Grifols announced that it has restated its 2005 agreement with OraSure Technologies. Additionally, Grifols is building a biological manufacturing facility in the San Francisco Bay Area.

Under terms of the agreement, Grifols supplies antigens for OraSure's OraQuick HCV Rapid Antibody Test. The test is FDA approved for qualitatively detecting hepatitis C virus antibodies in whole blood obtained through the use of a fingerstick or venipuncture. It enables healthcare providers to deliver results in 20 minutes from individuals 15 years of age and older.

"OraSure is committed to delivering high-quality infectious disease diagnostic products for our customers,” Douglas A. Michels, President and CEO of OraSure Technologies said. “As one of our trusted suppliers, Grifols' focus on service, quality and collaboration play a key role in our ongoing relationship.”

Additionally, Grifols is building a biological manufacturing facility in the San Francisco Bay Area. Grifols is in the process of validating the facility and preparing to file a license with the US Food and Drug Administration certifying proper design, monitoring, and control of manufacturing processes and facilities. The facility will provide commercial manufacturing for a developing product selection of diagnostic antigens, including proteins expressed in E. coli, yeast and mammalian cells.

The new Grifols manufacturing facility is expected to be completed in 2018.

MilliporeSigma, LabCentral to Foster Biotech Startups

MilliporeSigma will sponsor the startup program at LabCentral, a biotechnology incubator, in Cambridge, MA. LabCentral provides entrepreneurs and life-sciences startups with lab space and resources to support biotech companies, and has approximately 125 scientists and entrepreneurs.

MilliporeSigma's collaboration with LabCentral, provides access to process development tools, education programs and training. As a sponsor of the LabCentral Startup Program, MilliporeSigma will "adopt" a startup providing a priority spot and one-year prepaid lab bench in LabCentral's shared lab space. Candidates can consult program rules and submit their application at emdmillipore.com/start-up-program.

"Innovation is at the heart of the life science industry and startups play an important role in developing new and often life-changing, scientific discoveries," said Udit Batra, chief executive officer, MilliporeSigma. "We are collaborating with LabCentral to be a resource for these emerging companies and to help them get the best start possible."

"This is an exciting time at LabCentral as we begin construction on our facility expansion, which will make room for an additional 30 startups," said LabCentral co-founder and president Johannes Fruehauf, M.D., Ph.D. "Today, LabCentral has become the de facto standard in co-working facilities for biotech startups. From the breadth and quality of our infrastructure and equipment, to our supportive services and programming, to the LabCentral Startup Program-our sponsors are critical partners. We are thrilled to welcome MilliporeSigma as a Gold sponsor, and look forward to a fruitful collaboration with the technical team."

ProSolus Expands Transdermal Drug Delivery Capabilities

ProSolus is doubling down on its efforts to expand the utilization of transdermal drug delivery technologies. With the support of its parent, Mission Pharmacal, ProSolus has expanded its manufacturing capabilities and placed an increased emphasis on overall commercialization efforts. ProSolus, a wholly owned subsidiary of Mission, offers custom development and manufacturing of transdermal and trans-mucosal drug delivery products to treat a variety of health conditions.

Acquired by Mission in 2015 and headquartered in Miami, FL, ProSolus recently expanded its state-of-the-art commercial manufacturing capabilities by installing a second transdermal production facility as part of Mission’s Boerne, TX, manufacturing location. While both ProSolus facilities will continue manufacturing transdermal products, the Boerne location houses a larger production line than the Miami site, more than doubling the company’s total transdermal product output. Combined, the capacity of the two locations is now more than 100 million patches annually.

Transdermal drug delivery provides patients with a safe and convenient means of taking medications. In a recent New York Times article, titled, “The Cost of Not Taking your Medications,” it was stated that approximately 50% of medications for chronic disease are not taken as prescribed. Juan Mantelle, chief operating officer and chief scientific officer, ProSolus, together with the ProSolus team have developed creative ways to improve transdermal products, often resulting in improved compliance for the patient.

Recognized for his innovative and unique approach in this highly specialized area of drug delivery, Mr. Mantelle was named to PharmaVOICE magazine’s prestigious annual list of the 100 most inspiring people in the life sciences in 2016. “For us, it’s all about the convenience and wear-ability of patches—creating more desirable, smaller sizes that stay in place while working effectively,” he said. “We are consistently searching for new and better ways to bring transdermal products to market.”

Transdermals deliver medication through the skin and directly into the bloodstream, avoiding the digestive tract. Patches need to adhere to the skin without irritation, wear well for the duration of treatment, and not lose skin contact to ensure efficacy. When manufactured and administered well, transdermals typically have fewer side effects and provide better therapeutic benefits than other drug delivery options. They also tend to utilize lower doses of active ingredients.

Led by industry veteran Jim Self, the new ProSolus commercial team will provide potential partners throughout the pharmaceutical industry direct access to the state-of-the-art research, development, and manufacturing capabilities of ProSolus. Partners can capitalize on the ProSolus team’s extensive experience in all phases of product development, from formulation development and regulatory filing to commercial scale manufacturing. They also are adept at developing new NDA and ANDA prescription products, as well as over-the-counter consumer products. Beyond any potential new development projects, ProSolus has an existing portfolio of prescription and consumer assets available for prospective partnership opportunities.

A former business development executive at a global pharmaceutical company, Mr. Self sees this as a unique opportunity for both ProSolus and its potential clients. “We look forward to increased partnerships with a wide array of pharmaceutical companies looking to commercialize products utilizing leading transdermal patch technology,” he said. “Together we will be able to efficiently develop what are normally considered high-barrier-to-entry solutions and expand the overall transdermal market space, ultimately improving the care and treatment of patients.”

Prior to acquiring ProSolus, Mission was a ProSolus client. As Mission leadership began to fully understand what Mr. Mantelle and the ProSolus team were capable of and how the two organizations shared a vision of delivering exceptional science and skill into customers’ hands through innovative and convenient products, the thought of joining ProSolus to the Mission family of companies became a reality.

“ProSolus enables Mission to offer the latest, highly effective transdermal patches in a wide variety of therapeutic categories,” said Terry Herring, president of commercial operations, Mission. “Now, with the expanded manufacturing capabilities at the site in Boerne, paired with Juan and his team’s unparalleled skill in the area of transdermals, our ProSolus commercial team is poised to help us forge new and exciting partnerships that will ultimately benefit patients.”

Fresenius Kabi Acquires Akorn

Fresenius Kabi has acquired Akorn, a U.S.-based manufacturer and marketer of prescription and over-the-counter pharmaceutical products, for approximately $4.3 billion. The deal is expected to close by early 2018. The agreement and transaction have been approved by the boards of both companies and will be recommended by Akorn’s board to its shareholders.

“Joining our two companies and product portfolios will strengthen and diversify both businesses,” said John Ducker, president and chief executive officer, Fresenius Kabi USA. “Akorn brings to Fresenius Kabi specialized expertise in development, manufacturing and marketing of alternate dosage forms, as well as access to new customer segments like retail, ophthalmology and veterinary practices. Its pipeline is also impressive, with approximately 85 ANDAs filed and pending with the FDA and dozens more in development.”

Raj Rai, chief executive officer, Akorn, said, “Fresenius Kabi is an excellent fit for Akorn, strategically and culturally. Fresenius brings to Akorn the strength and resources of a global leader with an experienced U.S. team and an outstanding record of growth and award-winning service in the U.S. We look forward to working with Fresenius Kabi on this next phase of our growth. When the transaction closes, we will strive to ensure a smooth transition for our employees and customers.”

Fresenius Kabi specializes in sterile injectable medicines. Akorn produces a diverse portfolio comprising sterile ophthalmics, topical creams, ointments and gels, oral liquids, otic solutions (for the ear), nasal sprays and respiratory drugs in addition to sterile injectables, which made up just 35% of Akorn sales last year.

Akorn products are sold in retail pharmacies—prescription and over-the-counter—and directly to physician and veterinary distributors, in addition to hospitals and clinics, virtually all in North America. Fresenius Kabi is a global health care company with a worldwide network for pharmaceutical and medical devices R&D, manufacturing, sourcing, sales and supply chain that will be a valuable resource to grow Akorn’s portfolio in the U.S. and abroad.

The U.S. headquarters for Akorn and Fresenius Kabi are both in Northern Illinois, located in close proximity. Akorn employs more than 2,000 people worldwide. Fresenius Kabi employs more than 30,000 worldwide.

Fresenius Kabi has a successful track record of growing pharmaceutical acquisitions in the U.S. Fresenius Kabi acquired APP Pharmaceuticals in 2008 and has more than tripled its sales to nearly $2 billion. The company acquired the Simplist line of prefilled syringes from BD last year.

Sawai Buys Generics Upsher-Smith

Leading Japanese generics firm, Sawai Pharmaceutical, has purchased the generic pharmaceuticals business of Upsher-Smith from its parent ACOVA for $1.05 billion.

Minnesota-based Upsher-Smith is a privately held pharmaceutical company, owned by the Evenstad family through their company, ACOVA. Mark Evenstad is the chief executive officer of Upsher-Smith, and his father, Ken Evenstad is the chairman. Upsher-Smith has a diversified product portfolio of over 30 pharmaceutical products, mainly oral solid preparations, and a pipeline of over 30 products.

The deal is expected to close near the end of June 2017. Rusty Field, the current president of Upsher-Smith, will continue leading the company. Upsher-Smith's non-generic pharmaceuticals businesses will remain with ACOVA.

The acquisition will mark a major expansion of Sawai's presence in the U.S. market. Moving forward, Sawai plans to build a U.S. business that leverages its intellectual property and combines R&D capabilities with Upsher-Smith's manufacturing base, strong distribution network, established commercial relationships and respected brand. For Upsher-Smith, the acquisition brings access to Sawai's state-of-the art manufacturing technology and opportunities to bring its medicines to new markets like Japan.

Upsher-Smith offers a broad array of generic and branded medications, and through its pharmacist heritage, has built long-standing relationships with pharmacies, wholesalers, retailers and healthcare organizations to distribute its products.

