SCHOTT has set up a ready-to-use (RTU) center of excellence at its Lebanon, PA production facility, aimed at bringing together SCHOTT’s experts and pharma partners at the heart of manufacturing. Coinciding with the launch, SCHOTT hosted a symposium on packaging trends and current production considerations, including the need for closer partnerships between the pharma industry and its suppliers in order to uphold patient safety, reduce particle contamination in packaging, and secure the supply chain.

Experts at the SCHOTT event reported that specialty drugs are driving medical growth in developing countries, and the self-administered drug market is expected to double in the next five years. Also, particle-related drug recalls have increased more than 300% since 2012, according to the company. Pharmaceutical manufacturers are relying more on RTU packaging in an effort to achieve particle-free drug filling, and it allows for filling different container formats on the same filling line, making the processing of smaller batch sizes more cost-effective.

SCHOTT’s Lebanon manufacturing plant will serve as a hub where SCHOTT and its partners can develop solutions to exploit the full potential of sterile packaging concepts. Also, the plant’s manufacturing capacity ensures the security of supply of RTU vials and other pharma packaging.

At the launch, SCHOTT highlighted its adaptiQ system for RTU vials, which come sterile in a nest and tub configuration. The nest holds as many as 100 sterile vials, which can be loaded onto production lines without the manufacturer having to perform pre-treatment steps such as washing, drying, or sterilization, according to the company. The system is designed to reduce scratches from vial-to-vial and vial-to-machine contact during the entire process, including lyophilization. Finally, adaptiQ has been designed so vials can be filled on production lines normally used for syringes, with minimal changeover times.

“Packaging is a critical cog in pharmaceutical delivery, and recent regulatory papers highlight the importance of high-quality processing and manufacturing of packaging,” said Christopher Cassidy, vice president sales and marketing of SCHOTT Pharmaceutical Systems in the U.S. “SCHOTT’s center of excellence in Lebanon is the manifestation of the relationship we have with our partners, and our collaborative efforts create safe, reliable, and easy-to-use packaging products.”

Sterigenics to Expand Sterilization Capacity

Sterigenics International the global provider of contract sterilization, gamma technologies and medical isotopes, is investing $15 million to expand its West Memphis, AR facility that will triple gamma sterilization capacity.

The facility currently offers 2.5 million cubic feet of gamma sterilization capacity and with the installation of a new gamma cell will triple capacity to 7.5 million cubic feet and upon completion in early 2017, will result in approximately 20 additional jobs.

“Our West Memphis location is experiencing increasing demand for sterilization services,” said Philip Macnabb, president of Sterigenics International LLC. “Given the importance of Memphis as a major U.S. logistics hub, it is a critical piece of our global network that we will continue to build upon and expand in order to best serve customers.”

Catalent to Expand Biologics Facility in Wisconsin

Catalent says it is contemplating expanding its Wisconsin single-use biologics facility as strong demand from SMEs and biotechs has almost filled current capacity.

Catalent’s Vice President of Global Operations Steve Leonard said the contract development and manufacturing organization (CDMO) is ready to expand its biomanufacturing site in Madison, Wisconsin in order to keep up with strong demand for services.

“We’re contemplating the next round of investment, as the significant investment made out there a couple of years ago is really almost full already - which is a great problem to have,” he told us.

“When we built the facility , we built enough footprint to house additional suites inside and so we’ve facilitated a couple of the equipment trains and suites, and we’re now starting to look at the next round of investment to fund some more scale capacity.” While Leonard said an expansion would further increase commercial capabilities – the firm has recently implemented a 1,000L single-use bioreactor – much of the space is dedicated to early-phase projects, driven by demand from biotech and start-ups looking to speedily move their molecule through the development process.

“In the biologics space, the majority of our business and our new clients is coming from the SME sector,” he said. “We deal with a lot of early phase startups that are moving from one venture capital funding tranche to the next.

“Our job is to help them as quickly as we can to get to the proof of concept and reach the next milestone so they can get there next tranche of funding.”

This is why the facility is fully single-use, he continued, as the speed associated with disposable equipment is the most important factor for such customers. “They have a tranche of funding and they’re on the clock, so everyday matters and if we’re taking time to turn around, cleaning validation and all the risks that come with that they just can’t tolerate that.”

