A leader in advanced technology, Hodess Cleanroom Construction (HCC) has recently finished the design-build program for Advanced Accelerator Applications (AAA) in Millburn, N.J. A radiopharmaceutical company that produces nuclear medicine on the molecular level, this is AAA’s first U.S. manufacturing facility.

HCC provided design and construction management and full onsite supervision of the

15,000 sq. ft. facility, including ISO Class 7 and 8 cleanroom areas. The facility was built to also meet both EU and FDA standards; cleanrooms were built to meet Grade C and D and clean nonclassified requirements. Hodess was also responsible for the build out of the office space, locker rooms, conference rooms and cafeteria, as well as redoing the entire exterior of the building.

Hodess added Dryvit insulation systems to three sides of the manufacturing space and Rheinzink architectural metal panels on three sides of the office front, as well as provided a new thermoplastic polyolefin (TPO) white roof membrane. Hodess had to remove the interior slabs and replace them with reinforced slabs for the owner’s equipment. Also necessary was reinforcing the existing roof steel in order to support the new air-handling units, exhaust fans and equipment screens.

The company provided new mechanical, plumbing and electrical systems and services, including a new transformer and primary power to the building. Cleanrooms were built with Dagard modular pharmaceutical wall systems, including walkable ceilings. Sheet vinyl flooring was installed in all of the manufacturing spaces, and imported Italian ceramic tile were laid in the office areas. The tile, as well as specific steel window systems, front lobby desk and the company’s signage, were all imported to match their European facilities.

CUNY School of Public Health Nutrition and Food Science Lab. NY

Size: 4,930 sq. ft.

Project Team: Cooper Robertson

The City University of New York (CUNY) has rich programs in the social sciences, including its innovative School of Public Health. The School’s Nutrition and Food Science Labs are hosted in the new Silberman School of Social Work building in East Harlem designed by architects Cooper Robertson. The School of Public Health is the first program in the country dedicated to urban issues: those arising from the impact of genetics, aging, medicine and the environment in the worldwide migration into cities. Twenty years from now, two-thirds of the anticipated world population of 8.1 billion are expected to live in cities. And cities are where many contemporary health problems, from HIV infection to variants of chronic diseases like asthma and diabetes, have emerged. Cities also are where medical researchers are turning cancers, which were once most often considered fatal diseases, into chronic conditions.

Former CUNY Chancellor Matthew Goldstein believes the new school is an important addition to the University. "Urban health problems, like diabetes and obesity, are on the rise," he says. "As the largest urban public university in America, we hope to be able to work against these scourges."

The Nutrition and Food Science Laboratories consist of an Experimental Foods Lab and a Sensory Evaluation Lab. Cooper Robertson designed the Foods Lab to meet teaching, research and outreach needs, emphasizing experimental approaches to food. In addition to serving as an active teaching laboratory, this lab is used for student research and consumer workshops, and includes a dozen kitchen units composed of stainless steel sinks and counter tops, professional gas cooking ranges with convection ovens, as well as hand and dishwashing facilities. Current audiovisual equipment supports the digital content and associated processes in the lab.

The Sensory Evaluation Lab and Testing Area allows for discriminative, descriptive and consumer panel methodology efforts. The lab facility supports school research and also provides scientific and technical support to food-related and consumer products industries. Bruce Davis, Cooper Robertson’s design partner for the lab project, finds the sensory lab to be perhaps the facility’s most interesting component. The testing area is temperature controlled and includes numerous individual booths with sliding pass-through doors from an adjacent food preparation room, resilient countertops, and touch screen computers. Two banks of individually controlled fluorescent lights (cool white, red or green luminaires) surround each booth, which mitigate color cues and thus testing bias during food product evaluation. Space adjacent to the test area is used for panel training, focus groups, and interviews.

Kenneth Olden, founding dean, calls the decision to place the school in the lower-income area of East Harlem "A stroke of genius, because schools of public health and social work ought to be out in the community where the public health problems are. The location speaks volumes for the commitment of this institution." Bruce Davis comments further that “Our design is a direct response to supporting the needs of the local community right where it has the most immediate and profound impact.” To underscore this point, the Cooper Robertson design was awarded “Best Neighborhood Catalyst” by New York’s Municipal Art Society.

Olden sees the need to ensure that the approximately 29 million Americans who lack health care can obtain it. He advocates an emphasis on wellness and prevention, which includes cleaning up and protecting the environment. "We don't have enough resources in the U.S. Treasury to handle the health-care problems of chronic diseases" if every elderly person becomes ill.

Completion Date: 2011

Apotex Expanding in USA

Generics maker Apotex will construct a manufacturing and packaging facility as part of a $184 million U.S. expansion.

Apotex Inc. announced it is expanding its footprint by investing $184 million (€174m) at a site in Miramar, Florida, set to become the U.S. headquarters for the Canadian generic drugmaker.

Along with office space and an R&D center, the investment will include a drug manufacturing facility as well as housing the packaging operations for Aveva Drug Delivery Systems, acquired by Apotex in 2012.

While Apotex has over three million square feet in manufacturing and R&D facilities in its native Canada, Apotex CEO Jeremy Desai said having manufacturing presence in the U.S. had a number of advantages.

“Expanding our footprint in the U.S. is a central component of our strategy for global growth and reflects the critical importance of the U.S. and Latin American markets to our success, as well as our confidence in the future of the American manufacturing and biopharmaceutical sector,” he said in a statement. Furthermore “We are only permitted to manufacture controlled substances in the U.S. when serving this market, so expansion in Canada was not feasible.”

The investment is expected to create over 150 jobs in Florida when construction is complete, expected early 2019.

Pfizer Mulls Sites for NC Gene Therapy Plant Year after Bamboo Buy

Pfizer has confirmed it assessing potential sites in North Carolina for a gene therapy production plant.

Reports in the US press suggested Pfizer is considering either expanding its existing facility in Sanford, North Carolina or building the plant at a site nearby.

Kim Bencker, head of communications at Pfizer Global supply, related in an emailed statement “We recently announced that we’re moving forward with scoping potential sites in Sanford for our new gene therapy site. She added: “This work is still in the preliminary stages and we aren’t able to share additional detail at this time.”

The move follows a little over a year after the US drug manufacturer acquired Bamboo, a North Carolina-based gene therapy developer.

The deal included a recombinant Adeno-Associated Virus (rAAV) vector design and production technology, a Phase I candidate for Giant Axonal Neuropathy and a preclinical program targeting Duchenne Muscular Dystrophy (DMD).

Pfizer also gained an 11,000 sq. ft. gene therapy manufacturing facility in Chapel Hill that Bamboo bought from the University of North Carolina in 2016.

Texas Tech University Experimental Sciences Building Underway

Administrators from Texas Tech University and the Texas Tech University System broke ground on 22 February for its Experimental Sciences Building II (ESB II), which will significantly expand the university’s research capabilities.

The 117,000 sq. ft. Experimental Sciences Building II (ESB II) will include an animal vivarium, four general wet labs, three instrumentation labs and two synthetic labs, in addition to offices, collaborative spaces and three conference rooms.

Its construction was funded by US$70m from the Texas Legislature’s authorization of a tuition revenue bond and $7m in revenue finance system funds to be repaid by Higher Education Assistance Funds.

The purpose of ESB II is to increase Texas Tech’s research capacity by:

Developing and expanding research areas that align with the university’s existing strengths and address areas of national importance
Increasing the number of faculty with common interests within each research area who can collaborate on large-scale projects
Expanding research infrastructure to support thematic research areas.

"The Texas Tech University System is committed to world-class research that impacts lives," said Chancellor Robert L. Duncan. "The new Experimental Sciences Building will increase our capacity to do this important work in a first-class facility."

ESB II will contain collaborative research laboratories and expanded state-of-the-art small-animal research facilities, said Mark Sheridan, Vice Provost for Graduate and Postdoctoral Affairs and Dean of the Graduate School who chaired the committee that solicited input on the design and use of the building.

"The design of the common spaces, labs and support spaces better fosters collaboration between and among graduate students, postdoctoral researchers and faculty," Sheridan said. "The improved animal research facilities enable research opportunities we didn’t have previously; ESB II will have Biosafety Level 2, which is required for many types of biomedical research."

In keeping with Texas Tech’s focus on sustainability, the facility will be constructed according to Leadership in Energy and Environmental Design (LEED) standards. LEED is the nation’s preeminent program for the design, construction and operation of high-performance green buildings."

The building will be constructed by TreanorHL architects, with exterior façade and interior finish design by AyersSaintGross. The project’s landscape architect is Prairie Workshop.

Cornell University Opens Food Processing Validation Facility

The commercial-grade processor at Cornell is the first in the US installed within a Biohazard Level 2 facility.

With the installation of a commercial-scale high-pressure food processing unit, Cornell University’s College of Agriculture and Life Sciences says it has the first commercial scale validation facility for the high pressure technology used to foodborne pathogens and extend product shelf-life.

The new Hiperbaric 55 high-pressure food processor at Cornell’s New York State Agricultural Experiment Station in Geneva, New York, will set food safety standards for the increasingly popular high-pressure processing, favored by companies for its ability to retain fresh quality attributes in food while inactivating spoilage and pathogenic microorganisms.

High-pressure food processing takes ready-to-eat foods, already in their final packages, surrounds the packages with water, and then subjects them to isostatic pressure up to 87,000 pounds per square inch. For comparison, that is more than six times the pressure at the bottom of the Mariana Trench, the deepest ocean trench on earth.

