hosted their scientists for extensive training at our headquarters in Gaithersburg, MD,” said Hill.

IIVS also provided protocols, standard operating procedures, and workbooks.

The non-profit also recently partnered with researchers to develop a replacement for the Rabbit Vaginal Irritation Test (RVI), which is the most commonly used method to assess the potential of personal lubricant to cause irritation.

The project received the FDA go-ahead as the agency looks to modernize tests used to develop and evaluate medical devices.

The Centre for Cancer Immunology, University of Southampton

The University of Southampton’s Centre of Cancer Immunology is currently under construction at Southampton General Hospital site, located adjacent to the Somers Building, and will be the first and only center in the UK when completed. It is being developed by the University Hospital Southampton NHS Trust and Southampton City Council.

The center will have well equipped research facilities, including a clinical trials unit, suite of molecular biology laboratories, and a pre-clinical immunology lab to support the development of new cancer immunotherapies.

Construction of the facility is expected to be completed with an estimated investment of £25m ($32.46m) this autumn, while the official opening is expected next spring.

Project details

The University of Southampton launched a campaign to raise £25m ($32.46m) fund for the construction of a new cancer immunology center in 2015. The center received donations from the Wolfson Foundation, Matthew Hodgson of Warwick Capital Partners, and Coldplay.

Solent LEP contributed £4.5m ($5.84m) for the construction of the center, which is being carried out as part of the procure 21+ NHS procurement framework.

The planning application for the construction of the center was approved by Southampton City Council in February 2016. The topping out ceremony of the building was held in October 2016.

Design and features

The Centre for Cancer Immunology will be situated in a four-story building, which will have a total floor space of 43,040 sq. ft. (4,000m²). The upper two floors of the building will have space dedicated for researchers and administration, while the lower two floors will house laboratories.

The ground floor of the building will include an impressive atrium, along with space for meeting rooms and the clinical trials unit, and an open plan and dedicated office space.

The first floor will include an open-plan work space, in addition to interdisciplinary breakout areas. It will also include space for meeting rooms for researchers, PhD and undergraduate students, senior academics, and clinicians in cancer immunology.

The second floor of the building will be a hub for laboratory research. It will have space

The Centre for Cancer Immunology will accommodate world-leading immunotherapy scientists, clinicians and technical experts to collaborate in an interactive environment to generate new knowledge and to develop new treatments.

It will include sophisticated research equipment for the development of new cancer immunotherapies ranging from discovery in the lab to clinical trials. It will act as a hub for academic and industry partners worldwide, and will enhance clinical trials to explore new areas to develop lifesaving drugs for cancer.

It will include a clinical trials unit, a suite of molecular biology laboratories, and a pre-clinical immunology lab. It will significantly enhance the number of staff working on cancer immunology and the number of patient clinical trials.

The new facility will attract leading scientists from all over the world in the development of immunotherapy treatments, and will partner with Francis Crick Centre in London. It will perform research in multiple cancer forms from lung to skin, and pancreatic to neuroblastoma.

Contractors involved

PM Devereux was awarded a contract to provide the design for the Centre for Cancer Immunology. Kier Construction Southern was contracted to provide general construction services for the project.

Capella Biomedical Research Laboratory, Cambridge Biomedical Campus

Construction of a new laboratory building known as Project Capella was initiated at the Cambridge Biomedical Campus in February 2016.

Located next to the Cancer Research UK building near Addenbrookes hospital, the new facility will allow collaborations between scientists and clinicians to further advance the application of stem cell discoveries into the patient setting.

The University of Cambridge was granted planning permission for the Capella building in February 2016. The project is expected to be completed with an estimated investment of £79m ($112.48m) by Q2, 2018.

Capella biomedical research facility design and features

The Capella research facility will be a six-story building with a total floor space of

193,680 sq. ft. (18,000m²). The exterior will feature a two-story glazed box with gold metal detail and double-height entrance foyer. The spine of the building will be clad with flat-faced graphite panels.

The building will include a green screen to enhance the public area surrounding the development. It also will feature a bespoke timber frame structure with green roof, which will provide 324 cycle spaces on site.

Facilities at Capella biomedical research laboratory

The facility will include sophisticated laboratory spaces, offices, cafés, seminar rooms, exhibition spaces, and meeting suites to accommodate a variety of biomedical research groups.

It will also accommodate the Cambridge Institute for Immunotherapeutics and Infectious Disease, the Milner Therapeutics Institute, and Cambridge Stem Cell Institute. It aims to advance a center of excellence and initiate a foundation for the development of new medical treatments.

The facility will also include robotics suites for customized drug screening and gene editing, as well as bioinformatics support.

Construction of the Capella biomedical laboratory began in February 2016. The facility is being constructed using building information modelling (BIM) techniques. More than 80% of the frame and façade was built off-site as precast modules comprise precast columns, edge beams, and precast floor slabs with structural toppings. The topping out ceremony was held in April 2017.

Installation of mechanical services inside the building commenced after installing 6m pre-fabricated modules on the ground floor and fan coil units from ground to third floor in January 2017.

Installation of all external cladding panels and gold box glazing was completed in March 2107.

Contractors involved with Capella biomedical research laboratory

The designs for the Capella biomedical research laboratory were provided by Fairhurst Design Group (FDG).

The building construction contract was awarded to Kier Construction, which is being assisted by a team of consultants including Arup (consulting engineer), Arcadis (project manager), and Aecom (cost consultant).

PCE was selected as offsite superstructure construction partner, which provides hybrid precast columns with a combination of precast concrete edge beams and structural steel delta beam spine beams.

Alcrete Building Systems was appointed by PCE to provide design, manufacture, deliver, and install more than 100 precast units.

The building is being constructed with the aim of achieving Building Research Establishment Environmental Assessment Method (BREEAM) excellent rating.

Navesta Pharmaceuticals’ Sterile Pharmaceutical Manufacturing Plant

Sri Lanka-based company Navesta Pharmaceuticals has opened a sterile manufacturing facility in the town of Horana in August 2017.

Construction began in October 2015, and the plant is said to be the first of its kind in Sri Lanka. The facility is intended to produce sterile dry powder injectables of beta lactam antibiotics, which were previously imported to the country.

Built with an investment of more than LKR1.4bn ($9.1m), the Horana facility has generated more than 100 direct and 500 indirect jobs for locals in areas including bio-chemistry, pharmaceutical sciences, molecular bio-science, drugs, engineering, and ancillary services.

The factory will allow Navesta to export its pharmaceutical products to markets globally, contributing to the country’s economic development. It will also support the Government of Sri Lanka’s aim to achieve self-sufficiency in the pharmaceutical industry by 2020.

Design details of Horana sterile pharmaceutical plant

Located in the Kalutara district, Navesta’s new factory has a total floor area of 40,000ft².

The plant is designed to comply with good manufacturing practice (GMP) standards set by the EU and the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

An advanced building management system (BMS) at the facility ensures compliance with the EU-GMP and PIC/S standards. It is used to control humidity, temperature, and differential pressure at production and testing rooms to destroy all viable microorganisms.

The interior of the factory features cleanroom panels built with pre-coated galvanized iron to provide protection from external contaminants.

The facility is also fitted with environmentally sustainable features including energy efficient lighting and comprehensive waste water treatment systems.

Equipment installed at the plant

The sterile pharmaceutical manufacturing factory is installed with 13 incubator chambers and two walk-in incubators, which are designed in compliance with 21 Code of Federal Regulations (CFR).

The plant also incorporates a Grade A and Grade B microbiology laboratory, which helps develop comprehensive advanced in-house testing methods.

The testing and measuring equipment installed in the facility are calibrated as per accreditation standard ISO 17025 and ISO 9001 to achieve valid results.

Production capacities of Navesta’s Horana sterile pharmaceutical plant

Navesta’s Horana sterile pharmaceutical manufacturing facility will initially produce 50 million vials a year for filling sterile dry powder injectables of Beta Lactam.

Pharmaceutical products to be produced at the factory will primarily serve the requirement of 12 penicillin-based beta-lactam antibiotics in the form of dry powder for the local market. They will also be exported to global markets, which accept EU-GMP and PIC/S accreditations.

The plant is planned to be expanded in future to further increase Navesta’s production capacity by three times in the coming years. If undertaken, the expansion will provide approximately $500m of savings to the country, which currently imports $800m-worth pharmaceutical products a year.

Headquartered in Rajagiriya, Navesta Pharmaceuticals is engaged in manufacturing beta lactam antibiotics.

The company’s products include Ticarcillin-clavulanic, Piperacillin-tazobactam, Co-amoxiclav, Flucloxacillin, Cloxacillin, Ampicillin, Benzathine penicillin, Fortified Procaine Penicillin, and Benzylpenicillin.