"Upsher-Smith has developed and delivered crucial therapies to patients, from infants to the elderly, with a broad array of on-market generic pharmaceuticals. We have also built a pipeline that will enable even more patients to get life-changing therapies over the next several years. After owning and operating Upsher-Smith for the past 47 years, my family and I made the decision to sell the largest part of our company, the generic pharmaceuticals business, to Sawai," said Mark Evenstad, chief executive officer, Upsher-Smith. "It was extremely important for us to find a buyer that shared Upsher-Smith's values, was completely committed to its long-term success and was looking for a strong and fully operational U.S. platform for growth. Sawai is a compelling strategic fit and we are delighted that the generics business is poised to benefit from the extensive resources and management focus that Sawai will bring."

With the aging Japanese population, and the increasing focus on bringing down the cost of medicines, in 2015 the Japanese government set a target of raising the share of generic prescriptions to 80% by fiscal 2020. In August 2016, Sawai announced in its medium-term business plan, "M1 Trust 2018", focused on providing a stable supply of generics to meet this government goal and maintaining its number one position among manufacturers of generic medicines. As part of this medium-term business plan, Sawai spelled out its intent to target the U.S., the world's largest pharmaceutical market, for expansion.

"We are delighted to sign this agreement today with ACOVA to acquire Upsher-Smith, which is our first overseas investment. Upsher-Smith, like Sawai, has a long history as a private family-owned generic pharmaceuticals company that is also focused on patient needs, centered on our philosophy of patients first. We look forward to working closely with Rusty and the talented management team to forge a new global chapter in Upsher-Smith's future together. Most importantly, we are committed to the entire team at Upsher-Smith, and to expanding the opportunities for the U.S. workforce at Upsher-Smith," said Mitsuo Sawai, president, Sawai Pharmaceutical.

No changes to Upsher-Smith's operations are currently anticipated, and under the leadership of Rusty Field, the current management team will continue to lead Upsher-Smith from its current headquarters in Minneapolis.

Fujifilm Establishes New Process Development Facilities

Fujifilm Corporation will increase production capacity by investing approximately $130 million in the United States and UK to expand the business of its BioCDMO Division.

In the US, at Fujifilm Diosynth Biotechnologies Texas, a cGMP production facility has been completed. This facility was built in part with funding from BARDA (Biomedical Advanced Research and Development Authority), an office of the U.S. Department of Health and Human Services, and Fujifilm plans to outfit the facility with mammalian cell culture bioreactors. This facility will start operation at the beginning of 2018.

Fujifilm Diosynth Biotechnologies Texas was acquired by Fujifilm through Fujifilm Diosynth Biotechnologies U.S.A. in 2014. In March of this year, FDBT became a wholly owned subsidiary of FDBU exercising the option early included in the initial deal to take 100% ownership. In addition, $9 million investment will be made to expand the Process Development capabilities at Fujifilm Diosynth Biotechnologies UK Limited near to its Billingham, UK site. This facility is scheduled to be operational in summer of 2017.

The FDBT facility will be the manufacturing center of excellence for the company's Saturn Monoclonal Antibody Platform with an initial cell culture capacity of 6,000L. The design of the facility allows for future expansion that can accommodate up to 24,000L of upstream capacity to meet customer’s clinical and commercial demands.

In the United Kingdom, the investments include the establishment of a dedicated Mammalian Cell Culture Center of Excellence. These laboratories are designed to incorporate the latest high-throughput technologies, including fully automated bioreactors and chromatography systems.

“Fujifilm Diosynth Biotechnologies is committed to its vision of being Leaders in the Bio CDMO space,” Steve Bagshaw, Chief Executive Officer, FUJIFILM Diosynth Biotechnologies said. “Our commitment is to transform the CDMO business through innovation and with our great people — providing long term support to our partners fulfilling our core purpose as Partners for Life - Advancing tomorrow's medicines.”

Emergent Unveils Expanded Facility in Baltimore

Emergent BioSolutions held a ribbon-cutting ceremony led by Dr. Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), and Daniel J. Abdun-Nabi, Emergent’s president and chief executive officer, to mark the formal opening of the company’s newly expanded Center for Innovation in Advanced Development and Manufacturing (CIADM) at its Bayview Campus in Baltimore. The facility is one of three centers designated by the U.S. Department of Health and Human Services to provide advanced development and manufacturing of medical countermeasures to support the U.S. government’s national security and public health emergency needs.

“With the expansion of our Bayview campus, Emergent is pleased to directly support BARDA’s vision of enhancing the nation’s capability to respond quickly to both known and emerging public health threats,” said Mr. Abdun-Nabi. “This milestone strengthens our manufacturing infrastructure, which is one of our core competencies, and symbolizes Emergent’s commitment to the City of Baltimore and the State of Maryland, where we are proud to meaningfully contribute to economic activity and job growth.”

“The Centers for Innovation in Advanced Development and Manufacturing were designed as public-private partnerships to provide greater speed, flexibility, and domestic capacity to produce medical countermeasures to address public health emergencies,” said Mr. Bright. “The work that we do in BARDA, and that we do together with industry partners at our CIADMs, is critical to protecting Americans’ health in emergencies and is fundamental to our nation’s security.”

Emergent has doubled the Bayview facility’s footprint to 112,000 square feet with investments to the original 56,000-square-foot facility purchased by the company in 2009. The facility, comprised of laboratory, manufacturing and office space, offers flexible manufacturing of drug substance from microbial, cell culture or viral production platforms and is equipped with disposable manufacturing technology to enable Emergent to meet the government’s domestic preparedness priorities on a cost-effective, reliable and sustainable basis. The new suite within the expanded facility is expected to come online with cGMP production capabilities in late 2018.

Since its inception, the Emergent CIADM has been awarded four task orders by BARDA to develop Ebola and Marburg therapeutics and a Zika vaccine. Emergent also successfully manufactured some of its product candidates at the CIADM and an Ebola vaccine candidate as part of a third-party collaboration.

BARDA contract HHSO100201200004I, awarded to Emergent in June 2012 to establish a CIADM, consists of an eight-year base period of performance valued at approximately $220 million (cost-shared between the government and Emergent) and up to 17 additional one-year option periods. BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

UPM Celebrates 100-Years of Mfg. at Tennessee Site

Bristol facility grows from a $25 hand-operated tablet machine to a 500,000 square-foot campus.

UPM Pharmaceuticals is celebrating the 100-year anniversary of pharmaceutical manufacturing occurring at its Bristol, TN, facility. Pharmaceutical products have been continuously manufactured at its current site since 1917.

In March 1917, S.E. Massengill purchased the site and transformed it into a pharmaceutical manufacturing facility. According to historical records, the Massengill brothers purchased their first piece of manufacturing equipment, a $25 hand-operated tablet machine and began the legacy. In 1971 the site became home to Beecham Laboratories’ North American headquarters. King Pharmaceuticals acquired the site in 1993, which was then sold to Pfizer in 2011. In July 2013 UPM bought the facility from Pfizer.

UPM is an independent contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology industries.

During the 100 years of production at the Bristol site, operations have expanded from a small facility footprint of less than 10,000 square feet and only two small buildings, to a modern campus of over 475,000 square feet and additional warehouse and distribution space of almost 250,000 square feet.

“We are proud of the legacy of the Bristol, TN, site in the history of the pharmaceutical industry,” said James Gregory, chief executive officer, UPM. “The success of the products and the growth of the capabilities of the site stand as testimony to the many outstanding employees who have worked here over the past century."

UPM Pharmaceuticals originated as a drug formulation and cGMP laboratory within the University of Maryland School of Pharmacy, and today offers a full breadth of capabilities from early research and development to clinical trial material manufacturing and commercial scale product supply. It is also DEA approved to handle CII-CV manufacturing. The Bristol site has several low humidity manufacturing suites and the ability to handle potent compounds in dedicated suites.

The last FDA audit at the site was in October 2016. It was a general GMP inspection of all systems and a preapproval inspection of a product that the company’s R&D team developed. No 483s were issued and approval of the site to manufacture the product was recommended.

“Obviously, we were quite proud of this result,” said Mr. Gregory. “We also have yearly DEA inspections given our capabilities to handle controlled substance products and have had no notice of violations or 'for cause' investigations. UPM is fully committed to quality and manufacturing innovations to assure the timely supply of needed medicines."

According to the company, a new, proactive approach to quality was adopted in 2016 that is client-focused and includes implementation of manufacturing quality assurance (MQA), the use of metrics to evaluate performance and realignment of its laboratory functions to increase both efficiency and responsiveness.

Cambrex Invests in Former PharmaCore Site

Cambrex Corporation is installing a fourth reactor suite at its High Point, NC-based facility as it continues to grow with its customers in the market, says company VP at CPhI North America.

The North Carolina facility produces complex APIs and intermediates in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III.

According to the company, the $2.4m investment will increase the site's reactor capacity by around 30%. The new 400 sq. ft. suite, which is expected to be operational in early 2018, will feature two 2,000-liter reactors and a 0.6 sq. m. Hastelloy filter dryer.

“We fill capacity whenever the market is asking for that and the market is good at the moment, especially I think for western-based CMOs,” Stephan Haitz, Ph.D., VP sales and business development at Cambrex told us at CPhI North America in Philadelphia.

As part of a second investment at the 35,000 sq. ft. site, previously PharmaCore, Inc., Cambrex is also upgrading its analytical chromatography data systems for QC and analytical R&D to new, Empower 3 software.

The upgrade will be introduced in Q3 and Q4 of 2017.

“Our clear focus was always manufacturing, but you need to bring a product to manufacturing, and hence with PharmaCore, we have the ability to start earlier,” said Haitz.

“You need to know the market but you [also] need to have a very close relationship with customers,” he added. “Our strategy is to grow with our customers in the market, and we’re a big fan of doing it organically.”

CRO PPD Expands Vaccine Development Laboratory

Pharmaceutical Product Development, LLC (PPD), a global contract research organization (CRO), has expanded its vaccine sciences lab in Richmond, Virginia, enhancing its ability to provide industry-leading capabilities to meet biopharmaceutical clients’ growing research needs.

The laboratory expansion continues PPD’s ongoing investments in its Richmond facilities, which also include significant enhancements to its genomics, immunochemistry and automation services in recent years. PPD’s lab operations in Richmond employ nearly 700 people, including Ph.D.-level scientists, analytical laboratory staff and other scientific professionals.