Better understanding of high-pressure food processing is especially important for manufacturers of fresh, packaged, ready-to-eat foods: that segment of the food market is booming as consumers look for healthier choices but still demand convenience.

Food science professor Randy Worobo is overseeing the new validation center that houses the high-pressure processing unit. The validation center is part of the Institute for Food Safety at Cornell University, established in 2015 to harness Cornell’s strengths in food safety research and training to combat foodborne illnesses caused by pathogens such as Listeria and E. coli.

“The food industry is adapting high-pressure processing very rapidly because it retains the fresh-like character of the food products while guaranteeing safety by inactivating foodborne pathogens,” Worobo said.

“At Cornell University, we have a long-standing history of working very closely with the food industry to help companies innovate and create new products, while ensuring the safety of the food. This is just another example of our collaboration fueling economic opportunities for companies while protecting consumers.”

The commercial-grade processor at Cornell is the first in the US installed within a Biohazard Level 2 facility — which means researchers will be able to introduce pathogens to foods and test how well the pressure system kills them. That is important for companies in dealing with regulatory agencies tasked with ensuring food safety.

“Because high-pressure processing is such a new technology, the federal regulatory agencies are not that familiar with it, and what they expect is for companies to have validation studies that actually demonstrate that under this pressure, for this time, with this food, that you get a consistent pathogen reduction that meets regulatory guidelines,” Worobo said. “Cornell is setting the standards that companies will use to bring fresh, high quality foods to market in a safe way.”

Currently, the most common process used by food manufacturers to kill harmful pathogens such as Listeria and E. coli involves heat treatments. But that can be problematic for fresh, ready-to-eat foods such as salads, cheeses, guacamole, and hummus because heat changes the food’s flavor, texture and some nutritional components.

Another method to inhibit spoilage microorganisms is to apply chemical preservatives, but consumers are growing increasingly wary of that method. Ultraviolet radiation can be used to kill pathogens, but is limited to fluids where the UV light can penetrate

Contract Manufacturer Pfizer CentreOne Expands Fill-Finish Services

Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, announced that it has expanded its fill-finish services to its Kalamazoo, Michigan, site. Along with vial-filling of small molecules and biologics, the facility also provides vial-filling of sterile suspensions, expanding Pfizer CentreOne’s service portfolio.

“Kalamazoo was the obvious choice for expansion of our fill-finish services,” said Peter Stevenson, Pfizer CentreOne’s Vice President and General Manager. “Our Kalamazoo colleagues have been doing contract manufacturing for over 40 years on the API side – it’s part of the culture; and this is also one of Pfizer’s premier sterile-injectables sites. It’s a natural fit.” With more than 65 years of experience in injectables fill-finish, Kalamazoo currently supplies drugs to more than 100 countries around the globe.

Services at the Kalamazoo site encompass:

Small molecules and biologics
Sterile suspensions
Potent and controlled substances
Aqueous and oil-based formulations
Lyophilization
Vials 1-100mL; bulk formulation <1-1600 liters
Technical transfer

The Kalamazoo facility has dedicated, onsite technical, manufacturing science, regulatory affairs and quality teams. Over the last five years, they’ve successfully transferred 37 customer and Pfizer compounds into the facility. Among Kalamazoo’s extensive scientific resources are experts in API processes who know how to solve complex issues with active ingredients; and a team of commodities experts who trouble-shoot problems with stoppers, glass and excipients.

“Our biopharma partners will be in good hands at Kalamazoo,” stated Stevenson, “with a dedicated Pfizer CentreOne team by their side who deeply understand their needs, who can leverage a world of top-flight resources at the site on their behalf.”

Said Bob Betzig, Kalamazoo site head, who oversees all operations on the Kalamazoo campus, “We’re thrilled to expand our contract manufacturing services to include sterile injectables. We value our contract manufacturing partners and pride ourselves on producing difficult-to-make injectables. Our team is ready and waiting.”

Newage Industries Cleanroom Expansion, Southampton, PA

Cost: $9.5 million

Size: 40,000 sq. ft.

Project team: AES Clean Technology Inc. (architect, designer and engineer)

Preparations at NewAge Industries are underway to expand and renovate 40,000 square feet of space for more cleanroom suites, inspection areas and warehousing. The company is using an existing area at its headquarters and manufacturing facility located just north of Philadelphia, PA.

The need to expand arose primarily from the success of NewAge’s AdvantaPure product line. AdvantaPure’s tubing, hose and molded components are manufactured for high purity, Single-Use biopharm and pharmaceutical applications such as vaccine production and cell culture media transfer for harvest, filtration, fermentation, sampling and storage.

The area within NewAge’s building was previously rented to other businesses for several years—it even housed the local fire department, free of charge, while the firehouse was undergoing renovation—and more recently had been used for NewAge’s inventory overflow. The space will consist of 20,000 sq. ft. of five ISO Class 7 cleanrooms and an equal amount of area for warehousing. Demolition of existing structures within the expanse was completed last fall, and then followed by painting, utility work and other preparations.

NewAge expects to be able to move equipment from its existing cleanroom manufacturing areas to the newly renovated space during the second quarter of 2017.

Because the company has multiple tubing extruders and presses for molded components, the move-in will occur in phases, with one piece of equipment being shutdown, moved, validated and restarted at a time. There will be no production stoppages or shortage of products due to the plant expansion.

This is not the first time NewAge’s building has undergone major changes. In recent years the company invested in new lighting, new windows, floor resurfacing, new motors for its manufacturing equipment and air conditioning units, a new roof and a rooftop solar panel array consisting of over 4,000 panels. These panels currently produce half of the company’s electricity needs.

Completion date: April 28, 2017

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.

Tilray Grows Capacity in North America's Only GMP Cannabis Facility

Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.

The Nanaimo, Canada-headquartered firm supplies pharmaceutical grade cannabis for the treatment of a range of disorders, including for pediatric epilepsy and post-traumatic stress disorder (PTSD). It also has several oral cannabis-extract based drugs in clinical trials.

Tilray makes its products and drug candidates at a facility in British Columbia, which became the only good manufacturing practice (GMP) certified cannabis production site in North America after an inspection by the European Medicines Agency (EMA) in December.

The facility is 70,000 sq. ft. with 40 plant cultivation rooms and three laboratory spaces for extraction, manufacturing and packaging.

CEO Brendan Kennedy said, “The facility is a unique combination of industrial agriculture and pharma. In fact Tilray is the only GMP-certified producer of whole flower cannabis products - oils, extracts and other formulations - in the world.”

This was echoed by Joshua Eades, CSO of Tilray, who said the capsules Tilray uses to produce its candidate drug are also manufactured onsite.

The facility also houses a QA/QC laboratory. The potency of each batch of product is tested using liquid chromatography analysis (LC), adding that atomic absorption spectroscopy is also used to test for heavy metals.

The firm also tests for aflatoxin, a potent human carcinogen produced by fungi.

Eades explained: “because the APIs are extracted from a plant, we have to test for aflatoxin to make sure there's no contamination.”

Primarily the facility uses the Agilent 1220 c LC unit, along with other instruments from Agilent: “the nice thing about this is that it allows us to use the same software program – ChemStation.”

Gas chromatography is also used for non-routine testing, for solvent residue for example - to make sure the excipients in the product are below acceptable limits.

Tirlay has contracted cold chain logistics supplier World Courier to ship its candidate cannabinoid-based products to trial sites. Eades explained that: “We’re using cold chain on all the clinical products, as we're still gathering our stability data to see how they behave under different temperatures.”

Distribution of Tilray’s medical grade cannabis products is carried out by a number of contractors according to Kennedy, who told us the firm has 20,000 patients it supplies within Canada.

“We will continue to export from Canada, although it's likely we will build additional distribution [infrastructure] in the next 12 - 18 months.”

AB Biotechnologies Upgrades

AB BioTechnologies (AB), a provider of contract development and manufacturing services for the pharmaceutical industry, has selected Vanrx Pharmasystems to provide aseptic filling and lyophilizer loading systems for its new facility.

AB is expanding its services to enable customers to develop new drug products from preclinical through clinical trials using a single provider. The company’s expansion into automated aseptic filling and lyophilization complements its existing offering of formulation, analytical services, lyophilization cycle development and GLP/tox manufacturing.

AB BioTechnologies will be the first company in the United States to operate a complete Vanrx system. The full system consists of the SA25 Aseptic Filling Workcell, Accumulator and Lyophilizer Loader. Vanrx is the only manufacturer to offer a gloveless robotic isolator system for aseptic filling and lyophilization of sterile injectable pharmaceuticals. Vanrx systems can support clinical and commercial drug production.

“The flexibility and aseptic assurance of the Vanrx system will enable us to provide exceptional service to pharmaceutical companies. Clients will be able to bring drug products to market faster, with stable formulations and with process development already well underway for commercial production,” said Jeff Schwegman, Chief Executive Officer (CEO) of AB BioTechnologies.

“For a customer with Jeff’s high level of knowledge to choose Vanrx is a vote of confidence in our approach. We share their view that more companies should be able to bring drugs that benefit patients to market,” said Chris Procyshyn, CEO of Vanrx.

AB BioTechnologies is constructing a 23,000 square foot manufacturing facility in Bloomington, Indiana. The Vanrx aseptic filling equipment will be installed within a prefabricated modular cleanroom from Biologics Modular, and attached to a lyophilizer from SP Scientific. The SA25 will be installed for liquid GMP manufacturing by the fourth quarter of 2017, with added lyophilization capabilities beginning in 2018.