EMA to Relocate to Amsterdam, The Netherlands

The European Medicine's Agency is to begin working immediately with the Dutch government to ensure a successful move by the end of March 2019

The European Medicines Agency (EMA) will relocate from Carnary Warf, London to Amsterdam in the Netherlands. This decision was taken by the EU 27 Member States in the margins of the General Affairs Council (Article 50).

The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.

The new EMA headquarters is to be located in the Vivaldi Building, a brand new office building in Amsterdam Zuidas or ‘South Axis’ situated within the city of Amsterdam and only minutes away from Amsterdam Airport Schiphol.

“We welcome today’s decision on the new location of EMA. Now that we finally know where our journey is taking us, we can take concrete actions for a successful move,” said EMA Executive Director, Guido Rasi.

“Amsterdam ticks many of our boxes,” he continued. “It offers excellent connectivity and a building that can be shaped according to our needs. I am very grateful that the Member States took into account our requirements for business continuity and gave priority to the protection of public and animal health.

Our internal surveys have shown that a large majority of EMA staff would be willing to move with the Agency to Amsterdam. However even in this case, our activities will be impacted and we need to plan for this now to avoid the creation of gaps in knowledge and expertise.”

EMA has to relocate due to the UK’s decision to withdraw from the EU. Amsterdam was one of 19 offers to host EMA submitted by the Member States at the end of July 2017. Today’s decision on EMA’s new location follows an assessment of the bids by the European Commission and EMA.

“My staff and I am very honored that so many Member States showed an interest in hosting EMA,” Professor Rasi commented. “The huge effort invested by the bidding countries to put together their proposals is a reflection of the Agency’s important role in the protection of public and animal health and the stimulation of a vibrant and innovative pharmaceutical industry.”

The decision marks the official start of a challenging joint relocation project that will have to be delivered within extremely tight timelines whereby the relocation has to be completed by 30 March 2019.

Effective collaboration between EMA and the Netherlands on the basis of the commitments made in its offer to host EMA is essential to ensure a successful move and the continuation of EMA’s operations with minimal disruption.

EMA and the Netherlands will kick start their collaboration by establishing a joint governance structure to steer and oversee the relocation project. Because of its important role to safeguard public and animal health in the EU, EMA is committed to giving stakeholders and the public full visibility of the relocation project. In early December, the Agency will make available a monitoring chart on its website that will allow to track the progress made.

MSD Announces Plan to Establish UK Discovery Centre in London

MSD, known as Merck, in the US and Canada, announced its commitment to establish a state of the art life sciences discovery research facility in London, focused on early bioscience discovery and entrepreneurial innovation

For more than a century, MSD, a global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for the world’s most challenging diseases.

The new UK Discovery Centre is anticipated to create 150 new research roles with the aim of attracting the brightest and best research scientists to work in London.

It is intended that the UK Discovery Centre will become the location for MSD’s UK HQ, making the central London site a unique location within the UK pharmaceutical sector.

The new site is also intended to accommodate approximately 800 additional staff for the UK domestic market and other European clinical functions currently based in MSD in the UK’s Hoddesdon HQ.

The company is currently evaluating several potential locations in the London region with a target date of 2020 for operational readiness.

In the meantime, MSD plans to establish a small temporary research facility in the area and is actively recruiting for suitably qualified scientific talent.

The proposed investment is in line with MSD Research Laboratories’ continued pursuit of new innovative scientific discovery and collaboration and follows similar investments in new biomedical centers in the San Francisco Bay Area and Cambridge Massachusetts.

MSD believes that locating a research facility in London will expand MSD’s opportunity to engage with leading researchers in the UK and Europe.

Dr. Roger M. Perlmutter, President of MSD Research Laboratories, said: “Strong discovery capabilities and the pursuit of scientific excellence are foundational to MSD’s mission to save and improve lives around the world.”

“This new London location will enable us to build on our proud legacy of invention and be an important contributor to the vibrant and rapidly growing London life sciences community while providing access for more collaborations within the European life science ecosystem.”

“We believe London to be a unique bioscience center of excellence and a key component of the established golden triangle for academic science of London-Oxford-Cambridge,” said Louise Houson, Managing Director of MSD in the UK and Ireland.

“This investment presents a major opportunity for us to work in collaboration with the UK Government to build on the forward thinking and ambitious industrial strategy white paper published by the Government.”

With the recent relocation of the European Medicines Agency to Amsterdam and concerns in the pharmaceutical industry about whether Britain will continue to punch above its weight in the share of global life sciences investment it receives post-Brexit, Secretary of State for Business, Energy and Industrial Strategy Greg Clark said the investments represented "a huge vote of confidence" in the government's plans.

Pharma's Growing Complexity Needs Spur AMRI Aseptic Investments

AMRI has added a new line at a facility in Spain, effectively doubling its bulk aseptic API manufacturing capacity.

The multipurpose line is the result of an investment of over $10m (€8.4m) at the site in Valladoid, Spain, acquired by AMRI from Gadea Pharmaceutical Group for $174m in 2015.

The expansion is the latest to support AMRI’s active pharmaceutical ingredient (API) global manufacturing footprint, and effectively more than doubles its bulk aseptic capacity.

“We now have four separate facilities within the AMRI network; two in France and now two in Spain,” said George Svokos, chief commercial officer at AMRI.

“Capacity is a function of the mix of products; however, each of our four sites has the capacity to manufacture thousands of kilograms of sterile APIs with reactors ranging from 250L to 2,500L.”

“There are many parenteral products – existing and being approved – in the form of sterile suspensions and other such presentations that require the use of sterile API in their manufacturing. Certain ophthalmic products also require sterile APIs. This feeds well into our Drug Product business, which has capabilities in these types of sterile suspensions.”

He added the growing interest in biologics, controlled substances, and other complex compounds is further making the aseptic API space a lucrative opportunity for contract development and manufacturing organizations (CDMOs) like AMRI, which continues to grow its network in the space.

“Our intent is to remain a key player for complex and sterile API development and manufacturing, as well as sterile dosage form development and manufacturing,” he said, adding the expansion in Europe comes weeks after the firm announced the addition of new aseptic pre-filled syringe filling line at its Albuquerque, New Mexico site.

The firm is set to add capacity to manufacture roughly 50 million syringes per year from the facility – acquired for $110m from OsoBio in 2014.

AstraZeneca Establishes Joint Venture in China to Develop Innovator Drugs

The joint venture will focus on the discovery, development, and commercialization of potential new drugs for the global market as well as speed delivery of new medicines to China.

On Nov. 27, 2017, AstraZeneca announced that it is establishing a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally owned, stand-alone company in China that will discover, develop, and commercialize potential new drugs and speed delivery of innovative new medicines to China. FIIF is managed by the SDIC Fund Management Company (SDIC Fund), a private equity management company.

The joint venture company, Dizal Pharmaceutical, incorporates the scientific and technical capabilities of AstraZeneca’s Innovation Center China (ICC). It holds exclusive rights to develop and commercialize three of AstraZeneca’s potential drug candidates currently in preclinical development for applications in oncology, cardiovascular and metabolic diseases, and respiratory diseases. The joint venture is also expected to initiate clinical programs. The FIIF, which aims to promote the development and manufacturing of innovative medicines in China, will contribute funding and expertise in establishing strategic partnerships in China.

Dr. Xiaolin Zhang, previously head of AstraZeneca’s ICC, has been named CEO of the new company. All staff employed by the ICC have been invited to join the new company.

Pascal Soriot, CEO of AstraZeneca, said in a company press release: “AstraZeneca has a long-standing and strong commitment to China, which we are reinforcing [with] this ground-breaking joint venture. By joining forces with the FIIF, we aim to accelerate the local discovery and development of innovative, affordable medicines for patients in China and around the world.”

Cambrex Adds Potent API Capacity Citing Growing Generic Opportunities

Cambrex Corporation has announced plans to start making high potency APIs at its plant in Milan, Italy citing impending patent losses for small molecule drugs as an opportunity.

The US active pharmaceutical ingredients (API) manufacturer said it will install development and analytical equipment at the facility in Paullo to support the production of potent actives.

It also said it will increase hydrogenator and centrifuge capacity, predicting the project will be completed this year.

Cambrex declined to comment further.

As with other recent expansions, Cambrex cited increasing demand as the driver for the investment.

Aldo Magnini, MD of the firm’s Milan division, said: “We have seen increased growth of activity among highly potent molecules in the past decade for use in therapeutics for cancer and other indications, and it is now becoming more appropriate in the generic API business as patents on these begin to expire.”

The comments are in keeping with statements Cambrex made in August, when confirmed it plans to start building a facility for high potency APIs at its site in Charles City, Iowa.