“The recent expansion of our vaccine sciences lab, coupled with previous enhancements to our biologics capabilities, builds on three decades of drug development expertise to support pharmaceutical and vaccine programs from pre-clinical through post-approval,” said Bob Nicholson, senior vice president of PPD® Laboratories. “During that time, we have helped our clients earn FDA approval for 15 vaccine programs and countless pharmaceuticals. We’re confident our laboratory enhancements will enable us to build on that record of success for our customers.”

With nearly 17,000 square feet of new vaccines laboratory space, PPD has added significant capacity for vaccine efficacy testing using techniques such as cell-based assays and immunochemistry.

PPD Laboratories’ vaccine sciences lab, with its unique capabilities within the CRO industry, offers an extensive portfolio of services that support vaccine development. Most notably, those include method development, qualification and validation; extensive statistical and regulatory expertise; and high-throughput, automated and/or multiplex assays. The lab has diverse experience with multiple assay formats, including molecular genomics, immunology, cell-based and functional assays.

The vaccine sciences lab is part of PPD’s Richmond bioanalytical lab, which provides services such as small molecule, biologics and biomarker testing capabilities for all phases of drug development. PPD Laboratories’ operation in Richmond, elements of which have been in operation since 1985, has added about 50,000 square feet in recent years and now totals nearly 200,000 square feet, making it one of the largest bioanalytical labs in the world. Specific drug testing services offered at the lab include: understanding the pharmacokinetics and pharmacodynamics (PK/PD) of a drug; measuring in vivo absorption, distribution, metabolism and excretion (ADME) of the parent drug and its metabolites; monitoring for adverse drug reaction; in vivo ADME testing; dose escalation and ranging studies; immunogenicity; and immune response.

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

EAG expanding Bioassay Lab

EAG Laboratories is expanding its Columbia, Missouri-based cell bioassay laboratory to support multiple development programs.

“Tripling the footprint of EAG’s current cell bioassay laboratory, the expanded labs will include the addition of cell culturing incubators, as well as new instrumentation to increase capacity and assay throughput, enabling EAG to simultaneously support multiple development programs,” Siddhartha Kadia, President and CEO of EAG, said.

The scientific services company is also planning to increase its staff of biopharmaceutical scientists by up to 35% over the next several months.

The lab is being built at the Columbia, Missouri facility and will be divided into multiple suites to minimize cross-contamination of cell lines.

Additionally, Amanda Halford has been appointed as senior vice president, life sciences, in addition to her role as chief commercial officer. In her new role, Halford will be responsible for driving growth in EAG’s commercial and laboratory operations.

“Over the last year, we have made great strides as a company, including the unification of many small businesses under one brand. Amanda has been a critical part of that by putting in place a commercial strategy that leverages the scale and expertise of our entire organization,” said Kadia.

Paratek expands PA Site

Paratek Pharmaceuticals, Inc., a biopharma company focused on developing therapies based on tetracycline chemistry, has expanded its office in King of Prussia, PA to accommodate its growing development, manufacturing, and commercial organizations.

“It’s an incredibly exciting time at Paratek as we get closer to potentially bringing our lead product candidate, omadacycline, to market,” said Evan Loh, M.D., president, chief operating officer, chief medical officer and director at Paratek. “Our expanded home in King of Prussia provides our growing team with the physical space and resources to fuel our continued commitment to bringing the very best in innovative antibiotic treatment options to patients to improve and potentially save lives.”

The renovated space will initially house approximately 30 full-time employees, most of which are focused on development and registration activities to support the company's potential New Drug Application to FDA. Paratek plans to bring in additional resources to support the launch of omadacycline, a novel broad spectrum once-daily oral and intravenous antibiotic being developed to treat serious community-acquired infections such as acute skin and skin structure infections and community-acquired bacterial pneumonia. Paratek anticipates adding as many as 65 employees in King of Prussia over the next 24 months as registration and pre-commercial activities ramp up prior to launch.

Recipharm invests in New GMP Suite

Recipharm has opened a new GMP suite for clinical trial material manufacture at its North Carolina-based facility in Research Triangle Park.

The new suite enables the contract development and manufacturing organization (CDMO) to provide complete early development services at the Research Triangle Park location. These services include process development and scale-up, CTM manufacturing and packaging, product release and stability programs.

Ann Flodin, VP and General Manager at Recipharm Laboratories, explained the facility supports the manufacture of different non-sterile dosage forms, such as metered dose inhalers, semi-solids, and dry powder capsules.

“With this location being Recipharm’s center of excellence for orally inhaled and nasal drug products, and with an experienced research team in place, this is a natural development for the company, extending the capabilities of Recipharm group,” said Flodin.

The GMP suite is ISO 8 certified, features a walk-in downflow booth, and has the capacity to produce metered dose inhalers in up to 25L batches and offers semi-solid production capabilities up to 20L.

“We see the inhalation and semi-solid industries growing, and needing additional clinical trial manufacturing support," Flodin added.

"Also, the location is central in Research Triangle Park which is a rapidly growing science and technology cluster, with easy access for visitors through the nearby RDU airport.”

Catalent to Increase Spray-Drying Capacity for APIs at Pharmatek

Catalent Pharma Solutions has said it will increase spray drying capacity at a plant owned by recent acquisition Pharmatek Laboratories.

The US contractor announced the expansion plan, explaining that it will install a GEA Niro Mobile Minor spray dryer and a Gerties Mini-Pactor unit at the facility in San Diego. Both technologies are expected to be validated and operational before June.

Catalent cited customer demand as the driver for the expansion, but did not go into specifics.

The US contract manufacturing organization (CMO) bought Pharmatek last year, citing its capabilities in high potency active pharmaceutical ingredient (API) production as the motivation for the deal.

Barry Littlejohns, President of Catalent’s Drug Delivery Solutions business, said the capacity expansion “is the first of several strategic investments that we have planned for the San Diego facility in the immediate future.”

The site, where 200 people are employed, provides development and analytical services as well as manufacturing and formulation development support.

Pharmatek has used a GEA Niro Mobile Minor for the production of amorphous spray dried dispersions since 2015. The firm installed a Gerties Mini-Pactor at the site in 2014.

Elizabeth Hickman, Director of Sales & Marketing at Pharmatek said, "When Catalent acquired Pharmatek last year, it was to increase our bioavailability toolkit with the introduction of spray drying technology, and also to widen the scope of the work we can perform for our customers.

She added that: "Pharmatek has significant experience working with companies at earlier stages of development, and this opens up opportunities for us to do more with existing customers, and attract new customers at those earlier stages too."

SCA Pharmaceuticals Is Building Manufacturing Facility

Injectable pharmaceuticals manufacturer, SCA Pharmaceuticals, is building a 90,000 square-foot manufacturing facility in Windsor, Connecticut, U.S.

The company is responding to an increased demand for injectable pharmaceuticals, SCA Pharma spokesperson Matthew Cronk said.

Hospitals are contracting numerous injectables suppliers, so as to safeguard their supply, which has also increased demand, he said.

Connecticut State’s Department of Economic and Community Development (DECD) is supporting the construction with a $8.5m (€7.81m) loan for leasehold improvements and the purchase of machinery and equipment.

SCA Pharma expects to create approximately 361 new jobs over the next four years.

“This is an important sector of our economy, and we are thrilled that this company is adding hundreds of good, high-quality jobs in our state,” said State of Connecticut governor Dannel Malloy.

Connecticut lt. governor Nancy Wyman also expressed support for the industry, “These investments position us to attract new business and development, grow jobs, and further establish Connecticut as a global competitor in bioscience and healthcare.”

SCA Pharma expects to open the facility in August.

The company currently manufactures injectable pharmaceuticals in ready-to-administer dosages for use at hospitals and healthcare facilities at its facility in Arkansas, U.S.

The announcement comes four years after the closure of one of the world’s largest sterile injectables manufacturer, Ben Venue Laboratories.

Years of quality and GMP issues at Ben Venue’s Ohio, U.S.-based site caused major drug shortages at the beginning of the decade.

Halo Pharma forms Pediatric Center of Excellence

Halo Pharma has unveiled the formation of its Pediatric Center of Excellence in support of the development and manufacture of dosage forms tailored for pediatric indications. Halo has been working closely with pharmaceutical companies to apply its expertise in formulation sciences and its integrated manufacturing capabilities across a broad range of scales and dosage forms to overcome the challenges in developing pediatric dosage forms (PDFs) of already approved adult dosage forms. Halo provides specialized contract development and manufacturing services that meet the regulatory requirements of the U.S., Canada, and Europe, where Halo Pharma is already manufacturing PDFs for commercial sale through its sponsors.

Pharmaceutical companies are often asked by the U.S Food and Drug administration to conduct clinical trials for pediatric indications of adult dosage forms. The advantages of developing PDFs include the potential for extended patent protection and to obtain expanded indications in pediatric populations.

In support of its Pediatric Center of Excellence, Halo Pharma has developed the infrastructure, process trains and equipment needed for efficient, cost-effective, and rapid production of small- to medium-scale cGMP clinical drug products that are used in pediatric clinical studies. Halo Pharma provides technical expertise needed to modify adult dosage forms for pediatric use. This may include reformulation to enable a lower strength or making changes to the adult dosage form to improve patient compliance by making the medication easier to take and/or taste better.

Halo Pharma has partnered with several pharmaceutical companies already to develop commercially viable PDFs that have received both U.S. and international regulatory approvals. In addition, the company currently has multiple clinical and commercial PDF programs underway. In nearly all cases, developing a PDF from an adult dosage form requires additional product development work. In many cases, it is necessary to provide the PDF in various strengths matched to different pediatric age/weight brackets. Halo Pharma has the capabilities to manufacture batches of PDFs that typically range in scale from 5 Kg to 1000 Kg, with many requiring multiple processing steps.

“Our formulation development and clinical manufacturing capabilities can support a variety of oral solid and liquid dosage forms suitable for pediatric applications, such as granules produced using fluid bed technology and mini-tablets that can be packaged into stick packs, powder in bottles for reconstitution, and our liquid products, which are typically oral solutions and suspensions that can also be time release-based,” said Lee Karras, chief executive officer, Halo Pharma. “We offer our customers over 40 years of commercial drug manufacturing experience and a proven track record of approvals with regulatory agencies around the world.”

Avid Bioservices Expands Manufacturing Capacity

Avid Bioservices, Inc. is upgrading its Myford, CA clinical and commercial manufacturing facility with multiple Mobius 2000-liter single-use bioreactors from MilliporeSigma. The new bioreactors will be installed in mid-2017, expanding the company’s manufacturing capacity.

