Braeburn Pharmaceuticals will establish an R&D and manufacturing site in North Carolina for its subdermal implant candidate to treat opioid addiction.

The private Phase III pharma firm is investing $20m (€18m) into the new site in Durham County – close to Research Triangle Park (RTP) - over the next five years, and says it will create 52 new manufacturing and R&D specialist jobs.

VP of Commercialization and Manufacturing, Craig Brown, said in a statement the plant would help “provide patients with addiction, chronic pain, and serious mental illness with medications to treat their chronic disease.”

The plans were welcomed by North Carolina Governor Pat McCrory, who said: “Braeburn Pharmaceuticals joins a long list of life sciences companies that have made North Carolina the nation’s No. 1 state for bio-manufacturing jobs.”

He added: “This company and the pioneering work it plans to do here will make a difference in the lives of patients and families around the world while also adding value to the economy and community of the Research Triangle.”

Braeburn’s lead candidate is a buprenorphine HCl implant named Probuphine, intended to treat opioid dependence.

The product is a subdermal implant designed to deliver the opioid – currently available in daily-dose pill and film formulations - continuously for six months following a single treatment.

It uses the continuous drug delivery system ProNeura, developed by Braeburn’s partner Titan Pharmaceuticals.

The platform consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and the drug substance. This results in a solid matrix that is placed subdermally in the arm of an outpatient, and removed in a similar manner at the end of the treatment period.

The advantages of delivering buprenorphine this way include increased patient compliance and decreased risk of diversion, the firm says

The product has been submitted to the US Food and Drug Administration (FDA) and a Committee voted 12 to five in favor of approving Probuphine back in January. Braeburn and Titan await a final decision by May 27, after the FDA put back its action date from February.

Cirtec Medical Opens New Manufacturing Facility

Cirtec Medical, LLC, a leading provider of design and contract manufacturing services for active implantable and minimally invasive devices, announced the grand opening of their new 38,000-square-foot manufacturing facility located at 99 Print Shop Road, Enfield, Conn.

The new facility includes an ISO Class 7 cleanroom, additional controlled-environment assembly space, and advanced engineering and metallurgical labs. The configuration of the new space will allow the company to expand its use of LEAN manufacturing practices to continually improve product quality while reducing cycle times and production costs.

“We are very excited about the opening of what we consider to be a center of excellence for manufacturing active implantable medical devices,” said Brian Highley, CEO of Cirtec. “This world class manufacturing facility will enable us to increase capacity and expand our capabilities in providing innovative solutions to our customers.”

Cirtec Medical has a long history of providing design, development, and manufacturing services for active implantable devices to the world’s largest OEMs and innovative startups. Active implantable medical devices fall under the most stringent quality requirements in the medical industry. Manufacturing these devices is enormously challenging and, as a result, more device developers rely on Cirtec’s expertise and quality systems to speed development and to reduce risk.

"Cirtec is another example of a forward-thinking, advanced, innovative company choosing to locate in Connecticut. We have one of the most educated workforces in the world, and Cirtec will no doubt benefit," said Connecticut Governor Dannel P. Malloy. “Industry leaders like Cirtec are advancing research and development of new cutting-edge medical devices. It is companies like this that will help Connecticut continue to compete and win in the 21st Century economy, and we are proud Cirtec has chosen to call Connecticut home."

J&J Opens New Biotech Hub in Houston

J&J has opened a new 34,000 sq. ft. Houston life science hub site as its incubator program continues to reach across North America.

The Texas Medical Center (TMC) in Houston becomes the latest site to be funded by the JLABS program, which works as life sciences incubator for early stage firms. Dubbed JLABS @ TMC, the new hub opened its door for business.

JLABS works by providing life science entrepreneurs shared lab space, private offices and modular laboratory suites, as well as state-of-the-art equipment and value-added operational, education and business services--all vital lifelines for startups that struggle to gain enough funding to get off the ground.

JLABS @ TMC builds is the 5th JLABS facility to open in the U.S., with similar sites at San Diego (its flagship site), San Francisco, South San Francisco, Boston and, opening this spring, the first international location in Toronto, Canada.

The Houston site is, however, the first to open with a medical device prototype lab, including a 3-D printer, which will provide firms access to highly specialized tools, as well as skills building programs to design and develop smart health technologies.

JLABS @ TMC can accommodate up to 50 startups, and will open with 21 companies that represent a range of disciplines and geographies and include firms working on virtual reality sets to reduce anxiety in cancer patients, immuno-oncology drug targets and a nonsurgical heart pump.

This first class of resident startups includes the four winners of the JLABS Quick Fire Challenge, which awards promising early stage innovation companies with residency at the facility. These companies are: Adhesys Medical, Alterna Therapeutics, Procyrion and Resonant Therapeutics.

JLABS @ TMC is housed within the TMC Innovation Institute, neighboring TMC's life sciences accelerator TMCx, and the hope is that ideas across both sites may spark new innovations.

The firm gains access to some valuable technology and in turn gets to know some of the brightest minds and entrepreneurs in the life sciences space.

Many will likely not make it, but J&J has history in backing some of these startups and set up development collaborations that can help accelerate their growth. If J&J invests in a product or company that develops a future blockbuster, then this would be a good ROI for the firm--and that's exactly what it's betting on.

"Houston is already a very active life sciences hub, and we've recently seen a drive to further embrace the industry, establish clear leadership in biotech innovation and close the gap between research and commercialization," said Melinda Richter, head of JLABS.

Houston's activity in this space extends to the University of Texas MD Anderson Cancer Center and the Office of Technology Commercialization (OTC), which have helped build up a number of biotech startups over the past two decades.

Since 1987, OTC has been involved in the creation of 11 affiliated life science companies that have raised more than $300 million on the strength of MD Anderson technologies, including ApoCell, Castle Biosciences and DNATrix.

Four portfolio companies listed on Nasdaq have raised more than $230 million and funded $25 million in sponsored research at MD Anderson. JLABS @ TMC will hope to have similar successes on its books.

Currently, more than 100 early stage companies advancing biopharmaceutical, medical device, consumer and digital health programs are housed in the JLABS program, and this will increase to a total capacity for 225 resident companies once all 6 are open and operational.

Almac Group Opens Diagnostic Laboratory in Durham NC

Almac Group’s Diagnostics Business Unit announced the opening of their new companion diagnostic development facility located in the Research Triangle Park region of North Carolina, USA. The North Carolina facility will provide a US base to support Almac’s increased demand for its CDx development partnerships as well as a CLIA-accredited laboratory to support the downstream delivery of assays for patient testing.

Along with headquarters in Europe and partnerships in Asia, the new facility in the US will provide Almac Diagnostics with a strong global presence to continue to meet increasing customer demand and to support their growing client base.

The custom designed facility is located amongst one of the most prominent high-tech research and development centers in the world and contains molecular biology laboratories as well as office space. The state of the art laboratory is equipped with microarray and qPCR platforms appropriate for companion diagnostic development and will operate both research-use-only and clinical diagnostic tests. Plans are also in place to add additional technology platforms including NGS in the coming year.

‘The opening of our new CDx facility in the US is Almac Diagnostics’ latest initiative to better serve our global Biopharma partners. As we experience increased client demand for our companion diagnostic development services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and further demonstrating our commitment to personalized healthcare’ said Professor Paul Harkin, President and Managing Director of Almac Diagnostics.

Coppin State University, Science and Technology Center, Baltimore, MD

Cost: $83 Million

Size: 150,000 sf

Team: CannonDesign (Architects/Engineers), Barton Malow (General Contractor)

Description: Coppin State University’s Science and Technology Center is a building that addresses and fulfills the aspirations of the university, the students and the surrounding neighborhood. Coppin State’s desire to prepare its students for careers in science, technology, engineering and mathematics (STEM) required a new, state-of-the-art facility that would deliver increased opportunities for its high-minority student population to excel in STEM learning.

The design of the new building intentionally opens up the campus to the city as a place for optimism, transparency and hope. The building engages the neighborhood with a zone of teaching gardens, shallow site walls and landscape, all designed to allow for transparent visual connections and a comfortable and safe setting for the students. The adjacent green quadrangle, to be used for the commencement celebrations, is open to the public year-round and acts as a warm and welcoming gesture to share in the university’s success and the community’s pride.

A new set of broad campus steps link the lower level green quadrangle to North Avenue, a main east/west link to downtown Baltimore. These steps incorporate marble from the stoops of houses that were previously on the site to make a series of low stone benches at the edge of North Avenue. The steps also align with a focal point of the building, a cubic glass building volume which houses the faculty offices. The cube appears to float over the main building entrance and glow at night, revealing the activity inside.

The internal organization of the building was determined through numerous discussions with the faculty as well as a detailed program analysis. The design encourages faculty and students from different science departments to collaborate on projects that cross traditional departmental boundaries. All labs and classrooms are designed for project teams of two to eight people to work together as part of the STEM learning experience. General classrooms and computer labs for campus-wide use are included on the lower level. The entry level is active and vibrant, with exhibit space, a small café and a 100-seat lecture hall.

