Pennsylvania-based Recro Pharma ($REPH) has picked up a new plant and jumped into the contract manufacturing business, while Irish drugmaker Alkermes ($ALKS) is now one plant shorter and out of the CMO biz.

The two companies announced in March that Recro would pay Alkermes $50 million in cash and up to $120 million in milestone payments, as well as royalties, to get a DEA-approved manufacturing facility in Gainesville, GA, as well as a number of pain drugs. Recro is a specialty drugmaker focused on developing nonopioid drugs for postoperative pain.

The low-double-digit royalties will come from Recro's commercialization of meloxicam IV/IM, a late-stage, parenteral formulation of a nonsteroidal anti-inflammatory drug that Recro acquired along with Alkermes' rights to pain drugs Ritalin LA, Focalin XR, Verelan, Zohydro ER and BiDil. The deal closed last month.

The 85,000-square-foot DEA-licensed facility has 165 employees and manufactures the 5 approved drugs that Recro is buying. Besides getting additional manufacturing capacity, the plant does contract work that brought in about $70 million worth of business last year, Recro said. Alkermes said in its Q1 report last week that the Gainesville facility and products that were included in the deal generated $19.2 million of revenue and $7.3 million of non-GAAP net income for Alkermes in the first quarter ahead of closing the deal.

Recro CEO Gerri Henwood said in the deal announcement that it not only gives the company a Phase III-ready acute pain product that complements its development portfolio but also "adds infrastructure and cash flow which may help fund the development of our pipeline in the future."

Math, Science, and Social Science Building (MS3), Evergreen Valley College, San Jose, CA

Cost: $37.2 million

Size: 68,000 sq. ft.

Project team: HMC Architects (architect of record), RFD (laboratory planner)

Description: Designed to replace aging existing facilities and develop a new south campus precinct away from the Evergreen Fault underlying the original chemistry and physical science building, the new structure for the Departments of Social Science and Math, Science, and Engineering provides a highly functional and attractive learning environment for this vibrant campus serving the San Jose region.

Consisting of laboratories, classrooms and offices on two levels, this facility is organized around wide central circulation spaces which provide amenities to support student and faculty collaboration such as comfortable seating, writing surfaces, great lighting, and views into laboratories, classrooms and displays. Floor openings interconnecting these spaces bring daylight to the first level and provide a dynamic sense of openness.

The 13,941 sq. ft. of laboratory and laboratory support includes instructional facilities for Physics, Earth Science, General Chemistry and Organic Chemistry. The laboratory support spaces are positioned behind the instructional laboratories with direct access for highly efficient lab set-up and include Physics and Earth Science Prep and Storage, Rock Prep, Balance Room, Chemistry Instrument Room, Chemistry Prep and Storage, Glassware Storage and Chemical Storage. Four classrooms are sized and located to allow conversion to laboratories in the future if growth dictates.

Completion date: 2016

Adare Pharmaceuticals Opens

Adare Pharmaceuticals, a private global specialty pharmaceutical company, celebrated the official opening of its Corporate Headquarters located at 1200 Lenox Drive in Lawrenceville, New Jersey.

“We are very excited to officially open our corporate office. It is another milestone in the growth of our Company. The Lawrenceville location allows us to tap into the wealth of pharmaceutical talent in the New Jersey / Pennsylvania region and accelerates our strategic growth plans. We are appreciative of the support that we have received from the State of New Jersey through the Grow New Jersey program in the establishment of our new offices.” said John Fraher, CEO.

Building on a foundation of innovation, Adare has a strong growth trajectory through expansion of its marketed product portfolio, internal pipeline, and expertise in adding value to existing molecules. Adare has more than 40 products incorporating its proprietary technologies that are commercialized around the world.

BD Upgrades Nebraska Insulin Syringe Plant

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

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

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

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

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

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

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

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

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

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

Cambrex API Facility Expansion, Charles City, IA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

WuXi AppTec Manufacturing Center for Cutting Edge Cell and Gene Therapies

WuXi AppTec (WuXi), a leading pharmaceutical, biotechnology, and medical device technology platform company, celebrated the grand opening of their new 150,000-square-foot biomanufacturing facility in an event attended by Pennsylvania Lieutenant Governor Mike Stack and WuXi AppTec Chairman and Chief Executive Officer, Dr. Ge Li. The new facility is WuXi AppTec's third facility in the Philadelphia Navy Yard. When fully configured, the facility could employ an additional 200 manufacturing and support staff.

"The expansion by WuXi AppTec continues the growth of the Philadelphia Navy Yard as a hub for biotechnology and cell and gene therapy. It means workers in STEM fields will have more employment opportunities here. The commitment shown by a global pharmaceutical and biomanufacturing firms such as WuXi also demonstrates that Philadelphia and Pennsylvania are good places for science and technology firms to do business. We look forward to working with WuXi on future expansions," said Lieutenant Governor Mike Stack.

This facility is designed for cell therapy products that utilize viral vectors such as chimeric antigen receptor T cell (CAR T cell) therapies. In addition, the facility will permit expansion of viral vector manufacturing to support gene therapy clinical and commercial programs and will permit large scale production in 2,000L single-use bioreactors.

The new facility will supplement WuXi's existing 20,000-square-foot cGMP cell therapy manufacturing facility, as well as a 50,000-square-foot facility for the commercial manufacturing of allogeneic and autologous cell-based therapeutics. WuXi's 220,000 square feet of total manufacturing capacity in the U.S. expands its ability to be a single-source for process development, clinical and commercial cGMP manufacturing, and analytical testing to support the rapidly growing cellular therapeutic and gene therapy industry's unique requirements.

"Advanced therapies like CAR T-cells and gene therapy vectors offer significant new therapeutic options for cancer patients and those suffering from crippling genetic diseases. We are pleased to be at the forefront of this field, providing our partners with cutting-edge cGMP manufacturing capabilities and capacities," said Dr. Ge Li, Chairman and CEO of WuXi AppTec.

"We are proud to be an integral part of the biotech hub in the Navy Yard and an important center for the manufacturing of cell and gene therapies here in Philadelphia. With the capacity and capabilities we now have available, we can provide the integrated clinical and commercial manufacturing solutions needed by our cell and gene therapy customers," said Felix Hsu, Senior Vice President of WuXi AppTec's US Business Unit.

Medical Murray Adds Cleanroom Space in Two Facilities

Medical Murray, a device development and contract manufacturing company with ISO 13485 certification and FDA registration, has expanded cleanroom capabilities in their Illinois manufacturing facility and North Carolina location.

The additions come less than a year after Medical Murray purchased their Lake Zurich, Ill., 44,000 square-foot manufacturing facility, and built a larger 10,000 square-foot facility (doubling footprint) in Charlotte.

The new Lake Zurich cleanroom space is an extension of Medical Murray’s current capabilities focusing on general assembly and inspection of class II and III medical devices. Clean room space further incorporates molding, pad printing, laser welding, braiding and packaging.

