Catalent Pharma Solutions broke ground for a new $34 million expansion to its Madison, WI biologics manufacturing facility. When completed, the additional 22,000 sq.-ft. of space will accommodate a new 2 x 2,000 liter single-use bioreactor system, allowing the company to support late-phase clinical and commercial production of up to 4,000 liter batches. The new footprint will also support expansion of analytical and process development labs, as well as additional office space.

The Wisconsin Economic Development Corporation (WEDC) has awarded Catalent with as much as $1 million in state tax credits over the next three years.

“Our continued investment in biologics capabilities is in direct response to market demand, where underlying growth for large molecules is expected to exceed that for small molecule drugs,” said Barry Littlejohns, Catalent’s president of Drug Delivery Solutions. “We are immensely proud of our facility, and the people here in Madison who have helped achieve our customers’ program milestones and move toward larger commercial programs.”

Catalent’s Madison facility, opened in April 2013, is home to the company’s GPEx cell line technology used to create high-yielding mammalian cell lines. Catalent provides development, manufacturing and analytical services for new biological entities (NBEs) and biosimilars from the site.

Prudential Builds Cleanroom Laundry in Nashua, New Hampshire

U.S. based Prudential Overall Supply, a leader in cleanroom laundry service systems, has broken ground on its Nashua, New Hampshire cleanroom and industrial laundry processing facility.

Prudential is headquartered in Irvine, California, and this new project comprises a 131,371ft2 commercial laundry facility to be located at 45 Simon Street, Nashua, NH on a 14.23-acre tract.

It will consist of a one-story facility that will be built in three phases and will include offices, industrial space, employee areas and loading docks with 136 parking spaces on site for staff.

A 70,091ft2 building will be built during the first phase. That will be followed by a 45,000 ft2 section and, lastly, a 16,280ft2 addition. The building will occupy 12.2 acres of the site.

The Engineering contract was awarded to American Laundry Systems of Haverhill, MA, the civil engineer contract was awarded to Hayner/Swanson of Nashua, NH and the construction manager contract was awarded to Dacon Corporation of Natick, Mass.

Prudential’s President, Tom Watts said: 'Our team is thrilled to be building our newest facility in Nashua. The location will provide our Northeast customers with additional products and service offerings, and will help with our company’s expansion into additional markets.'

'We are very pleased to welcome Prudential Overall Supply to Nashua,' said Commissioner Jeffrey Rose of the New Hampshire Department of Resources and Economic Development.

'The capabilities it provides are vital to the many companies whose advanced manufacturing processes require high tech industrial laundry services. We look forward to watching them grow and prosper in New Hampshire.'

Datwyler’s Elastomer Components Manufacturing Facility, Middletown, Delaware

Switzerland-based industrial supplier Datwyler has announced a CHF100m ($102m) investment in a new elastomer component manufacturing plant in Delaware, US.

The proposed plant will be located in Middletown in Delaware and it will manufacture elastomer components for injectable drug delivery systems. It will be the company's second manufacturing plant in the US, while its first plant has been in operation since 1981.

Construction on the new plant is expected to begin before the end of 2016 and it is scheduled for completion in 2018. First production is expected by H2, 2018. The plant will create 120 jobs when fully-operational.

The manufacturing facility will have a built-up area of more than 275,000ft². Civil Engineering Associates has been chosen to provide designs and engineering services for the project.

Datwyler's new plant will be designed and constructed in accordance with the company's FirstLine standards, which includes the use of state-of-the-art systems comprising ultra-modern clean room, automated production cells, fully-automated camera inspection, and a unique washing process during production.

The innovative manufacturing concept helps deliver high-quality products, which exceed European and U.S. quality standards. The FirstLine process is also certified to ISO 15378 standards.

Adoption of the innovative technology is expected to also enable the company to supply locally-made high-quality elastomer components to customers in Europe and Asia.

Datwyler's sealing solutions for drug delivery systems include elastomeric closures for vials, elastomeric plunger stoppers, needle shields and tip caps to seal prefilled syringes, and plungers and rubber-lined aluminum seals for cartridges.

The company makes 13mm-32mm rubber stoppers, and aluminum caps and seals for glass vials used in the pharmaceutical industry.

The aluminum caps come in a number of design choices including flip and flush for smaller sealed vials, and finger and tear-off designs for large volume vials.

In addition, Datwyler makes pre-filled syringe components using advanced formulations based on halobutyl elastomers and lubricates them with silicon oil, with the option for a fluoropolymer coating for silicon oil-sensitive applications.

The Datwyler Group is an industrial supplier serving more than 100 countries and generating sales of approximately $1.21bn a year.

The group's sealing solutions division supplies customized solutions to a number of industries including automotive, healthcare, civil engineering, and consumer goods. Apart from solutions for drug delivery systems, the division makes components used in enhanced processing, medical devices and compounds in the healthcare industry.

The group also has another division named the technical components division, which distributes electronic and ICT, as well as automation components and accessories in Europe.

University of Michigan to Expand Medical Discovery Facility

Eight years ago this month, silence fell over a vast pharmaceutical research campus in northeast Ann Arbor. But today, it's a bustling part of the University of Michigan, which has spent recent years putting its laboratories, offices and event spaces back to good use.

Now, the last two empty buildings on the site will take on a new life, through a $78.5 million renovation project approved today by the U-M Board of Regents.

The U-M Medical School will use the space to create more than 50 modern research laboratories for its faculty scientists and their teams, and spaces for them to connect with one another to fuel discoveries about many diseases.

The project will renovate the last two usable buildings – called 20 East and 25 -- at what U-M calls the North Campus Research Complex.

Built by Parke-Davis in 1960 and 1984, respectively, the two structures at the heart of the NCRC campus already have many features that medical research buildings need. U-M will also repurpose lab benches, cabinets and other materials salvaged from areas of NCRC that it has already transformed.

As a result, the creation of nearly 101,000 square feet of renovated laboratory space will cost less than half what it would cost to build a new research building. It will even cost less than a typical lab renovation, while allowing the Medical School to grow its research base using its own financial resources.

The new labs will group researchers working on similar topics into "neighborhoods", with room for both labs and offices where teams can analyze the vast amounts of data that modern medical research generates.

The project will also give all researchers at NCRC a new gathering space, with a two-story atrium filled with natural light. A new two-story connector will make it easier for many at NCRC to navigate the interconnected buildings and connect with one another as they go.

"This is a major milestone in our progress toward redeveloping NCRC, and transforming it from an outpost of the university to a magnet," says NCRC executive director David Canter. "We're on track to achieve 100 percent utilization of the site's existing buildings by 2019."

Already, 2,700 people work at NCRC – a number that Canter projects will grow to 3,400. That's far more than worked there during its pharmaceutical heyday.

Canter also notes that in recent years, the Plymouth Road business corridor near NCRC has added new restaurants, shops and services in parallel with U-M's growing use of the site.

Other NCRC Projects Under Way

The other two major projects now under way at NCRC include an effort to create a new clinical pathology testing facility that will analyze blood samples and other specimens from patients at the U-M Health System, and a $3.8 million plan to turn a former drug manufacturing building into U-M academic archive space.

The same advanced climate control systems, multi-story storage and wide corridors that Pfizer once needed to create, package and ship promising new medicines will serve U-M's needs well too. The university will conduct a modest renovation to Building 550 to create a modern storage facility for several units on campus, including the Bentley Historical Library; William L. Clements Library; Museum of Art; School of Music, Theatre & Dance; and University Library. The space will provide a modern and stable environment for the preservation of these units' collections.

"Great universities by their nature have collections, which are an immense source of potential new knowledge, and must be accessible for academic research," says Canter.

The new projects will add to the already thriving community at NCRC made possible by strategic planning that began soon after U-M bought the 174-acre site and its 28 buildings in June 2009. The community includes:

Hundreds of researchers from U-M and the VA Ann Arbor Healthcare System who make up the Institute for Healthcare Policy and Innovation
Dozens of labs and offices for researchers studying cancer, cardiovascular diseases, material sciences, innovative medical devices, drug discovery, critical care, bioinformatics, and critical care
The M-City complex, built on formerly vacant land, where U-M and industry researchers can test autonomous vehicle systems on a closed test track, as well as offices for researchers from two of those companies, Ford and Denso
More than a dozen startup companies that grew out of U-M research, and lease space in the U-M Venture Accelerator run by the Office of Technology Transfer; as well as one larger company, Lycera, which has roots at U-M
Shared facilities and equipment that researchers from across U-M can use to study DNA, cells, nano-scale materials, living systems and biological samples
Offices that help U-M researchers conduct clinical and pre-clinical research, and provide essential laboratory, library and information technology services
Amenities from child care, a seasonal farmers market and a fitness facility to art exhibits and a cafeteria that gives local restaurants "pop up" opportunities and event space for U-M and U-M-sponsored groups.
Attention to environmental sustainability, from recycling and composting to public and shared transportation, and a DTE solar panel array.