DPT, Confab Increases Capacity and Capabilities in San Antonio and Montreal

DPT Laboratories and Confab, a DPT company specializing in complex solids, semi-solids and liquids, have completed a $10 million investment at its sites in San Antonio and Montreal.

DPT has invested in a new compounding suite and upgrades to production filling lines in San Antonio that will increase capacity, throughput and precision. Additional upgrades include enhanced security to further restrict access to the manufacturing floor and enhance GMP compliance.

Confab expanded its R&D capabilities with a new laboratory, new equipment, and additional R&D personnel. Confab can now offer pharmaceutical development capabilities ranging from formulation development and analytical method development to technology transfers at commercial scale.

“The investments in capital demonstrate our continuing commitment to provide high-quality development and manufacturing solutions to our partners,” said Paul Josephs, senior vice president of sales, marketing and corporate development. “We are excited about the strong demand for our services and look forward to discussing our enhanced capabilities with our customers during DCAT week.”

Lupin buys Gavis Pharmaceuticals - Their First U.S. Facility

Lupin acquired drug formulation developer Gavis Pharmaceuticals in a deal that gives it its first manufacturing site in the US.

The facility in New Jersey is operated by Gavis’ subsidiary, Novel Laboratories.

It is equipped to manufacture and store schedule II to V drugs and undertake solvent-based production processes. According to Gavis the site has passed three US Food and Drug Administration (FDA) inspections.

BMI Research said in a note to investors that: "Gavis' US-based R&D organization would complement Lupin's Coral Spring, FL, inhalation R&D center."

In addition to the manufacturing plant, the takeover gives Lupin a combined portfolio of 120 US-approved generic drugs and 185 pending ANDA applications, including 45 first-to-file (FTF) products offering 180 day market exclusivity.

The takeover was approved by the US Federal Trade Commission (FTC) on the condition Gavis sold assets for two generic products - doxycycline monohydrate and mesalamine ER – to rival G&W.

Gavis was also required to transfer manufacturing technology for doxycycline and to produce it on G&W’s behalf for a two-year interim period.

Similarly, Gavis must make mesalamine for G&W and give the firm access to knowledgeable production staff to allow the firm to seek FDA approval for the product.

Completion of the $850m (€744m) deal follows days after Lupin confirmed it plans to build a generic drug manufacturing facility in Tottori, Japan to try and capture a greater share of the country’s growing non-branded drug market.

Completion of the Gavis takeover also comes a few weeks after Lupin published financial results that illustrated the growing importance finished drug products to its business.

Total revenue the third quarter of FY16 increased 11.9% to INR35.6bn ($54 0 .5m) with the contribution from formulations – finished drug products – growing 7.4% year on year to INR30.82bn.

Lupin’s active pharmaceutical ingredient (API) business – which is founded on key products like cephalosporin antibiotics and cardiovascular and anti-TB drug actives - generated revenue of INR2.76bn, which is just 0.1% higher than in fiscal 2015.

Hovione to Build U.S. Plant

Hovione and Vertex Pharma have teamed up to set up a continuous manufacturing facility at the former’s site in New Jersey, US.

The project – which is scheduled to complete before the end of 2017 – is designed to support production of Vertex’s approved medicines.

Vertex’s approved products are the cystic fibrosis dugs Kalydeco (ivacaftor) and Orkambi (ivacaftor/ lumacaftor).

The firm's former product, the hepatitis drug Incivek (telaprevir) was discontinued in 2014. Vertex cited falling demand for the drug caused by competition from newer hepatitis C treatments.

The new manufacturing facility in East Windsor, New Jersey will house continuous blending capacity, wet and dry granulation systems, fluid bed drying platforms and tableting and coating technologies.

Filipe Gaspar, VP R&D at Hovione, described continuous manufacturing as “as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies.”

News of the collaboration follows a few months after Hovione said it would spend $24m (€22m) to expand production capacity and enhance the New Jersey facility’s potent active pharmaceutical ingredient (API) handling capabilities.

The expansion – which is due to be completed early next year – is expected to create 60 jobs.

Sherpa Completes Move to San Diego Facility

Sherpa Clinical Packaging has moved into a new packaging and distribution center for clinical trial supplies in San Diego, U.S.

The 37,5000 square foot site was built in response to “increased demand for Phase II and Phase III clinical studies and is a result of continued growth serving new and existing clients” according to Sherpa.

The site will provide primary and secondary clinical labelling and packaging, GMP storage for refrigerated, frozen and controlled room temperature, and temperature controlled shipping dispatch.

It also features an ISO 8 cleanroom for primary packaging of solid dose products.

The privately owned contractor finished construction of the facility in 2015.

"The new Sherpa facility will help sustain the continued growth of our company," said Mark Paiz, president of Sherpa Clinical Packaging.

"We are excited to be able to provide the diversity and quality of services to a large number of clients in all phases of clinical trials. Sherpa's mission is to be the customer service leader in the clinical trial materials management business and we offer each client the trusting and reliable relationship that people vested in clinical trials seek."

County Approves Funding for Westchester Med Center Expansion

Westchester Medical Center was approved for tax-exempt, low-cost financing on a new $230 million ambulatory care pavilion adjacent to its main hospital that promises significant upgrades in delivering healthcare to patients.

The county’s Local Development Corporation (LDC), which was created by County Executive Rob Astorino in 2013 to encourage nonprofits to build important projects and stimulate the economy, granted up to $340 million in borrowing for the medical center for the eight-story, 280,000-square-foot addition at the Valhalla campus. The project will include 185,000 square feet of ambulatory care space, 20,000 square feet for 48 private patient rooms and 75,000 feet for physician offices.

The board of directors for WMCHealth, the network that operates the hospital and six other facilities in the Hudson Valley, approved the project.. It is expected to open by late 2018.

Michael Israel, president and CEO of WMCHealth, said it will allow Westchester Medical Center to serve a wider population of patients more effectively. It has focused mainly on its trauma and tertiary care, one of the only facilities north of New York City to deliver those services, but leaves little time and space to help other patients.

“It gives us the ability to deliver ambulatory services in a way our patients and in a way our physicians want to deliver them,” Israel said. “The medical center itself has been more in-patient, advanced care focused. The health care system is changing, we have to change along with the system.”

The ambulatory care pavilion will include an advanced imaging center, an ambulatory surgery center and a heart and vascular institute, Israel said. Westchester Medical Center, built in 1977, is often so busy dealing with emergencies that a patient who comes in for a 9 a.m. surgery, for example, may have to wait hours for their procedure to be done, he said.

Also, the hospital is typically only able to use about 85 percent of its 415 beds because some patients require such advanced care that a private room is necessary.

Once the new pavilion is built, medical center staff anticipates being able to use 100 percent of its beds, Israel said. The hospital will maintain its license with the state at 415 beds, he added.

“It gives us more space to do more things going forward,” Israel said. “There’s not much available space in the hospital.”

Astorino lauded the proposal as one that will raise the quality of health care in Westchester and throughout the region as well as spur the local economy. The project is expected to generate 225 prevailing wage construction jobs and an additional 180 permanent full-time staff jobs.

“I appreciate this. I appreciate the investment you’re making in Westchester,” Astorino told Israel. “This is a great project that will help everyone not only in Westchester but the counties around us. In fact, the whole metropolitan area.”

He said the county had to work to amend legislation to include a public benefit corporation, such as the medical center, to be eligible for the low-cost financing. Previously, nonprofits had only been able to receive the LDC funding. The financing comes at no risk to the county and its taxpayers, Astorino added.

By the time the ambulatory care pavilion is built, Westchester Medical Center would have invested almost $1 billion in infrastructure, technology and expansion on the Valhalla campus in a little more than a decade, Israel noted. It also operates the 136-bed Maria Fareri Children’s Hospital and the 101-bed Behavioral Health Center for psychiatric patients. Israel said the children’s hospital has been operating above capacity and will also likely need an expansion to at least 175 beds in the coming years.

In addition to the $230 million in financing for the new construction, the additional money of up to $110 million will also include $44 million in other capital projects and possibly re-funding $52 million in bonds.

Astorino said the medical center project will also fit in well with the proposed North 60, that would be on mostly on county land near the site. That project calls for more than a couple million square feet of mixed uses, including science and medical research space.

Avid Bioservices Commissioned Biologics Manufacturing Facility

Peregine Pharmaceuticals – Avid’s parent company – announced the completion of the facility in Tustin, California, estimating that the capacity increase for its contracting arm will support "up to an additional $40m in revenue each year.”

Construction was actually completed last year according to Peregrine, which announced the facility was “ready for the initial phase of GMP manufacturing” in an SEC filing in December.