At the time CEO Steven M. Klosk said: “We are making this investment to address a growing demand in the market for manufacturing capacity that is capable of handling highly potent products. We expect the new facility to be ready for production in early 2019."

STA to Open Catalyst Screening Centre in Changzhou in November

STA Pharmaceutical Co is setting up a metal catalyst-screening center at its facility in Changzhou, China.

The firm – a subsidiary of WuXi AppTec – said the center would support screening activities for metal catalysts, ligands, bases, acids, chemical resolving reagents and amide formation coupling reagents.

STA said the center would in November adding that staff in training at its facility in Shanghai will relocate to Changzhou when the facility is up and running.

News of the new center comes just months after WuXi merged STA’s active pharmaceutical ingredient (API) business with its development services operation.

Earlier this year STA said it would employ a staff of 300 people at the Changzhou site, including 230 process chemists and 70 analytical chemists.

CordenPharma Ups Swiss API Development Services

CordenPharma has invested in its Swiss API development services a week after buying a manufacturing plant from Pfizer.

The contract development and manufacturing organization (CDMO) said it is investing €3.7m ($4.4m) into its site in Liestal, Switzerland to increase its small molecule development services and refurbish its purification capabilities.

Around €2m of the investment will be used to add automation equipment at the plant “to facilitate development services and an extensive upgrading and expansion of analytical equipment,” the firm said. But despite the automation tech, the firm expects an increase in the overall number of development staff.

The rest of the investment will be used to build a mini-plant and refurbish current purification capabilities at the site, to meet growing market demands in the g to kg’s range and at a scale of 1-70 liters, the firm said.

“The introduction of this new mini-plant will enable us to run small-scale batches for our customers, while at the same time demonstrating the routes readiness for further scale-up and addressing their material requirements for early-phase clinical stages,” Juerg Burger, managing director of CordenPharma Switzerland, said in a press release.

The expansion comes a week after the CDMO announced it was buying a highly potent active pharmaceutical ingredient (HPAPI) plant from Pfizer in Boulder, Colorado.

CTtoxLAB Purchases New Facility

The contract research organization (CRO) has purchased a new facility in Montreal, Canada, adding 20,000 square feet of laboratory space.

The new facility is a purpose-built laboratory dedicated to small and large molecule bioanalysis, flow cytometry, biomarkers, and biodistribution.

According to the contract research organization (CRO), the expansion is “an integral part” of its strategic plan to grow in the global laboratory services market and follows an increasing demand for bioanalysis and biomarker services.

The company will relocate some of its laboratory operations to the new building, which Jean-François Le Bigot, chairman and CEO of CiToxLAB Group said will free up space in the main building, allowing it to increase its animal room capacity.

Andrew Graham, site manager at CiToxLAB North America, added: “The new building we have just purchased will allow us to better meet the increasing needs of our clients for a one-stop-shop CRO in laboratory sciences investigations.”

Last November, CiToxLAB acquired AccelLAB, a preclinical medical device CRO to expand its services portfolio to medical devices.

Microbix Ups Antigen Capacity

Microbix says it has successfully converted its production process from roller bottles to bioreactors to cope with growing demand for its antigens.

The Ontario, Canada-based firm manufactures viral, bacterial and parasitic products used in immunoassays, quality assurance and proficiency testing controls, and for vaccine and antiviral R&D.

These “antigens are made by cultivating the different organisms at scale under the appropriate biosafety conditions, purifying them, inactivating them, titrating and packaging them and performing a series of QA and QC steps to ensure consistency of product,” said CEO Cameron Groome.

“In the case of bacterial antigens, the organisms are cultured directly, in the case of viruses, host cells to the viruses must be grown before viral particles can be produced.”

While antigens are traditionally made using roller bottles, Groome said increased industry demand calls for a shift in production to bioreactors and as such Microbix has ramped-up its site in Mississauga.

“Roller bottle production requires a great deal of space, labor and materials. Microbix would have had difficulty meeting the emerging demand growth for the referenced product without this shift in technology. Its successful conversion to bioreactors should enable the company to capture growing global product demand.”

He added that while growing mammalian cells in bioreactors is a known process, many companies have failed at scaling up from roller bottles.

“Microbix has not only succeeded in the culturing of mammalian cells in bioreactors, but has also kept those cells alive while infecting them with a virus and obtained consistent quantity and quality of the desired viral antigen particles,” he said. “Our management has likened this to the difference between hitting a target with a bullet and hitting a bullet with a bullet.”

Microbix has not disclosed the type, scale and brand of bioreactors it has selected for its processes but is increasing bioreactor capacity by 500%, going from one production-oriented bioreactor to six for a top-selling – and undisclosed – product. All six units have been delivered and will enter production in early 2018.

The firm said it is also increasing its downstream processing capacity to support the expansion.

Tjoapack Launches 19th Packaging Line

Tjoapack, a contract packaging organization (CPO) based in Etten-Leur, the Netherlands, has launched its new bottle packing line following a major investment earlier this year.

The new line triples their capacity, and is part of an ongoing investment plan to allow the company to better serve a global customer-base by utilizing the latest packaging innovations and creating a more efficient supply chain.

“This investment allows us access to the latest packaging technologies and will help us to continue to improve supply chain efficiencies for our customers. As we move into 2018 we expect to see the demand for outsourced packaging solutions increase and we will continue to innovate and invest in both our capabilities and capacities,” said Dexter Tjoa, director of corporate strategy at Tjoapack.

This brings Tjoapack’s number of packaging lines to 19, serving customers in over 42 countries across the world.

Recipharm Equips Three More Facilities for U.S. Serialization

Facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, have been equipped to supply serialized products to the U.S.

The next facilities to be equipped will be the company’s facility in Bengaluru, India, which will supply serialized products for the U.S.

Pharma Technology Moves into New HQ

Pharma Technology Inc. (PTI) is moving its headquarters into a 60,000 square foot state-of-the-art facility that is twice the size of their former site. The building will have a large research and development center to build upon the company’s services including tablet dedusting, capsule polishing, and OSD testing technology.

The new Nivelles, Belgium headquarters doubles Pharma Technology’s manufacturing capacity, and significantly increases its stocking space. Modernized technology will boost production of high-end equipment with continuous quality control through all manufacturing and assembly stages.

“Upgrading and upsizing our facility is a result of the tremendous growth we’ve experienced in the past few years, and the continued growth we anticipate moving forward,” said Nic Michel, general manager for Pharma Technology.

A formal inauguration for the new plant is planned for March 2018.

Pfizer Preps French Site For UK Prescription-Free Viagra

Viagra Connect will be available without prescription in the UK following a request from drugmaker Pfizer, which is preparing a manufacturing site in France for the demand.

The reclassification will change the drug’s status from prescription only medicine (POM) to pharmacy medicine (P), meaning that if marketed, the medicine will be sold following a discussion with a pharmacist, said the Medicines and Healthcare products Regulatory Agency (MHRA) in a statement.

The prescription version of sildenafil, marketed by Pfizer as Viagra, is indicated for the treatment of the symptoms of erectile dysfunction in adult men (aged 18 years and over). It is available in 25mg, 50mg and 100mg tablets.

Viagra Connect, the non-prescription, pharmacy-supplied version of sildenafil 50mg, is indicated for erectile dysfunction in adult men (aged 18 years and over). It is available in 50mg tablets.

Pfizer has been making the active pharmaceutical ingredient (API) for Viagra at its Rigaskiddy facility in Ireland, but spokesperson Lisa O’Neil said Viagra Connect will be manufactured in France.

“Pfizer will be investing in start-up costs to deliver Viagra Connect to the UK market and resulting investment will be made in manufacturing based on demand,” she said.

The reclassification responds to an application made by the drugmaker, said O’Neill.

This was confirmed by an MHRA spokesperson: “The company presented information to support its view that Viagra Connect 50mg tablets are suitable to be switched to Pharmacy status.”

Pharmacists will not sell Viagra Connect to those with severe cardiovascular disorders, liver failure, severe kidney failure, or patients taking certain interacting medicines.

“Use of Viagra Connect in these groups of men must continue to be under the supervision of a doctor,” the MHRA stated.

The MHRA announced it has seized more than £50m ($67m) of unlicensed and counterfeit erectile dysfunction medicines over the past five years, however according to the spokesperson, the decision to reclassify Viagra Connect is unrelated.

“Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines,” he said.

“It’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects,” he added.

Concept Life Sciences Invests In East Kilbride Analytical Services Facility

Concept Life Sciences (Concept), the integrated drug discovery, development and analytical services company, invested in new equipment at its East Kilbride analytical services site.