Air Liquide to Build New Specialty Ingredients Production Facility

Air Liquide has announced that its subsidiaries Seppic, healthcare specialty ingredients manufacturer, and Schülke, hygiene specialist, broke ground on a green-field state of the art production facility in Sandston, Henrico County - Virginia, United States. Expected to start operations in the first half of 2018, the planned investment is over $60 million and will create approximately 50 new jobs in the community.

This new production facility will manufacture ingredients for the cutting-edge cosmetic and pharmaceutical global markets. The market for personal care specialty ingredients is worth more than $10 billion globally, of which the U.S. represents 25 percent.

With this facility, the two companies will strengthen their proximity to American customers. The facility is located in the Northeast of the U.S., where the majority of the companies’ customers are. It will be run by a joint venture between Seppic and Schülke, named Polykon Manufacturing. Their resulting synergies will enable to create additional value in their field of expertise while addressing the growing need for innovations in these markets.

François Jackow, member of the Air Liquide group’s Executive Committee, supervising the Healthcare activities, said: “Seppic and Schülke have a long presence in the United States serving leading health and beauty care customers. This first manufacturing unit for the two companies in the U.S. will extend their innovative potential and enlarge their industrial footprint and proximity with customers within North America, while strengthening their manufacturing capabilities globally. With this investment, Air Liquide pursues the development of its Hygiene and Specialty Ingredients activities, thus strengthening the Group’s Healthcare business in this region.”

Cambrex API Facility Expansion, Charles City, Iowa

US-based innovative life sciences company Cambrex Corporation completed a major expansion of its active pharmaceutical ingredient (API) facility in Charles City, Iowa, US, on 12 July 2016.

The Charles City facility is one of the very few facilities in the US to be authorized by the US Drug Enforcement Administration to import narcotic raw materials on a commercial scale.

The $50m Pharma 3 expansion project has added production and warehouse facilities to the existing plant, as well as increased the production capabilities of the facility to meet the growing demand for Cambrex's APIs.

Initiated in February 2015, the project is the second significant expansion of the Charles City facility undertaken by Cambrex since its acquisition in 1991. The expansion also laid the groundwork for another expansion called Pharma 4, which Cambrex plans to undertake during 2017-2018.

The Charles City facility is spread over a 45-acre site in North Central Iowa, and produces a range of APIs and intermediates for pharmaceutical and biotech industries. Cambrex has invested more than $125m in the facility since 1991, to meet the growing demand and also to expand its product portfolio of small molecule and APIs.

The facility consists of three large-scale commercial cGMP manufacturing facilities, pilot plant facilities with different materials of construction, high-potency development center for ECB 4 chemical development, research and development (R&D) labs, warehouse, and analytical labs.

Equipment installed at the facility include 300gal and 100gal glass lined reactors, 300gal stainless-steel reactor, 100 gal Hastelloy reactor and cGMP Kilo labs.

In addition, the facility includes a high-potency development center with controlled access, micronization, drying and packaging units, and analytical and chemical labs. The center is equipped with 48 reactors of 94,000gal capacity, ten centrifuges, ten dryers, thin film evaporators, water injection system, and wastewater treatment unit.

Cambrex added a 7,000ft² (650m²) temperature-controlled facility in 2013 to increase API manufacturing capabilities. The expansion added 40,000gal of reactor capacity to the plant.

The Pharma 3 project added a 7,500ft² multi-purpose manufacturing facility with a 17,000ft² (1,579m²) first floor and a 16,000ft² (1,486m²) second floor. The facility is installed with 70m³ of glass-lined hastelloy reactors varying from 7m³ to 16m³ in size.

The hastelloy reactors will facilitate the handling of APIs at an occupational exposure limit (OEL) of down to 1µg/m³. The facility is also equipped with 6m² hastelloy filter dryers to facilitate multi-purpose centrifugation.

The project also added a new 45,000ft² (4,180m²) pre-engineered Ceco warehouse to accommodate the storage of raw materials and finished products. The warehouse has a storage capacity for 2,720 pallets and segregated 2-8oC refrigerated storage for 360 pallets. It is equipped with a state-of-the-art barcode system to facilitate automated bin location.

The cGMP-compliant, temperature and humidity-controlled facility includes a 7,500ft² (696.6m²) dedicated office area and a sampling room for safe extraction and handling of flammable materials.

The Pharma 3 project added a 7,500ft² (696.6m²) manufacturing shell to the Charles City facility as part of another planned expansion called Pharma 4. The final design of the manufacturing facility and equipment to be installed will be based on customer specifications. Construction of the manufacturing shell as part of the Pharma 3 project will reduce the lead time in bringing the new facility online.

Based on the capacity utilization of the Pharma 3 project, the timelines for the Pharma 4 project will be decided by the end of 2016 or early-2017.

Dean Snyder Constructions was contracted to provide construction services for the project.

BD Expands Nebraska Insulin Syringe Plant

Becton Dickinson says it is upgrading equipment and technology at its Holdrege manufacturing facility to better serve the global diabetes market.

The site in Holdrege, Nebraska produces over two billion insulin syringes per year – or around 250,000 per hour, nonstop – but a $100m (€89m) investment will increase capacity further, according to a BD spokesman.

“We aren’t disclosing specifics around the equipment or capacity for competitive reasons, but we can tell you that the new equipment and technology upgrades help improve overall manufacturing efficiency and helps ensure we continue to stay on the leading edge of insulin syringe production,” said Troy Kirkpatrick.

“The insulin syringes manufactured in Holdrege for sold through pharmacies directly to people with diabetes who inject insulin as part of their diabetes management regimen. So we are adding additional capacity to serve the broad diabetes market.”

The 350,000 sq. ft. facility currently employs over 650 workers and makes 20 different BD drug delivery and medical products.

While BD does not manufacture the insulin for these delivery devices, Kirkpatrick said the firm works with a number of pharma companies to develop pre-fillable syringes for patients with specific therapies.

“We also have other types of collaborations, where we manufacture a specific insulin syringe for a specific type of insulin,” he added. “We are currently collaborating with Eli Lilly on a new U-500 syringe that will be prescribed for use with Humulin R U-500 insulin, manufactured by Eli Lilly.”

BD has a long history in manufacturing insulin syringes, having first produced such devices in 1924. More recently, the firm has been developing systems with autoshields and smaller needles for safety and convenience.

And according to Kirkpatrick, for patients with diabetes, the “type of needle and proper injection technique can be just as important for outcomes as using the right type of insulin and diet.

“Syringe and needle selection, along with proper injection technique are a very important part of proper diabetes management.”

IMARC Research Expands

IMARC Research, an Ohio-based contract research organization (CRO), has expanded its footprint in the medical device market with a new office in Minneapolis, MN.

“Minneapolis/St. Paul is a vibrant medical device market, which is IMARC’S main market focus,” said John Lehmann, Director of Business Development, IMARC, adding that the company has key accounts in the market.

“IMARC is focused on the medical device market and has experienced tremendous growth with both mid-size and large companies who are seeking outside CRO support,” added Lehmann.

The CRO works in a variety of therapeutic areas, but according to Lehmann, most of the company’s growth is coming from the cardiovascular (interventional, peripheral and vascular), in-vitro diagnostic, wound care, and orthopedic markets.

Lehmann added that the company is focused on continued growth, and the expansion into the Minneapolis market is part of that plan. “We also plan on expanding business opportunities with our existing accounts and adding new clients to our roster,” he said.

IMARC recently also expanded its services offering to include data safety monitoring boards and clinical events committees, expanded its training offerings, and has grown its staff to meet the demand.

Biotrial Opens Headquarters in North America

The French contract research organization, Biotrial, has opened a new Phase I unit designed for early development studies in North America.

The company – most recently in the headlines after one volunteer died and five others were hospitalized during a Phase I clinical trial conducted by the CRO – opened the new 60,000 sq. ft. facility in Newark, New Jersey’s University Heights Science & Technology Park (UHSTP).

The park includes five universities and other biomedical organizations, including the New Jersey Institute of Technology’s Enterprise Development Center and its 90 incubator companies.

The 110-bed Phase I unit was designed for various early development studies, including first-in-human (FIH) trials, pharmacodynamic studies, food interaction trials, drug-drug interaction studies, and bioequivalence and bioavailability trials.

The facilities feature an EEG and sleep study ward in addition to areas for cognitive testing.

The company announced a successful third-party audit of the Clinical Pharmacoogy Unit in July, during which the facility and its staff were found to be in compliance with applicable FDA regulatory requirements.

According to the company, the audit was conducted over a two-day period and included an overview of the organization and personnel as well as a tour of the facilities.

Biotrial’s COO, Nicolas Fauchoux, commented in the company’s release: “Since setting up the unit earlier this year, we’ve had numerous sponsors come and audit our organization. These audits allowed us to confirm that our setup is in line with current regulations, guidelines and business practices. However, the outcomes of these audits are confidential.”