Peregrine said the plant – which houses single use bioreactors (SUBs) with capacity of up to 2,000 liters – will support clinical development of its own late phase cancer drug bavituximab and production of biopharmaceutical for other firms.

Peregrine CEO Steven King said: “This is an exciting milestone for our biomanufacturing business, which already had 20% revenue growth in our last fiscal year to $26.7 million and is expected to grow to $35-40 million in revenue for the current fiscal year that ends April 30.

He added that: "We have already had a tremendous response to the new facility and look forward to continuing to grow our biomanufacturing business which is an integral part of our overall business strategy."

Peregrine generates that vast majority of its revenues from contract manufacturing. According to its most recent filing Avid brought in $18.9m for the six months ended October 31, which was an increase of around $7m on the comparable period in fiscal 2014.

Peregrine’s technology licensing activities – which relate to a 2010 deal to develop its tumor necrosis therapy technologies - generated just $292,000 in the six months to October 31.

The formal commission of the facility follows a few weeks after Peregrine announced it was halting a Phase III trial of bavituximab – known as SUNRISE – after analysis showed that its drug combined with docetaxel did not perform better than docetaxel alone.

At the time a spokesman for the firm declined to comment on bavituximab future, telling us "unfortunately, as this is an unfolding situation with much data analysis remaining to be done, there is nothing more that we can say on the topic of the SUNRISE study."

AAIPharma/Cambridge Major Labs to Relocate Analytical Testing Facility

AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a provider of manufacturing and development services for the pharmaceutical and biotechnology industries, announced on Feb. 17, 2016 a planned investment of at least $10.7 million to relocate its St. Louis, MO analytical testing facility to the Cortex Innovation Center.

AAI/CML’s analytical testing business is comprised of three centers in St. Louis, MO; Wilmington, NC; and Edison, NJ. The company’s current St. Louis, MO facility specializes in chemical and microbiological analytical testing, including raw material testing, drug product release, stability, and environmental monitoring for both sterile and non-sterile drugs.

According to a press release from the company, the new facility will provide new testing capabilities, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification, and efficacy studies. The structural completion and build-out are expected to be complete by the fourth quarter of 2016 and transition from the existing location will occur in the first quarter of 2017.

AAI/CML’s additional sites in Edison, NJ and Wilmington, NC will serve as testing support. AAI/CML will absorb the cost of method transfer exercises, reverifications or method suitabilities related to the site move, ensuring relevant regulatory requirements continue to be met.

Eurofins Microbiology Opens ISO 17025 Accredited Laboratory in Louisville, Kentucky

The laboratory offers testing services to rapidly quantify, detect, or identify pathogenic, spoilage, and probiotic microorganisms.

It will also house food and microbiology testing, which Eurofins said should ‘foster diversity and synergy’ between scientific applications of molecular testing.

The site will include up to 110 employees, including lab technicians, chemists and biologists.

The 65,800 ft2 (6,113 m2) facility functions as the central genomics laboratory in North America, focusing on custom production of DNA and RNA oligonucleotides synthetic gene synthesis, and genomics services including DNA sequencing, synthetic biology and next generation sequencing (NGS).

Eurofins selected Gray Construction to provide design-build services for the facility, which houses both laboratories.

Eurofins will introduce synthesis technology in the facility, which it said will lead to increased quality and reliability in its oligonucleotides production capabilities.

Since 2005, Eurofins has invested over $800m to add or modernize over 3,766,000 sq. ft. (350,000m2) of laboratory surface to its network, and plans to add another 1,291,200 sq. ft. (120,000m2) by the end of 2017.

The microbiology laboratory is home to the ExpressMicro service which the firm said reduces turnaround time of results by up to eight hours over competing laboratories.

Mehgan Styke, business unit manager of Eurofins Microbiology in Louisville, said the service enables it to provide customers a quick time to result without compromising method or process quality.

Eurofins Kentucky Lab

“As the time waiting to release product or review results often impacts food production schedules and the bottom-line; it is exciting to have both a local and nationwide food safety and testing solution that incorporates customized logistics and high quality testing solutions via Eurofins ExpressMicro,” she said.

Dr Gilles Martin, Eurofins Scientific CEO, said: “Our ambition is to make it the most modern and innovative facility of its kind in the world. This state-of-the-art laboratory reflects the group’s commitment to quality, innovation, and to contributing to the advancement of scientific research and health sciences around the globe.”

Quality standards are supported by internationally recognized certifications such as ISO 9001:2008, ISO 13485: 2003 and an FDA certification for GMP production.

Greg Fisher, mayor of Louisville, said Eurofins is a great example of the type of company the city wants to attract.

While announcing its 2015 results, Eurofins said the US now makes up a third of group revenues.

It completed 21 acquisitions in 2015 to strengthen its leadership in existing markets or enter new segments.

The firm said growth in the food testing business continues to be robust, supported by manufacturers’ and retailers’ ever-increasing efforts to increase safety of their products, as well as regulatory developments to ensure consumer safety by improving transparency and increasing accountability in the supply chain.

Technological innovations such as new tests enabled by genome sequencing, provide additional support, as well as additional volume for testing.

Incidents of fatal food contamination, as well as product recalls continue to highlight the need for more effective testing, it added.

“Positive developments in the US food testing market, driven by regulatory developments as the FDA moves closer to partial implementation of the FSMA in late 2016-early 2017, as well as ongoing food contamination scandals, are reflected in the high single-digit organic growth generated by the group’s US food testing business,” said Eurofins.

In France, Eurofins’ second largest market bringing-in 19% of total sales, revenues increased 63.2% to €369.6m on organic growth.

The French food testing business performed strongly on the back of market share gains and contract wins such as the partnership with SODEXO. Eurofins has also been selected by the National Food Safety Agency (ANSES) to conduct nutritional analysis for the Table Ciqual.

Revenue contribution from Germany, which makes up 12.8% of revenues, was €250.4m in 2015, as acceleration in the second half of the year resulted in ca. 6% organic growth for the full year.

Growth acceleration in food microbiology and launch of new tests resulted in volume ramp-up in Q3 and Q4, compensating for the slower start of the year.

Revenues from the Nordic region, which generated 8.4% of total revenues, grew to €163.3m. The food and environment businesses in the Benelux generated revenues of €158.1m, up 9.6% versus 2014.

In the UK & Ireland, revenues grew 23.6% to €96.2m on organic growth and positive currency impact of 8.5%. The strong performance of the food and pharma testing businesses offset some weakness in environment testing.

Eurofins’ continues to expand in emerging markets and the Asia Pacific region, where revenues increased 29.6% to €269.2m on strong organic growth and selective acquisitions.

In Hong Kong, the group opened a lab to perform time-sensitive bacteriology tests, which it said is expected to increase penetration of the local food testing market. Eurofins is also expanding its main Chinese food testing lab in Suzhou, to support the growth in testing.

In India, Eurofins opened a food testing lab in New Delhi, the second in the country. The group also opened a lab in Coimbatore, in Southern India, housing its agrosciences expertise to support the country’s vast agricultural services sector.

In France, Eurofins launched six start-up labs in 2015, taking the group’s coverage to 13 satellite laboratories, complementing the large, regional central lab for water testing in Maxéville.

Eurofins is shifting several multi-building or multi-location labs in Germany into a large, single-site campus in Hamburg.

The group is also consolidating in the Benelux to bring several small labs into two large sites in The Netherlands. In Sweden, it is combining two labs into one larger site in Uppsala.

Between 2016 and 2017, the group has plans for another 1,291,200 sq. ft. (120,000m2) of modern lab surface, of which over 807,000 sq. ft. (75,000m2) is expected to come on stream in 2016.

Velesco Pharma Opens cGMP-Compliant Analytical Testing Laboratory

Velesco Pharma, an early stage pharmaceutical development and clinical manufacturing company, has boosted its cGMP analytical testing capabilities with an expansion of its analytical laboratory in Plymouth, Mich. The addition of a new cGMP analytical testing laboratory increases the breadth of services to more fully meet the needs of its broad client base.

The main activity supported in the new cGMP-compliant laboratory is the testing of clients’ stability samples. Specific testing activity includes:

Assay and related substances by HPLC (UV and RI) and UPLC-UV
Assay by titration; water content (Karl Fisher); pH; viscosity; osmolality; density/specific gravity; disintegration; dissolution and UV
Hardness and friability for tablets

In addition to executing clients’ cGMP stability programs, the laboratory is ideal for the testing of samples for cleaning validation studies, in vitro equivalency determination and test article characterization.

“Our new cGMP analytical laboratory is impressively designed, equipped and staffed so that we can meet our clients’ growing demand for analytical services,” said Dave Barnes, Ph.D., chief executive officer at Velesco. “We look forward to collaborating with our clients to ensure strong cGMP testing programs. Our clients can be confident their testing will exceed FDA compliance requirements.”

Alnylam Plans for Commercial RNAi Manufacturing Plant

Alnylam has acquired 12 acres of land in Massachusetts in anticipation of building a manufacturing facility for its RNA interference therapies.