Vanrx Aseptic Filling Workcells enable the production of liquid or freeze-dried drug products in a variety of vial, syringe and cartridge formats. It is a fully integrated, automated aseptic filling system that combines robotics, gloveless isolator and machine vision technologies.

Science & Learning Center, Whittier College, Whittier, Calif.

Cost: $36,000,000

Size: 90,728 sq. ft. (gross building)

Project team: RFD (Laboratory Planner), Steinberg (Architect), KCS West (General Contractor)

The Science & Learning Center at Whittier College in Whittier, Calif., encompasses 27,300 sq. ft. of laboratory and laboratory support space in a 90,728 sq. ft. building—housing the Departments of Biology, Chemistry, Environmental Science, Physics, Psychology, Math, and Kinesiology and Nutrition.

The facility includes multipurpose teaching laboratories to be shared by all departments to maximize utilization. To facilitate shared use while providing adequate services, the laboratories are categorized as Level I, Level II and Level III designed with increasing infrastructure for each level such as water, gases, ventilation and electrical power. Also included are Student/Faculty Research Laboratories for Chemistry, Biology, Environmental Science and Psychology designed to be flexible for shared use by interdisciplinary teams.

This completely renovated and expanded facility will also provide specialized laboratory support spaces including Tissue Culture Rooms, Instrument Rooms, NMR, Microscopy/Imaging, Dark Room, Cold Room, Culture Rooms, Optics, Atomic Force Microscopy, Machine Shop, Field Equipment Storage, Testing Rooms and Hazardous Material Storage.

Completion date: September 2016

Borger Welcomes New Livestock Genetics Center

A Texas Panhandle city traditionally associated with oil is moving toward the forefront of agricultural science.

The city of Borger welcomed the opening of a new livestock genetics center.

The center will be located at Frank Phillips College, and will focus its work on the transfer of cattle embryos. These embryos are removed from sought-after cows of good breeding, and placed into less expensive cows. The cheaper cows then serve as surrogate moms. This allows ranchers to spread superior cattle across the ag market more quickly.

A hormone used by Frank Phillips faculty and students causes superior cows to produce 15 or 20 embryos, instead of one. Those extra embryos are then transplanted to the surrogates.

The 4,500-square-foot facility holds a classroom and containment area for cattle.

Aramark Opens New Processing Facility

Aramark, a leader in food, facilities management and uniforms, is increasing its capacity to provide cleanroom services to customers throughout the Southwest region of the US with its new 34,350 sq., ft. processing plant in McKinney, Texas. Over the next three years, the new operation is expected to create approximately 120 new local jobs.

"This expansion is designed to drive innovation and improve the speed of service for our growing cleanroom service customer base in the Southwest," said Brad Drummond, Chief Operating Officer for Aramark's Uniform business.

"The McKinney processing facility is the second recent expansion of our cleanroom service capacity, as we opened a smaller, but similar plant in April 2015, in Toronto."

Headquartered in Philadelphia, Pennsylvania, and active in 19 countries, Aramark supplies sterile garments and contamination control supplies, serving critical environments in the pharmaceutical, medical device, microelectronics, semiconductor and aerospace manufacturing industries.

The company offers products for cleanroom environments such as the Aramark Acuity Goggle which retains visual clarity after sterilization, MicronSwep a ceiling to floor microfibre cleaning system, and CleanTrak, a proprietary inventory control system that tracks the history of every garment from first use, to repairs and expected last date of use.

All of Aramark's cleanroom processing facilities are ISO Class 5 certified, and use a proprietary wash formula with deionized water to help ensure garments meet Institute of Environmental Sciences and Technology (IEST) recommendations.

The company provides uniform rental and uniform leasing services to more than 300,000 customer accounts nationwide from more than 225 service locations and distribution centers across the US. Its full-service employee uniform solution includes design, sourcing and manufacturing, customization, cleaning, maintenance, and delivery.

US PDA adds ISO Class 8 Cleanroom

The US Parenteral Drug Association (PDA) has completed a six-month enlargement of its Training and Research Institute (TRI) in Bethesda, Maryland.

The expansion permits PDA Education to increase its capacity for hands-on aseptic processing and lecture-based training at TRI.

The centerpiece of the buildout is a new 400 sq. ft. ISO Class 8 cleanroom that will house additional hands-on aseptic processing training courses. The cleanroom is enclosed by modular walls from Servicor and the air is processed with a HEPA air system.

"The hands-on aseptic processing instruction offered in an industrial setting at the Training and Research Institute is a critical component of PDA's educational program," said Craig Elliott, PDA Vice President of education.

He added: "PDA Education's Aseptic Processing Training Program provides an in-depth experience with the technologies associated with the manufacture of aseptically produced products, and now we have the capacity to train even more professionals each year."

Last year PDA trained over 300 US FDA personnel, but could not keep up with the increasing demand.

Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance pharmaceutical/ biopharmaceutical manufacturing science and regulation so members can better serve patients.

Biomarin Building Plant for Gene Therapy Candidates

A Californian manufacturing facility to support clinical development of a haemophilia A gene therapy will be completed this year, says BioMarin.

Last year, BioMarin Pharmaceutical released proof-of-concept data to support BMN 270, a gene therapy candidate using an AAV-Factor VIII vector intended to treat patients deficient in the blood clotting protein Factor VIII.

And with plans to begin a Phase IIb study later this year, the firm has said it is constructing a facility in California to manufacture clinical batches.

“Our new gene therapy manufacturing facility is expected to be completed by mid-year, enabling us to move the BMN 270 program forward, without constraints on materials needed for the Phase 2b registration enabling study in the third quarter,” CEO Jean-Jacques Bienaimé told investors.

Henry Fuchs, president of worldwide R&D, added making the investment in-house ensures has control of its supply chain for the upcoming trials, heading towards a commercial launch.

“The facility design was recently reviewed with US health authorities and the feedback was consistent with our plans for construction and operational control. The approach laid out was well received and discussed in depth with industry, academic and health authority representatives.”

Yet while the design of the facility gave consideration to the potential for use with other gene therapies in BioMarin’s pipeline, management did not want to “get the cart before the horse,” and wanted to await BMN 270’s success before making any decisions, according to EVP Jeff Ajer.

The investment made in the site was not divulged, but capital expenditure for 2016 stood at $168m (€159m), though this included the buildout of a manufacturing facility in Shanbally, Ireland , to support commercial supply of the firm’s enzyme replacement drug Vimizim (elosulfase alfa).

For the full year, the firm saw revenues of $1.12bn – up 26% on 2015 – though reported a net loss of $630m (up from $155m) attributed in part to higher operating expenses.

Camfil APC Dust Collection Standard Testing Laboratory, Jonesboro, Ark.

Cost: $210,000 (total cost of expansion and equipment)

Size: 1,600 sq. ft. (new ASHRAE 199 test lab); 1,600 sf (existing renovated ASHRAE 52.2 lab); 200 sq. ft. (Existing dust sample lab with new equipment)

Project team: Alex Wells (test engineer), Daniel Vangilder (filter engineer), Tim Hudson (R&D/product manager of filters

Camfil Air Pollution Control (APC), a manufacturer of dust, mist and fume collection equipment, has doubled the size of its testing laboratory to include a climate-controlled facility with a new full-size dust collection test rig. The new equipment is dedicated to testing in accordance with a new standard issued by the American National Standards Institute (ANSI) and American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). This standard, #199-2016 Method of Testing the Performance of Industrial Pulse Cleaned Dust Collectors, is important because unlike other air filter standards that focus on HVAC systems, it analyzes how well filters actually clean and how dust collectors perform as a whole.

Camfil APC served on the Standard 199 project committee since its inception and helped to develop the standard. Moreover, the company was proactive in designing the testing lab and completed the facility prior to the official issuance of the standard in 2016.

To accommodate the new testing site, an existing room in the warehouse was converted into the ASHRAE 199 lab. Camfil APC will use the test rig for both internal product quality testing and to help customers simulate real-world conditions to evaluate the compliance and effectiveness of various filters. Using a cartridge dust collector with four high efficiency filters, the unit feeds dust into the collector under specified conditions, measuring pressure drop and downstream emissions.

Camfil APC’s lab expansion also includes new equipment for research and development, customer support and testing for regulatory compliance. A new, highly sensitive scanning electron microscope is equipped with the high level of magnification and resolution required to analyze high efficiency filtration media with nano fiber and PTFE membrane coatings. This microscope is the most sophisticated available today and will be used both for quality control of existing filter media and analysis of new media with potential performance improvements. The lab also houses an array of equipment used for bench testing of customer dust samples to take the guesswork out of dust collection, including a video microscope, particle size analyzer, moisture analysis and abrasion testing devices.

Cadence Celebrates Grand Opening of New Wisconsin Facility

Cadence Inc.’s Sturgeon Bay, WI facility celebrated its grand opening of the new 63,000 sq. ft. facility with a ribbon cutting ceremony. The new building nearly triples the footprint of the previous facility and enables increased production capacity of the team’s core capabilities in precision and microstamping, multi-slide forming, injection and insert molding, and automated assembly.

“I am truly honored and proud to be here today as we celebrate the grand opening of our beautiful new facility,” said Sandy Sekadlo, VP of manufacturing for Cadence Wis. “We look forward to expanding our current capabilities to better serve our customers' needs and also anticipate adding to our workforce over the next several years.”