As listed on the company’s website, Biotrial is currently hiring for several positions at the location, including a director of business development, clinical research pharmacy manager, core lab EEG technician, and clinical project manager.

WuXi Boosts Capacity with New Facility

WuXi Apptec has opened a facility in Philadelphia offering chimeric antigen receptor T (CAR T) cell therapy manufacturing.

The 45,000 sq. ft. plant is the third at the Philadelphia Navy Yard, Pennsylvania site and bolsters the Chinese CDMO’s current cGMP cell therapy capabilities which include a 50,000 sq. ft. facility for allogeneic and autologous cell-based therapeutics commercial manufacturing.

The new plant will focus on cell therapy products that use viral vectors such as CAR T cell therapies offering up large scale production in 2,000L single-use bioreactors.

“Advanced therapies like CAR T-cells and gene therapy vectors offer significant new therapeutic options for cancer patients and those suffering from crippling genetic diseases,” said WuXi’s CEO Ge Li in a statement.

“We are pleased to be the forefront of this field, providing our partners with cutting-edge cGMP manufacturing capabilities and capacities."

Spokesperson Sun Liyun was unable to disclose any information regarding demand for such services, or the investment ploughed into the site when asked by this publication. However, the facility is expected to add up to 200 manufacturing and support jobs when fully configured.

Speaking in March 2015 when commissioned, the firm told this publication the new plant supports growth in the cell therapy industry, which has come from the likes of deals by Kite Pharma and Cardio3 Biosciences. Specifically, the new facility will provide manufacturing capability and capacity to meet the rapidly expanding demand around clinical trials and commercialization.

The news comes just weeks after the firm opened a fully disposable perfusion plant in WuXi City, China – the first part of a $150m biomanufacturing investment which will include a biomanufacturing plant housing fourteen 2,000L single-use bioreactors for batch-fed cell culture.

UC Merced to Nearly Double its Size by 2020

To accommodate rises in its national stature and enrollment, UC Merced has embarked on an ambitious four-year expansion program that will add new academic, housing, and student-life facilities to its enlarged campus.

The University of California, Merced has launched a $1.3 billion expansion that will nearly double its physical capacity over the next four years, and support enrollment growth to 10,000 students, from around 6,700 today.

Its Merced 2020 Project will add 1.2 million sf in academic, housing, and student-life facilities. These will include three new teaching and research lab buildings, 1,700 new beds for on-campus housing, 1,500 new parking spaces, a student wellness center, and the expansion of the university’s childhood education center.

This project will add a new entrance to campus and transit hub to improve student circulation. Students will have new dining options, too, as well as a conference center for community and campus events, and NCAA-II class outdoor athletic and recreation fields and a pool.

The first of three phases broke ground on October 14, and the project will be completed in phases from the fall of 2018 through the fall of 2020.

UC Merced opened on 2005 in California’s San Joaquin Valley. It is the 10th and youngest school in California university system, but UC Merced is attracting more students and rising in national rankings. Last year, it received 22,000 undergraduate applications for 2,100 open spots. “We’re coming of age in a remarkably quick period of time,” Dorothy Leland, UC Merced’s Chancellor, told the Los Angeles Times.

Merced 2020 will increase the size of the campus to 219 acres, from 104 today. The university has signed a 39-year contract—approved by the University of California, Board of Regents in July—with Plenary Properties Merced (PPM), a private development consortium, to maintain major building operations at an annual cost of $10 million. PPM is responsible for the design, construction, operations, maintenance and partial financing for all new facilities added under the expansion program.

The development team includes Plenary Group (lead developer, equity provider, and financial arranger), Skidmore Owings & Merrill (campus planner), Webcor Construction (GC), and Johnson Controls (lead operations and management firm).

Merced 2020 is projected to produce a one-time benefit of $1.9 billion for the San Joaquin Valley and $2.4 billion statewide. It is expected to create hundreds of permanent jobs.

Alcami Announces New Highly Potent API Capabilities and Capacity

Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, announces its plans to expand capabilities for development and manufacturing of Active Pharmaceutical Ingredients (APIs) at its Germantown, WI facility.

Alcami plans to invest in 2016 and 2017 toward the enhancement of new and existing kilo labs to introduce the development and manufacturing of highly potent APIs. The two new fully qualified cGMP state-of-the-art Highly Potent API (HPAPI) production suites will focus on primary containment technologies with engineering controls designed to meet the established Occupational Exposure Limit (OEL) of minimally 0.03 µg/m³ (SafeBridge^® Category 3).

The 5,000 square foot renovation will be operational by Q1, 2017. The newly designed space will include up to 150L reactor scale with cryogenic capabilities to service a wide range of complex chemistries. These advancements position Alcami to meet the demands of a growing highly potent API market. Coupled with Alcami's established presence in the potent Drug Product market, this investment strengthens an industry leading end-to-end offering.

These advancements follow operational and technology enhancements across development, clinical and commercial manufacturing to increase production capacity by 50%. This positions Alcami's global API operations (Germantown, WI and Weert, The Netherlands) to meet the increasing demand of new clinical candidates, of which greater than 70% originate from small and mid-size pharma and biotech.

"This investment in highly potent capabilities is consistent with our vision to be a technology leader and address unmet market needs. Alcami is committed to ongoing investments in our people, technology, equipment, and capabilities to enable us to exceed our customers' needs – from preclinical to commercial," stated Ted Dolan, Chief Operating Officer.

The Germantown, WI facility recently completed an FDA General Inspection that resulted in zero 483 observations. This result demonstrates Alcami's commitment to quality and regulatory compliance.

Allergan Plans to Expand in New Jersey

On August 9, 2016, the Board of the New Jersey Economic Development Authority (EDA) approved Grow New Jersey (Grow NJ) tax credits in order to encourage Allergan to remain in NJ. The EDA is also encouraging Allergan to combine its four existing company locations into a 431,495-square-foot facility in Madison, NJ.

The Board approved Allergan for Grow NJ tax credits of up to $58.2 million over 10 years based on the expected creation of 300 new, high-paying jobs, the retention of more than 1000 jobs at risk of leaving the state for Pennsylvania, and private investment of more than $103 million. The project is expected to result in a net benefit to the state of more than $384 million over 20 years.

Allergan subsidiaries Watson Pharmaceuticals, in Parsippany, and Forest Laboratories, in Jersey City, have existing projects approved under the Business Employment Incentive Program. Those grants will be required to be withdrawn in order for Allergan to qualify for the Madison Grow NJ project, forfeiting more than $15.2 million in future payments.

Agilent Plans Expansion of Oligo Manufacturing Capacity

Agilent Technologies announced on Aug. 9, 2106 that the company has acquired 20 acres in Weld County, CO, on which it plans to build a pharmaceutical manufacturing facility that will more than double its commercial manufacturing capacity for nucleic acid APIs. The expansion will add 150–200 jobs, the company reports.

"The products manufactured at this site will be used by our customers to improve the lives of patients suffering from a variety of diseases," said Skip Thune, general manager of the company's Nucleic Acids Solutions Division in a press statement. "At Agilent, we are committed to meeting the ever-increasing needs of our customers for oligonucleotides."

Agilent's 65,000-sq.-ft. facility in Boulder, CO, manufactures oligo APIs for clinical trials. Capabilities include four synthesis/purification trains and two lyophilization units. A commercial GMP plant expansion was completed in 2010 and can produce multi-kilo lots of late-stage clinical materials, as reported on the company website.

Jacobs Wins Contract for New Alnylam Biopharmaceutical Manufacturing Facility

Jacobs Engineering Group Inc. announced it was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

Under the terms of the agreement, Jacobs is providing engineering services and procurement for the multi-product facility being built to supply RNA interference-based therapeutics for clinical and commercial needs.

In making the announcement, Jacobs Senior Vice President Global Life Sciences Robert Norfleet stated, “Partnering with Alnylam on this major development that enables the company to realize its goal of becoming a fully integrated, commercial-stage company is an exciting opportunity. We’re proud Alnylam turned to Jacobs as its design partner, and we look forward to delivering a state- of- the-art facility.”

The 200,000 square foot facility is expected to be completed in 2018.

Jacobs is one of the world’s largest and most diverse providers of full-spectrum technical, professional and construction services for industrial, commercial and government organizations globally. The company employs 60,000 people and operates in more than 30 countries around the world. Its Global Life Sciences business is the largest professional services provider to the pharmaceutical and biotechnology industries. For more information, visit www.jacobs.com.

TruTag Technologies’ Manufacturing Plant Achieves GMP Compliance

TruTag Technologies announced that its silica microtag manufacturing facility in Kapolei, Hawaii has achieved compliance with current good manufacturing practices (cGMP) for the manufacturing of TruTag microtags for pharmaceutical and food products for global manufacturers and brand owners. The facility was audited by a third party and meets the requirements of the International Pharmaceutical Excipients Council guidelines.