This follows more than £250,000 of new instrumentation, which was added to the facility in 2016.

The investment has doubled capacity across many capabilities, including GC/MS (Gas Chromatography/Mass Spectrometry), GC/MS headspace (for analysis of volatile compounds), GCxGC (comprehensive two-dimensional gas chromatography), metal and anion analysis, and forms part of a wider programme to upgrade and add to systems.

The investment will help Concept Life Sciences to better support customers’ testing requirements and provide faster turnaround times.

Concept also plans to increase headcount at the site by 8 FTEs to support the increase in capacity and workload, in addition to the 7 FTEs that joined the team in 2017.

Darryl Chapman VP Sales and Marketing, Concept Life Sciences, said: “The recent investments in the East Kilbride site demonstrate Concept’s continued commitment to enhancing the customer experience and to growing the business in Scotland.”

“This latest investment brings Concept’s total investment into the Scottish economy in the last three years to in excess of £20 million, following the acquisition of businesses in Dundee and Edinburgh.”

Arran Chemical Completes First Phase of “ADAPT” Expansion

Arran Chemical Co., a provider of fine chemicals and pharmaceutical intermediates, has completed the first phase of its ADAPT (Arran Deploys Advanced Production Technologies) expansion with a multi-million investment and application of its select AZyme technology.

Acquired by the Almac Group in November 2015, Arran has completed the first phase of a sustained investment program. Manufacturing plant assets have been upgraded with the installation and qualification of a new 6,300 L glass lined and 2m3 Hastelloy vessels, bringing the total manufacturing capacity to approximately 50 m3. This has been accompanied by a major refit of the multi-purpose pilot plant in addition to enhancement of the existing refrigeration, warehousing and waste processing facilities.

With enzyme technology becoming the tool of choice to lower cost of goods and increase process scalability, the company has expanded it selectAZyme enzyme platform to include over 4,000 unique enzymes from diverse biological sources. Many of these pertain to entirely new enzymes classes and are ready for deployment at kilogram to ton scale.

“The deployment of the ADAPT strategy, the recent expansion of core production facilities and the development of next generation manufacturing technologies, sets the pace for future growth.” said Tom Moody, vice president of Technology Development and Commercialization, Arran Chemical Co. “As the demand for outsourced procurement of advanced intermediates and building blocks continues to grow, we remain fixated upon meeting our clients’ present and future requirements for uninterrupted supply.”

SCHOTT Expands in China

SCHOTT, a technology-based group of glass manufacturers and developers, has opened a new packaging production plant in China that will produce upwards of 2 billion pieces of pharmaceutical packaging per year. The new site allows the company to more effectively provide Chinese pharmaceutical manufacturers with packaging products.

The plant is located at the SCHOTT Xinkang headquarters in Jinyun, Zhejiang, and will manufacture ampoules, vials and cartridges made of premium glass tubing for the domestic pharma industry.

The new production facility adds to the company’s global network of manufacturing sites in 13 countries. This year, the group also invested in its plants in Müllheim (Germany), Lebanon (U.S.) and St. Gallen (Switzerland), among others.

Sterling Expands API Capabilities

Contract development and manufacturing organization (CDMO) Sterling Pharma Solutions is investing £6 million into a new facility at its UK site to strengthen and expand its milling, micronization and solid form capabilities.

The 40-acre site in Dudley, North East England, will meet growing demand for pharmaceutical API particle size control technology, as well as expanding Sterling’s laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection and particle engineering and crystallization scale-up.

Four new milling areas will house a range of new technologies, including mechanical milling, spiral jet milling and small lab scale trial mills. Supporting the CDMO’s expertise in handling potent and hazardous materials, the facility will also provide containment to handle OEB 4 classified molecules and offer ISO 8 cleanroom environments.

“From our UK facility, we are building a global API services business with customers in the U.S., UK, Europe and Asia,” said Kevin Cook, chief executive officer, Sterling Pharma Solutions. “This latest investment is an important step in bolstering our offering so we can cater to growing market demand, including the need for high potency capabilities to reflect the global drug pipeline.

“We are proud that we can take products from proof-of-concept to commercial scale manufacturing all on one site, and the new facility will strengthen our current offering by adding additional milling, micronization and solid form capabilities.”

Established in 1969, Sterling’s site has a strong heritage in API services and a successful track record of compliance with both the MHRA and FDA. The investment forms part of a 15-month strategic development plan totaling almost £12 million, which will also see the expansion of the CDMO’s GMP kilo laboratories and pilot plant.

Expected to be operational by mid-2018 the milling, micronization and solid form facility will create more than 15 jobs over the next 18 months, bringing Sterling’s total workforce to around 400 employees.

“Our strong growth can be attributed to a number of factors, including the emerging pharma sector in the U.S. and big pharma demand for the complex and hazardous chemistries we provide,” said Mr. Cook. “We have focused our strategy on the diversification of our customer and product base and have recently expanded our presence in the Asian markets including Japan. We will continue to invest to ensure we meet the diverse needs of our customers globally.”

Novasep to Expand Cryogenic Production Capacity

Novasep is investing €4 million to expand cGMP capacity for clinical and commercial supply of APIs at its Chasse-sur-Rhône (FR) facility.

The investment includes the installation of a new cGMP cryogenic production line, capable of operating at temperatures as low as -80°C. It is equipped with a 4m3 Hastelloy reactor, filter drier and cleanroom.

The investment also includes an expansion of the cGMP pilot-plant capabilities with the addition of a new stream comprising a 400L Hastelloy reactor, filter drier and clean room. This will add flexible small-scale manufacturing capacity and enhance the site's capability to handle both clinical development needs and low volume APIs.

The expansion will bring Novasep's total low temperature capacity to more than 35m3 and is expected to be operational in early 2018.

"By increasing cryogenics capacity at the current Chasse-sur-Rhône facility, we strengthen Novasep's small and large-scale volume offering for low temperature manufacturing." Jean-Pierre Pilleux, General Manager of the Chasse-sur-Rhône site said, "It will give us more flexibility and allow us to address the increasing market demand for these types of capabilities."

Brazil’s Biolab Pharma Selects Ontario for Its First International Facility

Brazilian pharmaceutical firm Biolab Pharma has collaborated with the Government of Ontario, Canada, to open its first international research development and innovation (RD&I) facility in the province.

The new 13,000ft² RD&I facility, which is part of the firm’s overall C$57.4m ($45.41m) investment, will see a funding of C$2.8m ($2.2m) through the Ontario’s Jobs and Prosperity Fund.

Biolab Pharma CEO Cleiton de Castro Marque said: “We are pleased to partner with the Ontario government on this exciting initiative as we expand our operations internationally.

“Our new facility will help us sharpen our competitive edge and better serve our customers by continually improving and creating innovative products.”

The firm is also planning for new equipment and special software to improve its research capabilities, which could allow development and commercialization of new products in North America and Europe.

Planned to open in Mississauga city, the facility is anticipated to be complete by December 2020 and is expected to create new life sciences jobs, aiding economic growth of Ontario.

Ontario Finance Minister Charles Sousa said: “Through the Jobs and Prosperity Fund alone, businesses have created or retained more than 35,000 jobs, including 40 announced at Biolab Pharma.

“These partnerships contribute to the strong and sustained growth of the Ontario economy, with over 794,500 net new jobs created since the recession.”

With more than 50% of Canada’s total life sciences economic activity, Ontario’s life sciences sector employs approximately 60,000 people.

Biolab Pharma develops, manufactures and commercializes prescription medicines, with a primary focus on drugs for cardiology and dermatology.

Servier CDMO Expands Chromatography Platform in Normandy

Servier CDMO has invested $7.5 million in expanded technology including continuous chromatography with simulated moving bed (SMB) and super critical fluid chromatography (SFC) with solvent recycling at its Bolbec site in Normandy.

The company anticipates a 50% increase in productivity in addition to the existing configuration of the high-volume batch columns that are used for drug manufacture. The investment will allow the chemical purification of 50kg (kilograms) per day, and the chiral separation of 10kg per day to support clinical trials and market supply upon approvals.

The Bolbec site offers experts in chemical processes and is certified to handle highly potent compounds to occupational exposure band five (OEB 5). Bolbec is a U.S. FDA cGMP site for pharmaceuticals.

Micro-Sphere Boosts Capsule-Filling Capabilities

Contract development and manufacturing organization (CDMO) Micro-Sphere has partnered with German machine manufacturer Harro Höfliger for the latest step in its €19 million investment into its facility in Switzerland.

Harro Höfliger has supplied a Modu-C MS capsule-filling machine, which boosts Micro-Sphere’s capsule filling production. A notional production of 72,000 capsules per hour and a 100% net weight check control, grant the correct dose when filling capsules for dry powder inhalers.