Cadence is a single-source manufacturing partner for medical device, diagnostics, industrial and automotive companies worldwide, providing end-to-end solutions focused on best-in-class total value.

University of Oklahoma Biomedical Engineering Facility

The University of Oklahoma is planning to build a biomedical engineering facility on the campus in Norman. The 90,000 sq. ft. building will house reconfigurable and dual-use research and teaching laboratories as well as offices, classrooms and a large lecture hall. Page is the designer, and J.E. Dunn Construction has been selected as the construction manager.

The total cost for the project is currently estimated to be approximately $30,000,000.

UCB Opens Innovation Center in Tech Square

UCB officially opened this its UCB Solution Accelerator – a unique environment designed to drive collaboration between UCB and the Georgia Tech community to develop solutions that will positively impact the lives of those living with severe diseases.

For the past year, UCB has collaborated with Georgia Tech’s Interoperability & Integration Innovation Lab (I3L) in using predictive analytics to answer the question: how can we better fit medications to patients and positively impact patient care?

The 2,500-square foot innovation center will be located in the Centergy Building at Technology Square, part of Georgia Tech’s innovation neighborhood.

With its North America Headquarters in Smyrna, GA, UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to treat severe diseases of the immune and central nervous system. As the first pharmaceutical company with an innovation center in Technology Square, UCB will be able to tap into Georgia Tech’s state of the art machine learning and advanced analytics resources to improve patient care as well as the patient experience.

“Establishing a presence in Technology Square is a natural extension of our existing relationship with Georgia Tech,” said Jeff Wren, head of UCB’s Neurology Patient Value Unit. “We are thrilled to join this vibrant innovation community to learn and grow our own capabilities. We are confident that co- location and proximity to the Georgia Tech community will enable us to quickly develop quality solutions that will create real value for the patients we serve.”

“We are delighted to welcome UCB as the first pharmaceutical company to join the growing innovation ecosystem in Tech Square,” said Georgia Tech President G. P. “Bud” Peterson. “We have already begun several collaborations with the company, and look forward to future opportunities for Georgia Tech students, faculty, and staff to help develop solutions to positively impact patient care for those living with chronic, severe diseases.”

UCB expects the space to be used by multiple collaborators from Georgia Tech researchers, faculty and students, to UCB interns and staff from its North America headquarters as well as from its global headquarters in Brussels Belgium.

Cambrex to Acquire PharmaCore

Cambrex Corporation, a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), announced that it has agreed to acquire PharmaCore Inc., a privately-owned company specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects, for approximately $25 million. PharmaCore was founded in 1999 and occupies a 35,000 sq. ft. GMP site in High Point, North Carolina, USA.

PharmaCore develops and produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg to support clinical trials from Phase I to Phase III. The company is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. PharmaCore has more than 60 full time employees, focused on projects at laboratory and pilot plant scale, with nearly 40 lab-based Process and Analytical Chemists, the majority of whom hold PhDs.

The acquisition will enhance Cambrex’s portfolio of small molecule API services and complements its existing large scale, multi-purpose manufacturing facilities in the US and Europe. PharmaCore is currently generating $15 to $17 million per year in revenues and just over two million dollars per year in EBITDA. Cambrex expects the transaction, net of deal fees, to have a neutral impact on earnings per share in 2016 and to be accretive in 2017.

“We are excited to announce our acquisition of PharmaCore, which we believe underlines our commitment to continually enhancing our service offering to our global pharmaceutical and biotech customers. The acquisition will provide the capability and expertise to efficiently develop early clinical phase products and new technologies. We expect PharmaCore’s substantial customer base and robust project pipeline to broaden our potential late stage clinical development and commercial manufacturing opportunities,” commented Steven Klosk, CEO of Cambrex.

He added, “Through the end of 2016, Cambrex will have invested over $200 million in capital projects within our existing facilities, including a recently completed $50 million production and warehousing expansion of our large scale US API facility in Charles City, Iowa, and a $9 million investment to expand large scale manufacturing capacity at our Karlskoga facility in Sweden, which we expect will be completed shortly.”

Rob Maddox, President of PharmaCore added, “PharmaCore is proud of the reputation we have developed, both as a trusted CMO and a company with a strong track record of innovative chemistry. We are thrilled to be joining Cambrex’s global network and to have the opportunity to participate in Cambrex’s growth strategy.”

PharmaCore’s NC facility has a 15,000 sq. ft. chemistry laboratory and a 13,000 sq. ft. pilot plant, with reactor capacity ranging from 20L to 2000L, with supporting GMP analytical services.

The completion of the transaction is subject to customary closing conditions, and is expected to occur within 30 days. PharmaCore was advised on this transaction by Wombat Capital Markets, LLC.

Hodess Builds Cleanroom for Advanced Accelerator Applications

HCC provided design and construction management and full onsite supervision of the

AMPAC Fine Chemicals LLC (AFC) Acquisition of UniTao

Pharmaceuticals LLC assets, comprising the former Boehringer Ingelheim manufacturing facility in Petersburg, Virginia.

Dr. Aslam Malik, AFC's President & CEO, reports, "This is a world-class active pharmaceutical ingredient (API) manufacturing facility with a long history of producing Controlled Substances and Highly Potent APIs. It is a perfect fit for AFC's growing demand for APIs." Dr. Malik adds, "We have also retained a core team of experienced professionals at the Petersburg facility to support cGMP production of intermediates and APIs. This will ensure a seamless integration into AFC's network of production plants. AFC is witnessing robust customer demand for our core technologies combined with our development & manufacturing expertise. Customer response to this acquisition has been positive since it provides additional cGMP capacity in the US to support their current and future API needs."

The Petersburg facility, now known as AFC-Virginia, includes four plants with multiple cGMP manufacturing lines totaling more than 80,000 gallons of cGMP capacity, the most recent of which was brought on-line in 2009. AFC-VA has a long history of producing Schedule II Controlled Substances. Capabilities also include High Potency manufacturing suites plus multiple 100 to 2000 gallon production bays.

This transaction is a continuation of AFC's targeted acquisition strategy, first demonstrated in its successful integration of the AFC-Texas plant, which is now supporting numerous validated programs.

Additionally, the AFC-California facility is undergoing a major expansion that is scheduled for completion in early 2017.

Eurofins Expands Clinical Diagnostic Footprint with the Acquisition of VRL Laboratories

Eurofins Scientific has announced the acquisition of VRL Laboratories, one of the leading laboratories in pre-transplant testing for the eligibility determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in the US.

Founded in 2010, VRL has become a reference laboratory solely focused on donor eligibility testing and microbiology testing for the transplant and medical communities. The company offers a broad menu of infectious disease screening assays to support the FDA’s 21 CFR 12711 donor eligibility determination testing requirements, specifically for eye, tissue, organ, stem cell and cord blood, as well as reproductive tissues. VRL employs a total of 60 staff across its main facility in Denver CO, and its satellite laboratories in Boston, MA, Dallas, TX, and Atlanta, GA.

The acquisition of VRL reinforces Eurofins’ footprint in specialty clinical testing services and consolidates the Group’s leadership in the transplantation testing market. Furthermore, VRL’s microbiology testing services expands Eurofins’ testing portfolio and increases client penetration in the transplantation testing market. In return, VRL will have access to the Group’s clients and competencies, as well as its laboratory network infrastructure, which should support its further development.

Comment from Dr. Gilles Martin, Eurofins CEO: “The acquisition of VRL is another demonstration of our strategy of expanding and strengthening our network of competence centers. In combination with ViraCor and Diatherix, VRL reinforces the Group’s footprint in the testing market for transplantation and infectious diseases.”

REST OF WORLD

GE Healthcare Adds Purification Equipment at FujiFilm Diosynth

GE Healthcare has completed another tech installation at FujiFilm Diosynth’s biopharmaceuticals facility in Billingham, UK, integrating a single-use purification system with bioreactors it provided in 2014.

The project – which involved integrating an AKTA purification system with bioreactors installed at the facility a few years back – was completed in just over a year according to a GE spokeswoman, who said the timescale fitted Fujifilm need to increase capacity.

“The objective was to duplicate and mirror FujiFilm’s existing production capacity in North Carolina, USA to Billingham” she said, adding that the contract manufacturing organization (CMO) had seen an increase in demand from customers with drugs in trials.

“FujiFilm Diosynth needed a solution that would allow them to quickly turnaround larger numbers of smaller batches. The key was to create the right capacity for their customers that is both flexible and efficient.”

The project was not a full-blown “FlexFactory” - which is GE’s bespoke modular plant technologies that have recently adopted by firms like BeiGene, Gallus, JHL Biotech and Nanotherapeutics.

Rather it consisted of several separate installations of technologies. The facility houses technologies spanning the full range of upstream and downstream bioprocessing operations.

Single-use technologies are core to the plant according to the GE spokeswoman.

She said, “FujiFilm Diosynth have been early adopters of single-use technologies, so they had experience and confidence running a single-use facility and its production processes. As a result, GE helped FujiFilm Diosynth to design their new facility around single-use technologies.”

BeiGene Forms JV to Build in Guangzhou

BeiGene Ltd has said it will build a biologics manufacturing plant in collaboration with Guangzhou Development District (GDD).

The Guangzhou plant – plans for which were announced in a US Securities and Exchange Commission (SEC) filing - will be operated by a joint-venture called BeiGene Biologics. The facility will produce commercial quantities of biopharmaceuticals for the Chinese market.

The site will be located on a 100,000 square meter site the JV will buy at the Sino-Singapore Guangzhou Knowledge City.