TruTags are covert, edible, and encrypted optical memory devices made from pure silicon dioxide (silica), a material that is considered “generally recognized as safe” (GRAS) by FDA. TruTags enable the digitization of medicine and food so that customers can identify, authenticate, and track products throughout the global supply chain. TruTags serve as a digital cookie for analog products. According to the company, when TruTags are applied to products, manufacturers are able to assess the provenance of each item and collect information such as manufacturing site, dosage, authorized distribution channel, lot numbers, and other valuable information including the entire drug package insert or related safety information, if needed.

TruTag’s manufacturing facility is the world’s largest cGMP nano-porous silica production plant and houses the company’s application engineering and advanced materials research center. TruTag’s cGMP facility features fully automated and robotics-enhanced production lines.

REST OF WORLD

Berendsen expanding UK Vehicle Fleet

Berendsen supplies cleanroom products and services throughout Europe. Eleven specialized cleanroom laundries operate in Germany, The Netherlands, Ireland, Poland, Denmark, Sweden, Norway, United Kingdom, The Czech Republic and Russia. These eleven cleanroom laundries form a unique platform of knowledge in services, products, solutions and back-up facilities.

As part of on-going improvements to Berendsen Cleanroom Services in Newbury, the cleanroom laundry provider has expanded its fleet of vehicles for customer deliveries. The increase in demand for the products and services provided by the company by new and existing customers has prompted the acquisitions.

Transport Department Leader Matt Turner said "as the business grows we want to ensure a seamless schedule of deliveries", Turner added "safety of our drivers and other road users is paramount, and having reversing cameras and sensors is a great addition in general road use and at customer sites".

Berendsen is proud to have been one of the first companies in the UK to be awarded the Carbon Trust Standard Certificate to recognize environmental achievements. Every year targets are set for carbon reduction, focusing on all aspects of operations including production and transport. By having vehicles with fewer carbon emissions it enhances Berendsen's commitment to its environmental ventures.

Ashland Opens Pharmaceutical Excipient Production Facility in China

Commemorating the opening of a new pharmaceutical excipient facility, senior leaders at Ashland cut the ribbon at the start of a new production line in Nanjing, China, fulfilling a pledge to produce its world-class excipients in Asia.

Demand for polymer excipients, the substances formulated alongside the active ingredients of medications, is rising in China as the country’s pharmaceutical industry moves to modernize oral drug manufacturing and comply with new quality standards set forth in the 2015 edition of the Chinese Pharmacopoeia.

Ashland is one of the world’s leading producers of high-quality, problem-solving polymer excipients sold into pharmaceutical markets around the world.

“Ashland teams around the world are comprised of 5000 passionate, tenacious solvers who thrive on developing practical, innovative and elegant solutions to complex problems in applied chemistry, always pushing the boundaries of what’s possible and advancing the competitiveness of customers across diverse industries,” said William A. Wulfsohn, Ashland’s chairman and chief executive officer. “Opening a world-class excipient facility in Nanjing is a testament to our willingness to partner with industry in China and to support the integrity and usability of pharmaceuticals produced in a country that is rapidly modernizing its healthcare infrastructure.”

William Zhao, general manager of specialty ingredients, Greater China echoed Wulfsohn’s said, “Opening a facility in Nanjing to manufacture the world’s most respected brands of polymer excipients within ‘tight’ world-class specifications is a vote of Ashland’s long-term confidence in the Chinese pharmaceutical industry. Making a commitment to the Chinese market with a state-of-the-art facility, Ashland may now supply highly functional excipient technologies to manufacturers of oral pharmaceuticals and provide tailor-made formulation solutions that enable the delivery of vital health care to everyone in China.”

Among the cellulose-based excipients, Ashland will make available to China’s markets include those sold under the Klucel HPC, Benecel HPMC, Blanose CMC, and Aqualon EMC trade names. The company also will make available a series of PVP--based polymer excipients, including Plasdone PVP and Polyplasdone PVPP polymers. All of these products are sold with a Registered Pharmaceutical Excipient Certificate, as required by the China Food & Drug Administration.

Alongside Ashland’s first ever pharmaceutical excipient production facility in China is an advanced quality control laboratory that contains equipment to measure and analyze products throughout the production process, including Thermal Fourier transform infrared spectrometers, Agilent liquid chromatography systems, and PE ICP optical emission spectrometers. The quality control system design and advanced analytical equipment allow Ashland to test all excipient products in accordance with Chinese Pharmacopoeia quality standards.

“Ashland has designed the excipient production facility in Nanjing to meet Pharmaceutical Excipient GMP standards, and that high level of manufacturing integrity is evident in outstanding product quality testing results,” said Zhao. “Moreover, our machines for each processing stage, including screening, grinding and packaging, are all global leading brands, and further support the manufacture of products that meet the same high standards as our world-class facilities outside of China.”

Experts in the structure-function relationships of excipients and their impact on the end-use functionality of oral pharmaceutical dosage forms, Ashland is able to support formulators of pharmaceuticals with formulation studies that solve complex formulation problems.

“Ashland’s goal is to help amplify the efficacy and refine the usability of customers’ products with functional excipients proven to solve common formulation problems. Toward that end, we recently expanded the Ashland technical center in Shanghai to support current and prospective customers in China with best-in-class services that may be required to ensure the best-in-class manufacture of robust tablets containing an Ashland excipient,” said Zhao.

“Working through our pharmaceutical technical center in Shanghai, these customers will gain access to state-of-the-art capabilities for bioavailability and solubilization enhancement and the latest coating and tablet formulation technologies.” added Zhao.

Sterinova Inaugurates Sterile Injectable Site in Canada

Sterinova, a new pharmaceutical company specialized in the development and manufacture of sterile ready-to-use injectable products, has inaugurated its plant in Saint-Hyacinthe and will offer syringes or premix solutions containers.

The new company, based in Saint-Hyacinthe, in the Montérégie region, is the result of a total investment of approximately $70 million, made by the Fonds de solidarité FTQ, Quebec Manufacturing Fund (QMF), Saint-Hyacinthe Technopole through the Pharmaceutical Development Centre for the construction of the building and the City of Saint-Hyacinthe for guarantee funding, Desjardins, Investissement Québec and Canada Economic Development for Quebec Regions (CED).

“Sterinova is one of the few pharmaceutical companies in the world to be entirely dedicated to the manufacture of ready-to-use injectable products. Its state-of-the-art technology and its production capacity will make Sterinova an important Canadian player on international markets,” said Jean-Philippe Gentès, president, Sterinova.

Located in the City of Biotechnology in Saint-Hyacinthe, one of the most important economic centers in Quebec and Eastern Canada, Sterinova is located at a site approved by Health Canada since 2015 for the manufacture of sterile biological products. The building of 6,225 square meters (67,000 square feet) was planned to allow to double its size. The plant is equipped with fully automated equipment and the whole production process meets the Canadian Good Manufacturing Practices (cGMP) and they have an objective to meets the European and U.S. requirements.

Analytik Jena Sets Up Joint Application Center

Analytik Jena and the Fresenius University of Applied Sciences are to create a joint application center for customers for teaching and research.

They signed an agreement with the Wesemann laboratory furnishing company, which provides laboratory furniture of the LABterminal series.

Analytik Jena is making available six analytical instruments with a value of €500,000 for use in water, environmental, food and pharmaceutical analysis.

The laboratory at the university’s site in Hessen, Germany will be constructed, set up and put into service in the coming weeks with an inauguration next month with a scientific lecture program.

“With the new application center, Analytik Jena is responding to growing demand for consulting, seminar, and training opportunities in the Frankfurt am Main economic region,” said Klaus Berka, CEO of Analytik Jena.

Future cooperation between Analytik Jena and the Fresenius University of Applied Sciences will extend to student training and continuing education as well as research and development.

The university and Analytik Jena are also discussing potential joint research projects.

Prof Dr Thomas Knepper, VP for the chemistry and biology departments at the university, said: “With the new high-end equipment, we are setting a milestone in the area of analysis and are among the best-equipped universities in all of Germany, as measured by available laboratory space.”

Biotronik Includes Class 7 Cleanroom at New Singapore Facility

German medical technology company adds new facility to support global growth from the Asia Pacific region.

Biotronik's new manufacturing center for medical devices in Singapore has begun operations.

The move adds to the German company’s hubs in Europe and the US, and positions manufacturing close to growing Asia Pacific markets.

The new site includes a16, 149 sq. ft. (1,500m2) ISO Class 7 cleanroom, supplying the global market with products for the company’s vascular intervention and cardiac rhythm management businesses.

It produces Orsiro, the world’s first hybrid drug-eluting coronary stent, along with Solia pacemaker leads.

'Singapore’s skilled workforce, excellent infrastructure and favorable business environment made it a natural choice for Biotronik as we seek to expand our global footprint,' said Erik Trip, Managing Director, Asia Pacific Manufacturing, Biotronik.