”We are excited about the new cleanroom and look forward to adding more employees and work spaces due to the tremendous amount of transfers from development that are currently taking place,” said Paul Imaoka, VP of operations. “We also expect to add more automation including molding and braiding machines as our business continues to grow.”

Medical Murray’s N.C. facility has also experienced tremendous growth, and it has expanded its cleanroom services to include mid-level manufacturing in addition to general assembly, advanced packaging and logistics.

In addition to expanding their cleanroom services, Medical Murray continues to strengthen their overall design, development and manufacturing services to their customers in North America and globally. The company’s mission is to continue to build strong partnerships by responding quickly to customer requirements in a concise, proactive manner during all phases of complex development processes.

MedPharm Opens US Facility in Research Triangle

Dr. Andrew Muddle, Cofounder and CEO of MedPharm, said the company wanted to give “an even better service” to its customers.

Currently, he explained more than 50% of the company’s business revenue is from US-based clients.

“With the new labs we believe this percentage will increase,” he said, adding that MedPharm has seen the most demand from large and small dermatology companies.

“Significant contracts are being negotiated which are validating our decision to open US laboratory facilities,” Muddle said.

The new facility will offer performance testing for topical and transdermal products. Specifically, performance testing including skin (and other mucus membranes) penetration studies and biological testing on dermatology skin disease models, Muddle explained.

Lonza Expands in Texas

The cell and gene therapy plant Lonza is building in Pearland, Texas will be bigger than originally planned to according to the city’s economic development corporation.

When Lonza started work on the facility this year its intention was to create a 100,000 square foot plant at which it will produce commercial quantities of viral gene and cell therapies.

The Swiss firm committed to add an additional 150,000 square feet of manufacturing space at the site according to an announcement by the Pearland Economic Development Corporation. The facility is scheduled to open at the end of 2017.

The decision follows a few months after Lonza was contracted by Bluebird Bio to manufacture its Lenti-D and LentiGlobin products at the facility.

At the time, company spokesman Dirk Oehlers said the deal was a further indication of growing demand for the type of specialist contract manufacturing skills needed to make cell and gene therapies.

News of the plant expansion also follows just a few weeks after Lonza licensed rights to synthetic adeno-associated viral (AAV) vectors and associated production technologies from US hearing research center, Massachusetts Eye and Ear.

Luk Vandenberghe, from Massachusetts Eye and Ear, said the tech – which Lonza will use at Pearland - is used to “optimize AAVs for therapeutic gene transfer applications on clinically relevant parameters including host immunity, production yields, tissue targeting and specificity.”

“The benefit of this approach is that it enables rationally informed design of therapeutic gene transfer vectors to address aspects important to safety and efficacy. “

Moderna to Build Facility in Norwood, MA

Moderna Therapeutics, a clinical stage biotechnology company pioneering messenger RNA (mRNA) Therapeutics™ to create a new generation of transformative medicines for patients, announced that it has signed a long-term lease (15 years plus renewal options) to build a state-of-the-art Good Manufacturing Practices (GMP) clinical manufacturing facility in Norwood, MA.

Moderna is committed to developing a broad array of medicines leveraging its leading mRNA platform, and to delivering on the promise of mRNA science for patients as quickly as possible. Moderna and its partners are simultaneously advancing mRNA drugs for many diseases toward the clinic, and the company anticipates conducting many clinical studies across its portfolio in parallel.

To support and manage this anticipated breadth of clinical studies, Moderna’s 200,000 square foot Norwood facility will enable the manufacture, quality, control and supply of clinical grade mRNA therapies and vaccines for Good Laboratory Practices (GLP) toxicology studies as well as Phase 1 and Phase 2 clinical studies. At the site, Moderna will carry out all manufacturing activities—from raw material production to active pharmaceutical ingredients (APIs), formulation, filling and finish. Moderna will begin initial build-out of the new facility in October 2016. The company plans to open the facility by early 2018.

“We are thrilled to announce the site selection for our GMP manufacturing facility, as this is a critical component of the early development engine we are building to advance many mRNA programs in parallel in human clinical studies,” said Stéphane Bancel, CEO of Moderna. “With our development pipeline expanding, we need to scale up from our current Cambridge-based GMP clinical supply manufacturing facility. Our Norwood facility will enable us to deliver our mRNA therapies and vaccines quickly, which will support rapid progression from development candidate nomination to human proof-of-concept. I’m very grateful to our team and our partners for enabling us to progress to this exciting next phase in Moderna’s history. With the addition of this new facility, we are moving a significant step closer to delivering novel mRNA medicines for patients.”

Moderna’s Norwood clinical supply facility will host GMP manufacturing and quality control; the company’s Personalized Cancer Vaccines unit; preclinical technical operations and testing; and general administrative functions to support these teams. At the facility’s opening, the annual GMP manufacturing capacity will be 40 GMP mRNA lots and is expected to scale up to over 100 GMP mRNA clinical scale lots annually in the future. Approximately 100 of Moderna’s current 460 team members will move from the company’s three existing locations in Cambridge, Mass., to the Norwood facility. In addition, Moderna plans to hire more than 100 new employees for the Norwood site.

“With the addition of this facility, we are pleased to expand our presence as a driver of innovation in Massachusetts. We appreciate the support we’ve received at both the state and local levels, and we look forward to creating new jobs and continuing to contribute to the life sciences community and the economy here in Massachusetts,” said Mr. Bancel.

“This is quite an ambitious project and will result in a truly unique facility,” said Steve Harbin, Senior Vice President, Manufacturing and Operations. “We are designing the Norwood site to accommodate a broad range of GMP manufacturing needs that reflect the diversity of our pipeline—from small-scale, rapid cycle-time manufacturing of personalized cancer vaccines to larger scale Phase 2 clinical study supply across a number of therapeutic areas. This will be among the most integrated end-to-end process facilities I have built and seen in my 25 years working in the pharmaceutical industry.”

In addition to the Norwood facility, other key components of Moderna’s early development engine include its collaborations with leading research organizations Charles River Laboratories, to support GLP toxicology studies, and Pharmaceutical Product Development, LLC (PPD) to support Phase 1 and Phase 2 studies. The company is also building a highly automated and digital enterprise to seamlessly integrate and orchestrate cloud-based IT systems to manage and industrialize the complex planning and execution of its mRNA pipeline scale-up at every stage of development. In addition, Moderna has amassed deep institutional expertise in the U.S. and global regulatory landscape. The ability to share and apply learnings from ongoing regulatory interactions across its ecosystem of internal therapeutically focused ventures and external partners generates a network effect that benefits Moderna and its partners, helping to advance programs through regulatory processes.

Construction Finished on the World’s Largest Forensic Anthropology Lab

The lab’s main purpose will be to help in the investigation, recovery, and accounting of Americans lost in past wars.