Avid has installed the appropriate systems to allow integration of the Mobius bioreactors. The 40,000-square foot Myford facility was designed to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial biologics production. The facility can operate multiple bioreactors simultaneously, improving manufacturing capacity and efficiency.

“An integral part of our complete single-use offering, Mobius® bioreactors help companies like Avid move toward the goal of fully disposable manufacturing,” said Udit Batra, member of the Executive Board, Merck KGaA, Darmstadt, Germany and chief executive officer, MilliporeSigma. “We will continue to support Avid as it upgrades its facility to help customers advance molecules into the clinic and to market so that patients have better access to life-enhancing drugs.”

GSK invests to Expand Capacity

GlaxoSmithKline will invest $139 million in its biopharmaceutical manufacturing site in Rockville, MD to support production of BENLYSTA (belimumab) for systemic lupus erythematosus (SLE). The Rockville site is also expected to house production of a new subcutaneous form of belimumab which is currently under FDA review.

The investment will provide additional internal capacity to increase bulk drug substance production by nearly 50% to respond to increased demand. Benlysta has grown at least 18% per year in the U.S. on a constant exchange rate basis. In 2016, the company reported $377million in BENLYSTA sales in the U.S.

"Benlysta is the first medicine specifically developed and approved for SLE in over 50 years. We are so pleased that on the first day of Lupus Awareness Month we are able to announce this expansion in Rockville, increasing our ability to provide this important medicine to patients," said Sheri Mullen, VP Immunology & Rare Diseases, GSK.

The Rockville site consists of two FDA-licensed facilities for large and small scale manufacturing, which employ more than 400 scientists, engineers and manufacturing and quality professionals.

The company has made several additional investments recently, including: $50 million to continue to develop its Global Vaccines R&D Headquarters in Rockville, MD, and $245 million to upgrade its Upper Providence, PA site into one of two major R&D hubs for GSK globally.

Brammer invests in Gene Therapies

Brammer Bio says its commercial-scale gene therapy manufacturing facility in Cambridge, Massachusetts, US, will open in the second half of 2017.

The contract development and manufacturing organization (CDMO) said the site offers process development, clinical phase, and current Good Manufacturing Practices (cGMP) services for cell and gene therapies.

“We are delighted to add an experienced commercial biologics team and facilities to help meet the needs of this transformative industry,” said Mark Bamforth, CEO of Brammer.

Brammer has completed a Type-C meeting with the US Food and Drug Administration (FDA) to assess the plans for the Massachusetts-based site. A Type-C meeting regards the development and review of drugs or biological drug products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

A Site Master File will be submitted later this year to support Brammer’s clients’ product applications.

The site originally housed Biogen’s clinical and commercial biologics manufacturing facility.

Brammer purchased it along with Biogen’s distribution center in Somerville, Massachusetts, on January 1, 2017.

The Somerville site offers Brammer nearby storage and distribution capabilities.

The announcement follows Brammer’s 2016 plans to renovate its 50,000 square-foot facility in Lexington, Massachusetts, to cater for late stage and commercial therapy supply.

Brammer’s facilities now offer 230,000 square feet of development, distribution and cGMP manufacturing capabilities across Florida and Massachusetts, U.S.

Lupin expansion in Somerset, NJ

On May 9, the leadership of Lupin Limited gathered along with state and local leaders, including Rep. Bonnie Watson Coleman (DNJ – 12th District), to celebrate the grand opening of the company's 100,000 square foot expansion of its manufacturing facilities in Somerset. The new facility will focus on making affordable medicines for treatment in various therapeutic areas.

Commenting on this milestone for the company, Vinita Gupta, Chief Executive Officer of Lupin Limited, said, "We are very pleased to officially open our new facility at Somerset. This expansion enables us to serve the growing need for affordable medicines for U.S. patients, providers, government and other stakeholders. In the last three years, we have made strategic investments in the U.S. in R&D and manufacturing to establish a deeper footprint in the country, and access technology capabilities for niche technology platforms."

Since 2016, Lupin has invested over $1 billion in R&D and Manufacturing in the United States. Lupin employs 635 highly skilled and specialized employees in the U.S., with that number expected to grow as Lupin expands. In March 2016, Lupin acquired the Somerset facility for $880 million. Since acquisition, over 80 jobs have been created to support the site bringing the total number of employees in Somerset up to 380. 50 more jobs are expected to be added over the next 12 to 18 months. In addition, Lupin has invested around $35 million in R&D and infrastructure.

"The opening of this facility in Somerset enhances our scale in the U.S. generic market, and is a complement to Lupin's Coral Springs, Florida, inhalation R&D center," stated Lupin President Kurt Nielsen. "We have set ambitious targets for ourselves in the U.S. market. This 10-fold expansion of our manufacturing site will enable us to meet and exceed our targets. We are confident that we will continue to grow, and look forward to creating additional opportunities which benefit our community."

SCA Pharmaceuticals opened in CT

Governor Dannel P. Malloy announced that SCA Pharmaceuticals, an Arkansas-based company, has decided to establish a presence in Connecticut through the creation of a new 90,000 square-foot manufacturing facility in Windsor, where the company has plans to create approximately 361 new jobs over the next four years.

SCA manufactures injectable pharmaceuticals in ready-to-administer dosages for use at hospitals and healthcare facilities. The company helps healthcare facilities increase efficiencies and reduce costs while improving patient care.

“The commitment from SCA Pharmaceuticals to choose Connecticut for its expansion reinforces how our strategic location and world-class workforce makes our state a great place for businesses that are looking to bring their operations to the east coast,” Governor Malloy said. “This is an important sector of our economy, and we are thrilled that this company is adding hundreds of good, high-quality jobs in our state.”

Dr. Gene Graves, CEO of SCA, said, “Connecticut represents an ideal location for SCA, driven by its incredible workforce and myriad of transportation options.”

SCA is leasing a facility at 755 Rainbow Road in Windsor. The state, through the Department of Economic and Community Development (DECD), will support the project with an $8.5 million loan for leasehold improvements and the purchase of machinery and equipment. The funding will require approval from the state Bond Commission.

SCA employs 210 people at its Little Rock, Arkansas facility.

East Tennessee Children’s Hospital Surgery and NICU Expansion, Knoxville, Tenn.

Cost: $75 million

Size: 271,121 sq. ft.

Project team: Realty Trust Group (Owner’s Program Manager); BarberMcMurry architects (Architect of Record); Shepley Bulfinch (Design Architect); ESG (Engineering Services Group) (Mechanical, Plumbing); Vreeland Engineers Inc. (Electrical); Land Development Solutions (Civil); Ross Bryan Associates Inc. (Structure); CRJA and Hedstrom Design LLC (Landscape)

Description: An official opening has been held for the East Tennessee Children’s Hospital Surgery and NICU addition and renovations. Located in Knoxville, the new tower houses a 14-room surgery platform, multi-specialty outpatient clinics and a 44-room all-private neonatal intensive care unit (NICU) to meet the growing demand for pediatric health services in the region. This expansion and the accompanying renovation of vacated space in the old building fulfills the goals of Children’s Hospital’s strategic master plan, significantly upgrading its facilities and enhancing Children’s Hospital’s visibility as the region’s only comprehensive pediatric center.

Symbolizing the hospital’s continued commitment to exceptional patient- and family-centered care, the roof garden with a view of the Smokey Mountains and the multi-level glass bridge featuring both family and public spaces become the central design features of the new expansion. The metal panel exterior frames the bridges and the roof garden, creating an urban signature for the new expansion, while the use of terracotta on the façade blends the addition with the existing brickwork of the older hospital buildings. The bridge spans the entryway below joining new and old, while the public spaces and roof garden animate the campus. The five-story tower, which seems to change color depending on vantage point, emphasizes the significance of natural light in this project. The entire expansion sits atop a 165-space, two-story parking garage.

One of the most successful aspects of the Children’s Hospital expansion is the 44-bed NICU located on the top floor of the building. Featuring all private rooms, amenities in the new space include a family suite with kitchen facilities, resource center, and a walk-out roof garden that became a defining space for the NICU and provides a much-appreciated outdoor respite area for families and staff. The large private rooms allow for unlimited bonding time with parents and other family members, especially siblings who had previously been prohibited from visiting due to space limitations and potential health concerns.

East Tennessee Children’s Hospital in Knoxville light courts were incorporated into the design and planning of the unit, providing daylight to every interior room. They define the neighborhood organizational model for the unit, making the space feel more personal and private and contributing to intuitive wayfinding. BarberMcMurry served as the architect-of-record and Shepley Bulfinch was design architect.

The challenge of ensuring that every private NICU room had direct exterior/daylight access turned into a tremendous opportunity for BMa and Shepley Bulfinch, and led to the incorporation of light courts into the design and planning of the unit. The design team developed a NICU neighborhood concept to create intimate healing spaces for families and to provide clinical teams with the necessary support services to deliver efficient and effective care. The light courts provide daylight to every interior room and define the neighborhood organizational model for the unit, making the space feel more personal and private and contributing to intuitive wayfinding. As an added benefit, the light courts also feature three-dimensional artwork by local artists that are integrated into Children’s Hospital’s family healing art program. Cross-functional teams at Children’s Hospital worked closely with the design team to engage all NICU stakeholders in the development of this model.

Although pediatric healthcare delivery is distinct from adult care and the needs of pediatric patients are different from those of adults, pediatric healthcare environments are incubators for hospital design innovation.

Completion date: April 2017

Alcami Invests to Expand in South Carolina

Alcami Corp., a provider of custom development and manufacturing services for the pharma and biopharma industries, is investing $5 million to expand its Charleston, SC operations. This project is expected create at least 30 new jobs.

Alcami will continue to expand its filling and freeze-drying capabilities. The site has also produced clinical supply from its recently-qualified second line and doubled both its filling capacity and freeze-drying capacity with increased scheduling flexibility, including a third operating shift. Hiring for the new positions is currently underway.

"The Charleston facility is an integral part of the Alcami network. We are excited about the growth potential of the site and its ability to support the increased demand for sterile drug product development and manufacturing," said Dr. Stephan Kutzer, Alcami’s chief executive officer, chairman and president.