In its end of year report, Alnylam Pharmaceuticals announced it bought the undeveloped land in Norton, Massachusetts, for around $8m (€7.2m) last week where it intends to build a manufacturing facility for its clinical and commercial drug products, including siRNAs (small interfering RNA) and siRNA conjugates.

The firm said in the filing it expects the transaction to close in the first quarter 2016, and to incur approximately $100m in expenditures related to the planned facility during the year, something management reiterated during a call discussing results last week.

The news comes as Alnylam prepares to submit its lead therapy patisiran (ALN-TTR02), an intravenously administered RNAi therapeutic to treat the inherited disease Transthyretin (TTR)-mediated amyloidosis.

“We're entering the dawn of our commercial transition with planned regulatory submissions in 2017 for patisiran approval,” said CEO John Maraganore.

If successful, Alnylam would become the first company to commercialize an siRNA therapy, something predicted by drug discovery pioneer Kathryn Whitehead from Carnegie Mellon University in Pittsburgh, PA.

“Alnylam’s work has been exciting and validating for those in the siRNA delivery field, because it shows that a long-term commitment to a challenging therapeutic platform can result in new therapies for patients in need,” she said..

A new facility also represents the latest stage in a turnaround for Alnylam which – following the ending of its alliance with Novartis – spent the first part of this decade reducing its headcount.

Furthermore, the company has grown through the acquisition of Merck & Co. subsidiary Sirna Therapeutics for $175m , and been boosted by investments from French Biopharma firm Sanofi who owns a 12% stake in Alnylam.

University of Minnesota Health, Clinics and Surgery Center, Minneapolis, Minn.

Budget: $165 Million

Size: 342,000 sq. ft.

Project team: CannonDesign (Architect), Studio Five Architects (Partner Architect) Affiliated Engineers (Engineering) and McGough Construction (CM)

Description: The University of Minnesota Health (M Health), Clinics and Surgery Center is a destination ambulatory care center designed to elevate an inter-professional care delivery model while providing an entirely new type of patient experience that introduces improved care delivery models, patient flows and turnaround of outpatient procedures.

The five-story, 342,000 sq. ft. outpatient center in Minneapolis, MN is uniquely designed with innovative ideas pulled from other consumer industries including retail and air travel to orchestrate a patient experience that promotes personalization, convenience and the elimination of touchpoints. The facility is also powerfully efficient—allowing M Health to accommodate twice as many patients as it could with its previous facility, with far fewer exam rooms.

Key examples of the Clinics and Surgery Center’s cross-market influences include:

Inspired by Retail Design and specifically Apple Stores, the Clinics and Surgery Center features no formal check-in or check-out areas. Instead, patients are greeted by a staff member with a mobile device capable of checking them in, filling out health forms, finding their exam room and scheduling future visits.

Modeled after the check-in procedures for airlines, M Health’s new facility offers patients’ technologically-advanced check-in solutions they can use from home to eliminate the need for a formal check-in process.

M Health also leveraged contemporary workplace strategies in the redesign. In lieu of space allocated to private offices that tend to be empty up to 90 percent of the time, the new facility features touchdown spaces and enclosed offices—all of which can be reserved for pieces of time, but are not designated for one individual. This allowed underutilized space to be reallocated toward collaborative and social staff areas which take advantage of abundant daylight and views of the campus.

Embedded within the Clinics and Surgery Center’s creative design are also highly flexible and adaptable clinical modules designed to accommodate changes in program development, best practices and innovations over the decades ahead. These modules further promote M Health’s inter-professional care model, which brings medical, research and education professionals together for collaboration and teaching.

Completion Date: Feb. 2016

Athenex to Invest in Biotech Facilities

Athenex will invest a minimum of $1.62 bn over the next ten years in labor, materials, and supplies, to create a new manufacturing facility and to expand its North American headquarters.

Governor Andrew M. Cuomo announced the expansion, which is made possible by a partnership with the SUNY Polytechnic Institute. He said: "I am proud to congratulate Athenex – which could have gone anywhere – on beginning this exciting new chapter, creating good-paying jobs and further strengthening the region's and state's economy."

Athenex will invest a minimum of $1.52 billion to create a 300,000 square foot High Pharmacy Oncology Manufacturing Facility in Dunkirk, with an additional $200m investment from the state. The facility will manufacture sterile high potency oncology drugs in a specialized, controlled environment.

The plant will also focus on manufacturing oncology pharmaceutical products which are often on the FDA's drug shortage list. According to the release, a specialized plant such as this has not been built in North America in more than 15 years.

It also added that the partnership with New York State will secure the company’s presence and growth in the state, as well as accelerating “the goal of converting investments made in medical research into long term sustainable manufacturing jobs in high tech pharmaceutical products.”

The conference and expo brings together big pharmas, biotechs, research institutions, academics and their partners from Asia Pacific and beyond. Meet over 2000 attendees, 150 speakers and 50 exhibitors.

Additional plans include a major expansion of Athenex's North American headquarters at the Conventus Building in Buffalo – a formulation product development center and a pilot plant where the oncology products are perfected and refined before being produced in Dunkirk.

This expansion will involve a minimum investment of $100m from Athenex and $25m from the state, bringing the total investments to $1.62bn and $225m, respectively.

Dr. Johnson Lau, Athenex CEO and Chairman, thanked the Dr. Alain Kaloyeros at SUNY Polytechnic Institute, and added: “This collective leadership in New York is accelerating the transformation of the State's economy into a global leader of next generation manufacturing across many industries. With this partnership, millions of cancer patients around the world will benefit from the oncology drugs made in New York.”

REST OF WORLD

Hisun to Expand Capacity

Chinese firm Zhejiang Hisun Pharmaceutical Co (Hisun) has invested €4.5m in pharmaceutical solid dosage technology from GEA, including high-containment granulation, coating and drying solutions to expand its oncology production line capacity. This takes the firm's total investment with GEA to more than €50m since 2009.

Expanding its current production capacity for oncology treatments, Hisun will add four complete high-containment solid dosage granulation, coating and drying lines, incorporating GEA’s proprietary PharmaConnect and FlexStream equipment, and machinery manufactured in Europe.

Hisun was established in 1956 and currently employs more than 5,000 people. The company has evolved into one of the largest bulk active pharmaceutical ingredient (API) manufacturers in China, with approximately 80% of its API output being exported to North and South America, Europe and Asia.

Hisun is GEA's most important pharmaceutical customer in China. They been working together for more than six years in a variety of different application areas, including solid and liquid dosage forms, and biopharmaceuticals, with a strong focus on freeze drying. Offering finished dosage forms such as capsules, tablets and parenterals, Hisun’s products include antibiotics, anti-infectives, cardiovascular and oncology treatments.

Over the years, Hisun has invested in a range of GEA’s equipment, including 10 lyophilisation production lines with the latest high-specification loading systems and isolators, and high-containment granulation lines.

Omya Opens New Lab

Officially opened on 15th March 2016, Omya’s new pharmaceutical and nutraceutical laboratory is now operational. The innovative facility at the company’s Swiss headquarters in Oftringen comprises a wet lab for product development, a dry lab for granulation, tabletting and performance analysis, as well as storage and office space. Cutting-edge equipment – including fluid-bed technology, a roller compactor and a rotary tablet press – allows for high-quality mineral research, development and technical customer support.

Until now, Omya has done pharmaceutical and nutraceutical product development with external partners through third-party agreements. However, securing intellectual property rights in collaborations such as these can be challenging. With its own lab, Omya can react to market needs much faster now and ensures legal certainty for both itself and its customers, which is a prerequisite for the company to be able to sell its products without restrictions.

Of paramount importance for the new laboratory will be developing innovative applications and maintaining ongoing natural minerals research projects. These include the award-winning Omyapharm^®, a Functionalized Calcium Carbonate and ideal excipient that allows granules and tablets with high levels of mechanical strength and fast disintegration times to be produced. Owing to its outstanding properties, Omyapharm^® was selected from 20 shortlisted substances and presented with the 2015 CPhI Pharma Award for most innovative excipient.

“With the new laboratory, we are able to protect intellectual properties and further extend our specialist calcium carbonate expertise. This includes developing new structured minerals that are tailor-made for specific applications or optimizing existing products to meet the changing needs of the industry. Moreover, our experienced team of scientists and technicians is available to support customers regarding product development and ensure shorter times-to-market for pharmaceutical and nutraceutical products,” explains Stefan Lander, Vice President Consumer Goods at Omya.

Waters and BioCity Inaugurate Analytical Laboratory

Waters Corporation has opened a new open access laboratory with BioCity at Alderley Park, Cheshire, UK

Waters Corporation, a US manufacturer of advanced analytical and material science technologies, has opened a new open access laboratory with BioCity, the UK's largest bioscience incubator company.