The total value of the project is RMB2.2bn ($330m).

BeiGene will contribute RMB200m with GDD’s affiliate Guangzhou GET Technology Development Co., Ltd (GET) adding RMB1bn. The organizations plan to raise the rest of the funding through loans.

In addition to paying for the facility, a proportion of the money raised will also be used to pay for clinical development of candidates produced there.

CEO John V. Oyler said: “It is our strategic priority to secure high-quality large-scale manufacturing capacity based on the increasing biologics opportunity we envision in China and global markets.”

BeiGene declined to share details of the plant construction plan or the likely size of its workforce.

At present, BeiGene’s manufacturing operations are based at a 1,506 sq. ft. (140 square meter) manufacturing facility in Beijing, which produces and supplies preclinical and clinical trial materials for some of the firm’s small molecule drug candidates.

The firm is building a monoclonal antibody (mAb) plant at the Suzhou Industrial Park an hour outside Shanghai, completion of which is expected this year.

SGS to Open Clinical Pharmacology Unit in Budapest, Hungary

SGS has signed a partnership agreement with the Medical Center of Defense Forces Hospital in Budapest, Hungary to operate the unit

Life sciences, clinical and bioanalytical contract solutions provider, SGS, has announced that it has signed a partnership agreement with the Medical Center of Defense Forces Hospital in Budapest, Hungary to operate a dedicated clinical pharmacology unit for conducting Phase I inpatient clinical trials within the hospital's oncology facility. The Budapest unit is the latest addition to SGS's embedded hospital clinical pharmacology network, complementing existing units in Antwerp and Mechelen, Belgium and further strengthening SGS's early phase inpatient capabilities and therapeutic area reach.

The new patient unit will have five hospitalization beds and will occupy a separate, secured wing in close proximity to the intensive care unit. In addition to the five beds, the unit is equipped with an examination room, a sample preparation area, a sample storage area/locker and restrooms suitable for multi-day stays.

Early phase trials will be undertaken by a permanent, dedicated on-site SGS team, working in close collaboration with hospital physicians, trial experts and investigators, to ensure solid patient recruitment capacity, rapid subject enrollment with high quality data collection and on-time study delivery.

This partnership will greatly contribute to keeping the hospital at the cutting edge of applied R&D, enabling the staff to gain greater expertise in early phase clinical trials, but the most important benefit is the ability to offer new therapeutic solutions as early as possible to the suitable patients

The Medical Center of Defense Forces, a leading facility within Hungary, undertakes both military and public healthcare with 1,800 beds and access to two million residents. The hospital has been conducting clinical trials for over 15 years. Among its therapeutic areas of expertise, cancer is the most significant. Approximately 40 clinical trials, spanning Phase I to Phase III oncology studies, have been conducted at the center over the last four years, covering indications such as soft tissue and bone tumors, and gastrointestinal tumors. The oncology department has 44 beds and 24 chairs for day care treatments in total, treating more than 1,200 new solid tumor cases every year.

"This new Phase I Unit plays a crucial role in the early phase studies conducted by our clinical research personnel and clinical project managers," concluded Jean Luc Marsat, SGS Clinical Research Managing Director. "As part of the SGS Life Sciences clinical network, this unit can operate as a single unit or as part of a multisite approach, depending on the needs of the study, and fits with our global strategy to establish SGS as the leader in early phase clinical trials in Europe."

Novartis to Consolidate Slovenian Logistics

Novartis subsidiary Lek Pharmaceuticals will consolidate its Slovenian logistics and warehousing operations from 10 sites to one.

Lek, an offshoot of generics maker Sandoz, part of Swiss pharma giant Novartis, confirmed it is looking to consolidate its logistics operations in Slovenia and optimize costs through a deal with third-party service provider Kuehne + Nagel starting 2018.

“Lek has decided for a single business partner in logistics because high volume growth resulted in a need to bring the logistics to a higher level,” spokeswoman Katarina Klemenc said.

“We aim at improving the existing Novartis warehousing network in Slovenia and make it best suited to support our internal and external customers’ growing needs in the future. Existing warehousing footprint of Novartis in Slovenia is dispersed over 10 locations.”

Kuehne + Nagel is building a 376,600 sq. ft. (35,000m2) logistic center near Ljubljana airport with more than 70,000 pallet places which – when it opens in 2018 – will provide enough warehousing capacities for Lek over the coming years, Klemenc said.

“Lek will transfer to Kuehne + Nagel final products storage and part of production materials storage. Both parties will work together on the transfer of the business, including IT system development and implementation of quality standards, which apply in pharma industry.”

She added around a dozen jobs would be affected by the transfer but “Lek employees will keep all existing rights in accordance with local legislation.”

Lek’s manufacturing operations in Slovenia include a site in Prevalje which recently saw a production capacity expansion due to increased demand for Sandoz’ version of GlaxoSmithKline’s Augmentin, a broad spectrum antibiotic that consists of amoxicillin and clavulanic acid.

The firm also has a protein manufacturing facility in Menges, central Slovenia, which makes the drug substance for its Epogen (epoetin alfa) biosimilar.

GSK Increases Vaccine Production

The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.

Part of GlaxoSmithKline’s global vaccine manufacturing strategy, the £40m ($62m) investment will consolidate global diphtheria toxoid (DT) and tetanus toxoid (TT) production in one location, Gödöllö.

“Ultimately, this investment will help secure the long-term supply of the Infanrix/Boostrix franchise to meet global demand,” said spokeswoman Angel Hill, adding the investment will include extensions to the existing TT/DT facility and a new media preparation building at the site.

Construction is set to begin in August with commercial operations planned from 2023, following regulatory approval. Hill also confirmed 104 jobs will be added to Gödöllö’s 230 headcount as a result of this investment.

The vaccine Infanrix clocked in worldwide sales of £769m last year, while GSK’s other diphtheria and tetanus vaccine Synflorix added £504m to the UK-headquartered Big Pharma’s 2016 top line. The booster immunization against tetanus, diphtheria, and pertussis added a further £470m.

The investment includes the transfer of Infanrix and Synflorix production from GSK’s site in Marburg, Germany, a former Novartis facility added to GSK’s network through a $7bn asset transfer deal in 2014.

As part of the deal, GSK acquired Novartis’ vaccines unit – excluding the flu vaccine business, sold to CSL Behring – and last October the firm pledged €172m ($183m) to support production in Marburg.

This included plans to install a €10m mumps vaccine production line, and to construct a €162m ($170m) antigen production facility for its meningitis B vaccine Bexsero.

According to GSK Germany spokesman Volker Husslein, the vaccine – approved in the US in 2015 and the EU in 2016 – is still being manufactured on behalf of GSK by Novartis from its Kundl, Austria plant, but by bringing Bexsero production in-house, GSK will take complete control of the supply chain.

G-CON Manufacturing Collaborates on Bioprocess Facility in China

Just Biotherapeutics along with its affiliated company, Hangzhou Just Biotherapeutics, and G-CON Manufacturing are working together on a biologics facility in the Hangzhou Economic and Technology Development Area (HEDA) of China.

Currently under construction, the cGMP facility is expected to be completed and operational in early 2018.

This will be the first commercial facility for the biotherapeutics company, which was formed to significantly reduce the cost of biologics to make them more accessible to a global population.

In support of that goal, Just's China plant employs a flexible, rapidly deployable and efficient design that creates a new standard for bioprocessing industry facilities.

A key feature in the plant will be the use of G-CON prefabricated cleanroom PODs. In this application the G-CON PODs, which G-CON refers to as J.Pods, are fully equipped processing units capable of running highly intensified bioprocesses.

G-CON will simultaneously build multiple PODs in the US in parallel with construction of the host facility in Hangzhou, to significantly reduce the overall project timeline and facility readiness.

Off-site pre-qualification will help shorten on-site qualification work once the J.Pods arrive in Hangzhou. Additional PODs can be quickly deployed, redeployed or repurposed to meet increasing product demand or flexibility requirements.

The PODs will also feature AES’s Pharma Wall System, an aluminum framed, non-combustible composite panel, featuring a uPVC finish. Such panels will provide an interior finish that does not absorb moisture and is impact resistant. This project will be the first time that G-CON and AES have provided a joint solution since the announcement of their collaboration in April 2016.

Maik Jornitz, CEO and President of G-CON Manufacturing, said: “We are seeing that our flexible, compact PODular cleanroom systems are becoming an attractive and cost efficient alternative for the industry, compared to traditional brick and mortar or stick built systems."

Jim Thomas, President and CEO of Just Biotherapeutics, said: “Utilizing G-CON’s POD technology enables our mission of increasing access to important biologics worldwide. By creating J.Pods we focus our molecular and process technologies into an efficient, integrated design that enables low cost, flexible manufacturing.”

“J.Pod represents the next-generation smart manufacturing platform, providing unique advantages in fast-growing markets like China. Our aspiration is to become an innovation leader and by working with G-CON we are confident that we will deliver high quality and affordable biologics to more patients worldwide,” added Yining Zhao, CEO of Just China.

Just Biotherapeutics of College Station, TX, US, is a design company focused on technologies that accelerate development of biotherapeutics and substantially reduce manufacturing costs. Its core strengths are molecular design, process and product design and manufacturing plant design.

Siegfried’s New Plants

Siegfried saw higher sales in 2016 thanks to the API business it bought from BASF and opening of new plant in China, but profits fell on integration costs and higher taxes.