Alcami offers services across active pharmaceutical ingredients, drug products (sterile, oral solid dose, packaging and labeling), development services and analytical testing, with six locations in the U.S., and a seventh in the Netherlands.

Patheon completes Sterile Expansion

Patheon, global provider of drug development and delivery solutions, has completed an expansion project at its manufacturing site in Greenville, NC.

The company invested approximately $26m to update one of its sterile Pharmaceutical Development Services (PDS) suites and to build a fully integrated sterile PDS suite which are compliant with regulatory authorities. The PDS Suites 1 and 2 provide 7,000 sq. ft. in GMP sterile manufacturing space.

The newly built PDS suite will manufacture sterile liquid and lyophilized drug products. It features freeze dryers and a fully integrated filling line fitted with a Restricted Access Barrier System (RABS) for sterile drug products.

The company has made the investment in disposable manufacturing in this suite eliminating the need for cleaning verification for liquid filling, reducing set up time/product losses and enhancing sterility assurance.

This suite is fully integrated and designed for products in clinical development with the ability to scale up to much larger batch sizes.

Patheon’s Greenville manufacturing site is a large, multi-purpose pharmaceutical manufacturing and packaging campus.

The facility provides both solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilisation of both biopharmaceuticals and small molecules.

Another development in Greenville is the installation of a continuous manufacturing suite.

Plastics One has Expanded into Medical Packaging

The company has added independent ISO Class 7 cleanrooms to house production and sterile barrier packaging for validated medical pouch sealing for medical cables and devices. Plastics One is ISO 13485:2003 and ISO 9001:2008 certified.

Potatoes Spend Time in Cleanroom before Heading to the Plate

Microtuber potato cultivars used in research by the Wisconsin Seed Potato Certification Program inside an environmentally-controlled growth room at the Biotron Laboratory at UW–Madison.

Years before that French fry landed on your plate, the plant that would eventually give rise to the spud your fry was cut from was sealed away deep in a secure-access building, growing slowly in a test tube inside a locked growth chamber.

At least, it was if it was the product of the Wisconsin Seed Potato Certification Program, or WSPCP, a 104-year-old program run by the University of Wisconsin–Madison dedicated to supplying Wisconsin seed potato farmers with quality, disease-free tubers.

All that security helps keep these important plants clean. And clean is a big deal for potatoes. Because they are grown from the eyes of tubers, called seed potatoes, rather than from true seeds, potatoes can easily carry bacterial and viral diseases in their starchy flesh from generation to generation. The solution is exacting cleanliness and rigorous testing at every stage of potato propagation.

WSPCP supplies 70 percent of the seed potatoes for Wisconsin’s 9,000 acres of farmland dedicated to propagating seed potatoes. The program certifies 200 million pounds of seed potatoes every year, enough to plant roughly 90,000 acres for commercial growing. Those spuds are then sold to commercial potato growers in Wisconsin, other states and around the world to be turned into farm-fresh potatoes, chips and fries.

Each one of those potatoes’ progenitors once passed through the hands of two researchers at UW–Madison, Andy Witherell and Brooke Babler. In about three months, they can turn a handful of small potato plants growing in test tubes into hundreds. Multiply that by dozens of different varieties of potatoes — Caribou Russet, Magic Molly, German Butterball — and together Witherell and Babler produce tens of thousands of potato plantlets every year.

Witherell and Babler work out of the Biotron, a facility on the UW–Madison campus designed to replicate any climate needed for research. The building’s secure access and clean protocols help them scrub the potato plants of any diseases and propagate them in sterile environments until they’re ready to plant in soil.

“This is a good place to grow plants because we’ve got a system that’s really clean,” explains Witherell. “The Biotron air is filtered, and we have a cleanroom to work with.”

The researchers start by sterilizing an eye of a tuber and then inducing it to grow in a sterile container full of a jelly-like growth medium containing bacteria- and virus-inhibiting chemicals. As the spud sprouts into a small plant, they ramp up the heat to try to kill off any viruses.

Babler and Witherell can keep their plantlets in stasis in cold storage until the call comes in — 308 plantlets of Dark Red Norland are needed by July. Babler pulls out a box with several plantlets and takes them to the cleanroom, a space about the size of a parking place. On a sterile work surface, she takes out a scalpel and slices the plants into several pieces before replanting them in a new box. Just a small portion of one plant’s stem will grow an entirely new plant under the right conditions.

In this way, eight potato plants become 30. Four weeks later, those 30 become 80; then 80 become 310. They are all genetically identical clones of one another and they are all still clean.

Thousands of plantlets of different varieties are shipped to the program’s farm in Rhinelander, Wisconsin, where they are grown hydroponically or in pots to begin producing tubers. Over several generations, one plant gives rise to many spuds, which in turn are replanted to make even more potatoes. In a few growing seasons, what once was handled by Witherell and Babler in the Biotron now weighs hundreds of millions of pounds and requires the work of two dozen independent, certified farms to manage.

Along their journey, the potatoes are screened for diseases that might have crept in. Once Babler and Witherell leave the Biotron for the day (they don’t return, the better to keep from bringing in pathogens from outside), they work in Russell Laboratories, where they help run diagnostic tests on potatoes to screen for viral and bacterial infections.

“Part of the certification process is to walk the fields and visually assess plants for the disease,” says Babler, a native of Viroqua, Wisconsin, who earned both her bachelor’s and master’s degrees at UW–Madison. “You can visually assess plants, but sometimes you can’t tell exactly what the disease is. So the inspectors ship the plants back to us and we do diagnostics throughout the growing season.”

As part of her research, Babler is developing an improved test for a relatively new potato disease, Dickeya. The bacteria can spoil up to a quarter of a farmer’s yield under the right conditions, and has recently taken hold in North America. Seed potato programs like the WSPCP are designed to detect and restrict the spread of new diseases like Dickeya, which spread primarily through infected seed potatoes.

Only those potatoes with a healthy pedigree get the WSPCP seal of approval. A portion of the sale of each bag of potatoes that commercial growers buy, certified to be as clean as possible, supports this years-long, labor-intensive process.

It’s a certification well worth the price — ensuring that Wisconsin potato growers continue to succeed, helping keep the state one of the top producers of potatoes in the country.

REST OF WORLD

The Biotech Training Facility in Leiden, The Netherlands

Hands-on teaching offers drugmakers, vendors and regulators a better understanding of bioprocessing, according to the managing director of a training facility in Leiden, The Netherlands.

The center, funded through European and local grants and private investment, began operations last year offering companies and individuals training across a wide-range of biotech processes.

Customers so far have included Big Pharma firms, small biotechs and vendors themselves, looking to test equipment in GMP-like conditions.

According to managing director Ronald Kompier, the chance to test equipment and biomanufacturing processes hands-on is more valuable than learning through lectures or online.

The facility is not the only example of such a service for the biotech industry. In Ireland, the National Institute for Bioprocessing Research and Training (NIBRT) has been described as 'a flight simulator' for biopharma manufacturing.

And furthermore, sites like North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), and Austin Community College in Texas have benefited from government funding to help train bioprocessing staff.

LabCorp to Relocate and Expand UK CMC Business

LabCorp will relocate its UK CMC services unit to a larger site and has said it is confident the Government will maintain its commitment to the drug industry after Brexit.

LabCorp announced that BiopharmaCMC – the UK chemistry and manufacturing services unit operated by its Covance division – will move to a facility in York in leased space at the National Agri-Food Innovation Campus (NAFIC).

Covance said the new facility - which is expected to be operational by the end of the year – will provide services for firms developing large-molecule (biologic) medicines, including antibodies, vaccines, biosimilars and cell-based and gene therapies.

A spokeswoman said, “We anticipate 20 to 30 people will be working from York at the end of 2017 with continued growth into 2018 and beyond.”

The UK is due to drop out of the European Union (EU) in 2019.

In March, Tory Prime Minister Teresa May chose to trigger Article 50 of the Lisbon Treaty on the back of the narrow 'leave' vote in the non-binding, advisory referendum last year.

What impact Brexit will have on UK laws and the economy will not be clear until the terms of the departure are negotiated, however, drug regulation is one of many areas likely to be affected.

The European Commission confirmed the European Medicines Agency (EMA) will leave London, which is something the Association of the British Pharmaceutical Industry (ABPI) raised as a concern ahead of the referendum.

Despite the uncertainty, Covance is confident the UK will still be a good place for a drug chemistry manufacturing and controls (CMC) services firm to be located after Brexit.

The spokeswoman said, “Has long established roots in the UK and the life-science industry remains an area of focus for Government.”

She cited recent growth seen in BiopharmCMC business – currently based in Harrogate – for customers supplying both EU markets and the US as likely future drivers.

The spokeswoman also pointed out that: “The UK has reciprocal recognition agreements in place with the EU which are expected to minimize any impact from Brexit.”

Volition Opens New Research and Development Facility in Belgium

VolitionRx has opened its new research and development facility in Belgium.

The building will enable the company to increase capacity to carry out clinical trials and to expand its scientific team, expediting the large number of trials underway. The facility comprises 9,000 square feet of office space and 10,000 square feet of laboratory space. The facility is located in the Crealys Science Park, Isnes in the Wallonia region of Belgium.

"Our capacity to run large clinical trials has increased significantly with this five-fold increase in laboratory space,” Dr. Marielle Herzog, Research and Development Director of Volition said. “This will facilitate large scale manual and automated robotic testing. We will now have the ability to work on several large trials at the same time, namely; the frontline screening colorectal cancer tests and lung, prostate and pancreatic cancer.”

AstraZeneca Announces ‘Topping Out’ of Global R&D Center and HQ in Cambridge, UK

AstraZeneca announced the ‘topping out’ of its new R&D center and global corporate headquarters at the Cambridge Biomedical Campus (CBC). The company has already moved 2,000 employees to Cambridge, UK, including its biologics research and development arm, MedImmune. Occupation of the site will begin in stages in 2018.

The ‘topping out’ milestone represents the completion of the new building’s concrete frame.

The R&D site will become AstraZeneca’s largest center globally for oncology research, as well as housing scientists focused on respiratory, cardiovascular and metabolic diseases. The site will also house a joint research center with the Medical Research Council, where partnering scientists will work side-by-side with AstraZeneca’s high throughput screening group.