Located in the BioHub at Alderley Park, Cheshire, the laboratory offers Waters’ state-of-the-art liquid chromatography (LC), mass spectrometry (MS) and informatics technologies, within a suite of analytical modules for scientists working in the pharmaceutical and life science industries.

Chancellor of the Exchequer, George Osborne, said: 'This is more great news for Alderley Park and for life sciences in Cheshire. We are home to so many innovative and growing businesses in the sector and I was delighted to hear that BioCity Group and larger employers like Waters are helping to nurture new talent.'

The laboratory will be resourced with many of Waters’ latest technologies, including Acquity, QDa, Acquity H-Class, Acquity UPC2 and Acquity PDA Detector, along with the expertise required to leverage the power of these instrumentation platforms. The laboratory also includes a nuclear magnetic resonance (NMR) system provided by Manchester Science Partnerships, the owners of Alderley Park.

'At Alderley Park, and indeed across the BioCity group, we are working with a growth formula that provides emerging and growing companies with access to everything they need to succeed – be it people, facilities, finance or technology,' said Glenn Crocker CEO, BioCity Group.

'The fact that our model and the work we are doing in partnership with Waters and MSP is recognized by the Chancellor is encouraging to hear. We are proud to be playing a leading role at the forefront of both the local and national economy.'

Shott API Process Development Plan for Former Covance Lab

Shott Trinova has confirmed its intention to offer API production and process development at the UK laboratory it acquired from Covance.

UK-based Shott bought Covance’s laboratory in Alnwick, Northumberland in a deal prompted by the expiration of a preclinical services contract the US contract research organization (CRO) had with French drug developer Sanofi.

Shott set up a contract research arm called ARC Trinova to run the lab. According to a Covance spokeswoman the new CRO “will continue to provide certain capabilities to Covance that are linked to the work performed at other Covance sites in the UK.”

Shott Trinova also plans to offer process development and manufacturing services for active pharmaceutical ingredients at the site.

A spokeswoman for Shott said the idea is to “provide an integrated service to clients at a key stage of drug development, spanning preclinical and early clinical phases.”

She added that “process development and manufacturing carried out at the site will span from tens of grams to low kg scale” and said that production will begin “during 2016.”

Shott, was established by Ian Shott former CEO of Excelsyn.

The Alnwick lab employed 130 people. Most staff have been kept on by ARC according to LabCorp-owned Covance, whose spokeswoman to us the transfer was part of the sale agreement.

“The majority of the staff transferred to ARC Trinova. As part of the agreement ARC Trinova agreed to retain a minimum of 50 employees and will continue to provide certain capabilities to Covance that are linked to the to work performed at other Covance sites in United Kingdom.”

Covance’s other UK sites are in Maidenhead, Harrogate, London and Leeds.

JHL Biotech Completes Phase of its Wuhan Biopharmaceutical Manufacturing Facility

JHL Biotech and GE Healthcare's Life Sciences business have announced the mechanical completion of JHL Biotech's JHL-1 biopharmaceutical manufacturing facility in the Biolake area of Wuhan, China.

The campus was built to be compliant with the highest international standards, and after site validation is completed in June 2016, the facility will be the largest monoclonal antibody manufacturing facility in mainland China to be constructed around single-use bioreactor technologies.

In a first for the pharmaceutical world, the JHL-1 facility was constructed in just over one year, significantly faster than the three-year development timeline typical for the industry. This speed of construction was made possible by commissioning GE Healthcare Life Sciences' innovative modular off-the-shelf factory, KUBio^™.

Designed to increase speed to market and reduce capital construction costs, GE's KUBio modular biopharmaceutical factory enables rapid deployment of manufacturing capability. Built in Germany to Chinese, European and American regulatory standards, shipped to and assembled in China at the Wuhan site, JHL-1 will be equipped with GE Healthcare's flexible single-use FlexFactory biomanufacturing platform.

JHL Biotech's Wuhan facility will be used for cell line development, process development, and cGMP manufacturing of JHL's late-stage clinical and commercial products. The facility will also be used for contract manufacturing orders for select customers.

Jan Makela, General Manager BioProcess at GE Healthcare Life Sciences, commented, "We'd like to congratulate Racho Jordanovon this important step in further realizing JHL's outstanding vision for biopharmaceutical manufacturing in Asia. JHL's investments in KUBio and FlexFactories will help meet its need for speed to market across multiple sites, increasing patient access to these important medicines."

Racho Jordanov, Co-founder, President and CEO of JHL Biotech, added, "JHL Biotech will make world-class biopharmaceuticals affordable to more people through innovation and consistently high quality. JHL Biotech now has the largest volume of single-use cell culture capacity in Asia with the installation of cGMP manufacturing in our Wuhan facility. Because our biomanufacturing capabilities are shared across our facilities in Asia, we provide our partners a unique offering."

Pfizer Expanding Australian Drug Facility

Adelaide will become the national hub for producing a drug used to reduce infections in cancer patients when the expansion of a $21 million facility in the city's inner-west is completed, the State Government says.

Adelaide site director of pharmaceuticals company Pfizer Dr Tony Mulcahy said the manufacturing facility at Thebarton would deliver $380 million to the South Australian economy over the next seven years.

The expansion will not create any new jobs but Dr Mulcahy said 100 people were involved in the production and global exportation of the drug called pegfilgrastim.

Dr Mulchay said essentially the injectable drug stimulates the level of white blood cells a patient produces, helping them deal better with any complications after chemotherapy.

"Normally a complication of cancer therapy is that your immune system is actually wiped out," he said. "What happens is that you have very, very low white blood cell counts and it's then that you're really susceptible to normal infections and they're life threatening because you don't have that immune protection."

Dr Mulchay said the facility would be the only one of its kind in Australia.

He said the active ingredient for the medication would be made in Adelaide.

"There are probably two similar facilities in Australia that use a different manufacturing process, but this will be state-of-the art," Dr Mulchay said.

"It's the only one of its type in Australia, using the background of the living organism that we use.

"This pegfilgrastim we make here in Adelaide so we make the intermediate and then we work with our sister facility in Zagreb, where they put the chemical on the peg and put it into pre-fill syringes but we make the active ingredient here."

Health Minister Jack Snelling said the expansion was a sign of job security into South Australia's future."This is a wonderful sign of the transition of the South Australian economy to the jobs of the future — jobs of the future in pharmaceuticals and health industries," Mr. Snelling said.

"The Government, a few years ago now, made a very conscious decision that really we had a unique opportunity, that we had a proud history in medical research, to actually find opportunities to commercialize that research.

"We indentified health research as a component of the economy that was growing really quickly."

BioMarin Expects Commercial Production

BioMarin Expects Commercial Production of its recently approved orphan drug Vimizim (elosulfase alfa) to begin at a secondary facility in Ireland – acquired from Pfizer – mid-2017.

In 2011, drugmaker BioMarin announced it was buying Pfizer’s Shanbally biologics facility in Cork, Ireland, for $48.5m (€43m) in order to manufacture its then Phase III candidate N-acetylgalactosamine-6-sulfatase (GALNS) enzyme replacement therapy.

The product, since approved in the US and EU in 2014 to treat the rare congenital enzyme disorder Morquio A syndrome, is currently manufactured at the firm’s Novato, California facility and headquarters, but plans to meet commercial demand through the opening up of the secondary Shanbally site are “proceeding very well,” according to management.

“We are going through the process qualification manufacturing campaign now that started in the beginning of January,” said Robert Baffi, EVP of Technical Operations during a call discussing Q4 2015 results.

“The campaign will end in the June timeframe. We'll then have to write up the documentation and submit it. We'll probably have inspections in the first quarter of 2017 and are anticipating approval in the major regions - US and Europe - by mid-2017.”

He added Californian supplies of the product – which costs patients $380,000 for a year’s supply – will be “more than adequate” to bridge the gap until then, and then BioMarin “will be able to produce product at two different sites for Vimizim, meeting all the commercial demands as required.”

Completing validation and gaining approval at the site will contribute heavily to the firm’s expected $150-175m capital expenditure for the upcoming year, management said.

For 2015, total sales were $890m, up 18.8% year-on-year, driven by the continued global launch of Vimizim. The product itself contributed $228m to the results.

At the time of EU approval, the drug’s active substance was being manufactured at Novato with fill/finish – in Europe at least – being conducted by CDMO Vetter in Germany, according to the European Medicine Agency (EMA) assessment report.

The report also described the manufacturing process using BioMarin’s cell banking system derived from a CHO-K1 cell line:

“Following transfection in the host cell line, a stable pool was generated by selection and the pool was limited-dilution cloned for single cell clones producing elosulfase alfa.

“One clone was selected from the stable clones based upon titer and viability, and was selected to use in creation of the master cell bank (MCB). The resistance marker was removed from the culture process prior to preparation of the development bank, and was not utilized during generation of the MCB.”

It added the product is purified in a sequence of chromatography, viral inactivation and filtration, and ultrafiltration/diafiltration steps.