“Low dose capsule filling is becoming increasingly popular across the market and at present we are the only CDMO in Europe offering this level of capability,” said Micro-Sphere founder and president of the board, Michele Müller. “Harro Höfliger’s powder expertise and technological competence is particularly evident in the Modu-C MS. This investment is an important next step in our expansion plans, allowing us to meet demand for greater capacity and speed up project delivery for our customers.”

Based in Allmersbach, Germany, Harro Höfliger develops and manufactures production and packaging systems and is a valued development partner for many pharmaceutical and medical technology companies.

Marco Laackmann, business unit leader, inhalation, Harro Höfliger, said, “The capacitive fill quantity control of the Modu-C MS offers excellent process reliability and is a great choice for Micro-Sphere in line with its continued expansion. We’re delighted to be a part of their exciting future.”

From its GMP, SwissMedic and FDA approved facility near Lugano, Ticino, Micro-Sphere’s team supports customers in the U.S., Europe, New Zealand and Asia with spray drying and capsule filling capabilities for the development and manufacture of both potent and non-potent pharmaceutical products, with a particular focus on inhalable dosage forms.

Almac Passes MHRA Inspection at Charnwood Facilities

Almac Group has successfully completed an inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its new Pharmaceutical Development & Manufacturing facilities at Charnwood Campus, in Loughborough England.

In November 2015, the company began an expansion of its pharmaceutical development and manufacturing services with the acquisition of a significant proportion of the 70-acre Charnwood Campus, a science and technology park. The facilities have since undergone significant investment both in building enhancements and the installation and validation of new processing and analytical technology.

The successful inspection provides the necessary licenses to develop, manufacture and pack non-potent and potent, solid oral drug products for clinical trials and commercial supply at the site, with the new facility complementing the existing development & GMP services offered from the company’s Craigavon NI headquarters.

Trevor Clarke, global head of Quality Systems said, “We are extremely pleased with the successful roll-out of our Global Quality Management System to the new Charnwood site. This positive endorsement by the MHRA provides our clients with increased capacity governed by the same pharmaceutical quality system which they are already familiar with at our existing sites in Craigavon, Northern Ireland and Audubon, PA.”

Pfizer CentreOne Expands Contract Mfg. to Nagoya, Japan

Pfizer CentreOne, a global contract manufacturing organization (CMO) embedded within Pfizer, is now offering services in Nagoya, Japan. The Nagoya site will provide in-country manufacture of highly potent oral solid dosage forms. It will also provide gateway services into Japan—inspection, packaging and testing—for highly potent oral solid drugs and sterile injectables made by Pfizer CentreOne outside the country.

“We’re pleased to add Pfizer’s Nagoya facility to our manufacturing footprint,” said Peter Stevenson, vice president of contract manufacturing, Pfizer CentreOne. “Pfizer has been manufacturing pharmaceuticals in Japan for 50 years. We deeply understand the exacting expectations of Japanese pharmacies and patients, along with the challenges they entail. That knowledge can help our biopharmaceutical partners attain a marketing edge, whether they manufacture their drug at our Nagoya site or bring it into Japan through our Japan gateway services.”

The Nagoya facility provides cGMP manufacturing of highly potent oral solid drugs that require containment to protect personnel from contact with hazardous materials and segregation to prevent cross-contamination of drugs in the plant.

The site manufactures highly active compounds, immunosuppressive drugs, sensitizing agents and controlled drugs. Dosage forms include high and multiple doses; combination products; multiple release and fixed dose.

Containment technologies at the Nagoya site span Occupational Exposure Band (OEB) one through five and Occupational Exposure Limit (OEL) down to 0.01 µg/m3. OEBs and OELs protect production personnel by categorizing the risk of the drugs they handle and setting limits to their exposure to these materials.

Inspection and packaging services include inspection of primary, secondary and tertiary packaging to assure drugs and their packaging are free of defects before leaving the facility; and custom packaging development to maximize functionality for the pharmacy, and appeal and user-friendliness for the user.

Batavia Biosciences Expands Its Viral Vector and GMP Facilities

Batavia Biosciences has expanded its viral vector process development facilities in the US and its GMP cleanroom facilities in the Netherlands to accommodate increasing market demand

The R&D facility in Medford, located just north of Cambridge (MA) allows Batavia Biosciences to extend the existing service portfolio in the US, adding complete pre-clinical process development capabilities for viral vectors including AAV, Lentivirus, VSV and Adenovirus systems to its portfolio of CHO cell line generation and process development services for recombinant proteins and antibodies.

Chris Yallop, CSO Batavia Biosciences, said: “Recent advances in cancer vaccines and gene therapy have given rise to a profound increase in the global demand for process development and clinical manufacturing of vector based products.”

In addition expansion of its GMP cleanroom facilities in Leiden, the Netherlands better aligns the company’s GMP capacity with its increased R&D capability to further support the manufacturing of master cell banks and vaccine seed stocks.

Menzo Havenga, CEO Batavia Biosciences, said: “At Batavia Biosciences we are very much aware of the fact that the patient is waiting. With the completion of this investment, the company is now better positioned to maintain the speed and quality of bringing candidate biopharmaceuticals from bench to clinic.”

Xellia Pharmaceuticals Expands Investment in Copenhagen

Ground is broken for new 10,760 sq. ft. (1000m2) multi-story building for sterile manufacturing of critical care products

Xellia Pharmaceuticals, a specialty pharmaceutical company focusing on providing anti-infective treatments against serious and life-threatening infections, has held a ground breaking ceremony for a new US$25 million expansion at its Copenhagen headquarters and product manufacturing plant.

The ceremony celebrated the start of the construction of a state-of-the-art multi-story building that will house the latest sterile manufacturing equipment and containment solutions in a purpose built environment.

Xellia’s Copenhagen site is responsible for manufacturing, stability testing and packaging of both sterile active pharmaceutical ingredients (APIs) and the finished dosage forms (FDFs) for anti-infectives such as vancomycin and colistimethate sodium.

Anti-microbial resistance is one of the world’s most serious threats to human health and Xellia’s specialty anti-infective medicines are often used as a last line of defense, where all other medicines have failed.

This upgrade in facilities will ensure that Xellia is able to continue to provide a reliable supply of injectable anti-infective critical care medicines and remain at the forefront of manufacturing excellence.

Xellia CEO, Carl-Åke Carlsson said: “We are pleased to celebrate the ground breaking ceremony of our new building. Xellia is one of the world’s leading suppliers of specialty anti-infectives and we are committed to constantly improving our facilities so that we can continue to produce a high quality and reliable supply.”

Since 2013, the Copenhagen site has increased its employee numbers by around 150 across different functions including roles relating to manufacturing.

Wholly owned by Novo Holdings A/S, the holding company of the Novo Group, Xellia has over the past 15 months invested significantly across several of its global sites. Recent developments include expanding production capacity for sterile injectable products in the US, while a new production facility in Cleveland, Ohio, received notification from the FDA in November 2016 to allow packaging and distribution of drug products. Full manufacturing of products is anticipated during 2018.

It completed the expansion of a new $13m, 32,280 sq. ft. (3000m2), multi-story Centralized Laboratory Services building at the company's Budapest, Hungary, manufacturing site in August this year will strengthen its global anti-infective product capabilities with additional product stability and release testing expertise and capabilities.

The company is also expanded the Product and Innovation R&D team with more than 15 new scientists and around 10,760 sq. ft. (1000 m2) of new lab space at its purpose-built Centre of Excellence in Zagreb, Croatia in September 2016.

The Zagreb site, now has around 100 employees, working to provide solutions for improving the efficacy, safety and delivery of existing anti-infectives, and reducing toxic side effects, to developing novel drug-device combination anti-microbial therapies.

Fujifilm Adding Three 2 Single-Use Bioreactors as Part of Expansion

Following a ‎¥14bn ($125m) investment in April, Fujifilm Corporation has committed a further ‎¥3.2bn across its biologics contract manufacturing business.

In April, Japan’s Fujifilm Corporation announced it was investing ‎¥14bn in its biologics contract development and manufacturing (CDMO) business to increase production capacity in the US and build an additional process development facility in the UK. And now the firm says it is investing a further ‎¥3.2bn ($30m) across the two sites.

Fujifilm Diosynth Biotechnologies’s monoclonal antibody (mAb) production facility in College Station, Texas will receive ¥2.2bn to bolster production, and will effectively double the planned bioreactor capacity expansion. The site was fully acquired from Kalon Therapeutics in March.

The firm’s site in Wilton, UK will receive ¥1bn to add a further 9,684 sq. ft. (900m2) of area at the 10,007 sq. ft. (930m2) mAb production development facility which opened its doors in September. Fujilfilm added the UK site and a facility in North Carolina in 2011 from Merck & Co.