AstraZeneca’s drug discovery scientists are working with Microsoft to use a cloud-based simulation that brings alive the millions of potential changes that make cancer cells multiply uncontrollably, to better understand the disease.

A novel agreement is also in place that will give researchers from the University of Cambridge access to key compounds from the AstraZeneca drugs pipeline.

Low & Bonar Opens Testing Lab

A test lab aimed at developing new and enhanced filtration solutions to meet the increased demands for cleaner industrial and automotive air opened in Arnhem, Netherlands.

Performance materials company Low & Bonar intends to escalate the rate at which proprietary technology is turned into market-adopted filtration applications at the new Arnhem Centre of Expertise.

Working directly with the customers of its premium brand BonarPure, the lab will incubate and test ideas based on market insights, creating and implementing prototype solutions that will enable buyers to increase speed to market with products that are fit for purpose and scale globally.

With filtration markets growing at a rate of 7% annually, customer-driven developments are seeing a sharp increase.

Brett Simpson, CEO, comments: “Our goal is to partner with our customers, identify their unmet needs and develop a better quality, personalized solution that improves the performance of their end products. Our customers face evolving challenges, from population increases to the growing scarcity of resources such as clean air and water. With their input and feedback, we hope to get results that make a positive impact on the quality of life of those living with and using products containing our materials.”

A range of attributes based on Colback technology will be tested including filtration efficiency, air permeability, pressure drop and conditioning. In addition, the lab’s new scanning electron microscope will enable better understanding of the strengths and synergies between Low & Bonar’s set of technologies. Initial results show that Colback-based media has a lower pressure drop at comparable efficiencies to meet industry standards, and provides manufacturers with extra space in cost-conscious product design.

Flamma opens Facility in China

Flamma has opened a new cGMP workshop and R&D Center in Dalian, China and is looking to add capacity at several other sites as part of its “Flamma 2020 plan.”

The $20m investment from the contract manufacturing organization (CMO) ups the total capacity of its Chinese operations in Dalian to 200 m3.

Kenneth Drew, Ph.D., sr. director, North America sales and business development said the main driver to add capacity at its Flamma Honkai facilities in Dalian is to diversify its customer offerings.

“We can now service customers interested in IC4C (In China for China) and we can also sell into the Chinese marketplace with our line of generics like minoxidil and others,” he explained.

Drew said the company has been seeing a growing demand in both in North America and Europe.

“Much of this is thanks to the dedicated staff we have in Italy and in China that help customers achieve their goals,” he added.

Next steps include working towards Chinese FDA inspection.

The company is also looking to add capacity and features to its Italian sites.

According to the company, by 2018 it plans to spend an additional $5m to expand its R&D capabilities with a new facility at its Chignolo d’Isola headquarters.

The goal is to increase production capacity at the facility by 40% with the addition of another cGMP workshop by 2020 – and according to Drew, the “Flamma 2020 plan” is “well on its way to succeed.”

“While the CMO industry appears to be consolidating with mega-mergers and such, we feel that being family owned, privately held and managed company has significant value to customers,” he added.

“We stay true to what we do well and continue to expand our chemical toolbox with new and interesting projects from both old and new customers.”

Project for Specialist Science Laboratory in Newcastle Begins

Kier Group plc, a leading property, residential, construction and services group, has been appointed to deliver the latest specialist laboratory building at science central in Newcastle.

The £20m project, due for completion in late 2018, will see the design and construction of a new 77,000 sq. ft. laboratory facility for Newcastle City Council and forms part of the wider Newcastle Science Central development in the city.

The building will provide bespoke laboratory areas, offering high quality incubation space to meet the needs of innovative businesses in the life science and healthcare sector.

Newcastle Science Central is a new urban quarter in the center of Newcastle that will provide 500,000 sq. ft. of office space. The largest development of its kind in the UK worth £250m, it will attract leading scientific and technology organizations to the area encompassing a variety of research and development, educational, business and residential uses.

Commenting on the build, Brian McQuade, managing director of Kier Construction Scotland and north east, said: “We’re looking forward to delivering this new bespoke laboratory facility, building on our expertise in the biotech sector. Kier has extensive experience delivering research facilities and we’re proud to be providing the latest addition to Science Central development as it continues to expand.”

Pat Ritchie, Chief Executive of Newcastle City Council said “there’s a shortage of specialist laboratory space in the city” therefore such investment is welcomed to the city.

“Newcastle Laboratory will provide this flourishing sector with the much needed specialist facilities - enabling life science organizations to continue growing, innovating and producing pioneering research and products. Newcastle Science Central provides the perfect home for these specialist facilities, and as the flagship location for life sciences, it provides the infrastructure businesses need to collaborate as well as globally-renowned academics and students also based on site.”

The building has been developed by a design team led by Aura alongside award-winning architects Ryder, who have been supported by leading industry specialists including CAM-SCI, to ensure the building meets the needs of the healthcare and life sciences sector.

Abertay University in Scotland to Unveil New Science Labs

Abertay University in Dundee, Scotland, has invested £3.5m to create cutting edge science laboratories for food, forensics and biomedical sciences.

One of the university's fields of research is Food Science and Nutrition and it offers consultancy services for the food industry. For example, the new Consumer Experience Laboratory is unique in Scotland and comprises 12 climatically controlled booths designed for the sensory analysis of food.

It has a preparation and serving room linked to a kitchen as well as a waiting room which can be used for consumer experience testing, student tutorials and small group working.

The New Product Development Laboratory will be used for pilot scale food manufacture schemes across a range of food processes and industries.

Designed to food manufacturing and environmental health standards, the zone features a controlled barrier, change area, walk-in cold room and store.

A teaching area featuring two new labs will be used by the forensic science and biomedical science divisions.

Both are linked, equipped with two high-tech fume cupboards, and designed specifically to accommodate 30 students each.

Features include a controllable camera, independent monitors and a total of 15 display screens which can be operated collectively or independently by teaching staff and students.

The final space – a learning/social area – is multi-purpose and includes an 84-inch screen and seating. A link corridor around all of the labs has seating and lockers.

Students had a major hand in the design of all areas, inputting valuable user comment that helped to shape layout and decorative features.

Professor Carl Schaschke, Head of the School of Science, Engineering and Technology, said the new facilities will provide a major boost to learning and research. He added: “This project forms part of the University’s commitment to excellence in teaching and research.

“Not only will the new labs benefit Abertay students for years to come, the facilities have huge potential for business and we already have a significant engagement with a number of local companies who are keen to work with us.”

The official opening of the new facilities in Dundee will take place on May 30, attended by guests from the worlds of science, industry, business and academia. Distinguished biologist Dame Anne Glover will formally unveil the suite of labs.

Boehringer Ingelheim opens Shanghai Contract Biomanufacturing Plant

Boehringer Ingelheim says the biologics plant it opened in Shanghai, China will cater for customers targeting local and international markets.

The plant at the Zhang Jiang Hi-tech Park in Pudong will make “therapeutic proteins from mammalian cell culture” according to spokesman Ralph Warsinsky, who added “it has already been operational for the production of clinical trial supplies on a smaller scale.”

The site was built in collaboration with Zhangjiang Biotech & Pharmaceutical Base Development Company Warsinsky said, adding that: “As part of this joint venture, our local partner is for example providing the property at which the facility is built.”

According to a presentation Boehringer Ingelheim gave at BPI Europe in Amsterdam, The Netherlands in April the Pudong site houses 2,000L of disposable bioreactors capacity. The firm also revealed it plans to make an isolator liquid filling line operational at the site in 2018.

When Boehringer announced its plant to build the plant in 2013, it said the aim was to encourage international drug companies that would otherwise be put off by the complexities of supplying the Chinese market.

The plan is working so far according to Warsinsky, who said: “We have so far seen a great interest from customers, including local Chinese drug companies as well as multinational drug companies. We do already have existing contracts with both local Chinese as well as multinational companies.”

However, while the focus will be contract manufacturing, the site may also produce Boehringer Ingelheim’s own products for markets in Asia.

“The plant will at the start be operating for industrial customers. As the plant is designed to accommodate additional capacities based upon market demands, we will have the potential to in the future also produce products marketed Boehringer Ingelheim” Warsinsky said.

The Pudong plant will also make biologics for other markets, including the US, according to Warsinsky who said: “Before the start of commercial operation today, we have already been producing clinical trial supplies for international markets, including the US.”

Boehringer Ingelheim expanding in Austria

Boehringer Ingelheim has broken ground on a €700m stainless steel bioproduction facility set to house 135,000L of mammalian cell culture capacity.

The drugmaker and third party biologics manufacturer pledged a significant investment at its Vienna, Austria bioproduction site back in December 2015, and broke ground on the project earlier this month.

And at the Bioprocess International (BPI) European Summit in Amsterdam, Boehringer Ingelheim’s head of Biopharma Austria Christian Eckermann said the €700m ($763m) project – around €200m more than announced in 2015 – is the largest single investment ever made by the company.

The facility is planned to be operational in 2021 and will initially house six 15,000L stainless steel bioreactors. However, the plant is being built to be able to incorporate a further three 15,000L tanks, giving mammalian cell culture capacity of 135,000L at the site once fully going.

The investment will help satiate the rising demand for biomanufacturing capacity, Eckermann said, both for Boehringer Ingelheim’s own product pipeline and for its customers from its biologics contract manufacturing business BioXcellence.

He told delegates worldwide biologic production stood at around 19 metric tons of product in 2015, but this will more than double by 2020 with industry demanding 33 metric tons of product to service commercial pipelines.

This helps explain the spate of investment in capacity by both biopharma firms and contract manufacturing organizations (CMOs) he said. Over the past few years, Biogen, Novartis, Regeneron, Roche and Samsung Biologics are among those firms which are expanding capacity by more than 100,000L.

“At the moment about 67% of capacity coming on line is product based, 24% is CMO based, and 9% is hybrid based.”

When the new facility is fully operational, Boehringer Ingelheim will have a total of 375,000L of stainless steel mammalian cell culture capacity, a further 4,000L of single-use capabilities, and 12,000L of microbial fermenter capacity (stainless steel) across its four sites in Germany, Austria, China and California (US).

United BioPharma Opens New Facility in Taiwan

United BioPharma Inc. (UBP), with government backing, has selected GE Healthcare’s FlexFactory manufacturing platform for its new facility in Hsinchu Industrial Park, Taiwan.