The Swiss active pharmaceutical ingredient (API) and drug supplier generated revenue of CHF717.7m ($711m) in 2016, up 49.3% year-on-year.

Siegfried attributed the gains in part to the API business and sites it bought from BASF in 2015, explaining the assets are now fully integrated into its manufacturing setup.

Spokesperson Marianne Späne told us growth of Siegfried's CMO business has been driven by upscaling intended to support the launch of customer products and implementation of new projects.

The firm also said its intermediates plant in Nantong, China – which was approved by Government authorities last summer – and the new facility at its headquarters in Zofingen, Switzerland, had both contributed to the revenue growth.

Costs associated with the facilities and the integration of the former BASF business impacted earnings.

Net profit for the 12 months ended December 31, 2016 was CHF27.9m, down from CHF39.1m in 2015.

Siegfried also announced it will expand its research and development capacity this year, citing customer demand.

The firm is adding about 40 new laboratory workstations at its site in Zofingen and is due to begin building a logistics facility at the plant this year.

Siegfried predicted high single-digit sales growth in 2017. The firm also suggested that earnings will improve as a result of “identified synergies,” but did not provide details.

CellGenix Headquarters Expands

CellGenix, a global manufacturer of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, started facility expansions as more customers approach late-stage clinical development and commercialization.

Through early 2018, research and development laboratory as well as production and warehouse space will be added to its German headquarters in Freiburg. Consequently, new positions in research and development as well as quality control and production will be filled. The upgrade also introduces state-of-the-art, large scale, filling capacities for recombinant protein products in the existing GMP facilities.

The expansion is the result of robust, sustainable and profitable growth which the company has experienced over the previous years. These advancements are reflective of the rapidly expanding cell and gene therapy space as promising therapies approach market authorization and commercialization. The experienced industry growth and strong forecasts in cell and gene therapy lead to an increased demand in GMP-grade raw materials for production.

“The investment we are making is a very positive sign for the gene and cell therapy space and the future of CellGenix. It will allow us to fulfill the increasing demand for GMP-grade cytokines and serum-free media. It also shows the importance of high quality GMP reagents for safe, reliable and successful cell and gene therapy manufacturing.” says Prof. Dr. Felicia Rosenthal, CEO of CellGenix.

Frank Hecht, Vice President Marketing & Sales at CellGenix, adds: “With this expansion we strengthen our position as a leading partner for all companies active in the manufacturing of cell and gene therapies and we are ready to grow with them into their commercial phase.”

Granules to Expand Indian API Plants

Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank.

The Indian drug firm confirmed the plan that it will use the $47.5m (€44.9m) World Bank grant to build the Bonthapally active pharmaceutical ingredient (API) plant and up capacity at its ingredient facility in Visakhapatnam (Vizag).

Granules will also increase capacity at a plant in Gagillapur where it produces pharmaceutical formulation intermediates (PFIs).

A spokesman for the firm said, “Existing capacities are not sufficient to meet customer demand” adding the new and expanded facilities will supply both local and international markets.

He also confirmed the expansions will create jobs.

Granules also confirmed that it plans to add manufacturing capacity at its finished dosage facility in Chantilly, Virginia in the US. However, the firm related that World Bank grant will not fund the project.

The spokesman said: “Investment in finished dosage facility at Chantilly, Virginia is being funded through internal accruals and funds brought in promoters.”

News of the plan to invest at Vizag follows just a few months after the facility was inspected by the US Food and Drug Administration (FDA).

The visit - confirmed by Granules in a Bombay Stock Exchange (BSE) filing in December - saw the US agency raise seven (7) observations,” details of which were not provided.

At the time Granules' head of investor relations, Sumanta Bajpayee said, “This the first inspection for the site and we believe it is positive step towards getting the site approval."

He added: “Teams have already acted upon some of these observations and will send the response to the FDA within stipulated time period. We cannot disclose the observations till we submit our response to the FDA."

Richmond CRO Opens Site at London Guy’s Drug Research Unit

Richmond Pharmacology has opened up a third Phase I research center in London Bridge, taking over the former Drug Research Unit at Guy’s teaching Hospital.

The London, UK-based contract research organization offers outsourced services for early phase trials including Adaptive, Thorough-QT, Japanese Bridging Studies and Patient Studies in oncology and indications like amyloidosis.

The new center in London Bridge offers expanded capacity in the capital, designed to help Richmond conduct further patient recruitment locally through the NHS.

“London [has] 8.3 million NHS patients, a third of which were born overseas, provides an excellent platform for clinical research organizations like Richmond Pharmacology,” said Sarah Haywood, CEO of Med City UK.

Based out of national health service (NHS) teaching hospitals Croydon University Hospital and St George's University of London, Richmond claims that overall it conducts approximately 10% of all Phase I studies performed in the UK, and 1 in every 100 studies worldwide.

To do this, the firm utilizes a data management system able to cope with its 200,000 patient database called RPL Data Management, which it launched as a service in 2009.

Jorg Taubel, CEO of Richmond Pharmacology said: “The opening of our new research facility, at what was formerly known as the Guy’s Drug Research Unit, is an exciting addition to our research capability, and will help us to provide the best possible support for our clients in their drive to increase the effectiveness and cost efficiency of developing new drugs and taking them to market.”

Quintiles Ltd. also has Phase I research links at the Drug Research Unit on Guy’s campus.

Curtec Production Facility Gains Good Manufacturing Practices (GMP) Certification

CurTec has announced its official status as good manufacturing practice (GMP) certified production facility.

Safety and security of packaging is an important consideration for pharmaceutical buyers. There are many quality systems to assure product quality and reliability, but GMP provides the ultimate level of security.

GMP is a system for ensuring products are consistently produced and controlled according to quality standards. It is designed to minimize risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, every time a product is made.

In recent years, CurTec has invested much time and money to implement GMP. A few weeks ago, the production plant in Rijen, The Netherlands, was audited and certified according to the ISO 15378 standard.

Becoming a GMP-certified packaging manufacturer is a milestone in the history of CurTec and a compliment to all the employees who work hard to keep the quality management systems alive and evolving.

With this latest step in quality assurance, CurTec wishes to further inspire confidence to its customers and enable them to increase the added value of their product and the satisfaction of their customers.

Beximco forms Manufacturing JV with Malaysia's BioCare

Beximco Pharmaceuticals Limited has partnered with BioCare Manufacturing Sdn Bhd to make generic drugs for the Malaysian market.

Under the accord, Beximco is helping BioCare set up a manufacturing plant at Seri Iskandar Pharmaceutical Park in Perak, Malaysia.

When completed the plant will be operated by a joint venture firm in which Bangladesh-based Beximco will hold a 30% stake.

A metered dose inhaler manufacturing site has already been completed and deemed to be in compliance with good manufacturing practice (GMP) standards by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) according to the firms.

Nazmul Hassan, Beximco managing director, said: “Our JV with BioCare will help address the unmet needs of patients and physicians by supporting the Malaysian government’s initiative to promote the local pharmaceutical industry.”

Financial details of the accord have not been disclosed, however, according to Beximco’s statement for the six months to the end of December the Bangladeshi firm Taka 16m ($201,000) in BioCare to date.

The Malaysian Government’s Economic Transformation Program was introduced in 2010. The aim is to increase the average income to $15,000 (€14,000) per person, attract $444bn worth of international investment and create 3.3m jobs by 2020.

Part of the plan is to increase the number of drugs made in Malaysia by repurposing existing capacity by enabling multinational companies to license production to local manufacturers.

The efforts have attracted a number of high profile manufacturers.

For example, in 2011 Indian biopharma firm Biocon invested INR500m ($118m) in an insulin manufacturing plant in Johor. Last week the firm was awarded a contract to supply a biosimilar insulin pen by the Malaysian Ministry of Health (MoH).

Services have also been attracted. In 2015, analytical and downstream technology firm Waters has opened a subsidiary in Kuala Lumpur.

Novo Nordisk Foundation Funds Pharma Fermentation Pilot Plant

The Novo Nordisk Foundation has awarded a DKK118m ($17m) grant to fund development of a fermentation pilot plant for cell line scale up experiments at the Technical University of Denmark.

The plant is intended to support development of so called “cell factories,” which are bacteria, yeast and mammalian cells modified to produce drugs or chemicals used their production.

A University spokeswoman said, “The plant will be located in the headquarters of The Novo Nordisk Foundation Center for Biosustainability – DTU Biosustain – that is at Technical University of Denmark in Kongens Lyngby.”

She added that: “We expect the plant to be fully operational by May or June this year.”

The facility will allow researchers to test how the cell lines are impacted by industry relevant parameters like temperature, pressure and oxygenation according to Bernhard Palsson, CEO of the Novo Nordisk Foundation Centre for Biosustainability.

“Developing a cell line that is very productive in small trials does not guarantee that the cells will produce efficiently in the large bioreactors used by industry.

Palsson added that: “The new plant can give a more realistic idea of the potential and the costs associated with specific types of products.”

The Novo Nordisk Foundation Centre for Biosustainability was established at the Technical University of Denmark in 2011 with the support of a grant from the Novo Nordisk Foundation.

A spokesman said the foundation “supports free and independent research at public research institutions and any research result belongs to the researchers and their institutions.”

Sanofi and Lonza JV to Build in Visp

Sanofi and Lonza will construct a large-scale mammalian cell culture manufacturing site in Switzerland, with an initial investment of CHF 290m ($288m).

Lonza will design and construct a monoclonal antibody production facility in Visp, Switzerland, which will be jointly operated with Sanofi to support the French firm’s pipeline, around 60% of which is biologic-based.