A new 136,497-sf building in Oahu, Hawaii has become the largest forensic anthropology lab in the world. Designed by SmithGroupJJR, the Defense POW/MIA Accounting Agency’s (DPAA) new Forensic Identification Laboratory combines operations that were previously dispersed across three military locations.

By combining these operations into one facility efficiency, productivity, and support of the DPAA mission, which is to “provide the fullest possible accounting for missing personnel to their families and the nation,” are all greatly improved.

The building has advanced investigation laboratories, a flexible and sustainable working environment for staff, and appropriate spaces for the families of the deceased. The primary laboratory space includes the DPAA Laboratory, the Material Evidence and Life Support Investigation Lab, a DNA lab, and a complete forensic medicine facility.

The DPAA Laboratory space is on the third floor of the building and includes 70 examination tables. Half of the floor is dedicated to lab space while the other half consists of a family viewing room, offices, and administrative spaces. The DPAA Laboratory conforms to Biological Safety Level Two.

The Forensic Identification Laboratory’s design is meant as an homage to the Hickam Air Force Base (now known as Joint Base Pearl Harbor-Hickam). The uniquely Hawaiian structure features structural concrete and pre-cast concrete panels that are fashioned with an abstracted Hawaiian pattern, a three-story garden space, and a craftsman-like shade trellis that welcomes visitors.

SmithGroupJJR also acted as the MEP engineer and laboratory planner and programmer.

Architecture Conservation Efforts Begin at Salk Institute of Biological Studies

After three years of research, the Getty Conservation Institute (GCI) announced construction work is underway to conserve key architectural elements of the Salk Institute for Biological Studies in La Jolla, California. Designed by famed architect Louis Kahn and completed in 1965, the site is widely considered to be a masterpiece of modern architecture.

Dr. Jonas Salk, the developer of the polio vaccine, commissioned Kahn to design the campus for his new scientific research institute on a coastal bluff in La Jolla, just north of San Diego. Kahn worked closely with Salk on the design of the building, which houses laboratories and other research facilities.

But fifty years of exposure in a marine environment has caused the institute’s distinct teak window walls, set within the monolithic concrete walls of the site’s study towers and offices, to weather and deteriorate in a non-uniform manner. The construction work, designed by Wiss, Janney, Elstner Associates, Inc. will address these issues. Getty-led research and funding launched in 2013 as part of the GCI’s Conserving Modern Architecture Initiative (CMAI) helped to initiate the current construction work.

The 203 teak window walls are significant elements of the overall site, expressing a human element and scale within the monumental structure. Although prefabricated, each window has a handcrafted quality due to the detailing of the teak wood by carpenters and customization to fit many sized openings. Each offers a different combination of sliding windows, louvers, and shutters, allowing staff to control light and air in their workspaces.

Research found that the window walls suffered from surface erosion, the growth of a fungal biofilm (likely spread by nearby eucalyptus trees) that gave the wood a black appearance that varied significantly by exposure, changes to teak color due to previously applied sealers and finishes, insect infestation, and moisture infiltration due to the omission of flashings and weather stripping and the failure of sealants.

The GCI and its consultants engaged in historical research, including visits to the Khan archives and collecting oral histories, in order to better understand the significance of the window walls and Kahn’s original vision for the site. It explored the extent of damage to the window walls and performed physical and laboratory analysis to identify materials used and various causes of damage and deterioration. The GCI also convened a meeting of Salk representatives, other Kahn building owners with similar wood conservation issues, and preservation professionals. Possible treatments for the wood and wood replacement options were also researched, as well as design modifications to improve the overall performance of the assemblies. Finally, the GCI, along with the architectural and engineering firm Wiss, Janney, Elstner Associates, Inc. (WJE), which served as the historic preservation consultant to the Salk Institute, developed a series of on-site trial mock-ups to evaluate different repair approaches and treatments to identify the most appropriate ways to move forward.

WJE has developed comprehensive construction documents to implement the repair and conservation of the window walls, with interventions ranging from minor (cleaning and repair), to moderate (cleaning, repair, and some replacement of materials), to major (removal of the entire window assembly where severely deteriorated and replacement using like-for-like materials). At this time, WJE is currently implementing the repair work, which is expected to be completed in 2017.

University of Nebraska Biological Process Development Facility

The Biological Process Development Facility (BPDF) at the University of Nebraska offers biopharmaceutical process development for technology transfer from bench to large-scale GMP manufacturing. The services range from microbial strain construction and Master Cell Bank development to production of multiple gram quantities of purified Bulk Drug Substances.

Current clients include government, academia, industry, and philanthropic organizations.

Specializing in recombinant peptides and proteins, the facility has produced GMP materials since 1998.

The 20,000 sq. ft. facility houses more than 6000 sq. ft. of Classified cleanroom space for GMP production The facility has equipment for high cell density bacterial and yeast production of secreted or intracellular products at volumes ranging from 1 to 150 liters. Dedicated utilities include a pure steam generator, water for injection condenser and quality control and stability testing services.

Capsugel Announces Expansion at Quakertown Facility

Capsugel announced that it will be expanding its Quakertown, PA facility to meet demand for micronization services for clinical and commercial manufacturing. The expansion will double the size of its current pilot-scale capacity for clinical-trial quantities and increase the number of suites for commercial manufacturing.

The Quakertown facility, which Capsugel acquired as part of its purchase of Xcelience and Powdersize in January 2016, operates as a full-service provider of particle-size reduction and particle-size control/classification technologies for pharmaceutical customers. The acquisition expanded the company’s suite of bioavailability tools aimed at improving the bioavailability of APIs with either dissolution or solubility challenges. In addition to enabling increased capacity, the added suites will include single-use containment technologies to accommodate potent and highly potent compounds. The new equipment and suites are scheduled to be operational by January 2017.

REST OF WORLD

GSK Announces New Investment in UK

Total of £275 million to be invested in sites at Barnard Castle, Co. Durham; Montrose, Scotland; and Ware, Hertfordshire.

Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio.

GSK announced £275 million of new investments at three of its manufacturing sites in the UK to boost production and support delivery of its latest innovative respiratory and large molecule biological medicines. The vast majority of these products will be for export to global markets.

GSK has a significant manufacturing presence in the UK, with nine sites employing approximately 6,000 people. The company views the UK as an attractive location for investment in advanced manufacturing due to a number of factors including the skilled workforce, technological and scientific capabilities & infrastructure and a competitive corporate tax system. This includes the Patent Box, which encourages investment in R&D and related manufacturing in the UK by delivering a lower rate of corporation tax on profits generated from UK-owned intellectual property.

Andrew Witty, CEO, GSK said, ‘Today’s announcement reflects further investment to support our pharmaceutical pipeline and meet growing demand for our innovative portfolio of newly launched products. It is testament to our skilled UK workforce and the country’s leading position in life sciences that we are making these investments in advanced manufacturing here. From their manufacture in the UK, many of these medicines will be sent to patients around the world.’