Spokesperson Kana Matsumoto said: “We invest capital investment in US and UK in order to incorporate the CDMO needs of monoclonal antibody that are growing particularly among growing biopharmaceuticals.”

“In order to respond to growing customer needs in this field, Fujifilm has decided to make additional investments earlier than scheduled.”

Matsumoto told us the firm’s current mammalian cell culture capacity is 9,000L, but is set to increase to 15,000L next year following the announced addition of three 2,000L single-use bioreactors in Texas in April.

This latest investment will add a further three 2,000L single-use systems, supplied according to Matsumoto by GE Healthcare, pushing total capacity to 21,000L across the three sites by 2019.

On the microbial front, current total fermentation tank capacity is 17,000L, not including 20,000L available through a collaboration at a plant owned by Merck & Co.

The continued expansions support ambitions to increase the CDMO’s biologics revenues to ¥100bn by 2023 – up from current sales of around ¥30bn – placing it in league with Lonza and Boehringer-Ingelheim.

GE Investment in Swedish Site to Support Biopharma Demand

GE Healthcare will invest $50-70m a year until 2022 in its bioprocessing equipment and consumables site in Uppsala, Sweden.

The site in Uppsala was set up in the 1950s when Pharmacia moved from Stockholm to Uppsala. Amersham Life Sciences bought Pharmacia in 1997, and eight years later the business and site were acquired by GE Healthcare.

The 1,721,600 sq. ft. (160,000m2) site looks like a construction site because it is.

Uppsala is undergoing constant upgrades and expansions, driven by Biopharma’s strong demand for chromatography resins and equipment, said Lotta Ljungqvist, CEO of GE Nordics.

Currently over 200 approved biologics use technologies or consumables made in Uppsala, but with industry’s growing and blossoming pipelines she said there is a continuous need for GE to expand.

“Because of the growth in the biopharma industry and the need for this equipment, we are investing heavily into our manufacturing capacity both here and across our other manufacturing sites.”

In Uppsala alone, Ljungqvist said GE has committed between $50m (€43m) and $70m per year, from 2017-2022, to increase product capacity. Over five years this will equate to as much as $350m.

Theo Papadopoulos, general manager of operations at the site, added such investment was necessary to cope with double-digit growth in its chromatography tools.

There are currently 14 manufacturing areas on the site across two multipurpose facilities, and current capacity stands at 350,000L of resin per year.

However, while capacity expansion is a major – and very much visible – aspect of the investments, Papadopoulos said much of the Capex is allocated to modernizing procedures, through data digitalizing and automation projects.

The site has existed in Uppsala since the 1950s, at the time owned by Pharmacia. The protein separation by gel filtration still part of GE’s product portfolio is based on the research by two Nobel Prize winners in Chemistry: Theodor Svedberg (1926) and Arne Tiselius (1948) both from Uppsala University. They developed techniques for separation and characterization of proteins and started collaborating with the industry.

One late night during 1957, as a young scientist from the Tiselius group was leaving the lab, he made a mistake. The mistake would be a turning point for his professor, Jerker Porath, and lead to the remarkable discovery of Sephadex (SEparation PHArmacia DEXtran, the chromatography medium launched in 1959.

Because the young scientist forgot to turn on the power switch when he left the lab that night, Jerker Porath realized that a gel made of crosslinked dextran could be used to separate macromolecules, without applying electrical current. The molecular separation was based purely on size. This technique is also referred to as gel filtration or size exclusion chromatography.

GE’s life sciences business continues to see year-on-year growth of upwards of 8%, while many of its bioprocessing lines are seeing double-digits.

But as a multinational conglomerate, General Electric Co has been heavily underperforming, and CEO John Flannery said in an investor meeting his management team was looking to address this through a refocused vision and the potential divestment of a number of businesses.

He also announced GE was cutting both the dividend and its 2018 earnings forecast by half, causing share price to fall to a one year low.

However, in his vision of a future GE, Healthcare features highly and while specifics were not divulged he said the firm planned investments to lead in a number of areas, including precision health, biopharma tools and digitization.

Constantia Flexibles to Expand Production Capacity in Austria

Constantia Flexibles Group will invest a double-digit million euro amount in the expansion of production capacity at its manufacturing site for pharmaceutical packaging, Constantia Patz in Austria.

The company will install one double-sided lacquering machine for foils and laminates, as well as one slitting machine operating in a new Class 8 cleanroom.

The extra capacity is expected to come on stream early 2019.

“Our investments will meet growing demand for different blister foil specifications manufactured on focused production lines with the highest hygiene, quality and safety standards,” said Pierre-Henri Bruchon, Executive VP for the Pharma division.

Constantia Patz is located in Loipersbach, Lower Austria and employs approximately 350 people at its plant.

It produces blister foils and coldform for leading pharmaceutical companies worldwide.

Constantia Patz already operates four certified cleanrooms for lacquering, laminating, slitting and printing of aluminum-based specifications.

Datwyler Bolsters Presence in India

Datwyler, the Swiss-based specialist supplier of drug packaging solutions and medical devices has expanded its plant in Pune, India.

In the FirstLine production the elastomeric components are manufactured in cleanroom conditions according to ISO 15378 quality standards.

Completion is expected by the end of 2017 and first samples will be supplied to market by July 2018.

The facility underlines the company’s commitment to India and acknowledges the country’s role in the global pharmaceutical market.

The expanded facility will manufacture according to the First Line concept, making India the first market in APAC region to incorporate this standard.

Strategic vision

The facility plays a substantial part in Datwyler’s efforts to cater to regional and global markets. Once the production site is fully operational, the facility will cover approximately 58,000 sq. ft. and will create up to 500 jobs, which will be staffed by members of the local community.

Product portfolio

Set against the background of the ever-evolving requirements for drug packaging, Datwyler provides a unique range of future-proof health care sealing solutions and services for primary and secondary packaging.

This includes the most advanced elastomer formulations, proprietary coatings, sterilization options and aluminum seals for high-efficiency production lines, which not only meet the demands of current pharma trends, but go beyond them.

In India, Datwyler’s core business consists of container closures. Manufacturing close to four billion components for vials, pre-filled syringes, and diagnostic devices per year, the Pune facility plays an increasingly strategic role for the company.

India in a global pharmaceutical market

In recent years, the Indian pharma and healthcare market has become increasingly important for global manufacturers, suppliers and customers.

Rahul Dev, Vice President India, Datwyler, said, “The Indian market is of strategic value to Datwyler and our market share is quite substantial. We are currently supplying to the top ten pharmaceutical companies and global players in the region. For this reason, we are expanding our presence in India. We invest in growth and believe it is one of the core strengths of the Indian market – and of Datwyler.”

Datwyler’s First Line manufacturing concept for high-quality elastomer components is based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection and a unique validated washing process.

Datwyler’s facilities aligned with the First Line manufacturing standard are specially designed and operated under a zero-defect philosophy.

The process flow, gowning protocols, personnel and material flow, and state-of-the-art technology and automation all result in the lowest endotoxin, bioburden, particulate and defect levels available in the industry.

This innovative approach to manufacturing exceeds the most stringent quality standards of the European and US regulatory authorities and is certified to ISO 15378.

Celltrion Prepping to Enter US Generics Market

Celltrion Pharm's facility in Ochang, North Chungcheong Province has been audited by the US FDA.

Celltrion Pharm has received an FDA facility inspection in Korea ahead of a first venture into the US generics market.

Celltrion is one of only a handful of successful biosimilar developers in the US having seen its version of J&J’s Remicade (infliximab), Inflectra, approved by the US Food and Drug Administration (FDA) and commercialized through its partnership with Pfizer.

But the South Korean manufacturer is now looking to enter the US generics market, spokesperson Gunhyuk Lee confirmed.

“Celltrion Pharm has been preparing [its] generic manufacturing and [was] just inspected by FDA,” he told us.

“This is the first case and first venture with generic drugs into the US market for Celltrion Pharm.”

Lee was unable to disclose further information regarding the type of generic Celltrion was looking to bring to the US, or any details of potential partners.

The facility visited by FDA inspectors is a chemical pharmaceutical production plant in Ochang, North Chungcheong Province, about 100km east of the firm’s FDA approved biomanufacturing plants in Songdo, Incheon.

The site, which received cGMP approval from Korean regulators MFDS in 2015, makes over 10 billion tablets for vascular, mental and digestive diseases per year, according to Lee, with extra space available. The 413,614 (38,440m2) space employs close to 600 staff.

If successful, Celltrion would become the latest Korean small molecule generic firm to enter the US. Earlier this year, Daewong launched a version of AstraZeneca’s antibiotic Merrem (meropenem), making it the first Korean generic in the US.