ICIG Acquires Sandoz Site in Frankfurt-Höchst

International Chemical Investors Group (ICIG) and Novartis Group have entered into an agreement under which ICIG will acquire all of the shares in Sandoz Industrial Products GmbH, a Frankfurt-Höchst-based manufacturer of enzyme-based fermentation products and intermediates for the pharmaceutical industry, especially for the use in antibiotics. Closing of the transaction is anticipated to occur on April 1, 2016.

Sandoz’s decision to withdraw from the production of intermediates for 7-ACA antibiotics for external customers in May 2015 initiated a dual track process preparing the site for a sale and securing its customer base while alternatively considering a shutdown of its operation at the Industriepark Höchst. -

Sandoz Industrial Products GmbH will maintain its operations associated with the CordenPharma Group, the pharma platform of ICIG. The business will be complementary to both ICIG’s pharma activities as well as to its fine chemicals activities within the WeylChem Group. The site represents an important building block for further expansion into fermentation-based production technology for ICIG.

With the acquisition of the Sandoz Höchst site, CordenPharma Group will become one of the major suppliers of 7-ACA to customers worldwide. CordenPharma will also use the material in-house for its own antibiotics value chain at its Latina site in Italy.

“The new site will expand CordenPharma’s operations, growing its enzymes-based manufacturing portfolio and dedicated antibiotics technology platform and will add state-of-the-art capabilities in microbial fermentation and enzymatic reactions to WeylChem’s extensive non-GMP production capabilities as well,” said Achim Riemann, managing director, ICIG.

“With the newly acquired plant at the Höchst site, ICIG further increases its footprint in the Frankfurt Rhine-Main area,” said Patrick Schnitzer, managing director, ICIG. “We are focused on the continuation and further development of the business, as we have successfully demonstrated in many other transactions.”

FPS Opens R&D and Test Center

FPS is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of Fine Size Reduction machines and Containment Solutions (sterile and highly toxic API).

Following the enlargement and modernization of the production facility in Fiorenzuola d’Arda, Italy, FPS dedicated a specific area to the new R&D and test center. Three ISO8 (Class 100,000) grade test suites allow the execution of short to medium duration micronisation technical tests, ranging from laboratory to production quantities.

The center is equipped with up-to-date machines and modern instruments to assure product and operator protection during activities to assess process validity/optimization. Special configuration of micronisation equipment can be arranged for dedicated testing on a large range of size reduction machines:

Spiral Jet mills
QMills (loop type)
Pin mills
Hammer mills

Additional services related to particle size reduction include:

De-lumping
Co-micronisation
Sieving
Blending
Cryogenic operations
PSD Analysis

Starting from June 2016, an isolator will be available in the test center for technical test on HPAPIs with R&D and Lab Jet Mills, up to PilotMill-6 and Pin Mill-100 units. The isolator will be complete with gravimetric feeder and PLC controls. The isolator will be exhibited during next Pharmintech and Powtech shows in April.

Rental units are also available to carry out testing at customers' premises. The necessary technical support is assured by FPS experienced technicians.

Lupin Confirms Kyowa Wants New Generics Plant in Tottori

Lupin is mulling building a manufacturing plant with capacity to make two billion tablets a year in Japan in response to growing demand for generics.

The Indian drug firm confirmed that the board of its wholly owned subsidiary Kyowa Pharmaceutical Industry Co had proposed setting up a new facility in a filing on the Bombay Stock Exchange (BSE).

In the confirmation, which the Exchange sought after a report in the Economic Times , Lupin states “in order to meet the rapidly growing demand of generics, the Kyowa Board has proposed the setting-up of a 2 Bn. Tablets capacity Plant at Tottori, Japan.”

The Indian drug firm added that the facility “would be designed to efficiently handle mass volume products and provide flexibility in allowing easy future expansion.”

Kyowa already operates a manufacturing plant in Sanda, Japan.

The Japanese Government has been trying to promote use of generic drugs since 2007 when it said it wanted to increase the market share held by non-branded meds from 17% to 30% by 2012.

Generic use has increased, although not as rapidly as expected. In 2013, 28% of all drugs sold in Japan were non-branded products.

The Government’s response has been to intensify its efforts according to Masaki Muto, chairman of the Japan Generic Medicines Society (JGA), who predicted a rapid increase in uptake at a drug industry conference in Tokyo last year.

He told delegates at CPhI Japan that measures introduced by the Ministry of Health Labour and Welfare (MHLW) in 2014 – including price reductions – would boost generic uptake.

The MHLW wants generic drugs to hold 60% market share by the end of fiscal 2017 in Japan.

Colorcon Opens Colombia Formulation Lab

Colorcon has opened a formulation laboratory in Colombia to build its presence in the fast growing South American pharmaceutical market.

The facility, in Bogota, houses a formulation lab and a service center and was designed to meet “internationally recognized certification for the containment and safe handling of Level II and Level IV active pharmaceutical ingredients (APIs)” according to Colorcon.

The ability to handle API is important for customers according to regional sales manager Carlos LaCruz, who said: “We can provide specialized support to accelerate development and commercialization of robust, high quality pharmaceutical drug formulations.”

This was echoed by regional technical manager Plinio Sandoval, who said: “Colorcon has invested in new-instrumented equipment, including high shear granulation, an instrumented press machine, advanced film coating equipment and USP dissolution apparatus.

“Access to this advanced technology and analytical tools enables more robust formulation development, provides release profiles and ultimately better prediction for scale-up to manufacturing.”

The Bogota service center is Colorcon’s fourth in Latin America. The coating technology and formulation services firm has similar sites in Argentina, Mexico and Brazil. It also operates a sales and distribution center in Venezuela.

The laboratory is the first new site Colorcon has opened since it set up facility in Beijing's YiZhuang Biomedical Park in China last year.

BioOutsource Contract Testing Facility Passes FDA Inspection

Sartorius Stedim Biotech is pleased to announce that the Glasgow facility of its subsidiary Sartorius Stedim BioOutsource Ltd. has successfully passed an inspection by the U.S. Food and Drug Administration (FDA).

In January 2016, the FDA Compliance Safety Officer spent two days at BioOutsource’s facility reviewing its quality systems and their application to the analytical services that support the testing of biologics, vaccines and biosimilars. The inspection confirmed that the Glasgow site is compliant with the principles and guidelines of Good Manufacturing Practices (GMP). Not a single Form 483 observation for non-conformance was issued.

At the closing meeting, the FDA inspector was very satisfied with the facility and complimented Sartorius Stedim BioOutsource on its GMP systems, organization during inspection and the expertise of its team members. The success of this FDA inspection, combined with the positive feedback from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2015, as well as reports from numerous biopharma clients that have visited and audited the Glasgow facilities in recent years, demonstrates BioOutsource’s commitment to maintaining excellence in its quality systems.

Gerry Mackay, CEO at BioOutsource stated: “We’re delighted with the positive outcome of our FDA inspection, because it shows that we are committed to offering quality analytical and safety testing. This provides biopharma firms with confidence that we are a partner they can trust with their biologic and biosimilar drug development programs.”

Chugai Pharmaceutical to Construct a New Plant

Chugai Pharmaceutical announced its decision to construct a new plant for manufacturing antibody active pharmaceutical ingredients (APIs) at the existing Ukima Plant located in Kita-ku, Tokyo, Japan, in October 2015.

The plant will enable high-mix low-volume production of antibody APIs for investigational drugs in late-stage clinical studies to initial commercial products.

Its construction began in January 2016 and is scheduled to be completed by December 2017, while operations are expected to commence by June 2019.

Reactors are expected to be installed by July 2018. Demolition of old facilities at the existing Ukima plant is currently underway.

The new API facility will be situated on a 23,636m² (5.84 acre) site and will have a built up area of 4,066m². Combined floor space of the old and new facilities will be 492,593 sq. ft. (45,780m²), on completion of the project.

The manufacturing plant will produce antibody APIs, injection products and investigational drugs for clinical studies. It will expand Chugai's capability to meet demand for initial commercial products in the future.

It is also expected to support Chugai's plans to obtain global top-class competitiveness by minimizing the time required from the development to launch a new drug by introducing simultaneous development of multiple drug candidates.

The new plant will be installed with six 6,000l capacity bioreactor tanks.

It will enhance the total capacity of the site to 49,000l bioreactor tanks together with the existing Ukima plant, which has two 2,500l capacity bioreactor tanks used for antibody API production and four 2,000l capacity bioreactor tanks used for the production of antibody APIs for investigational drugs.

"The plant will enable high-mix low-volume production of antibody APIs for investigational drugs in late-stage clinical studies to initial commercial products."

Total investment for the construction of the new plant is estimated to be ¥37.2bn ($310m). Chugai invested ¥2.9bn ($25m) at the Ukima plant to double its antibody drug production capacity.

Kajima Corporation is in charge of general construction of the project, while Hitachi is responsible for the manufacturing facilities.