The investment announced is split across three UK sites:

Barnard Castle in County Durham is one of GSK’s biggest secondary manufacturing sites, employing 1,100 people. The site supplies nearly half a million packs of products per day to 140 global markets. The investment of £92 million will fund the construction of an aseptic sterile facility supporting the manufacture of existing and new biopharmaceutical assets in our pipeline.
Montrose in Angus in Scotland manufactures active ingredients for respiratory, HIV and vaccine products and employs over 450 staff. This investment of approximately £110 million will provide a new, state-of-the-art facility for the manufacture of respiratory active ingredients.
Ware in Hertfordshire, employs 1200 staff, manufacturing innovative respiratory products. The investment of £74 million will support further expansion of the company’s new Ellipta respiratory inhaler through additional manufacturing capacity at the site.

In addition to jobs associated with the construction of the new facilities, the announcement will support current employment at these three sites and is expected to lead to the creation of new employment opportunities.

PCI Pharma Services has Expansion Program at its Site in Tredegar, South Wales.

Pharmaceutical outsourcing provider PCI Pharma Services has announced a footprint expansion program at its site in Tredegar, South Wales. This latest expansion demonstrates continued investment in PCI Pharma Services’ Tredegar facility.

This most recent expansion program in July of this year saw PCI Pharma Services acquire a further 26,500 square feet of additional footprint at Unit 6 Tafarnaubach Industrial Estate in Tredegar. This represented a continued expansion of its operations as a fully integrated service provider for the global healthcare industry. The new site will house a number of key departments to support the continued business growth, including offices and laboratories.

The Tredegar site expanded its capabilities in 2013 with the opening of a dedicated Contained Manufacturing Facility (CMF), specifically designed and built to enable the specialist processing of highly potent molecules into tablets and capsules utilizing contained technology. This investment resulted in global industry recognition when the site was awarded ISPE Facility of the Year in 2014, a highly prestigious award.

In 2014, PCI acquired Penn Pharma, adding drug manufacturing capability to its portfolio of services and PCI has continued its substantial investment in this specialization. The site undertook a further investment program increasing capacity of large scale commercial manufacturing capabilities by means of a single pot granulation process. In 2015, the site added additional granulation capabilities in the form of roller compaction technology providing a granulation technique for those products sensitive to heat and moisture. The Gerteis MiniPactor is also fully contained technology, further complimenting the site specialization for the development and manufacturing of highly potent molecules. 2016 saw continued investment in the form of contained Xcelodose^® technology, providing a cost- and time-effective option for first in man studies.

Norman Barras, Managing Director, PCI Pharma Services Tredegar, commented: “I am delighted that we are continuing to grow and expand as a site. This additional footprint will ensure that we are even more able to meet the growth demands of our business and deliver excellence to each and every customer.”

Barras continued: “The site has benefited from significant investment over the last five or so years, delivering a center of excellence for manufacturing and uniquely positioning PCI Pharma Services within the global market place. This next phase of investment will help deliver a center of excellence for analytical services.”

Ken Richardson, Global Vice President, Engineering, PCI Pharma Services added: “With world-leading capabilities for the development and manufacturing of pharmaceutical products, this investment in and expansion of the Tredegar site will ensure that we continue to provide a truly integrated full-service solution to our clients. This additional footprint will assist in securing the growth potential for PCI Pharma Services moving forward.”

Alvotech Opens mAbs Biosimilar Facility in Iceland

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Alvotech opened a new biologics manufacturing plant dedicated to the development and manufacturing of biosimilar monoclonal antibodies (mAbs), the company announced on June 8, 2016. The facility opening marks a significant milestone for Alvotech, an independent sister company of the global pharmaceuticals company Alvogen.

Alvotech worked with the US FDA and the European Medicine Agency to design and build the 139,880 sq. ft. (13,000-m2) facility, which is located in the science park of the University of Iceland in Reykjavik. The manufacturing process is based on 1000-L and 2000-L single-use bioreactor fermentation design and has a total capacity of 16,000 L laid out in two independent up- and downstream areas. The facility also houses fully automated vial and syringe filling capabilities and quality control laboratories.

“We have 8000 L in place (four, 1000-L and two, 2000-L tanks) and are ramping up in the near future to keep up with demand,” says Eef Schimmelpennink, CEO of Alovtech. “Manufacturing for development and tech transfer has started, and commercial production will be in line with demand driven by loss of exclusivity of products in our portfolio.” Alvotech’s initial pipeline comprises six biosimilar mAbs which will be brought to market after patents expire.

The facility uses the SmartFactory platform from Finesse, a California-based manufacturer of measurement and control solutions for life-sciences process applications. The process control, batch automation, and data management platform features an open architecture with universal controllers. Process flow can be designed in a modular and scalable manner while maintaining quality and regulatory compliance in electronic batch records. The flexibility of the SmartFactory lets a user select the level of automation required for each unit operation. Users can also focus simultaneously on the compatibility of single-use materials between upstream and downstream for global process yield optimization, according to a Finesse press release.

German Merck Opens M-Lab Center in Korea

As it looks to boost its presence in East Asia, and its R&D capacity, German Merck says it has launched its “M Lab Collaboration Center” in the Songdo district of Incheon, Korea--a burgeoning biotech hub in Asia.

This new Center was unveiled (but how much it costs was not) and starts off with 20,067 sq, ft, (1,865 square meters) of space and around 10 scientists and engineers, with the plan to rub shoulders with other major Asian players in the region--such as Samsung Biologics.

In a statement, Merck said its new digs were designed to allow: “Biopharmaceutical manufacturers with a shared, exploratory environment where they can closely collaborate with Merck scientists and engineers to solve their toughest challenges and accelerate development and production of new therapies.”

The Center will include a simulated manufacturing environment and offer full end-to-end process development support, the pharma said, while also seeking to serve local biopharma manufacturers.

Udit Batra, member of the Merck executive board and CEO of its Life Science unit, said: “With a rapidly growing biopharmaceutical industry in Korea and demand for novel and cost-effective therapies worldwide, there is a clear need for innovative concepts like our M Lab Collaboration Centers.

“At our new center in Incheon, our customers will benefit from our deep technical expertise to develop processes for manufacturing drugs faster, safer and more effectively than ever before.”

The German-based company, which also has a hand in other engineering and tech work outside of life sciences, has had its share of ups and downs in the drug research space--with one of its biggest setbacks coming five years ago when its MS hope Movectro (cladribine) was knocked back by the FDA after it asked for extra studies.

It had been approved in Australia and Russia in 2010, but it later pulled its applications in other regions, including Europe. Last year, however, the company said the EMA has accepted for review its med for a certain form of MS.

In 2015 Merck also said it would no longer seek approval for its solid tumor candidate evofosfamide after two Phase III trials failed to show efficacy. It also canceled its Stimuvax cancer vaccine program after it too failed to show it worked in lung cancer patients.