Nicolas Kressmann, a spokesperson for Sanofi, said, “This investment supports the launch of these products by enabling Sanofi to expand production capabilities in biologics.”

Projected to be complete by 2020, Kressmann explained that 18 of the French firm’s products are also set for market launch within this timeframe.

This includes six key product launches: Toujeo, Praluent, Dengvaxia, sarilumab, LixiLan and dupilumab, the combined income of which “could generate aggregate peak sales of €12bn to €14bn by 2025,” he explained.

Lonza will leverage its facility design expertise to start construction this year, in a similar style to the firm’s other production sites in the US and Singapore.

Constance Ward, a spokesperson for Lonza, said the space will be designed to accommodate 200 employees, although declined to comment on further details about the facility design.

“Lonza is a highly experienced partner in this field and the capabilities which this joint venture will create are critical to meeting our patients’ needs for these important therapies,” said Philippe Luscan, EVP of Global Industrial Affairs at Sanofi.

As part of the agreement, Sanofi will have additional access to biomanufacturing capacity “to support increasing demands.”

In the new facility, Lonza will be able to market its share and the extra capacity to third parties when it’s not being used by Sanofi.

“The strategic partnership with Sanofi represents the first module in this undertaking; and we are convinced that with this future-oriented approach, we can serve additional customers,” said Mark Funk, COO Pharma & Biotech, Lonza.

“It provides to Sanofi dedicated capacity, which allows for a clear win-win situation for all participants.”

Kressman said, “Over a period of five years, Sanofi has implemented an ongoing investment program in building internal production capabilities.”

These include €250m ($265m) in Vitry-sur-Seine; €350m in Neuville-sur-Saône, both in support of key product launches and reflecting the significant investments Sanofi has made in biologics-based R&D programs; and a €300m investment to expand the Sanofi biologics site at Geel in Belgium.

Biolabex's Mauritius R&D Lab Opens

Biolabex has opened a manufacturing and R&D laboratory at BioPark Mauritius, a biohub in Vacoas-Phoenix south of the capital Port Louis.

The 5,380 sq. ft. (500 sq. m.) facility houses capacity for analytical and manufacturing services, formulation development and regulatory consulting to the pharmaceutical, nutraceutical and cosmetics sectors.

Mauritius-headquartered Biolabex describes the facility as one of its two strategic locations, with the other being its office in Paris.

CEO Marc Labiche suggested that Mauritius site would help the firm attract clients interested in the Island nation’s biodiversity.

He said, "The Mascareignes archipelago and specifically Mauritius, close to Madagascar, is one of the famous biodiversity hotspots in the word, with a large amount of endemic plants. Therefore, Biolabex, a Mauritius-based services firm saw great potential in locating its first laboratory here."

Labiche added that "An international firm will find, with Biolabex, a unique successful combination: First, a rich source of natural active ingredients from locally grown crops, with sustainable development and fair trade.

"Secondly, a full spectrum of R&D and consulting services allowing a rational and scientific use of these local ingredients in developing new cosmetic and pharmaceutical products."

In 2013, the European Parliament backed plans for a trade partnership with East African nations.

The agreement – which is currently being negotiated - includes provisions to increase European firms’ access to markets in Madagascar, Mauritius, Seychelles and Zimbabwe, with pharmaceutical being among the products mentioned.

Allergan Expands in Ireland

Allergan has committed €42m ($44m) to increase capacity and capabilities at two manufacturing facilities in Ireland.

“The investment will encompass the company’s Clonshaugh and Westport manufacturing operations, supporting increased manufacturing capabilities for some of Allergan’s key current and future products,” a spokesperson said.

The 61 acre site in Westport, located about 200km west of Dublin, makes sterile pharmaceutical ophthalmic and biologics and was subject to a €270m investment in 2012 to support botox production.

“[The latest investment] will go towards adding additional capacity to its eye-care manufacturing operations and the expansion of its ocular implant manufacturing facility to accommodate both a capacity increase for existing products and also the capability to accommodate new products using this technology platform.”

Clonshaugh, meanwhile, was added to the firm’s network in 2014 when Allergan – at the time known as Actavis – acquired Forest Laboratories for $28bn.

Operations at the GMP site include weighing, mixing, granulation, tabletting, coating and packing of raw materials.

The announcement comes as Allergan celebrates 40 years in Ireland, a country which has become a major small and large molecule manufacturing hub for the pharmaceutical industry.

“Allergan were amongst the early arrivals to Ireland and helped to sow the seeds of what was then our emerging pharmaceutical sector, which thankfully took root with much vigor over the intervening years,” Ireland’s Taoiseach Enda Kenny said in a statement.

“Allergan has undoubtedly made a significant contribution to making Ireland home to a world class pharmaceutical industry and I wish to thank them for their ongoing commitment to their Irish operations.”

Currently the firm employs around 1,700 workers in Ireland, 1,100 of which at the Westport site.

“We do expect the investment into increased manufacturing capabilities and capacity will lead to new job creation,” the spokesperson said. “The company will provide further details as the projects advance.”

Merck KGaA's Allergopharma Opens Production Facility

Merck KGaA has opened a €42m production facility in Reinbek near Hamburg, Germany.

The 64,560 sq. ft. (6,000sq. meters) facility will be operated by Merck’s subsidiary Allergopharma and will focus on the production of treatments for allergy, including allergic asthma and hay fever.

Merck has been constructing the facility since 2013. At the time the firm said the facility would support expansion into new markets including China.

This was reiterated by COO Simon Sturge who said that the facility is part of a "global expansion, and will support our growing business in the allergy market place.”

Baxter and ScinoPharm Partner

Up to 20 injectable cancer drugs will be made at facilities in Taiwan and Germany under terms of a partnership between Baxter and Scinopharm.

Baxter International and ScinoPharm Taiwan announced a strategic partnership to develop, manufacture and commercialize an initial five oncology drugs, with scope for an additional 15 injectable molecules.

“The collaboration with ScinoPharm represents a rare and compelling opportunity to partner with one of the world’s leading active pharmaceutical ingredient [API] manufacturers with a 17-year history of quality and safety serving the global pharmaceutical industry,” said a spokesperson from Baxter.

“Current branded sales of the initial five products included in this partnership total more than $4bn annually. Baxter is not disclosing specific cost details associated with this partnership.”

Manufacturing will be carried out at both Baxter’s facility in Halle, Germany and Scinopharm’s injectable plant in Tainan, Taiwan.

A Scinopharm spokesperson added the latter will be ready for registration batch production by 2017, with the first in-house ANDA submission from the partnership set for 2018, and a subsequent US FDA inspection approval expected in 2019.

“ScinoPharm will be responsible for raw material sourcing for all APIs and the injectables made in-house by ourselves,” said Scinopharm. “Baxter will be responsible for raw material sourcing for the injectables made by themselves.”

Scinopharm invested NT$1.1bn ($36m) into its Tainan site in 2012 to build a high potency cytotoxic injectable plant, and as such does not need to add new capacity or staff to service this collaboration.

Ashland Opens Pharmaceutical Technical Center in Shanghai

After one year of construction and a month to fine-tune new equipment, Ashland put on display its Pharmaceutical Technical Center in Shanghai, formally opening the facility following a major upgrade. The state-of-the-art complex now accommodates all of the scientists and equipment Ashland requires to solve complex challenges for China’s producers of solid dosage forms.

Doubling the size of the original complex built in 2008, Ashland is now able to provide a range of pharmaceutical technical services to create and apply specialized chemistry in ways that enable customers to amplify the efficacy, refine the usability, add to the allure, ensure the integrity, and improve the profitability of their products and applications. These include binding enhancement, disintegration improvement, modified release, solubilization and film coating in China, to help companies operating in the country to improve the performance of tablets and other solid dosage forms.

Speaking to an audience of more than 80 guests during a dedication ceremony, Ashland’s Chairman and Chief Executive Officer, William A. Wulfsohn, expressed the extra value that the company brings to China’s pharmaceutical industry with an advanced facility and technical team firmly grounded in science-based solutions.

“The grand opening of Ashland’s pharmaceutical technical center is a testament to the demand for our scientists and process engineers who can look at a problem from a molecular perspective and move it all the way to a formulation and manufacturing solution,” said Wulfsohn. “It is our sincere hope and expectation that this newly expanded facility will be the site of many comprehensive solutions that further advance the pharmaceutical projects of our customers in China.”

Ashland currently operates three pharmaceutical technical centers throughout the world, including one in Wilmington, Delaware (USA), and one in Hyderabad, India. All three facilities operate individually – and in tandem – for the benefit of Ashland’s customers working regionally or globally.

One of the major challenges in the pharmaceutical industry is the rise of complex drug molecules that require new approaches to oral drug formulation and manufacturing. Scientists at Ashland’s Shanghai facility now use more advanced equipment on site to help customers in Asia enhance the solubility and bioavailability of sophisticated drugs with novel applications of excipients – the inactive but functional substances that serve as drug delivery systems.

David Neuberger, Vice President of Pharmaceutical, Nutrition and Agricultural Specialties expressed the importance of a full-service laboratory in Shanghai that enables the full and proper use of Ashland’s excipients in today’s more complicated world of oral drug formulating.

“Understanding excipient technologies and how they work within the context of specific drug molecules is our bailiwick,” said Neuberger. “Bringing that specialized expertise to our newly expanded pharmaceutical technical center in Shanghai, and adding the equipment we need to work alongside our customers, is a ‘healthy’ development for Ashland and China’s pharmaceutical industry.”