The plant will focus on late-stage clinical therapeutic monoclonal antibodies (mAbs), and in particular United candidate HIV treatment UB-421. The Phase II candidate is primarily intended for treatment of HIV infected patients experiencing HIV viremia, and not responding to other anti-retroviral drugs.

According to GE Healthcare, the Taiwanese government is supporting the project to improve access to biopharmaceuticals and develop the bioprocess market in the region.

Taiwan’s Ministry of Economic Affairs said, “We expect that the successful operation of this plant will further enhance global competitiveness of Taiwan’s protein drug industry.”

UBP said it will initially focus on the local Taiwanese market, before entering global markets.

FlexFactory

GE Healthcare’s FlexFactory is a centrally automated, flexible bio manufacturing platform. It is primarily comprised of single-use technologies and associated process hardware.

USB Chairperson Dr. Chian Yi Wang said the technology will address capacity issues, explaining "two of GE’s 2,000 liter single-use bioreactors and integrated manufacturing process…resolves the manufacturing bottleneck for UBP’s rich pipeline.”

GE Healthcare said the overall project timeline for setting up a FlexFactory is between nine and 12 months, compared to up to 24 months when installing a stainless steel production platform.

“This means that the single-use technologies can help to reduce build costs up to 50 percent compared with equivalent traditional steel facilities,” said Sven Henrichwark, General Manager of GE Healthcare Life Sciences’ Global Commercial BioProcess department.

He added that: “FlexFactory…brings simplicity to the process. It reduces cost and risk compared with constructing a conventional fixed biotherapeutic manufacturing line.”

GE Healthcare cited other benefits, such as reduced cleaning procedures, which can result in diminished carbon dioxide emissions, water and energy consumption.

GE Healthcare did not disclose the sale price.

Other firms to have installed the FlexFactory platform include Beigene, JHL Biotech and Nanotherapeutics.

DSM Sinochem Expands Capacity at Delft Plant

DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

The firm cited demand for sustainably produced 7-ADCA (amino-deacetoxycephalosporanic acid) – which is used to make cephalosporin active pharmaceutical ingredients (API) - as the driver for the investment.

The expansion - which will see DSP install a new fermenter - is due to be completed by the end of the year.

DSP – which claims to be the only remaining 7-ADCA producer in the Western hemisphere – makes the intermediate using patented - US 8,541,199 B2 and EP 1,610,766 B1 – enzyme-based processes that do not use solvents.

The firm says the enzymatic approach – intellectual property for which was recently licensed to Sandoz – is more environmentally sustainable and has a smaller carbon footprint than production methods used elsewhere.

Beyond eliminating solvents, DSP also claims its production of 7-ADCA at Delft is more sustainable than rivals because of the site’s dedicated waste water treatment facility.

The firm said the water treatment plants “operate all year round as an integral part of DSP’s manufacturing process at Delft and all other sites, in combination with the testing of effluents for antimicrobial activity.”

DSP has been vocal about the role some ingredient suppliers play in furthering the spread of antimicrobial resistance (AMR), suggesting that manufacturers whose sites lack dedicated treatment capacity are a major problem.

The argument – which is supported by a recent research by the European Health Protection Agency (EHPA) - is that mixing of improperly treated waste at shared plants promotes allows resistant bacteria to exchange generic information, creating multiply resistant “superbugs.”

Daiichi Sankyo Expands Antibody-Drug Conjugate Production

Daiichi Sankyo will plough ‎¥15bn ($135m) into three Japanese manufacturing facilities to support its antibody-drug conjugate pipeline.

Details as to where in Japan the investments would be made were not disclosed by spokeswoman Chikako Mani, but she confirmed the ¥15bn would be used to build new and refurbish manufacturing lines at three plants.

“These improvements will optimize and expand the production of fully synthesized ADCs and ensure a stable supply for future investigational and commercial use,” she said in a statement.

According to Mani, ADCs are one of the most important franchises for Daiichi Sankyo, which has a pipeline consists of six such products. The two most advanced candidates are DS-8201 and U3-1402, both in Phase I clinical studies for breast cancer.

While there are no plans to hire additional employees as a result of this investment, she said the firm is “strengthening [its] internal human resources to ensure there will be qualified staff who can handle ADC production as well as related quality control and assurance procedures.”

Like fellow Bioppharma firms Pfizer, AbbVie, Genentech and GSK, Daiichi Sankyo licenses its conjugation technology from Seattle Genetics.

The key components of Seattle Genetics’ technology are the stable linkers, which the firm says showed up ten times more stable in blood than conventional means of attaching drugs to antibodies in preclinical studies, and the synthetic cytotoxic agents.

The technology is used in the US FDA approved ADC Adcetris, developed in partnership with Takeda. The only other ADC available on the market is Roche/Genentech’s Kadcyla, which uses conjugation technology licensed from ImmunoGen.

Sorrento Therapeutics Completes GMP Manufacturing Plant in Suzhou

Sorrento Therapeutics announced its subsidiary, Levena Biopharma completed construction and put into operation a 25,000 square foot Good Manufacturing Practice (GMP) manufacturing facility in Suzhou, China. The facility will be dedicated to supporting Sorrento's antibody drug conjugate (ADC) pipeline.

Sorrento currently has a dozen pre-clinical cancer focused ADCs partnered with biopharmaceutical companies worldwide, under the Levena brand. These partnerships have ADC candidates at various stages of development, including a HER2-targeting ADC which has an expected IND filing with the China Food and Drug Administration (CFDA) in 2017. Sorrento expects to receive service revenue and royalties on its partnered ADC programs. Additionally, Sorrento is advancing two proprietary anti-cancer ADC product candidates into IND enabling studies, including its proprietary anti-CD38 ADC and an anti-c-MET ADC. Both proprietary anti-cancer ADC programs were generated from Sorrento's fully human GMAB library and leverage on Levena's proprietary site-specific conjugation chemistry (K-Lock and C-Lock) and proprietary novel toxin payloads.

"ADC process development and manufacturing has historically been challenging to the industry as it requires a high level of technical expertise and specific know how,” Dr. Henry Ji, President and CEO of Sorrento. “Our new plant has been designed to provide full analytical support capabilities, GMP production of toxin-linkers based on our proprietary technology and methods, as well as GMP-grade bioconjugation of the antibody to produce ADCs. The launch of this state of the art plant, in addition to our existing ADC research sites in Nanjing, China and San Diego, demonstrates Sorrento's commitment to our ADC pharmaceutical partners as well as ensures a consistent supply for our own ADC franchise which is nearing the clinic."

PCI begins Move-In Phase of European Clinical Site Expansion

PCI Clinical Services (PCI) has begun to move into its expanded Clinical Services Center of Excellence at Bridgend, UK.

The new storage and distribution facility will provide PCI with a substantial addition of space, complementing its existing footprint currently utilized for specialist clinical trial logistics as well as packaging, labeling and qualified person activities for investigational medicinal products.

Full completion is scheduled for September 2017, with the facility set to be validated and operational by January 2018.

The latest addition to PCI’s Clinical Services Center of Excellence provides a modern, high-spec unit with warehouse and office space across two floors, purpose-built to support PCI’s specialist secondary packaging, storage and logistical needs. It also provides scope for further expansion in the future with an option for a further addition to the new building – reinforcing PCI’s strategy for continued growth and its ongoing commitment to investing in its Clinical Services provision.

Once operational, the new facility will give PCI the opportunity to offer its capability and expertise in supporting temperature-sensitive therapies, including cold chain and ultra cold chain, at temperatures ranging from controlled ambient 15-25°C, 2-8°C, down to -20°C, -30°C -40°C, -60°C to -90°C and including liquid nitrogen vapor phase storage below -150°C for advanced therapeutic medicinal products (ATMPs), as well as bespoke refrigerated and frozen temperatures according to client needs.

“We are seeing growing global demand for temperature-controlled packaging and labeling services for many therapeutic categories and drug delivery forms, particularly for growth in biologics as well as the exciting advances in cell and gene therapy,” said Fiona Withey, managing director, UK Clinical Services, PCI. “Our latest investment at Bridgend allows us to continue to provide extensive resources and capacity to meet the changing needs of our clients, providing extra, highly specialized infrastructure for their products and ensuring a safe, secure supply chain to expedite the development of their life-saving medicines for patients around the world.”

Parker Domnick Hunter Starts UK Production

In March, international bioprocessing solutions provider Parker Domnick Hunter – a division of the Parker Hannifin Corporation and a specialist in motion and control technologies – strengthened its European operation by enhancing its manufacturing capabilities at its Birtley, UK site. The facility will now manufacture the company’s automated systems, complementing existing production at its site in Oxnard, California.

This is the first time that Parker Domnick Hunter – which designs, supplies and delivers single-use systems for pharmaceutical and biopharmaceutical manufacturing – has manufactured automated systems in the UK. The move will enable European markets to be serviced more effectively, shortening the supply chain and making it easier for users to access automated systems and receive specialist technical support.

Offering the ability to manufacture automated systems from dual sites in the UK and USA will also provide additional assurance to customers and aid in their business continuity planning.

The division will manufacture a wide range of automated systems to European standards at the Birtley site, including the SciLog Filter and Dispense System, designed for bulk drug filter and dispense, the SciLog SciPure System, aGMP-ready system for tangential flow or normal flow filtration applications and the SciLog SciFlex System, which is used for tangential flow and normal flow filtration applications, from discovery to pilot-scale production.

Additional fabrication of stainless steel products used in the automated systems will be carried out at Parker Domnick Hunter’s fabrication unit in nearby Boldon, enabling the company to control more of the supply chain.

The news follows last year’s announcement about the installation of a new ISO Class 7 cleanroom at the Birtley premises which facilitated the production of single-use manifolds incorporating tubing, bioprocess containers, filters, sensors and other components for use in the bioprocessing industry.

Graeme Proctor, product manager, single-use technologies at Parker Domnick Hunter, said: “Our automated systems have been designed to improve process control and consistency, decrease batch turnaround times and increase operational flexibility, and we’re delighted to announce that they will now be manufactured in the UK as well as in California.”

He added: “By bringing the manufacturing of our automated systems to the doorstep of our European customers, we will simplify project management and delivery enabling us to provide solutions to biopharmaceutical producers more quickly and efficiently. This, in turn, will help companies have more confidence in their own operational integrity."