These problems have led to CEO Karl-Ludwig Kley betting big on the company’s $17 billion acquisition of chemical firm Sigma-Aldrich to reduce Merck’s dependence on its marketed meds, coming after a decade of failing to develop a new drug and bring it to market.

Following the same philosophy, it also bought Millipore, a U.S. maker of lab equipment and chemicals, for about $6 billion in 2010 and then added AZ Electronic Materials a few years later for $2.5 billion.

But it’s certainly not walking away from developing medicines and is ramping up its footprint in Asia-- In August 2014, it started construction on an €80 million (then $107.67 million) plant in the Greater Shanghai region, with a focus on production of diabetes drugs Glucophage, Concor and Euthyrox, as well as drugs for heart and thyroid conditions.

It’s also moving more deeply into biosimilars, announcing recent plans to invest €380 million ($494 million) in developing these copycat meds.

And perhaps most promising is its PD-L1 program, of which it has a near $1 billion partnership with Pfizer, as it looks to get in on the checkpoint inhibitor blockbuster space.

Eurofins Genomics Opens DNA Sequencing Facility in Toronto, ON, Canada

Eurofins MWG Operon LLC., a Eurofins Genomics company, one of the world leaders in genomics products and services, announces the launch of a new DNA sequencing Laboratory in Toronto, Ontario, CA. This new sequencing facility will provide fast, high-quality DNA sequencing services using the Sanger method to researchers all over Canada.

Overnight Sequencing is one of Eurofins Genomics' signature services and has generated rapid growth and expansion in the US market. With the new Toronto-based laboratory, Eurofins' will replicate the same model of success and speed. "This new DNA sequencing lab in Toronto is launched to directly address the growing needs of the scientific community in Canada. Through this new lab, we remain committed to delivering overnight DNA sequencing services, which our customers in the United States now enjoy, to researchers in the greater Toronto area and elsewhere in Canada," said Martin Kunz, President of Eurofins MWG Operon LLC.

In addition to a full range of sequencing services, Canadians will receive bilingual support, both in English and French. "Researchers around the world know Eurofins Genomics as an American, European, or Asian company, but today, Eurofins Genomics is proud to be Canadian,” said Benjamin Senior, Manager, DNA Sequencing Business Unit

Cambrex Opens Pilot Plant at Milan, Italy Site

Cambrex Corporation (NYSE: CBM) the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), announced the validation and ISO certification of a new pilot plant at its state-of-the-art manufacturing and R&D site in Paullo (MI), Italy.

The cGMP plant, which can produce batch sizes from 1kg to 15kg, was constructed in order to meet customer demand for small-scale API volumes, both for validation to support a DMF filing for Abbreviated New Drug Applications or generic registrations, and for API supply to niche markets, including ophthalmic drugs. The new facility will also provide custom manufacturing of NCEs and intermediates for early stage drug development and clinical trials.

“We currently have a product portfolio comprising over 70 generic APIs, which are manufactured under cGMP, for the global generic pharmaceutical industry,” commented Aldo Magnini, Managing Director, Cambrex Milan. “We have invested in the pilot plant to expand our small-scale volume offering for customers worldwide and to give us greater speed, flexibility and capacity in this market space.”

The new facility is equipped with a hydrogenator that can operate at 30 Bar and two separate lines of 150 liter glass lined and stainless steel reactors. ISO 8 classified, the plant is also equipped with a static dryer, milling and micronization capabilities.

Cambrex plans a further upgrade of the pilot plant in 2017 to support production of Class 3/4 high potency products.

GE Healthcare Bio Park, Cork, Ireland

Global healthcare service provider GE Healthcare has announced plans to invest $170m in the development of a new biopharmaceutical campus in Cork Country, Ireland. The proposed project aims to meet the increasing demand for biopharmaceuticals, while providing cost-efficient technology to drug developers.

Construction of the facility is expected to commence in mid-2017 after receiving the necessary contract and planning approvals, while completion is scheduled for late-2018.

The project is expected to generate 800 jobs during construction and another 400 after completion. It is being supported by Ireland's Department of Jobs, Enterprise and Innovation through the Industrial Development Agency (IDA) of Ireland.

Once operational, the bio park will be Europe's first campus to be owned and operated by GE.

The bio park is proposed to be built on a site owned by IDA at Loughbeg, Ringaskiddy, Cork County, Ireland.

Being one of the world's top pharmaceutical locations, Ireland is attracting more biotech investments into the country with the help of IDA Ireland. The country has already witnessed investments of more than €10bn in the past ten years from companies such as Pfizer, Sanofi, Alexion, MSD and Allergan.

The new bio park will act as a catalyst by helping IDA in attracting more investments into Ireland.

The bio park will house four of GE's trademarked prefabricated single-use modules called KUBio. The facilities will be owned and operated by independent biopharmaceutical companies. GE will provide all the companies in the campus with infrastructural facilities and shared utilities.

GE's KUBio modules are ready-to-operate, cGMP-compliant facilities that help biopharmaceutical manufacturers to quickly develop and manufacture their products and bring them into the market to meet the growing demand for biological medicines.

The KUBio modules can be configured to use GE's FlexFactory single-use bioprocessing technology or hybrid processing technology depending upon the needs of manufacturing. The modules are equipped with heating, ventilating and air conditioning systems along with all the necessary piping facilities.

The pre-fabricated factories are 25-50% cost-effective and can be built within 14-18 months when compared to traditional manufacturing plants, which take roughly three years. KUBio facilities also reduce water and energy usage by 80% and carbon emissions by 75% when compared to the traditional facilities.

Biological medicines have emerged as a more effective and targeted treatment for smaller sets of patients and their demand is growing exponentially. Bringing new biological treatments quickly into the market poses a number challenge to pharmaceutical companies including cost pressure, which GE aims to address through the use of KUBio facilities.

GE has already established the world's first KUBio in May 2016 in Wuhan, China. In June 2016, Pfizer too announced its plans to install GE KUBio facilities at its new bio manufacturing center in Hangzhou, China.

Along with the development of the campus, GE has entered a partnership with National Institute for Bioprocessing Research and Training (NIBRT) to set up NIBRT-GE-Single use Center of Excellence at NIBRT's Dublin facility.

The center will facilitate trainings on innovative biological manufacturing technologies for approximately 1,500 professionals. GE expects the partnership with NIBRT to accelerate the introduction of new technologies into the biopharmaceutical industry, while reducing production costs. The company hopes to eventually employ these technologies at the Cork bio park.

CPI’s National Biologics Manufacturing Centre, Darlington, UK

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

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

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

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

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

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

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

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

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

Construction on the National Biologics Manufacturing Centre started in April 2014 and the facility was opened in September 2015. The £38m ($64m) design-and-build contract was awarded to Interserve Construction, a company based in Darlington, in March 2014.

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

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

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

Lonza Constructing Dedicated Suite

Lonza will construct a dedicated suite to produce commercial supply of rucaparib API on behalf of Clovis Oncology.