'We are building a professional team at the new site and will eventually create hundreds of new jobs in this exciting industry. This investment will support Biotronik’s dynamic growth, both in the Asia Pacific region and globally.'

The company plans to create more than 200 jobs in R&D and senior leadership roles, investing more than €20 million into operations in Singapore over the next few years.

Biotronik has been a pioneer in implantable pacemakers, defibrillators and stent therapy for more than 50 years, and has achieved double-digit revenue growth over the last decades. Its Asia Pacific headquarters have been located in Singapore since 2012.

Donaldson Opens Cleanroom in Germany

The firm moves into food and pharmaceutical filter production with its new LifeTec range

International filter manufacturer Donaldson has just opened a new production line in North Rhine-Westphalia, Germany, to meet demand for particularly clean liquid filters for the pharmaceutical and the food industry.

The products are produced at the new facility in Haan under very strict hygiene conditions and part of the process takes place in a 250 ft2 cleanroom.

Headquartered in Minneapolis, US, and known mainly for systems that purify air, steam and gases for aerospace, automotive and other industrial sectors, the company's latest line of products are designed to capture microbes, bacteria and particles from pharmaceutical and beverage products during manufacture.

Donaldson’s new LifeTec range includes PES-, PP- and PTFE-based cartridge elements for liquid process filtration, enhancing product performance in pharma, food and beverage production.

New media configuration and liner design provide significantly increased flow rates and particle holding capacities. The new liner design provides higher mechanical rigidity and helps to improve operational safety.

It is 'a third pillar' for the company and the company Donaldson expects this to be a great success, said CEO Heiner Carstensen.

Some 160 employees already work at the Haan site with around 10 new manufacturing jobs being created as well as a sales team for the new specialist product line.

SGS Investment in New cGMP Facility in Berlin

With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly owned global network to deliver harmonized solutions to large pharmaceutical and biotechnology firms

SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, has announced that it is to invest in a new facility in Berlin, Germany, to expand its activities in R&D/QC testing, and to offer new analytical services to clients.

The laboratories are scheduled to open mid-2017, and will replace the current 2500m2 facility in the city, which was opened in 1985, and offers a variety of analytical services to the pharmaceutical and related industries.

The laboratory will operate under cGMP conditions and has the potential to expand the workforce and capacity by one third. Its construction has been triggered by increased demand in stability testing, the handling of cytotoxic substances for oncology drug products, elemental impurity testing according to USP<232>, USP <233> and ICH Q3D (Step 4), particle testing and container testing according to USP and Ph. Eur.

'The Berlin facility has always had a core expertise in the stability testing of drug products, but the forecasted demand in this area means investment is crucial for SGS to maintain current and future client relationships,' commented Dr Sheida Hoenlinger, Director, Life Sciences Germany.

'The new facility also gives us the opportunity to expand in important growth areas such as oncology drug products and stability studies,' she added.

This investment follows the recent announcement by SGS that it has opened a new facility in Wiesbaden, Germany, as a dedicated Global Center of Excellence for the testing of extractables and leachables within pharmaceutical products.

Sterling Pharma Solutions Launches

Sterling Pharma Solutions’ site in Dudley has been in existence for 47 years and is the UK’s largest provider of API development and manufacturing services to the pharmaceutical industry.

UK-based Sterling Pharma Solutions has formed as an independent contract development and manufacturing organization (CDMO) following a management buyout (MBO) of the UK-based Dudley site.

Formerly operating as Shasun Pharma Solutions within Strides Shasun, the process of divesting the business to the current management team was completed in September 2016.

Following the MBO, the newly divested business has been rebranded and launched as Sterling Pharma Solutions. The CDMO will specialize in delivering API development and manufacturing solutions to support global pharmaceutical companies across the entire product lifecycle.

The management team will be led by Kevin Cook as CEO. Kevin joined the Dudley site in 1993. He says: 'We are delighted to complete the MBO and excited about building a global API services business with roots in the north east of England. Our offering is compelling as we can take projects from proof of concept to commercial scale manufacture all on one site. We also have the capabilities to handle the most hazardous chemical processes safely.'

'We have experienced significant growth in the US and Europe in recent years and believe the extensive capabilities at our site, coupled with our heritage in the API services sector, provide us with an excellent foundation to become the leading partner and provider of API services to the pharmaceutical industry,' he added.

Cipla Biosimilars Manufacturing Facility, Durban, South Africa

India-based pharmaceutical company Cipla has announced its plans to build a new manufacturing facility in Durban in the KwaZulu-Natal province of South Africa.

The new plant will be the first facility in the country to produce biosimilar drugs.

Cipla plans to invest $88m in the facility through its biotechnology subsidiary Cipla BioTech and the plant will be developed in special economic zone (SEZ) Dube Tradeport by South Africa's Department of Trade and Industries.

In addition, a memorandum of agreement was signed between Cipla BioTech and Dube Tradeport in October for the facility's development. It will be the company's second production plant, following the one built in Goa, India.

Construction of the new plant is expected to start in early 2017, with completion scheduled in Q3, 2018. The facility will produce drugs for the South African market and for export to the US, EU and Asian markets.

The project is expected to create 300 jobs including 180 skilled and 120 indirect positions in the engineering and biological science domains.

The Durban plant will be a modular facility with a small footprint and distributed manufacturing. It will utilize Cipla BioTec's innovative manufacturing technology, which includes in-house proprietary manufacturing software and single-use technology.

The facility will initially focus on the manufacture of Cipla BioTec's cancer therapies such as CBT 124, a biosimilar of avastin. This monoclonal antibody angiogenesis inhibitor aims to treat multiple cancers with fewer side effects. The first clinical trial on the drug is currently in progress.

Biosimilar drugs are manufactured from living organisms and have similar properties as the original biological agent, which remains patented by large research-based biotech companies. They are similar to generic drugs in the biopharmaceuticals space and are targeted at ailments such as cancer and other autoimmune diseases.

Biosimilar drugs are as safe and effective as the original drugs and have been introduced in western markets for a few years. However, they are also expensive outside of these markets.

It is estimated that just 8% of patients use biosimilar drugs worldwide due to their high-cost. In South Africa, just one in 50 patients has access to biosimilar drugs.

With the development of the new plant, Cipla aims to improve the usage to one in five by offering them at an affordable price.

Development of the facility is also expected to spawn the creation of South Africa's first bio-cluster, which will provide a number of opportunities for supply chain partners and related companies. It will not only attract research from international institutions but also enable existing research efforts to remain in South Africa.

Cipla is one of the leading biopharmaceutical companies in South Africa with approximately 11% of its revenues coming from the region. The company strengthened its position in the country through the acquisition of MedPro in 2013 and established its South African subsidiary, Cipla MedPro.

Cipla MedPro is currently the third biggest pharmaceutical manufacturer in South Africa. It offers a range of products targeted at areas such as cardiovascular and respiratory, diabetes, oncology, psychiatry, anti-malarials and HIV/AIDS.

With the construction of the new plant, Cipla BioTech will enter the South African market. This subsidiary focuses mainly on the research, development, manufacturing, and marketing of biosimilar products. It currently has a number of products targeted at cancer and auto-immune diseases in various phases of development.

PPD Expands GMP Lab Services in Athlone, Ireland

Pharmaceutical Product Development, LLC (PPD), has expanded its good manufacturing practices (GMP) laboratory operations in Athlone, Ireland, as part of its ongoing efforts to meet clients’ capacity needs and enhance its range of lab services offerings.

The lab, one of the largest of its kind in Europe, has added 400 square meters (4,300 square feet) of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices. The Athlone GMP facility now totals more than 3,800 square meters (41,500 square feet) of analytical testing and support space.

“The expansion of the Athlone GMP lab represents our ongoing investment in the continued growth of our contract research operations in Ireland and around the world to provide our clients with best-in-class laboratory services and state-of-the-art facilities and instrumentation,” said David Johnston, Ph.D., executive vice president of global laboratory services for PPD® Laboratories. “Our ability to deliver global scientific, technical and development expertise with expanded laboratory capacity enables us to meet the growing demand for these services in Europe, the Middle East and Asia-Pacific.”

The Athlone GMP lab provides fully integrated solutions for pharmaceutical product development, including analytical testing services, method development and validation, stability testing, and quality control and release testing. The operation also provides regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.

PPD Laboratories opened its Athlone laboratory in 2010 and, with the completion of this latest expansion, will employ nearly 200 people at the facility, including Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals. PPD Laboratories maintains another GMP lab in Middleton, Wisconsin, that offers all the same services as the Athlone lab. In total, PPD employs more than 1,300 people in its global GMP operations.