Lilly’s Bioproduction Expansion

Eli Lilly has confirmed it will build a three-story biomanufacturing facility at its site in Kinsale.

U.S. drugmaker Eli Lilly sought permission from County Cork Council to construct a three-story facility housing an additional production line at its bioproduction site in Kinsale, Ireland back in October.

The firm confirmed the project has been approved, leading to a spike in jobs at the site.

“The site is expected to require up to 130 additional staff by 2020, and those manufacturing jobs will be a mix of operations and technical support staff,” said Lilly spokesman Ger Kenny.

He added a further 350 jobs will be required throughout the construction phase.

The confirmation comes three months after reports in both national and trade media saying the project had been placed on hold ahead of proposed changes to US tax laws will make pharmaceutical imports more expensive.

A Lilly spokeswoman at the time rebuffed this, telling us reports the investment had halted in response to the proposed changes were the result of “people writing what they want to write,” and the firm was yet to have made a decision on expanding the site.

While some media outlets have said the expansion will cost Lilly around €200m ($212m), Ger said the firm is “not confirming a figure for the investment at this point.”

Biosurfit Plans Diagnostic Device Production Expansion in Portugal

In vitro point-of-care (PoC) diagnostics company, Biosurfit has drawn down a second €6m tranche from a €12m loan signed with the European Investment Bank in November 2015, to fund a move to industrial scale manufacturing and the rapid commercial roll-out of its spinit PoC device.

Commercially launched in 2014 by the Lisbon-based Biosurfit, Spinit provides fast, easy-to-use blood analysis for medical testing in the point-of-care setting.

Biosurfit will use the funds to support the ongoing commercialization of Spinit in key EMEA markets and to progress the regulatory approval processes in other new markets.

Together with additional Portuguese grants, the EIB funds will accelerate the company’s transition to industrial-scale manufacturing through the construction and commission of a manufacturing facility in Azambuja, approximately 50km from Lisbon. The 48,420 sq. ft. (4,500m2) facility with an ISO Class 7 cleanroom, will be modular in design to allow for rapid construction and flexibility for future expansion. Initially, it will include 26,900 sq. ft. (2,500m²) of space for automated manufacturing of Spinit instruments and disposable discs and 10,760 sq. ft. (1,000m²) of R&D lab space.

João Garcia da Fonseca, CEO of Biosurfit, said: “We are very pleased with the high level of customer interest in, and take-up, of the Spinit device. This, and the expected launch of our new lipids and inflammation panels during 2017, necessitates us upgrading our manufacturing capacity. The EIB funds will support the construction and commissioning of this facility and our continued commercial roll-out in both existing and new markets, including the USA and Asia, following the necessary regulatory approval.”

Biosurfit’s investment program is supported by “InnovFin – EU Finance for Innovators” MidCap Growth Finance, with the financial backing of the European Union under Horizon 2020 Financial Instruments. InnovFin is a range of EIB Group products designed to facilitate access to finance for innovative businesses.

Glenmark Production Line Expansion at Swiss Plant

A second single-use production line could offer commercial-scale capacity for bispecific antibodies but Glenmark says it would need to scale-up further to support more traditional biologics.

Over the past ten years, Indian-based firm Glenmark Pharmaceuticals has increased its focus away from generic small molecules to proprietary biologics and in 2014 opened a plant in La Chaux-de-Fonds, Switzerland to support clinical monoclonal and bispecific antibody production.

The site houses a single-use production line at a 250L scale, but according to head of GMP Manufacturing Pascal Torregrossa a second suite based on the same processes but at a 1,000L scale is being considered among several ways to adapt current production capacity.

“The [current] maximum capacity is eight batches a year at 250L. This is not efficient to accommodate all [our pipeline needs] so we need to add a second line, to increase the scale,” he told delegates at the Bioprocessing International (BPI) European Summit in Amsterdam last month.

A 1,000L scale line, like the 250L, would be completely single-use in the upstream and comprised of around 70% single-use equipment in the downstream, he continued, and would add capacity for six batches a year.

Glenmark’s research pipeline consists of “traditional” monoclonal antibodies (its most advanced being GBR 830 for atopic dermatitis) and bispecific mAbs made using the firm’s BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform based on a stable CHO cell line using standard processes.

The dose range for the bispecific antibodies falls on the ng/kg range and so the amount of such product needed per year across its pipeline is in the gram scale, expected to increase to ten to hundreds of grams for commercial production.

Traditional mAbs, however, require doses measured in mg/kg and thus Glemark needs kilograms of clinical product per year rising significantly at a commercial scale.

“With the [two line] setup we will be able to accommodate all the clinical needs for the conventional mAbs and the bispecifics,” Torregrossa said. “But if you think about more conventional mAbs, we would need to produce 10-100kg of per year.”

As such the firm is considering its future commercial options. “We need to think about 5,000L, 10,000L scale – or multiple 2,000L if we want to stick with single-use.”

CORRECTION: The original article said that the 1,000L line was installed and awaiting Swiss Medic approval. The 1000L line has not been installed, Glenmark has since said, and such an expansion is one way it is considering scaling-up given its ability to handle a broad range of cell lines with different productivities. The site is also not licensed for commercial production.

Selexis’ Swiss Investment in Mammalian Cell Lines

Selexis SA has announced its cell line development laboratory will is open in Geneva, Switzerland.

The facility includes space for bioreactors for research and development (R&D) and for the production of small batches of pre- and early-clinical materials.

The development is a response to Selexis’ partners’ needs, and will triple the company’s capacity, said Selexis CEO Igor Fisch.

“There is a large, increased demand within the industry for biologics produced from mammalian cell lines,” said Fisch.

The company expects the market for mammalian cell line development services to reach $4.5bn (€4.1bn) by 2022.

Selexis’ partners’ projects include mAbs, novel antibodies and difficult-to-express proteins targeting indications ranging from cancer to HIV to auto-immune disorders, said Fisch.

The facility will conduct work for Selexis partners including Sanofi and Xencor.

The facility and office space will also accommodate new employees.

“The company has grown from three to more than 30 employees in a short time, so more working space is needed to accommodate the headcount growth,” Fisch told us.

The company plans to add at least 15 additional positions in the next four years.

Selexis currently has one commercial product in oncology, two in autoimmune, and 73 biologic programs in development ranging from cancer to blood disorders.

Thermo Fisher Collaborates to Establish Single-Use and Automation Site in China

Mab-Venture Biopharma has entered a collaboration to establish an antibody development and production plant in China incorporating Thermo Fisher’s single-use bioreactors and SmartFactory automated technology.

The deal, signed at the 2017 China & US Investment Cooperation and Communication Meeting held in Guangzhou, sees Mab-Venture and Thermo Fisher collaborate on an engineering technology showcase and service center at the Guangzhou International Bio Island, offering local and international biotech firms antibody development and manufacturing services.

“China’s biomanufacturing service requirements are rapidly expanding and evolving. Capacity is also expanding rapidly, however there are still only a few organizations that understand the requirements to support manufacturing for both domestic and global programs,” said Mab-Venture spokesman Matthew Minakowski.

“Many smaller virtual companies are also approaching development and require external support and many of the large domestic pharma have large pipelines that now require external technical support and capacity.”

He added an increased presence of foreign companies entering the China market from both other Asian countries (such as Korea and Singapore) and the US, driven in part by updated quality and CMO regulations, means there is high demand for third-parties within China with technical aspects and experience with Western regulatory authorities to high quality biologics for both China and global supply.

The Shanghai-based firm has a long history working with Thermo Fisher and uses its 250L single-use systems in its current facilities, said Minakowski, and the new site will use Thermo Fisher single-use bioreactor systems up to 2,000L in capacity.

It will also be the first facility in Asia Pacific to incorporate Thermo Fisher’s SmartFactory, an automated control platform for single-use systems aimed at integrating manufacturing (batch) information and optimizing resource utilization.

SmartFactory will “accelerate construction/set up and validation of the facility as well as continuous use once it is up and running,” Minakowski said. “The technology will allow us and Thermo to provide a cost-effective and high-quality service to partners without sacrificing any technical aspects in R&D.”

Financial details were not divulged but we were told as the agreement is a partnership there is some sharing in costs of building facility between the parties.

WuXi Using Thermo Fisher to Equip Site in China

A WuXi Biologics facility tipped to be the world’s largest single-use mammalian cell culture site will be equipped with disposable systems from Thermo Fisher.

Construction on the $150m (€138m) facility in Wuxi City, China, began in 2015, and the contract manufacturing organization (CMO) has said it will be the largest mammalian cell culture manufacturing site in the world based on disposable equipment when it opens this year.

And the planned 28,000L of bioreactor capacity is being supplied by Thermo Fisher through fourteen 2,000L single-use systems, Dirk Tillich – VP of Global Sales at Thermo Fisher Scientific owned company Finesse Solutions – told delegates at last month’s BPI European Summit in Amsterdam.

As well as the clinical and commercial scale vessels, Thermo Fisher has supplied ten single-use bioreactors as seed vessels at the site, along with glass vessels and perfusion equipment at an on-site plant which opened its doors last year as the first phase in the $150m project.

The WuXi plant – located about 100km west of Shanghai – will manufacture a recombinant soluble LAG-3 protein on behalf of Prima Biomed among the deals already announced by the CMO.

CARsgen Therapeutics Opens CAR T-Cell Manufacturing Facility in Shanghai

The facility features capabilities to manufacture vectors and CAR-T cells to support CARsgen clinical programs. Upon completion of its final inspections, the 33,000-square-foot facility is expected to become China's first CAR-T cell manufacturing platform that is in strict compliance with current good manufacturing procedure (cGMP) regulations of China Food and Drug Administration (CFDA).

"This facility marks a significant milestone of CARsgen as it embedded our leading expertise and insights into CAR-T cell manufacturing,” Dr. Zonghai Li, President and CEO of CARsgen said. “We have already developed a strong CAR-T portfolio for treatment of many solid tumors including liver cancer, lung cancer, gastric cancer, pancreatic cancer, etc."

Founded in 2014, the company completed B series of financing of $30M in early 2016. Two of its CAR-T cell therapies, anti-GPC3 CAR-T for hepatocellular carcinoma (HCC) and cancer-specific anti-EGFR CAR-T for glioblastoma multiforme (GBM) have entered clinical trials.

McIlvaine Company

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com