In February 2013, Lonza entered into a contract with Clovis to supply clinical supplies of its ovarian cancer candidate rucaparib.

But this latest agreement, announced by the Boulder, Colorado-headquartered biotech in an SEC filing, will see the Swiss CMO “construct, in an existing Lonza facility, a production train that will be exclusively dedicated to the manufacture of the rucaparib API.”

According to the terms of the contract, Lonza will also manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib API, and Clovis will pay fixed fees on a per kilogram basis for quantities of both.

“Until the dedicated facility is completed and operationally qualified, Lonza will manufacture the rucaparib API in existing Lonza facilities at pricing established in the Agreement.”

Clovis’ lead candidate rucaparib is an oral inhibitor of poly (ADP-ribose) polymerase (PARP) being developed to treat ovarian cancer. The product was granted US FDA Breakthrough Therapy designation in April 2015.

The contract expires at the end of 2025.

Merck Opens Testing Plant in Korea

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

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

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

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

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

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

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

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

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

AbbVie API Plant Opens in Singapore

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

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

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

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

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

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

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

The Southeast Asian city-state is somewhat of a hub for pharma and biopharma manufacturing.

Along with AbbVie, Amgen, Novartis, and Baxter (now part of Shire) have invested heavily in manufacturing plants in Singapore, and life science tools and services companies have followed suit.

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

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

Xellia Pharmaceuticals Expands Capabilities in Croatia

Xellia Pharmaceuticals, a Copenhagen, Denmark-headquartered firm, has expanded its product and innovation R&D team and has added new lab space at its Centre of Excellence in Zagreb, Croatia. This Increases staff numbers at Centre of Excellence in Zagreb by almost 25% and adds around 10,760 sq. ft. (1000 m2) of new laboratory space.

Xellia Pharmaceuticals, a developer of active pharmaceutical ingredients (APIs) used in anti-infective treatments for bacterial and fungal infections, has expanded its product and innovation R&D team with more than 15 new scientists.

The firm's portfolio includes difficult to develop and manufacture fermentation-based APIs and sterile Finished Dosage Forms (FDFs).

Many of these anti-infectives are of last resort and play a vital role in tackling resistant microbes, often when all other treatments have failed, the firm said.

The Zagreb innovation team is working to develop new antibiotics with improved efficacy, safety and delivery, while reducing toxic side effects in an effort to tackle antimicrobial resistance.

The firm is also developing novel drug-device combination antimicrobial therapies.

The discovery and formulation of new chemical entities effective against resistant microbes, with novel modes of action is also of interest.

Carl-Åke Carlsson, CEO, Xellia said: 'While generic anti-infective APIs and FDFs are, and will continue to be, a core backbone of Xellia’s business, our investment in the expansion of the product and innovation Centre of Excellence highlights our commitment to developing a more balanced portfolio of more innovative and proprietary anti-infective products.

'The investment is timely in the wake of the escalating scale of the antimicrobial resistance crisis and even now we are starting to see steady progress in the form of an early stage pipeline of novel drug products and compounds.'

Dr Aleksandar Danilovski, CSO and Vice President Global R&D, Xellia, and Managing Director of the Zagreb site said the recent expansion increases the firm's total investment in innovation-driven R&D activities in Croatia to more than $30 million since the Centre was established in 2011.

'With its strong pharmaceutical heritage, Zagreb has been the ideal site for establishing and then growing an expert, specialist team of around 100 scientists,' he said.

'Our team is dedicated to providing innovative solutions and developing differentiated anti-infective products, to tackle the increasing global healthcare problem of antimicrobial resistance.'

Xellia has global facilities including operational and manufacturing capabilities in Denmark, US, Hungary and China, and currently employs more than 1,200 people.

Since July 2013, the firm has been owned by Novo, the holding company of the Novo Group.

BASF Inaugurates PVP Production Facility in Shanghai, China

BASF has opened a new facility for the manufacture of polyvinylpyrrolidone (PVP) in Shanghai, China.

The new plant will produce PVP K30 powder, a polymer used as a base for pharmaceutical excipients (under the Collidon brand), cosmetics, detergents and technical applications.

It will operate in compliance with local and international Good Manufacturing Practice standards.

The plant expands BASF’s reach to customers in Asia Pacific, especially in China, and will offer a continued reliable and high-quality supply, the German firm said.

'The new plant in Shanghai affirms our commitment to customers in multiple industries and marks a key milestone for the transfer of global PVP production technology to Asia Pacific,' said Michael Heinz, Member of the Board of Executive Directors, BASF SE, responsible for the company’s Performance Products segment.

In 2015, BASF announced plans for $70 million in global investments into its NVP (N-vinylpyrrolidone)/PVP production.

The plans include the extension of capacities in Ludwigshafen, Germany and Geismar, Louisiana (US), along with technology introduction in Shanghai.

The Shanghai plant is equipped with sophisticated production facilities, including a high-quality control laboratory and warehousing capacity.

BASF says PVP can be used in a broad range of applications because it is easily soluble in water and solvents. It also has excellent adhesive properties, enhances solubility of active pharmaceutical ingredients (APIs), and is non-irritating to the skin. In addition, it is temperature-resistant, pH-stable, non-ionic and colorless.

Scymaris Expands Brixham Laboratory

Scymaris, a UK-based scientific services provider, has relaunched the former AstraZeneca Brixham Environmental Laboratory in Devon with backing from Torbay Council and Plymouth University.

The firm has become the anchor tenant at Brixham Laboratory, located at Freshwater Quarry, and will provide environmental laboratory testing services to pharmaceutical, agrochemical and chemical industries across the globe.

The campus is owned by Plymouth University and currently also houses 25 other local firms.

Scymaris will create 80 jobs at the laboratory over the next three years and expects to attract customers across Europe, US and Asia.

It has the ability to provide direct access to both marine and freshwater laboratory testing as well as environmental fate and product chemistry services.

'Brixham Laboratory is a world-class facility with a deep 65-year history of environmental laboratory testing including: aquatic ecotoxicology, environmental fate and biodegradation services,' said Tim Derrington, CEO of Scymaris.

'A number of environmental laboratory tests are generally required as part of the approval process for new pharmaceutical or chemical products and understanding the possible risks and impact on the environment is critical.'

Derrington said next month the firm will meet several potential European customers to discuss placement of several projects.

The firm expects strong growth in environmental laboratory testing owing to the increasing importance of environmental protection and the ongoing need for new products in the pharmaceutical and chemical industries globally.

Scymaris is one of only a handful of testing laboratories across the world with direct access to both marine and freshwater capabilities.

Companies who wish to market chemicals, pharmaceuticals and agrochemicals must obtain government approvals to do so which requires this type of specialized laboratory testing.

Torbay Council is supporting Scymaris using funding from the Torbay Growth Fund.

The company has also been supported by TDA, Heart of the South West LEP and the Department for International Trade.

PCI Pharma Services Announces European Expansion

CI Pharma Services (PCI) has announced the expansion of its Bridgend UK clinical site.