“PPD has been a valuable member of Ireland’s business community, and particularly the Athlone region, since opening its world-class facility in 2010,” said Minister Mary Mitchell O’Connor of Ireland’s Department of Jobs, Enterprise & Innovation. “Through this facility and the people it employs here, PPD plays an important role in maintaining the economic vitality of our Midlands region and developing the scientific, analytical, clinical and logistical skills of the professionals who support the biotech and pharmaceutical sectors in the Midlands life sciences cluster.”

“PPD’s expansion of its GMP operations in Athlone is warmly welcomed by IDA Ireland and adds to the continued growth of life sciences in the Midlands,” said Barry Heavey, Ph.D., IDA Ireland’s head of life sciences. “This is another important investment for a regional location, and IDA looks forward to working with PPD to ensure continued success and development.”

The Athlone lab is licensed by the Health Products Regulatory Authority (HPRA) to support both investigational medicinal products and marketed products. It also is certified for quality control of medicinal products, including cell-based assay services for biologics.

In addition to the GMP labs in Athlone and Middleton, PPD Laboratories includes: central labs in Shanghai, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; bioanalytical labs in Middleton and Richmond, Virginia; a vaccine sciences lab in Richmond; and biomarker labs in Richmond and Highland Heights.

AbbVie API Plant Opens in Singapore

AbbVie has opened an oncology and women’s health API plant, part of its planned 1,291,200 sq. ft. (120,000m2) small and large molecule manufacturing site in Singapore.

In February 2014, AbbVie announced it was constructing a manufacturing facility in Tuas, Singapore to support its large and small molecule immunology and oncology pipeline at a cost of $320m (€285m).

Later that year the firm bought a small molecule active pharmaceutical ingredient (API) within the Tuas Biomedical Park, and after a 22 month refit it opened its door this week.

“The API facility here supports our oncology and women’s health pipeline,” said AbbVie spokeswoman Judy Low. “This facility came online more quickly [than the $320m plant] because we acquired it in 2014.”

The facility is part of a 1,291,200 (120,000m2) site, with the biologics facility expected to be operational in 2018.

“We are evaluating options for the facilities to work together,” Low added.

One area where having small and large molecule production plants together is antibody-drug conjugates (ADC) and AbbVie has previously told us the Singapore site will be used to help advance its pipeline, including ABT-414: an investigational EGFR (epidermal growth factor receptor) targeted monoclonal antibody drug conjugate in late-stage development.

Singapore, the Southeast Asian city-state is somewhat of a hub for pharma and biopharma manufacturing. Along with AbbVie, Amgen, Novartis, and Baxter (now part of Shire) have invested heavily in manufacturing plants in Singapore, and life science tools and services companies have followed suit.

“Besides its location and highly-skilled workforce, Singapore also offers a stable, pro-business environment supportive of manufacturing, backed by a robust infrastructure,” Low said.

And in a statement, Weng Si Ho, director, biomedical sciences, Singapore Economic Development Board (EDB) said: “Given our track record of providing a world-class business environment and skilled talent pool to companies, we enable companies such as AbbVie to develop and manufacture innovative products to deliver value for patients worldwide.”

CordenPharma Announces Completion of New Highly Potent API Process Bay

As part of a long term growth strategy designed to meet increasing customer demands, CordenPharma has completed a recent key investment to strengthen development and manufacturing capabilities for API offerings across its Highly Potent & Oncology Platform. This new investment comes after the completion in early 2016 of a new CTD2 facility for the handling (development / manufacturing) of oral solid dosage Drug Product manufacturing of Highly Potent & Oncology compounds in its CordenPharma Plankstadt (Germany) facility, along with further expansion of capabilities in handling sterile Oncology Drug Products at CordenPharma Latina (Italy).

The new API process bay, now installed in CordenPharma Colorado (USA), is designed to handle a wide range of chemistries and unit operations with flexible and scalable components up to multi-kg batches. The facility builds on CordenPharma Colorado’s SafeBridge certified 30+ year legacy of safe and reliable production of highly potent APIs.

“With the operational qualification now complete, the first cGMP campaign is scheduled to be completed in early Q4 2016,” comments Brian McCudden, President & Managing Director of CordenPharma Colorado. This new addition complements the existing state of-the-art infrastructure at CordenPharma Colorado, which is equipped to handle highly potent compounds up to OEB Level 5 spanning development to commercial-scale.

CordenPharma is considered the CDMO partner of choice for the pharma industry when it comes to the development and manufacturing of Highly Potent & Oncology compounds meeting the most stringent requirements from major global health authorities and customers. “With this new investment, CordenPharma is uniquely positioned to provide pharma customers with the most comprehensive Highly Potent & Oncology service in the industry spanning the entire API and Drug Product supply chain at any stage from development to commercialization,” adds Dr. Michael Quirmbach, Vice President of Global Sales & Marketing, CordenPharma International.

Avantor Begins cGMP Production

Avantor, a global supplier of ultra-high purity materials for the life sciences and advanced technology markets, has begun production at a new cGMP manufacturing area at its Panoli, India, facility. The ISO 9001:2008 certified and Indian FDA approved manufacturing facility makes Avantor unique in offering cGMP capabilities in the U.S., Europe and India.

The India-based cGMP manufacturing area produces Avantor’s J.T.Baker^® brand High Purity Low Endotoxin (HPLE) sugars using the same Avantor cGMP quality systems that are in place at the company’s U.S. and European facilities. Avantor’s proven global quality systems include a robust management of change program, fully traceable supply chain, globally accepted documentation support, and ISO 9001-compliant quality management systems.

“Avantor’s global cGMP manufacturing footprint offers strategic advantages for our life sciences customers,” said Devashish Ohri, Executive Vice President, APAC, for Avantor.

“Biopharmaceutical manufacturers can confidently expand into new markets with the security of knowing that J.T.Baker® brand materials, which meet the highest regulatory specifications, as well as Avantor’s applications specialists, are readily available.”

In addition to J.T.Baker^® HPLE sugars, the Panoli, India, facility produces Macron Fine Chemicals™ brand products under cGMP conditions that comply with India Pharmacopoeia (IP), U.S. Pharmacopeia (USP), National Formulary (NF), European Pharmacopoeia (EP), Japanese Pharmacopeia (JP) and British Pharmacopoeia (BP). Various pack sizes are available to support formulation development from discovery to full-scale production.

“The cGMP facility in Panoli, India, is equivalent in every way to Avantor’s cGMP facilities in the U.S. and Europe, and shares the same quality systems and capabilities that our customers have come to expect,” said Ohri. “The facility provides Avantor with a cGMP manufacturing hub in Asia, allowing us to provide the best service to our life sciences customers, regardless of their locations.”

UK Processing Training Center to Boost Pharma Manufacturing Sector

A newly opened training center in Leeds, UK will help fulfil demand for skilled workers in the drug production space, says the head of process manufacturing.

The Process Manufacturing Centre (PMC), part of Kirklees College, opened its doors as a specialist training site for process manufacturing industries.

“The PMC is focused on engaging and partnering with manufacturers to provide solutions to skill shortages and apprenticeship programs,” said Brian Lawson, head of process manufacturing at Kirklees College.

“It can be used to train in processes and activities which are associated with manufacturing. Often the early parts of a product lifecycle do not have any training associated with them and is typically assumed to be ‘known’ by those involved! We can train offer training for every stage.”

He added there will be synergies between employers, the process manufacturing center and the Northern Powerhouse – a government-backed project intended to boost economic growth and industry in the North of England.

“We have one ‘specials manufacturer’ with an apprentice on the Science Industry Manufacturing Technician programme. We have had interest from others such as Thornton and Ross, Dechra and Dr Reddy’s.

“In addition there are Pharma companies in Yorkshire who we will be engaging with in coming months,” he continued, adding that the offering will not be limited to the region with plans being explored to deliver these programs with residential and online capability.

The PMC consists of a process plant, a filling and packaging area and documentations systems.

The process plant includes 2,000L of batch mixing capacity and two storage tanks, a stand-alone 400L mixing vessel and centrifuge, and integrated powder induction and filtration loops.

Certara Establishes Phoenix PK/PD Centers of Excellence in China and Japan

Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that Peking Union Medical College (PUMC) Hospital in Beijing, China, and Keio University in Tokyo, Japan, have become Phoenix centers of excellence.

Phoenix is the most advanced, intuitive and widely used software for pharmacokinetic (PK), pharmacodynamic (PD) and toxicokinetic (TK) modelling and simulation. Phoenix is used by 6000 researchers at 1500 biopharmaceutical companies and 200 academic institutions in 60 countries.

Phoenix is also employed by many global regulatory agencies, including the United States Food and Drug Administration, the Japanese Pharmaceuticals and Medical Devices Agency and China's Food and Drug Administration.

'As regulators and sponsors recognize the growing importance of model-based drug development (MBDD), Certara has committed to educating the next generation of experts in this field, on a global basis,' said Certara Chief Executive Officer Edmundo Muniz, MD, PhD.