Among the equipment Ashland now has in place at the state-of-the-art facility are granulation, tableting and coating systems. The company also has in place pilot-scale manufacturing methods for continuous processing of oral dosage forms, such as hot-melt extrusion and spray drying of solid dispersions.

“Everything is now in place to perform all critical drug-excipient analysis and relevant trials pertaining to our customers’ projects in Asia,” added Neuberger.

APC Filtration Expands

In a strategic move to increase supply chain efficiency, expand air filter manufacturing operations, filter testing and create a world class research and development (R&D) facility.

APC will relocate its two existing manufacturing operations into a brand new, single facility located at 10 Abbott Court, Building “C”, Unit 303, Brantford, ON, N3S 0E7. This development will allow APC to more efficiently serve its entire customer base in North America with added responsive manufacturing and distribution footprint.

The target date for building completion is March 31, 2017. APC started to move its Ancaster, ON manufacturing and filter testing facilities on February 1, 2017 in preparation for the grand opening on April 3, 2017. APC will be contacting customers to minimize supply chain disruptions in the month of March.

APC will also carry out several expansion investments to meet current and future customer requirements.

APC will be expanding its cleanroom facility to support growing military, defense, pharmaceutical, life sciences and restoration markets. This cleanroom will be a world class facility manufacturing and testing HEPA and ULPA filters for critical air applications.

This expansion complements APC China’s current filter manufacturing and cleanroom facilities allowing APC to be more responsive globally and increase product development speed. The new Brantford facility will focus on development for local markets in North America, while APC China continues to use its global research and development for global product platforms.

“Having engineering, R&D, manufacturing and testing facilities under one roof will allow us to quickly develop custom filter products to meet our customer’s specific requirements,” said Russell Kelly, President of APC Filtration Inc. “The Brantford expansion is designed with our customers in mind as we continually strive to enhance new technologies and provide superior customer service as our long tenure of clients have come to expect from APC.”

Clariant Healthcare Packaging Facility

Clariant, a world leader in specialty chemicals, recently announced that the construction of its new greenfield production facility in Cuddalore, Tamil Nadu, India is proceeding as planned and is expected to begin production of dessicant canisters by the second semester of 2017. This plant will be a significant contributor to Clariant's global desiccant canister production.

Clariant's business line Healthcare Packaging had conducted the groundbreaking ceremony of this plant in January 2016. This facility will manufacture desiccant canisters, the primary desiccant platform for high-speed, high-volume packaging lines, often the case for generic drug manufacturers. In addition, Clariant is already assessing plans for expanded production, including plans to add high-capacity multi-lane production of its versatile Continu-StripTM desiccant packets, which can be inserted with numerous types of standard dessicant insertion machinery.

Clariant's extensive manufacturing footprint ensures quick delivery and competitive pricing, as well back-up capacity to meet the BCP (Business Continuity Planning) requirements of global players in the pharmaceutical industry. All products produced at the Cuddalore facility will meet US FDA and EU standards for use in pharmaceutical applications and will be USP compliant. The Cuddalore facility is equipped with an ISO Class 8 cleanroom and will implement GMPs and environmental controls with a path toward ISO 15378 certification.

"The new site will serve the Indian pharmaceutical industry with state-of-the-art desiccant products produced under the strictest quality and compliance standards, and within a secure, truly global manufacturing network," said Matthias Brommer, Head - Clariant Healthcare Packaging. "We are extremely excited that facility construction, and production plans are moving at full speed ahead, according to schedule. The production capabilities at this new facility will add significantly to our global dessicant canister production capacity during 2017."

Ketan Premani, Head – Healthcare Packaging India, adds that, "The facility will also offer the full range of globally produced Clariant protective packaging systems and components and link customers to Clariant's global packaging design capabilities. The facility and the other Healthcare Packaging facilities around the globe ensure available back-up capacity to meet the BCP (Business Continuity Planning) requirements of our global customers."

Advanced canister mold and assembly designs ensure their ability to withstand the rigors of high speed insertion, packaging, and use. Colored labelling — including bright red — is available to help differentiate desiccant canisters from drug products.

Clariant Healthcare Packaging is the leading supplier of pharmaceutical desiccants in India, with a long history of working with both branded and generic drug manufacturers. The Cuddalore facility, the newest in the rapidly expanding global manufacturing network through which Clariant Healthcare Packaging produces and delivers its desiccant and sorbent products, joins existing production facilities in the U.S.A., France, and China. The new facility is strategically located within the Bangalore/Chennai biopharmaceutical cluster, one of India's busiest pharmaceutical hubs, and is positioned to leverage Clariant's existing network and logistics resources to serve customers throughout India.

Takeda Builds Vaccine Manufacturing Plant

Takeda Pharmaceuticals Company will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany, the company announced on Nov. 29, 2016. The decision follows the successful initiation of a global Phase III clinical trial to evaluate the efficacy of a two-dose schedule of Takeda’s dengue vaccine candidate.

According to the World Health Organization, dengue is the fastest-spreading mosquito-borne viral disease, and 40% of the world’s population lives under the threat of the dengue virus. The plant will help meet important unmet needs in dengue prevention.

“Our colleagues in Singen have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine finished product,” noted Thomas Wozniewski, Global Manufacturing & Supply officer at Takeda, in a press release. Initial construction activities will start immediately, and the facility should be ready for production in 2019.

On Sept. 7, 2016, Takeda vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES). TIDES is now enrolling approximately 20,000 healthy children between the ages of four and 16 years living in dengue-endemic countries in Latin America and Asia. The study is a Phase III double-blind, randomized, placebo-controlled trial of Takeda’s live-attenuated tetravalent dengue vaccine candidate. The study is evaluating the efficacy of the vaccine candidate to protect subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the individual has previously been exposed to the virus. The study is also evaluating vaccine safety and immunogenicity, with two doses of the vaccine candidate or placebo administered 90 days apart.

“This dengue vaccine production facility is another strong indication of Takeda’s long-term commitment to vaccines,” said Dr. Rajeev Venkayya, president of Takeda Vaccines, in the press release. “The progress of the dengue TIDES clinical trial, our partnership with the Bill & Melinda Gates Foundation to eradicate polio, the recent initiation of the world’s first field efficacy trial for a norovirus vaccine, and our work with the US Government to develop a Zika vaccine, together demonstrate how Takeda is dedicated to developing and providing vaccines to protect people in need wherever they are.”

Valitacell Opens New Facility

On Nov. 30, 2016 Valitacell opened a new facility at the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland. The team will include a staff of four led by Terry McWade, CEO. Valitacell is an Irish early-stage life-science company with technologies that improve cell performance. Valitacell’s ChemStress technology replicates the stress cells encounter in an industrial bioreactor. This is achieved by coating the wells of the 96-well plastic plate with chemicals that have been selected based on their ability to impact the cells’ metabolism.

Chinese hamster ovary (CHO) cells are grown on the plate, and the response of the cells to the individual chemicals is measured in terms of cell growth and ability to produce the drug. The overall response to the individual chemicals is known as the stress response fingerprint. The stress response fingerprint is the basis for several applications that when combined with analytical algorithms, can predict cell performance, cell stability, confirm cell identity, and detect batch-to-batch changes in the food media used to grow the cells. The initial target for Valitacell’s technology is the biologic drug market.

Almac to Expand in Ireland

Almac Group will expand in Ireland by building a new facility set to employ 100 people in Dundalk, County Louth, at IDA Business Park, the company and Irish economic development agency IDA Ireland said today.

The company did not disclose the value of the new facility, except to say it would represent a “multimillion” pound investment designed to support ongoing global expansion in response to growing demand for its products. The new facility would add 32,000 square feet to its space across Europe, and provide a long-term presence for the company within the EU, Almac said.

Almac is headquartered in Northern Ireland, within the U.K.—where the government of Prime Minister Theresa May published the long-awaited bill giving her the power to trigger the “Brexit” by notifying the E.U. of the kingdom’s plan to leave.

“Almac’s decision to expand into Dundalk provides the company with certainty of access to the EU in the long term. This certainty of access is an increasingly important selling point for Ireland as we look to win business for Ireland,” IDA Ireland CEO Martin Shanahan said in a statement.

Almac’s expansion into Dundalk comes more than 2 months after the company disclosed plans for three expansion projects totaling £27 million (about $34 million)—one in the U.S., two in Ireland—set to increase its global workforce to more than 5000 employees by the end of 2017.

Almac said it would add to its existing 240,000-square-foot facility in Souderton, PA, and lease a 26,000-square-foot office space in nearby Lansdale, PA, projects projected to cost a combined £20 million ($25 million). The project is projected to create 312 new, full-time jobs and increase capabilities for Almac’s Sciences, Clinical Services, Clinical Technologies, and Pharma Services businesses.

In return, Almac won a proposed £1.3 million ($1.6 million) Pennsylvania First Program grant from the state’s Department of Community and Economic Development.

The company also said it will spend £5 million ($6.3 million) to build an additional laboratory and office facility at its global headquarters in Craigavon, Northern Ireland, as well as £2 million ($2.5 million) toward a renovation of the Arran Chemical Company facility in Athlone, Ireland, designed to add to its manufacturing capacity as well as its distillation and drying capabilities. Almac acquired the site in 2015.

In Craigavon, about 170 existing employees will be transferred to the new building, including chemists and analysts involved in supporting drug research, development, and manufacturing.

McIlvaine Company

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