Chugai Pharmaceutical is a subsidiary drug manufacturer headquartered at Tokyo, Japan and is controlled by Roche Holding. The company is engaged in biopharmaceutical and molecular-targeted drug discovery to create innovative drugs.

It also manufactures and commercializes pharmaceutical products in Japan and internationally.

The company develops product candidates in the areas of oncology, bone and joint diseases, autoimmune diseases, central nervous system, and other diseases. Its oncology product portfolio includes Avastin, Herceptin, Rituxan, Xeloda, Tarceva, Neutrogin, Perjeta, Kadcyla, and Alecensa. Joint disease products produced by the company include Actemra, Suvenyl, Edirol, Alfarol, and Bonviva, while renal disease products include Mircera, Oxarol and Epogin.

Seqirus to Build Vaccine Production Facility in Liverpool

Seqirus is to invest £22.1m to upgrade its UK manufacturing site in Liverpool where it employs 600 people. The company, which is part of Australian company CSL Limited, will develop a new £15.3m manufacturing facility at the site in Speke to support the production of influenza vaccines.

The firm has also spent a further £6.8m on a new warehousing facility at the site.

Seqirus was created following CSL’s 2015 acquisition of Novartis' influenza vaccines business for US$275m, and the subsequent merger with its existing vaccines and pharmaceutical business, bioCSL. The combined company employs more than 2,000 people and has operations in more than 20 countries.

Seqirus said the two developments would pave the way for the future expansion of product manufacturing at the Speke site.

The new formulation facility at the plant is expected to be operational by the middle of next year. Its development means that a key part of the influenza vaccine manufacturing process will be brought to the UK, having previously been outsourced to Italy.

Stephen Marlow, Senior Vice President of Manufacturing Operations for Seqirus, said: 'Our investment in the new formulation facility will enable us to bring a significant tranche of the influenza vaccine manufacturing process to the UK and in-house. It gives us the ability to ensure the highest quality production standards are maintained and will also allow us to offer new career opportunities for our talented Liverpool workforce.

'It’s a sign of our commitment to the city and our confidence in Liverpool as a good place for Seqirus to house a major part of our global influenza vaccine manufacturing network.'

GSK Invests in Two New Irish API Plants

GSK has invested €12m ($14m) into a site in Ireland to develop and manufacture ingredients for its future portfolio.

The site in Currabinny, Cork has been in operation since 1975 and currently manufactures nine active pharmaceutical ingredients (APIs) for GlaxoSmithKline’s pharma portfolio. Since then it has seen over €700m of investment from the firm.

But with this latest investment, GSK is looking at its future product range across diseases such as cancer, HIV and depression, the firm said, adding a €9.5m kilo-scale manufacturing facility and a €2.5m technical development laboratory.

“Our new Kilo Scale Facility represents an important new opportunity for GSK in Cork,” said the firm’s Head of Engineering Kevin O’Keefe. “The plant will expand our operating scale to allow us introduce new targeted medicines that require highly specialized manufacturing equipment.”

The Site Director, Joe Power, added the investment “demonstrates GSK’s strong commitment” to Cork and Ireland. “It’s a wonderful endorsement of the world-class technical capability we have here and will work to attract new business for the operation.”

The Currabinny site has seen a fair amount of drama over the past few years. In 2010, GSK axed 121 jobs due to “changing market situations.”

And in 2014, the site was hit with a US Food and Drug Administration (FDA) Warning Letter after inspectors found a number of GMP violations including equipment used to make API batches to be “contaminated with material from [its] pharmaceutical waste tank .”

This led to GSK issuing a recall of its antidepressant drug Paxil made at the site.

The FDA issued a close-out letter last August.

Clean Room Construction Wins New Contract with University of Leeds

A track record of delivering university cleanroom design and build projects has resulted in more contract success for Clean Room Construction at the University of Leeds in West Yorkshire, UK.

CRC has been awarded the construction phase for three new Transmission Electron Microscopy (TEM) rooms in a £500,000 fast-track scheme at the University. Work will start on site in March and the contract follows CRC’s successful completion of an Electron Beam close control room for the academic institution.

CRC is now about to embark on the RIBA Stage 3 detailed design for the prestigious Bragg project at the University, having previously been appointed to the professional team on Stage 2. The Bragg Centre forms part of an ambitious five-year-plan to transform the campus through the development of new sites and the refurbishment of older buildings.

The firm will produce the detailed design for a 7,747 sq. ft. (720m2) ISO Class 4, 5, 6 and 7 cleanroom. When it is completed, the Bragg Centre will become a base for world-leading engineering and physical sciences research.

CRC’s Projects Director, Richard Rowe, said: 'The University of Leeds is a world-class university, renowned globally for its research capabilities and facilities. Clean Room Construction has a successful track record of designing and building leading-edge facilities for top universities and we are proud to be working with Leeds on these two prestigious projects.'

Beximco Awards Telstar Contract for New Cleanrooms Asia

Generic drug manufacturer Beximco Pharma has awarded Telstar a contract to implement the architecture and HVAC system for the Bengali company's new insulin production plant in Dhaka, Bangladesh.

The new plant, which is planned to be finished in September this year, will occupy an area of 8,963 sq. ft. (833m2), dedicated to the manufacture of insulin vials and cartridges. The project awarded to Telstar by the first US FDA company in Bangladesh is complex and highly technical, incorporating construction engineering, as well as supply, installation, commissioning and validation processes for cleanrooms, the HVAC system, cold room, distribution of chilled water for air handling units and ventilated SAS pass through boxes.

The main objective is to design and construct a space covering 4,260 sq. ft. (396m2) for rooms with D, C, B and A classification, destined for dispensing, primary and secondary manufacturing, washing, sterilization, vial filling and staff changing rooms, distributed on a single floor.

In addition, the contract includes the design and construction of 4,702 sq. ft. (437m2) of space for unclassified rooms allocated to the storage of raw materials and finished products, inspection, tagging and blister rooms, as well as a BMS, server room and toilets. The scope of Telstar’s project also includes the design of an adjacent platform for placing the air handling units, and the integration of the production machines purchased by the client.

For the successful development of this detailed project, Telstar operates according to a multi-plant management model in close cooperation with its own engineering centers, using standardized tools which accommodate working simultaneously and in coordination with a multidisciplinary and international team. The project involves the close collaboration of Telstar specialized centers in Spain, India, Bangladesh and China, which share resources in engineering, project management, consultancy and qualification (Spain), manufacture of its own equipment (Spain and China), engineering and drafting (Spain and India) and site management (Bangladesh).

Telstar says this project execution model allows the firm to offer Beximco a guarantee of safety in process control relating to quality and cost efficiency, including the advantages of proximity and local knowledge of the technical and professional management.

WuXi AppTec's STA Subsidiary Opens New Campus in Changzhou

WuXi AppTec, a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology and medical device industries, has announced that its small-molecule process development and manufacturing subsidiary, Shanghai SynTheAll Pharmaceutical (STA), began operations at a new, fully integrated R&D and cGMP manufacturing site in Changzhou, China, in February 2016.

The new campus is being constructed in phases. The administration building, R&D building, one large-scale manufacturing plant and supporting units are now operating, with other buildings currently under construction.

On completion, the site will employ more than 500 scientists and will add more than 1000m3 of reactor volume, doubling STA's existing R&D capacity and quadrupling its manufacturing capacity. Besides adding capacity, this state-of-the-art integrated campus will provide a unique one-site solution for STA customers to advance their active pharmaceutical ingredients (APIs) and advanced intermediates through preclinical and clinical development to global commercial launch.

‘The new site in Changzhou brings our customers added capacity, greater flexibility and the unsurpassed quality of WuXi's operations,’ said Dr Minzhang Chen, CEO of STA. ‘It further strengthens STA's position as a world-leading CDMO, offering a truly unique integrated solution to our global partners.’

‘We are pleased to open our new Changzhou site, which greatly expands our small-molecule process development and manufacturing services,’ said Dr Ge Li, Chairman and CEO of WuXi AppTec. ‘This new facility further strengthens WuXi's comprehensive, integrated open-access platform of R&D services to serve our global customers.’

Essentra to Expand in Newport with Welsh Government Support

Essentra will be producing pharma packaging with both tamper evidence and serialization solutions at the Newport facility.

Specialist packaging firm Essentra, whose clients include pharmaceutical firms, is creating a further 170 jobs at its flagship facility in Newport, South Wales.

The additional employment follows the announcement in November last year that Essentra was investing in a second facility in Newport, with the initial creation of 70 jobs.

In common with the previous investment, this latest project is also being supported by the Welsh Government.

Essentra is a key member of the life sciences sector in Wales and provides specialist secondary packaging and authentication solutions, with its targeted end-markets being the pharmaceutical, health and personal care and consumer goods sectors.

The news was announced by Economy Minister Edwina Hart ahead of the life sciences showcase event BioWales 2016, in Cardiff having attracted more than 700 delegates, including 100 international visitors.