'We are achieving that goal by partnering with eminent scientists at designated academic centers of excellence around the world and providing them with access to our Phoenix software — which is the gold standard in PK/PD — for teaching and research.'

The Phoenix centers of excellence routinely publish their work so that other researchers can benefit from their progress. They also serve as an informal scientific advisory group.

At PUMC Hospital, Professor Pei Hu, MD, Professor and Director of its Clinical Pharmacology Research Center, will use Certara’s modelling and simulation technology for first-in-human, point-of-care and late-phase clinical trials. MBDD strategy has been routinely applied in her unit to support Chinese new moiety entity development.

Founded by the Rockefeller Foundation in 1921, PUMC Hospital conducts clinical research into severe, rare and complicated diseases. It has 4000 employees and is affiliated with both PUMC and the Chinese Academy of Medical Sciences. For the past 6 years, PUMC Hospital has been named the number one hospital in the list of the best Chinese hospitals published by FuDan University, the most famous ranking list in China.

Certara also has ongoing collaborations with pharmacometrics leaders in Japan. Considered to be Japan’s leader in PK/PD, Professor Yusuke Tanigawara, PhD, is professor of clinical pharmacokinetics and pharmacodynamics at Keio University School of Medicine. Keio University is the oldest institute of higher education in Japan.

Certara’s other Phoenix centers of excellence are located at the University of Auckland School of Medicine, the State University of New York Buffalo School of Pharmacy and Pharmaceutical Sciences, the University of Minnesota School of Pharmacy, the University of North Carolina at Chapel Hill Eshelman School of Pharmacy, the University of Maryland School of Pharmacy and the Kansas State University College of Veterinary Medicine.

Merck Expands Biotech Production Capacity in Spain

Investment of €15m in Tres Cantos facility will increase production capacity by 50% and employ 20 percent more staff.

Merck KgaA has completed a major expansion at its biotech plant in Tres Cantos, Madrid, Spain, resulting in a 50% increase in the facility’s production capacity. Tres Cantos is Merck’s main site for the production of the active substances of its fertility treatment Gonal-f and growth hormone disorders treatment Saizen.

The €15m investment, which was made over the 2014-2016 period, adds 9,684 sq. ft. (900m²) of biotech production space and a two-floor office building, bringing the total constructed area of the Tres Cantos site to 86,080 sq. ft. (8,000m²). The facility complies with cGMP (current Good Manufacturing Practices) quality standards and also observes the highest international standards in terms of environment, health and safety. It is certified by ISO 14001 environmental management and safety by OHSAS 18001. The site employs 170 highly qualified professionals.

'The demand for our core portfolio of medicines keeps increasing worldwide,' said Simon Sturge, Chief Operating Officer of the biopharma business of Merck. 'The expansion in Tres Cantos is part of our continuous commitment to deliver high quality medicines at the right time to our patients.'

In 2016 alone, Merck has invested around €250m in its global healthcare manufacturing network.

CDMO Recipharm to Open New GLP Bioanalysis Laboratory in Sweden

Recipharm, the contract development and manufacturing organization (CDMO), has announced a 5 million SEK investment into a new GLP (Good Laboratory Practice) compliant bioanalysis laboratory at its development facility in Uppsala, Sweden, in response to growing customer demand.

The investment will see the opening of a 5,380 sq. ft. (500 square meter) purpose-built facility in November 2016, which will become the largest GLP bioanalysis laboratory of its kind in the Nordic countries.

Recipharm’s development team in Uppsala specializes in medicinal chemistry, offering synthesis and analytical preclinical development services to drug development companies progressing products through clinical trials.

From its new laboratory, the CDMO will significantly increase its capacity, with the capability to process more than 10,000 plasma samples per week.

Commenting on the investment, Fredrik Lehmann, General Manager at Recipharm Development in Uppsala said: “This is a strategic investment for Recipharm as there is a real need for more GLP bioanalysis laboratories in the Nordic region.

"Bioanalysis requires specialist expertise and establishing the necessary capabilities can be a costly investment, proving a barrier to entry for many contract services providers. Having first started out in a collaboration with a subcontractor, we are now delighted to be able to expand our offering in-house to service an unmet need for bioanalysis capabilities."

“The new laboratory will dramatically increase our capacity, allowing us to continue to grow our European customer base and expand our expert team of chemists,” added Fredrik.

In order to support the increasing demand of bioanalysis services, Recipharm Development in Uppsala plans to recruit several new PhD level chemists in the coming months and aims to more than double its team of 35 in the next couple of years.

CPI’s National Biologics Manufacturing Centre, Darlington, United Kingdom

Construction of the National Biologics Manufacturing Centre (NBMC) at Central Park in Darlington, UK, began in April 2014. The facility is used for conducting research on biologic products by promoting collaboration between academia, the National Health Service (NHS) and the industry.

The facility was opened in September 2015 and is managed by Centre for Process Innovation (CPI).

Novasep installed BioSC Lab protein purification technology in the National Biologics Manufacturing Centre in November 2015.

The new NBMC has a total floor space of 53,800 sq. ft. (5,000m²) and is equipped with flexible laboratory and pilot plant areas. It helps companies in the biologics market to produce, demonstrate, prototype and scale-up the next-generation of biologic products, as well as processes and technology. It also helps companies based in the UK to develop a competitive foothold in the growing biologics market.

GSK’s Biopharmaceutical Plant, Ulverston, UK

It will manufacture medicines for treating diseases that include cancer, autoimmune, and hereditary ailments.

The facility has a dedicated space for Good Manufacturing Practices (GMP) process, analytical and technology development, and clean rooms to carry out research. It is also facilitated with state-of-the-art lab equipment. It is designed to feature flexible, open-plan areas and houses offices, and meeting rooms and spaces for training and conferencing.

It was developed with a £38m ($64m) investment by the government as part of the 'Strategy for UK Life Sciences' programme initiated in 2011, which promised a £310m investment towards the support of discovery, development and commercialization of innovative medicines.

The facility is strategically located at Darlington as it is in close proximity to East Coast Mainline for transport facilities. It is also near existing pharmaceutical companies and relevant universities in the north of England.

NBMC's construction created new jobs for the region and helps to enhance the local economy, as well as the competitiveness of the UK biologics sector.

The NBMC is used for developing biopharmaceuticals and biologics using biotechnology. Production of biologic products needs to have biological foundations such as cells, bacteria, yeast and others to perform precise development processes. The new facility is equipped with all such tools, facilities and technology for the development of innovative biologic medicines.

Construction on the National Biologics Manufacturing Centre started in April 2014 and the facility was opened in September 2015.

The £38m ($64m) design-and-build contract was awarded to Interserve Construction, a company based in Darlington, in March 2014.

The UK-based Centre for Process Innovation (CPI) provides guidance to companies to develop new products and processes from concept to finished product. It uses applied knowledge in science and engineering together with sophisticated development facilities. It enables clients to develop, demonstrate, prototype and scale-up the next generation of biologic products and processes.

CPI was made part of the High Value Manufacturing Catapult (HVMC) network, which consists of seven technology and innovation centers, in 2011. The HVMC was established in the UK to access the best manufacturing talent and facilities.

Biological medicines account for 10% to 15% of pharmaceutical market and constitute more than one-fifth of new medicines launched in worldwide every year. The new facility at Darlington helps the UK to expand its contribution to the high value and high-quality production of biologic medicines in the global market.

Merck Opens Testing Plant in Korea

Korean CMO Samsung Biologics endorsed Merck's new bioprocessing collaboration center.

Germany’s Merck has opened a bioprocessing collaboration center in Songdo, Incheon - the latest investment supporting the burgeoning Korean biopharma industry.

The firm’s global M Lab Collaboration Centers enable biomanufacturing firms to view and test bioprocessing equipment, and a newly unveiled 20,067 sq. ft. (1,865m2) site reflects Korea’s growing biopharma ambitions, the firm says.

“With a rapidly growing biopharmaceutical industry in Korea and demand for novel and cost-effective therapies worldwide, there is a clear need for innovative concepts like our M Lab Collaboration Centers,” said Udit Batra, CEO of the firm’s Life Science division.

The facility replaces a smaller site in Seoul and is located in the area of Songdo, Incheon – a ‘smart city’ reclaimed from the sea – which is home to a number of biopharma firms including Celltrion and Samsung Biologics which are investing heavily in their respective biomanufacturing capacities.

In fact, the CEO of the latter - TH Kim – endorsed Merck’s new facility in a statement, saying it will play an important role in supporting the local biomanufacturing market.

“Merck's decision to invest in Songdo, fast growing as world largest biologics manufacturing hub with 520,000L of plant capacity by 2018, represents a significant milestone in the development of the Songdo Bio Cluster, which will accelerate the future growth of Incheon as well as Korean Biopharmaceutical industry.”

The unveiling complements a four year plan recently announced by the South Korean government intended to fuel the growth of the country's bio-health industry through incentives including offering drug companies higher tax benefits.