The Bridgend team will gain additional space in support of the secondary packaging and logistical services provided at the Clinical Services Centre of Excellence.

Ground works and construction began on 12 September of a new clinical services facility at Central Park on Bridgend Industrial Estate, one of four PCI Europe-based locations supporting investigational study materials.

The expansion will provide 37,500 sq. ft. of additional space in support of the secondary packaging and logistical services provided at the Clinical Services Centre of Excellence.

PCI has highly specialized 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.

This is the latest in a series of significant investments by PCI in developing its Bridgend site as its business has flourished: most recently with a purpose-built and dedicated -40°C facility; as well as a broader cold chain capacity expansion that increased site storage by more than 400%; in addition to continued expansion of frozen storage at -80°C.

These investments mirror PCI investments at other European and North American sites, supporting services for clinical trials and its considerable business growth in this segment.

The new building, which is expected to open for business in early 2018 following internal fit-out and a period of validation and licensing, will be adjacent to PCI’s current facilities at Bridgend.

Purpose-built for storage and clinical therapy distribution, there will be additional office space to meet staff growth plans, demonstrating PCI’s commitment to and continued investment in its clinical provision.

Kevin Williams, Operations Director at PCI, said: 'We are excited to see the initial construction begin on our new clinical facility expansion. With the market growth in biologics and the advent of biosimilars, the need for temperature-controlled therapies continues to increase dramatically.

'It is estimated that up to 37% of all drugs in the pharmaceutical industry pipeline currently are biologics. Likewise with advances in cell therapies and other cell- and tissue-derived treatments, there is increasing need for cryogenic temperature storage.

These trends, coupled with investigational studies increasingly being executed in more distant geographies, have demonstrated the need for expert specialist services in support of investigational studies.

'PCI’s continued investment in this area allows our clients to realize a safe and secure supply chain, ensuring their life-saving treatments are delivered on a timely basis to patients around the world with the highest degree confidence and assurance.'

Complementing its services for commercial medicines, PCI Clinical Services provides a broad range of support for investigational study materials including drug development and manufacturing, packaging and labelling, as well as a global network for storage, distribution and returns management for providing study materials to investigational sites around the world.

Pharmaron to Acquire Merck Sharpe & Dohme's Hoddesdon Research Facility in UK

Pharmaron has signed a non-binding heads of terms with Merck Sharpe & Dohme Limited (MSD) for the purchase of UK-based Hoddesdon site, which comprises MSD’s process development and research facility.

The deal is expected to be completed in the first quarter of 2017.

Pharmaron considers this an opportunity to acquire Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API) and formulation development in Europe to complement its chemistry and integrated drug discovery and development services globally.

As per the deal, MSD will continue on site and lease-back the main office buildings.

"This deal will secure the future of the site while meeting the changing business needs of MSD and its employees for the foreseeable future."

MSD UK and Ireland managing director Louise Houson said: “We are very pleased to be progressing this deal with Pharmaron. “It also ensures that MSD’s scientific legacy in Hoddesdon continues, with the potential to create local opportunities for our scientific staff in their areas of expertise.”

Pharmaron chairman and CEO Boliang Lou said: “This is an exciting opportunity to have an industry-leading R&D site join the Pharmaron group, which once again demonstrates our commitment to our mission to become a world leader in small molecule drug R&D services.

"It allows us to develop our global capabilities in process chemistry and the manufacturing services area, strengthening our capabilities in fully integrated R&D services.

"Together with the recent addition of GMP radiochemistry and GCP / GLP metabolism platforms through the acquisition of Quotient Bioresearch in the UK, this deal further consolidates our strategic position in Europe to better serve our partners globally, particularly in Europe.”

Commercial details of the transaction have not been divulged.

Pharmaron is a private R&D service provider for the life science industry. With about 4,000 employees, it has operations in China, the US and UK.

GE Opens Korean Tech Training Centre

GE Healthcare has opened a $7.4m bioprocessing technology and training center on the back of South Korea’s commitment to the biosimilar and biomanufacturing industries.

Already the area of Songdo, about 35km southwest of Seoul, is home to biologics makers Celltrion and Samsung Biologics , and now technologies and services firm GE Healthcare will join them with a Fast Trak Bioprocessing Technology and Training Center which opened this week.

“We’ve made this investment because Korea is becoming one of the fastest growing markets and R&D centers for biosimilars, mainly driven by strong government initiatives and investments to foster the development of the biotechnology industry,” said Umay Saplakoglu, Fast Trak global leader at GE Healthcare Life Sciences.

“The Korean government is heavily investing in the bio industry, which is seen as the new growth engine of the nation,” she continued.

Earlier this month, the South Korean government announced a four year plan to fuel the growth of the country's bio-health industry. This includes offering drug companies higher tax benefits and incentives for investing in R&D and undertaking clinical trials on locally developed products.

The government also aims to add nearly one million new jobs in the sector by 2020, cementing Korea’s aim of become a global powerhouse.

“We look forward to our center continuing to support growth in Korea and we continue to seek partnerships with government to grow together,” said Saplakoglu.

The 23,672 sq. ft. (2,200m2) site adds to GE’s global network, with similar facilities already established in the US, Sweden, India, and China and satellite Fast Trak Centers in Turkey, Japan and Singapore.

“All of our GE customers, both from the local region or globally, can access our Fast Trak training services,” Saplakoglu told us.

“The courses and services are designed to support R&D, process development, and biomanufacturing experts in all areas of bioprocessing, solving key manufacturing challenges, specialist techniques and supporting scale-up and (cGMP) biopharmaceutical manufacturing.”

The center currently employs 15 dedicated experts in bioprocessing, she added.

TxCell Launches New Manufacturing Process Development Laboratories and Technology Transfer Academy

TxCell SA, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, announces the launch of its new process industrialization laboratories and technology transfer academy facilities in Sophia Antipolis, France.

These new facilities will be primarily dedicated to the improvement of the existing TxCell manufacturing process for its ASTrIA platform as well as to the development of a manufacturing process for its new ENTrIA platform. These developments will be primarily achieved by combining the integration into the manufacturing process of findings from TxCell research with industry advancements in the life science and technology industries. The outcome will be an increase in automation and economic efficiencies as well as a shortening of the manufacturing process of all TxCell products across all of its platforms.

“TxCell is the only clinical stage cellular therapy company dedicated to the science of regulatory T lymphocytes (Tregs). As a result, TxCell is integrating its own research with recent technological advancements across a variety of fields to make the manufacturing process of our product portfolio as economic as possible,” said Miguel Forte, COO of TxCell. “The new TxCell facilities will be dedicated to accelerating the development of the commercial manufacturing process for products that result from the TxCell ASTrIA platform. In addition, it will allow the development of a new manufacturing process for products derived from the new TxCell ENTrIA platform.”