Central Institute for Translational Cancer Research, Technical University of Munich

The Central Institute for Translational Cancer Research (TranslaTUM) is a new interdisciplinary research building officially inaugurated at the Technical University of Munich in September 2017.

The building was developed by the Free Federal State of Bavaria with the support of the German Federal Ministry of Education and Research.

Developed at a cost of €60m ($71.64m), the facility received a €24m ($28.65m) contribution from the Federal Government of Germany.

TranslaTUM building design and features

The six-story, S-shaped TranslaTUM research building has a total floor space of 60,256 sq. ft. (5,600m²). It features an entrance hall with an open and curving staircase.

The facade of the building is arranged horizontally with a number of long, thin windows. It also includes white, grooved ceramic plates, which highlight the wave-shaped structure.

Public areas include a cafeteria, a seminar area, and an auditorium.

The building features 43,040 sq. ft. (4,000m²) research labs, which can accommodate up to 230 researchers.

Designed to carry out research in translational oncology, the facility is constructed adjacent to the Technical University of Munich’s (TUM) hospital Klinikum rechts der Isar to support rapid translation of novel knowledge and technology into patient care. It provides physicists, engineers, and physicians with a shared new laboratory for transdisciplinary research.

The facility’s staff will focus on tumor diseases of bone marrow and the digestive tract, exploring the process of recognizing and sending molecular signals in tumor cells. They will also study the impact of cancer cells on the immune system with the help of new imaging and analysis methods.

The facility will allow collaboration among different disciplines including biology, biomedicine, biochemistry, physics, engineering sciences, and doctors in clinics.

The facility includes a 700m² seminar and conference area, as well as an underground garage with 50 parking spaces.

Technology at TranslaTUM research building

The TranslaTUM research building has core facilities including imaging, preclinical research, and cell analysis. It also features state-of-the-art laboratory equipment in core facilities including a central sequencing unit, a microscopy unit, a histology lab, and a central bioinformatics unit.

The facility is equipped to offer a broad variety of imaging studies using established and validated methods such as good manufacturing practice (GMP) produced radiopharmaceuticals. The imaging infrastructure at the facility includes magnetic resonance (MR), multi-spectral optoacoustic tomography (MSOT), ultrasound (US), positron emission tomography (PET), single-photon emission computed tomography (SPECT), computed tomography (CT), and phase contrast-CT technology.

The laboratory at the facility is in compliance with S2-biolevel safety standards. A 7,532 sq. ft. (700m²) area is designed for animal holding, where mice and rats can be retained in sealed rooms. These comply with animal welfare and hygiene standards, and are equipped with high-efficiency particulate absolute (HEPA) and odor filters to stop the spread of incoming or outgoing particles.

Construction of the new research building began in 2014 and the first floor of the building was completed in July 2015. The topping out ceremony was held in November 2015.

doranth post architekten was awarded a contract to provide designs for laboratories, offices, the seminar area, the cafeteria, and underground parking in the research building.

GE Healthcare Wins Oligo Fit Out In China

RiBoBio has chosen GE Healthcare to equip its oligonucleotide API facility in Guangzhou, China.

Under the agreement, GE Healthcare Life Sciences will install its laser-based, cell imagine technology – IN Cell Analyzer 6500HS – and its ÄKTA OligoProcess platform, used to synthesize kilogram quantities of oligonucleotides.

Oligonucleotides – chemically synthesized short nucleic acid polymers designed to fuse with DNA or ribonucleic acid (RNA) sequences – are designed to treat infectious, and genetic diseases, as well as some cancers.

According to RiBoBio, the firms aim to “jointly build Asia’s largest oligonucleotide drug development and manufacturing facility in China.”

A RiBoBio spokesperson said the site will not uniquely target Chinese firms.

“RiBoBio will make oligonucleotide APIs [active pharmaceutical ingredients] to provide CDMO [contract development and manufacturing organization] services for clients worldwide,” said the spokesperson.

The firm did not disclose the cost of the facility, but said it expects the site to be operational by the end of 2018.

US oligo boost

The US has shown an increased interest in oligo treatments, with recent facility expansions in central and north-east states.

In August, 2016, Agilent announced plans for a nucleic acid API manufacturing plant in Colorado, and in July this year, Nitto Denko Avecia said it would launch its expanded oligo API facility in Massachusetts.

GE Healthcare and CordenPharma also announced a strategic agreement for oligonucleotide development in July, under which GE Healthcare’s Dharmacon will offer early-phase, and CordenPharma later phase, services.

Reddy’s Laboratories to Utilize GE Healthcare’s FlexFactory Manufacturing Platform

GE Healthcare has announced that Dr. Reddy’s Laboratories will be installing India’s first-ever FlexFactory, a single-use manufacturing platform to expand the biologics production capacity at its facility in Hyderabad, India.

FlexFactory will make Dr. Reddy’s biopharmaceutical manufacturing set-up more flexible and efficient, strengthening the company’s position in the global biosimilars market and allowing Dr. Reddy’s to continue increasing patient access across the world for biotech-based therapies.

The new FlexFactory will help Dr. Reddy’s increase its capacity to meet both the expected growth of its currently marketed biosimilars, as well as support the launch of a significant portfolio of new biosimilar products in the years to come.

With FlexFactory, Dr. Reddy’s will be able to increase its manufacturing capacity swiftly as the overall project set-up timeline for FlexFactory is typically nine to 12 months.

FlexFactory enables Dr. Reddy’s transition from stainless steel to single-use technologies that bring enhanced flexibility and efficiency into their manufacturing set-up. Single-use technologies facilitate multi-product manufacturing and improve productivity by increasing the number of lots manufactured, as the change over time between products can be reduced by 50% or more.

Head of biologics at Dr. Reddy’s Laboratories Cartikeya Reddy said: “We are delighted to be working with GE Healthcare to expand our biologics manufacturing footprint. We strongly believe that the FlexFactory platform from GE will enable us to rapidly ramp-up capacity and serve more patients in both emerging markets and highly regulated markets.”

Country manager of South Asia at GE Healthcare Life Sciences Milind Palsule said: “We are pleased to partner with Dr. Reddy’s in their efforts to increase the availability and affordability of biopharmaceuticals globally by bringing single-use, flexible manufacturing capacity to its facility in Hyderabad. India today has one of the fastest growing biopharma sectors in the world and we are keen to support this development and the production capability of Indian pharma players with the latest biopharma technology and know-how.”

About FlexFactory

GE Healthcare’s FlexFactory is a centrally automation integrated, flexible biomanufacturing platform. It allows manufacturers to quickly and seamlessly establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility.

FlexFactory is designed to help manufacturers such as Dr. Reddy’s to rapidly respond to regional healthcare needs to quickly bring lifesaving treatments to the global market.

This unique manufacturing platform is currently in operation throughout the world including Asia, Europe, and the US, offering a consistent platform for collaboration or transplant to other facilities. GE Healthcare’s Fast Trak Center has sites across the world including Bangalore. It will be providing training on FlexFactory equipment and technologies for Dr. Reddy’s personnel.

FlexFactory is primarily comprised of single-use technologies and associated process hardware and integrated with automation and control components for start-to-finish manufacturing of biopharmaceuticals.

Depending on current processes, FlexFactory can reduce carbon dioxide emissions by up to 75% and water and energy usage by approximately 80%.

Dr. Reddy’s Laboratories is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its pharmaceutical services and active ingredients; global generics; and proprietary products businesses, Dr. Reddy’s offers a portfolio of products and services including active pharmaceutical ingredients (API), custom pharmaceutical services, generics, biosimilars, and differentiated formulations.

The company’s major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy’s operates in markets worldwide and its major markets include the US, India, Russia, Commonwealth of Independent States (CIS) countries, and Europe.

Corning Set To Expand Capacity to Tap Pharma Opportunities

Corning says it is planning to increase manufacturing capacity for its Valor Glass packaging technology to take advantage of a multi-billion dollar industry.

In August, Corning launched Valor Glass which had been tested as a packaging solution for injectable drugs in vials and cartridges through collaborations with Big Pharma firms Pfizer and Merck & Co.

The glass is being supplied through contracts with Italy-based Stevanato Group and Germany-headquartered Gerresheimer, but speaking at the Credit Suisse 21st Annual Technology, Media & Telecom Conference, Corning CFO Tony Tripeny said it will soon up capacity.

“[Corning is] in the process of finalizing plans for manufacturing capacity and we will be announcing more details in the coming months,” he told investors.

He described Corning’s Valor Glass as “a revolutionary breakthrough in pharmaceutical glass packaging technology,” which improves pharmaceutical manufacturing by “dramatically reducing particle contamination, breaks and cracks by significantly increasing throughput.”