Merck joins fellow bioprocessing technology firm GE Healthcare, which announced it had opened a 23,672 sq. ft. (2,200m2) training center in Songdo at a cost of $7.4m.

Merck Completes Expansion of Madrid Gonal-f API Plant

Merck has completed the expansion of its biologics API manufacturing facility in Madrid, Spain increasing production capacity by 50 percent.

The German drug manufacturer announced it had finished work on the €15m expansion of the facility in the Madrid municipality Tres Cantos.

Simon Sturge, Chief Operating Officer of Merck’s biopharma business, cited increasing demand for the firm’s “core portfolio of medicines” as a driver for the investment.

The Madrid site is already the main global production hub for the active pharmaceutical ingredients (APIs) for Merck’s fertility treatment Gonal-f and growth hormone disorders treatment Saizen.

Demand for Gonal-f has increased in recent months. According to Merck’s Q2 financial results the drug generated revenue of €209m ($229m) in the second quarter, which is an increase of 23% on the year earlier period.

Around 75% of this growth came from the North America, which Merck said was a result of “a continued advantageous competitive situation.”

Merck’s product has benefited from a number of recalls of rival products in recent years. In 2015, Ferring Pharmaceutical pulled several lots of its rival product Bravelle after tests revealed it did not meet potency requirements.

More recently Merck’s unrelated US namesake Merck & Co said it had encountered problems making Follistim, another rival to Gonal-f.

China's Tot Biopharm Starts Work on Second Plant

Tot Biopharm has started work on a second monoclonal antibody (mAb) drug production plant at China’s Suzhou Industrial Park.

The plant will house five production lines with cell culture capacity of 2,000L and production capacity of 10,000L. Tot said it will use disposable bioreactor and processing systems.

The Chinese biopharmaceutical firm intends to use the facility to make antibody drug conjugates (ADC) for the local and international markets. It is scheduled to become operational in 2018 and to begin commercial production the following year.

Tot has been building up biopharmaceutical manufacturing capacity over the past few years beginning in 2012 when it opened its first production facility at the Suzhou site.

The existing facility houses an oral anti-cancer drug manufacturing area with separate production facilities for cytotoxics and non-cytotoxics, an injected anti-cancer drug plant and a GMP bio pilot plant with a capacity of 500L cell culture/ purification/ filling.

Work on the new facility follows just over six months after privately held Tot announced it had attracted what it called “new strategic shareholders.”

In March previous backer TTY Biopharm Co. had sold its Tot shareholding to a group including US investor Vivo Capital, Taiwan-based Formosa Laboratories – itself a producer of drug ingredients and ADCs – and Center Laboratories Group and Chengwei Capital.

At the time Tot said the transaction – valued at $24m (€21m) – would allow it to leverage Vivo’s experience in healthcare in both China and the US and facilitate strategic alliances including cross-border partnerships. It also said closer financial ties with Formosa will bring benefits in bulk pharmaceutical chemical production and manufacturing.

Oxford Genetics Opens New Facility

Oxford Genetics, a biotech that specializes in DNA design, protein expression optimization and cell line development technologies and services, has moved its operations to new state-of-the-art laboratories at The Oxford Science Park.

The move from Begbroke Science Park to the Medawar Centre increases the company’s laboratory space to 5,700 square feet and forms part of Oxford Genetics’ on-going growth strategy as it expands its operations to support new services for cancer fighting technologies

The company says it has experienced rapid growth in the last 12 months and has scaled its infrastructure and team to support its customer base in the biopharmaceutical industry. Oxford Genetics will use its new location to increase research and development into services to support cell and gene therapy, which is currently being trialed as a potentially effective, non-harmful treatment for cancer and many genetic disorders, and is a sector identified by the company as a key market for growth.

The new facilities will also include dedicated cell development suites and new robotic platforms for process automation. This will allow Oxford Genetics to scale its services, following an increase in demand from new and existing customers.

“As Oxford Genetics continues to grow, it is essential that we build capacity to accommodate our expanding team and suite of technologies and services,” said Ryan Cawood, chief executive officer, Oxford Genetics. “The dedicated facilities will enable us to meet more client requests, and allows us to broaden our customers’ access to the full spectrum of technologies that our scientists have developed.”

The opening of Oxford Genetics’ new facility follows the recent announcement that the company has appointed three industry veterans to its board: Matt Baker, Paul Brooks and David Hames. The appointments bolster its capabilities in DNA design, protein expression and virus and cell line development.

VBL Therapeutics to Establish New Facility

VBL Therapeutics has entered a long-term lease contract for a new stand-alone facility in Modiin, Israel that will house its local biologics manufacturing facility, as the company plans for potential commercialization of Phase III oncology candidate, VB-111.

The site allows for modular expansion of manufacturing capacity to supply demand following commercialization, while requiring limited capital resources in the immediate stage. The company projects that its current cash will support operations into 2019, beyond the pivotal GLOBE trial, while supporting a potential registration trial in ovarian cancer and the investment in the new facility.

“Securing this new facility in Modiin fits strategically with our development plans and is an important step as we advance multiple clinical trials and move closer to potential commercialization of VB-111,” said Dror Harats, chief executive officer of VBL Therapeutics.

The new facility will also include the company’s headquarters, discovery research and clinical development. VBL intends to operate and relocate to the new site in 2H17.

VBL anticipates that future commercial supply of VB-111 will likely involve a complementary source of supply via a contract manufacturing partner in North America, although plans have not yet been made.

The new facility will also include the company’s headquarters, discovery research and clinical development. VBL intends to operate and relocate to the new site in the second half of 2017.

Alexion to Build Biologics Manufacturing Facility in Ireland

In July 2016 Alexion Pharmaceuticals announced its plans to invest an additional €100 million (approximately $110.6 million) in the expansion of its Athlone, Ireland facility. The investment will include the addition of a new biologics manufacturing facility and create 50 additional jobs in Athlone, the company said in a press release. According to the company, the Athlone location currently houses a vial fill-finish facility.

Alexion is also constructing a large-scale bulk biologics manufacturing facility at its Dublin site in College Park. Between its facilities in Athlone and College Park, Alexion currently employs more than 250 people in Ireland, and expects to continue to grow to almost 500 employees by the end of 2019. Alexion has invested €600 million (approximately $663.82 million) in Ireland since 2014, the company noted.

Jacobs Awarded Design Contract for Pfizer Global Biotechnology Center in China

Jacobs Engineering Group Inc. announced it was awarded a contract to lead design and provide engineering services, procurement and construction support for Pfizer, Inc.’s new $350 million Global Biotechnology Center investment in the Hangzhou Economic Development Area in China.

Under the terms of the agreement, Jacobs is responsible for developing the overall site design, which includes aseptic fill/finish, drug substance and central utility buildings; a quality laboratory; administration offices; and a warehouse. The facility is being built to produce monoclonal antibodies and also serve as a process development and clinical supply site for biologic medicines in China.

In making the announcement, Jacobs Senior Vice President Life Sciences Robert Norfleet stated, “This is an exciting opportunity for our Life Sciences business. We have a long history of helping Pfizer grow and expand its global manufacturing capabilities. We look forward to partnering with Pfizer once again to develop this state-of-the-art biotechnology center in China.”

The facility is expected to be complete in 2018.

Jacobs is one of the world’s largest and most diverse providers of full-spectrum technical, professional and construction services for industrial, commercial and government organizations globally. The company employs 50,000 people and operates in more than 30 countries around the world. Jacobs’ Life Sciences business is the largest professional services provider to the pharmaceutical and biotechnology industries. For more information, visit www.jacobs.com.

Jacobs Awarded Contract for Novartis Biotechnology Center Expansion in France

Jacobs Engineering Group Inc. announced it was awarded a contract to expand the Novartis Pharma S.A.S. Biotechnology Center in Huningue, France.

Under the terms of the agreement, Jacobs is providing engineering, procurement and construction management (EPCM) services to increase the site’s production capacity by 70 percent and create a second line of purification that allows for multiple drugs to be manufactured simultaneously.

Already one of the world’s largest production facilities for monoclonal antibodies from mammalian cells, the expansion project adds cell culture bioreactors to the site.

Jacobs’ services are being led from its operations in Milan, Italy.

In making the announcement, Jacobs Senior Vice President Life Sciences Robert Norfleet stated, “We look forward to partnering with Novartis on the expansion of its Huningue site. We’re proud to have this opportunity to draw on our extensive global EPCM expertise for a project that can help Novartis improve the lives of people who depend on its treatments.”

The $100 million expansion project is scheduled to be completed in four years.

Jacobs is one of the world’s largest and most diverse providers of full-spectrum technical, professional and construction services for industrial, commercial and government organizations globally. The company employs 60,000 people and operates in more than 30 countries around the world. Its Life Sciences business is the largest professional services provider to the pharmaceutical and biotechnology industries.

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