The facilities will also host the TxCell Academy for Technology Transfer. The academy will be responsible for educating and training all contract manufacturing partners (CMOs, including MaSTherCell). In addition, the academy will train future strategic partners (licensed and/or co-developing pharmaceutical companies) on the manufacturing processes of TxCell’s personalized cellular therapies. This will have the aim of facilitating and accelerating all transfer of TxCell technologies to third parties.

These new facilities will be based in Sophia Antipolis, in the premises of GenBiotech, an affiliate company of the Genevrier Laboratories.

“The opening of the new process development and technology transfer laboratories in the facilities of GenBiotech is a great development for TxCell,” said Stéphane Boissel, CEO of TxCell. “A significant part of TxCell’s strategic focus for the next three years will include improving the manufacturing process for the current group of products from the TxCell ASTrIA platform as well as developing a process for products from the new TxCell ENTrIA platform. In addition, in the context of a rapidly developing market for cellular therapy technologies, educating our manufacturing partners and future strategic partners about these processes will be crucial for TxCell. This initiative will be instrumental for TxCell to advance the development of critically needed personalized cellular therapies.”

Valeant Pharmaceuticals Announces Significant Investments in Canadian Operations

Valeant Pharmaceuticals International, Inc. announced that its wholly-owned subsidiary Valeant Canada is expanding its Canadian manufacturing and export capacity with investments totaling $27.5 million in its Steinbach, Manitoba and Laval, Quebec manufacturing facilities.

"Our investments reflect our ongoing commitment to growing our operational presence and export capacity in Canada," said Joseph C. Papa, chairman and chief executive officer. "Over the past few days, I have had the opportunity to spend time with our employees in Steinbach and Laval, and am struck by the level of talent and innovation at these world-class manufacturing centers. These facilities play a critical role in advancing healthcare technology both in Canada, and around the globe, and we are proud to take on an even larger role in further bolstering Canada's life sciences economy."

Valeant will invest $15 million in its Steinbach, Manitoba facility by the end of 2016, including $7 million in upgrades to product manufacturing technology and $8 million for the transfer of North American production of Xifaxan^® (rifaximin) and Apriso^® (mesalamine). Xifaxan^® is prescribed to relieve symptoms of hepatic encephalopathy and irritable bowel syndrome and Apriso^® is used to treat ulcerative colitis. These investments will support the facility's growth and expand its role as a key exporter of leading healthcare products while ensuring robust security for products traveling through international distribution channels. Since 2012, Valeant has transferred 27 technologies to Steinbach for manufacturing.

Valeant also announced $12.5 million of investments in its Laval, Quebec facility, which includes $10 million to upgrade product manufacturing technology, as well as $2.5 million associated with the transfer of production of Arestin^® (minocycline hydrochloride) to Laval. The transfer of Arestin^®, an antibiotic treatment for periodontal disease, will create 15 new engineering and production jobs and builds upon the transfer of Jublia^® production to Quebec earlier this year. Since 2012, Valeant has transferred numerous technologies to Laval, resulting in the production of 67 new products.

Dalton Announces Completion Sterile Filling and API Manufacturing Expansion

Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider to leading pharmaceutical and biotechnology companies, announced the completion of a $5 million expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Completion of this expansion is a major step designed to meet the increasing global demand for sterile filling development and production, and supports the integrated drug development and manufacturing we offer our clients commented Peter Pekos.

The project added three new sterile processing suites and an active pharmaceutical ingredient (API) manufacturing suite, and included the addition of a semi-automated powder filling line with significant scale-up of lyophilization capacity. Also included were increased analytical capabilities, increased chemistry capacity, and facility upgrades to meet increasingly stringent sterile manufacturing GMP API standards. Approximately 20 new skilled jobs have been added over the past year.

This project was supported by $2.085 Million (Canadian Dollars) in FedDev Ontario funding through the Investing in Business Growth and Productivity Initiative. Combined with the company’s initial investment of $3.5 Million, the expansion project brings the total investment at the site to more than $5 Million.

This expansion and improvements to Dalton’s sterile manufacturing facility were planned to meet growing clients’ requirements ranging from preclinical development and small/medium clinical trial batches to commercial production, for both API and sterile finished doses.

“Increasing sterile filling capability and capacity for both powders and liquids has been a key part of our plan for strategic growth,” commented Peter Pekos, President and CEO. “Completion of this expansion is a major step designed to meet the increasing global demand for sterile filling development and production, and supports the integrated drug development and manufacturing we offer our clients.”

R-Pharm Produces Drugs with GE Healthcare's FlexFactory Platform

R-Pharm Group has opened an innovative biopharmaceutical production plant equipped with GE Healthcare’s FlexFactory™ manufacturing platform in Yaroslavl, Russia. R-Pharm’s FlexFactory will support the mass production of biologics and biosimilars focused on treating autoimmune diseases and cancer, and allowing for increased access to these critical therapies for patients in the region.

Sergey Tsyb, Deputy Minister of Industry and Trade of the Russian Federation, said: "Modern technologies have an important role to play for Russian biopharmaceutical companies developing new products within the national Pharma-2020 program. Opening of a new biopharma production platform, such as R-Pharm’s FlexFactory, shows that we have the right targets and milestones in place, and that companies are helping us to reach the objectives that we have set in the program.”

“Since we started implementing the program, a large number of the major foreign biopharmaceutical companies made the decision to manufacture within Russia, and as a result, the share of pharmaceuticals made locally has gone from 4% in 2009 to 35% in 2015. I’m certain that opening of the new production platform by R-Pharm will be a further catalyst for continued growth,” said Olga Kolotilova, Head of Department of Development of Pharmaceutical and Medical Industry for Ministry for Industry and Trade, Russian Federation.

R-Pharm selected GE Healthcare’s FlexFactory to address a common biopharmaceutical industry challenge: the need to reduce biologic time-to-market and increase production flexibility, all while remaining in compliance with global regulations and quality standards. The FlexFactory platform enables manufacturers such as R-Pharm to rapidly respond to local healthcare needs by bringing more biological drugs to market at a quick pace. R-Pharm’s FlexFactory is now ready to be validated according to US and Russia FDA and GMP requirements.

Vasilii Ignatiev, CEO, R-Pharm Russia, said: "We are pleased to announce the opening of our FlexFactory that will be used to produce biopharmaceuticals for treatment of autoimmune and oncological diseases. There is an increasing need for new treatment methods which is highlighting the necessity to develop new biopharmaceuticals and improve diagnostics and treatment.”

Andrei Demurin, Director of GE Healthcare Life Sciences in Russia, said: “We are proud of the opportunity to offer innovative solutions for the Russian biopharmaceutical industry that are enabling the industry to efficiently respond to the targets described in Pharma-2020. Opening of a manufacturing line in Yaroslavl equipped with GE Healthcare’s FlexFactory technology is a significant step for Russian healthcare. The line capacity is 2,000 L of cell culture per production cycle, and this should make a key contribution to the volume of biopharmaceuticals manufactured locally.”

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com