Overall, Essentra’s significant investment in an adjacent site in Newport will create a center of excellence for the production of labels and foils, with additional capability for cartons manufacturing and an on-site structural and graphic design studio.

This investment is being supported by £400,000 from the Welsh Government and will bring the total headcount at its Newport campus to approximately 330.

The Minister said: 'This is excellent news and another significant investment by the company in world class manufacturing facilities at its Newport campus. Essentra is rapidly expanding its operations in Newport and I am delighted the Welsh Government is supporting their investment and the creation of jobs.

'Life sciences are one of our key economic sectors and take center stage as the BioWales international conference and exhibition opens in Cardiff.

'We have seen significant growth and investment in the sector over the last five years, with jobs increasing by more than 5% annually during that period. Wales has a notable strength in the pharmaceuticals services sector which will be enhanced by this latest investment by Essentra.'

Hugh Ross, Managing Director, Essentra (Europe), said: 'Essentra’s multi-million pound investment in a second site entails a six-fold increase in our existing footprint in Newport, with our new facility being equipped with the latest technologies – including two new label machines, a carton production line, a block foiling machine and computer-to-print equipment – to deliver faster and more flexible production. With optimal manufacturing layout, centralized warehousing and a dedicated design studio, this investment thus reinforces Essentra’s commitment to creating centers of excellence from which to meet the exacting requirements of its international customer base.

'We recognize that employees are our most valuable asset, and we are committed to ensuring that the company is a great place to work.

'With Newport playing a pivotal role in Essentra’s future growth, I look forward to welcoming our new team members, who are keen to share in our future success.'

Essentra has 29 packaging manufacturing sites worldwide and customers in more than 100 countries are served from facilities in ten countries, with development and design centers supporting the division worldwide.

The firm opened its initial site on Imperial Park, Newport, in 2014 into which it has consolidated a number of its smaller packaging manufacturing operations. That 52,000 sq. ft. facility is equipped with the latest in digital printing and cleanroom facilities for the production of labels and primarily packaging foils for the healthcare and consumer goods end-markets. Last year it secured an adjacent 225 sq. ft. facility where the latest expansion will be accommodated.

Clariant Broke Ground for New Building in India

Clariant, a leading speciality chemical company, broke ground for building its new manufacturing and healthcare packaging plant in Tamil Nadu, India, on 20 January 2016. The facility is being built in Kudikadu region of the SPICOT industrial complex in the Cuddalore district.

The groundbreaking ceremony was attended by Deepak Parikh, Clariant's regional president, India, Christian Kohlpaintner, member of Clariant's Executive Committee, Marco Cenisio, Masterbatches business unit head, and Ketan Premani, Head Clariant Health Packaging sales, India.

The company is investing approximately Sfr10m ($9.85m) through its wholly owned Indian subsidiary for the construction of the new packaging plant. Completion and inauguration of the plant is expected in 2017.

The new plant will be built with state-of-the-art global healthcare manufacturing infrastructure that will be compliant with all cGMP and US FDA standards. It will support the production of Clariant's market-leading moisture control products and high-quality desiccants, by expanding the current capacities and providing ready access to the customers in the pharmaceutical packaging segment in India.

It will initially manufacture desiccant canisters and packets, which will be inserted into pharmaceutical packaging to control moisture levels and maintain the stability of the medicine during its shelf period. The production area will be compliant with Cleanroom Class 100,000 and certified ISO 8.

The new manufacturing and packaging plant will serve globally active, generic and branded pharmaceutical companies, as well as the Indian domestic pharmaceutical market. Once operational, it will procure Clariant's global-standard products directly produced in India for the customers.

The facility will enhance Clariant's medical speciality business and provide end-to-end solutions to the customers.

Clariant's new greenfield plant in Cuddalore along with its ten production sites in Gujarat, Maharashtra, Madhya Pradesh and Tamil Nadu, as well as its regional innovation center in Mumbai are part of its growth strategy in India.

Clariant is a speciality chemicals manufacturing company based in Switzerland. It is the biggest producer of pigments, and textile and leather chemicals in India.

Clariant Healthcare Packaging is a member of Clariant's Masterbatches business unit, which manufactures controlled atmosphere packaging solutions such as pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers.

It employs both active and passive packaging technologies, and offers an array of standard components and complete systems. It manufactures and markets textiles, leather, paints, plastic, printing inks and agrochemical products.

Plans Unveiled for UK’s new Research Hub for Cancer Research and Treatment

Plans for a £1bn 'global hub' for cancer research in London have been unveiled.

The London Cancer Hub will bring together 10,000 scientists and clinicians and aims to become a 'hotbed for talent' by renting space to biotech, pharma and software companies, and equipment manufacturers.

It will be based on the site occupied by the Royal Marsden Hospital and its academic partner, the Institute of Cancer Research (ICR) in Sutton, Surrey and will cover 265,000m2, which will double its current research and treatment space.

It aims to deliver at least two new cancer drugs every five years.

The partners are working closely with Epsom and St Helier University NHS Trust – which owns Sutton Hospital on the site – to open up substantial space for expansion and more efficient use of land.

New buildings will closely integrate research and cancer care – providing both laboratories and clinical facilities to foster interactions between scientists and clinicians.

A new secondary school will also be built on the site by 2018, specializing in the sciences.

Professor Paul Workman, Chief Executive of the ICR in London, said: 'This is a fantastically exciting project to create the world’s leading cancer research campus here in London.

'The ICR and The Royal Marsden are already world leaders in cancer research and treatment, but by working with the London Borough of Sutton and the Greater London Authority, we aim to take our facilities and outputs to a new level.

'The ambition is to discover more innovative cancer drugs, to run more clinical trials, and to partner with industry to take even more treatments to patients.'

Cllr Ruth Dombey, Leader of Sutton Council, added: 'The London Cancer Hub will do for South London what Tech City has done for East London. It will create thousands of employment and training opportunities for local people.'

Mayor Boris Johnson, who is providing start-up funding, said the London Cancer Hub would be 'a real coup for the city' and would help to 'ensure that the capital remains on the frontline of developing new treatments to cure the disease'.

The hub will be financed through a combination of private investment, Government grants, philanthropy and commercial rental income.

WHP Completes Bio-Manufacturing Facility for Oxford Biomedica

UK cleanroom design and construction firm WH Partnership (WHP) has completed Oxford Biomedica’s new cleanroom production facility in Yarnton, Oxford, which manufactures gene-based medicines for some of the world’s largest pharmaceutical companies.

Constructed to comply with stringent UK Good Manufacturing Practice (GMP) regulations, the additional 6,026 sq. ft. (560m2) of cleanroom space took less than a year from concept to completion and creates extra capacity.

WHP’s Managing Director, Nigel Hall, said: 'We have gained a strong reputation for our cleanroom design and construction in the biotechnology industry and the number and quality of projects that we have in the pipeline continue to grow. We are delighted to have brought our wealth of expertise in stringently-regulated sectors to OXB’s facility and look forward to supporting them in any future expansion plans.'

The Yarnton facility has also recently been approved by the Medicines Healthcare Products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs).

The additional capacity will support Oxford BioMedica’s proprietary programs in development as well as consolidating key current and potential new relationships such as the well-established CAR-T focused partnership with Novartis for CTL-019.

Purposely designed around the Group’s current and future LentiVector based platform processes, the extra cleanroom space bolsters the Group’s manufacturing capabilities, and increases total operational capacity across its two sites to 10,222 sq. ft. (950m2).

Further capacity expansion at the Group’s existing Harrow House facility (also based in Oxford) is scheduled for completion in the first half this year and will provide a third independent suite to house Oxford BioMedica’s next generation of serum free, suspension cell line based processes.

The firm says continued investment in its specialist biomanufacturing facilities and capabilities will help it address the industry’s challenges of bridging clinical and commercial supply, one of the main hurdles associated with the rapid progression of gene and cell therapies through Phase II and Phase III clinical trials, and then ultimately to market.

The successful commissioning of our second manufacturing facility is a landmark achievement for Oxford BioMedica

James Miskin, Chief Technical Officer of Oxford BioMedica, said: 'OXB is delighted with the recent completion of its new GMP cleanroom production facility in Yarnton. The WHP team worked closely and collaboratively with a small team of OXB in-house experts throughout the project, and WHP’s specific expertise, from detailed design to engineering solutions, was absolutely critical in completing this high quality facility in such a short period of time.'

John Dawson, Chief Executive of Oxford BioMedica, added: 'We are world leaders in the development of lentiviral vector-based products and the successful commissioning of our second manufacturing facility is a landmark achievement for Oxford BioMedica.

'This investment brings significant potential not only to support our own current and future pipeline of gene and cell therapy products in development but also to support our key collaboration with Novartis.

'Our IP, know-how, manufacturing operations and capacity now position Oxford BioMedica very strongly for securing further new partnerships and alliances.'

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