As such he said it represents “an outstanding opportunity” for Corning to build on its base life sciences business and build a “new long-term multibillion-dollar franchise” within the pharma packaging sector.

“Although, this industry moves at a deliberate pace we believe Valor has the potential the power Corning growth for the next decade and beyond. The industry is excited about our innovation and announcements and we continue to make strong progress.”

Back in June, Corning said it makes around $800m annually from the life science space, but the market opportunity is as much as $12bn and growing.

“The current market for pharmaceutical packaging is $4bn and growing at 5% annually. In addition, the industry spends another $8bn each year on issues associated with glass quality. In total, that’s a $12bn addressable opportunity,” said CEO Wendell Weeks, at the time.

Samsung Biologics Says 180,000L Plant Is Completed but Not Validated

The Korean CDMO says construction of its third – and largest – biomanufacturing facility is complete with the validation process expected to take a year.

Samsung BioLogics has completed the $740m construction of its third facility at its site in Songdo, Incheon, the firm said.

The site brings an additional 180,000L of stainless steel bioreactor capacity to the two operational plants on the site, and will, once validated, become the largest single bioproduction site in the world, overtaking Samsung BioLogics plant number two which boast 152,000L of capacity.

The CDMO stated on its website that “all the procedures related to mechanical building” were completed on November 30 and the plant will now undergo validation in a process expected to take a year.

The firm also rejected an apparent market rumor that a completion ceremony planned for the facility was cancelled ‘due to personnel problems,’ saying: “Since No.3 plant has to be validated for one year after mechanical completion, we did not schedule a separate building completion ceremony from the beginning.”

It added completion ceremonies did not take place following the construction of the 1st and 2nd plants at the site. The firm’s second plant was completed last year and recently received its first approval for the manufacture of a monoclonal antibody drug substance by the US Food and Drug Administration (FDA).

Once the third plant is validated, Samsung BioLogics will boast a total of 362,000L of mammalian cell culture capacity at the site, but in October CEO TH Kim said his firm is already considering constructing a fourth facility but this time outside of Korea.

“Considering the growing needs of our clients for tax reasons and geographic risk management, there is a lot of demand to build a plant out of Korea,” he told delegates at the CPhI Preconnect Congress in Frankfurt.

“We are seriously considering building a future plant out of Korea, hopefully in Europe or America, near to our clients.”

Gerresheimer’s TE-ring Production to Commence

Gerresheimer has announced that production of its US dropper bottles with a fixed TE-ring will be operational in Q3.

Produced in Poland, India and the US, the TE-ring is fixed to the Type A Eye-Dropper Bottle to meet new US Food and Drug Administration (FDA) regulations

Global executive vice-president at Gerresheimer Plastic Packaging Niels Düring said: “It’s often the technical details that add the finishing touches to packaging.”

The US Food and Drug Administration (FDA) now stipulate that the TE-ring must be firmly attached to the bottle. This product change was very easy to make, due to experience with the type B dropper bottle, which already has a fixed TE-ring.

Only minor adjustments were made to the design, while the dimensions, properties, and the materials are the same. The bottle and the dropper are made from low-density polyethylene (LDPE) and the cap from high-density polyethylene (HDPE). The existing type A dropper bottles can therefore be used for stability tests.

Gerresheimer produces type A dropper bottles holding 2ml to 360ml under cleanroom conditions. Depending on the size of the container, they are produced using the injection blow molding (IBM) or the extrusion blow molding (EBM) process. Radiation or ethylene oxide (ETO) sterilization is possible on request. All caps protect the original contents and can also be supplied with a child-proof screw cap.

Bio-Investment Boasts Do Not Diminish Brexit Uncertainties

The UK government has outlined its industrial strategy as it prepares to leave the European Union and boasts of investments and collaborations driving the life science sector.

The result of the referendum held last year, followed by the triggering of Article 50 of the Lisbon Treaty in February, launched the UK on a two-year unchartered journey to exit the European Union (EU).

With exit negotiations ongoing, the UK government has published a white paper setting out a long-term plan to boost the productivity and earning power, and high-lighted the life sciences sector as a current area of strength it thinks can grow post-Brexit.

“The UK is home to world-leading businesses such as GSK and AstraZeneca, a strong small and medium-sized business sector, major health charities such as the Wellcome Trust and Cancer Research UK, and the globally-admired NHS,” the roadmap states.

“We must build on our strengths, as exemplified by sectors such as… life sciences. Their success has often been enhanced through collaboration – by businesses, the government, research institutions, universities and colleges – to align policies, enhance investments and create sector-wide institutions.”

UK Investments

During this transition period, the government has been eager to publicize examples of Biopharma investment, referencing Novo Nordisk’s £115m ($154m) planned research center in Oxford and two new deals in this week’s white paper.

MSD (known as Merck & Co. in North America) is planning to open a life sciences discovery research facility bringing 950 jobs to London, while Qiagen is partnering with Health Innovation Manchester to develop a genomics and diagnostics campus.

In a statement, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said: “These deals are just the first steps but will be instrumental in securing the future strength of the UK life sciences industry, helping the UK economy prosper and allowing NHS patients to get better and faster access to world-class medicines discovered and developed here in Britain.”

But while the investments were hailed as “a huge vote of confidence” by UK business secretary Greg Clark, they are not quite as transparent as they seem.

It turns out the Qiagen partnership is yet to be finalized as a tweet Monday revealed the molecular diagnostics firm is still in discussions with Health Innovation Manchester:

“We appreciate the enthusiasm and support of the UK government, and their announcement about the new industrial strategy, but note that discussions are not yet completed,” the firm said.

Moreover, some of the examples heralded as evidence of boosts for the economy had been in the works long before the non-binding vote of June 2016.

Novo Nordisk was pushing through with a pledge made before the June 2016 referendum, encouraged in part through the generous ‘patent box’ incentive. Introduced in 2013, the incentive offers a generous R&D tax credit and cuts corporation tax rates on income generated by products patented in the UK.

Similarly GlaxoSmithKline’s announcement that it was investing £275m into its UK manufacturing network weeks after the referendum was just the continuation of its strategy at the time, rather than a specific “boost to post-Brexit economy” as touted by pro-leave media outlet The Daily Telegraph.

(In August, GSK shelved plans for a new facility in Ulverston and considered the sale of its cephalosporin antibiotics business, but said the UK’s decision to withdraw from EU did not play a decisive factor).

The uncertainty surrounding the UK and its attractiveness once it leaves Europe has actually halted investment and collaboration.

Fellow UK-headquartered Biopharma giant AstraZeneca has chosen to wait on the outcome of Brexit negotiations before committing to mid-to-large scale investments in the country. Like others, it has also voiced its concerns around regulatory matters in a non-EU Britain, and last week’s decision to move the EMA out of London only brings the certainty that European drug regulations will come out from Amsterdam.

The Telegraph (once again) reported Johnson & Johnson has pulled out of plans to build a JLabs R&D innovation site near Cambridge “over concerns that the UK is both politically and economically weak while negotiations to leave the European Union are ongoing.”

Micronclean Expand Into India

The Indian pharmaceutical market is expected to grow at over 15% per annum between 2015 and 2020 and currently accounts for 20% of the world’s volume in pharmaceutical products.

Micronclean’s expansion plans seek to leverage their existing knowledge and experience in both the cleanroom supplies and laundered garments arena to offer improved products and services to the Indian market.

In the field of cleanroom supplies Micronclean has recently entered into a joint-venture agreement with Span Divergent Ltd to establish Biospan Contamination Control Solutions which will sell Micronclean’s existing range of fully accredited cleanroom products into the Indian market.

To support the launch of the joint-venture the company is exhibiting at CPHi/PMEC exhibition in Mumbai which is the premier Indian Pharmaceutical exhibition.

In a separate development Micronclean has recently incorporated Micronclean India Private Limited.

This is the first formal step in Micronclean’s program to build an ISO5 cleanroom laundry in Bangalore, offering a laundered cleanroom garment service to the pharmaceutical companies in the region.

Micronclean’s cleanroom garment service will be a first for the Indian Market and builds on the knowledge and experience Micronclean have from running their existing ISO4 cleanroom laundry in the UK.

Simon Fry, Micronclean CEO, said: “Micronclean has an established reputation for quality and service within the UK market for both cleanroom consumables and for decontaminating cleanroom garments and we are using this knowledge and experience to target the growing Indian pharmaceutical market.

“As a company, we are fully aware of the challenges that lie ahead but we are confident that we can deliver both of these strategic developments to deliver business benefits both in India and back in the UK.”

McIlvaine Company

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