A common strategy for biotechs and start-ups is to sell their molecules to larger players once they have proved successful in the early-stages, and Leonard said Catalent is keen to continue “to have a relationship with that molecule as it changes hand.”

But Big Biopharma firms often have their own manufacturing networks which “their first priority is to fill up,” and therefore Leonard said Catalent has on occasion seen some products that it made in clinical batches move to Big Pharma.

“Where they have the capability, their first tendency is to make it themselves, and who can blame them?”

However, he added such firms are still major customers for Catalent, “they’ll continue to outsource for reasons of cost, reasons of capacity and reasons of specialist technologies, and the latter of these has always been our sweet-spot.”

Althea Building Site for Highly Active Bioproduction and ADCs

CDMO Ajinomoto Althea is opening a new facility to offer outsourced ADC (antibody drug conjugate) and HPAPI (highly potent active pharmaceutical ingredient) manufacturing, the Californian company has announced.

The contract development and manufacturing organization has begun retrofitting a facility it bought in May near its existing site in San Diego. It plans to open the site in Q2 2016, with full operations at the start of 2017.

The finished 57,000 sq. ft. plant will offer bioconjugation, formulation, purification, quality control, and aseptic fill-finish including lyophilisation. Construction includes measures for safe handling of very low OEL (Occupational Exposure Limit) compounds under high containment, aseptic and GMP conditions.

Althea said the site will offer clients contract services from early clinical phase to commercialization.

Althea’s head of ADCs, Jason Brady, said “Currently, there is limited capacity of high containment manufacturing in the United States. Althea is excited to make this significant expansion of our service offerings to address the needs of the ADC market as well as other highly potent products. Given our existing core capabilities in complex biologics formulation and aseptic filling, this investment in ADC and HPAPI fill finish manufacturing is a natural progression and logical step for Althea.”

Ajinomoto Althea was formed in 2013 when Tokyo-based chemical company Ajinomoto bought US CDMO Althea for $175m, including its biopharmaceutical production capabilities for microbial-derived recombinant proteins and plasmid DNA, upstream and downstream process development, analytical development, lyophilisation cycle, complex formulation, product release, ICH stability testing and cGMP vial and syringe filling.

Danish Novo Nordisk Planning New North Carolina Facility

Danish pharmaceuticals group Novo Nordisk is planning to invest $2 billion in new production facilities over the next five years, including a new active pharmaceuticals ingredients site in North Carolina, the company said in a statement.

The new facility will be based in Clayton and is expected to create close to 700 new production and engineering jobs. Novo Nordisk already employs around 700 people at its existing facility in the town.

Clayton’s newest facilities will produce active pharmaceutical ingredients (API) for existing and future diabetes drugs, but the company recently announced that it will initiate phase 3a development of oral semaglutide, which will be used to treat type 2 diabetes.

“We decided to place the new API facilities in the US for strategic reasons,” Novo Nordisk executive vice president Henrik Wulff said.

“The US is by far our largest market and there are many logistical and economic advantages of having a larger part of our manufacturing in our main market. After a thorough evaluation of multiple sites and an extensive vetting process, Clayton ended up being our preferred location,” he added.

“We already have a large and very professional organization there and an excellent collaboration with city, local and state leadership, and we appreciate the incentives they have secured in connection with this investment,” Wulff said.

Novo Nordisk is also planning a new facility in its native Denmark and the company said the expansion is aimed at helping it to meet the increasing worldwide demand for its diabetes medicines.

Cornell Partners in New Cancer Centre

Cornell University, in partnership with Memorial Sloan Kettering Cancer Center (MSKCC), is opening a new US$10m Center of Cancer Nanotechnology Excellence that brings together scientists, engineers, biologists and physicians to develop and translate new cancer care applications based on nanotechnology.

The MSKCC-Cornell Center for Translation of Cancer Nanomedicines is funded with an $8.2m grant from the National Cancer Institute’s Alliance for Nanotechnology in Cancer and more than $1.9m from MSKCC. The center, which will have one facility in Duffield Hall on the Ithaca campus and another at MSKCC in New York City, will focus on melanoma and malignant brain cancers.

The MSKCC-Cornell Center is based on the development and translation of Cornell dots (C dots), silica-organic hybrid nanoparticles smaller than 10nm in size that are designed to either adhere to and light up cancer cells or quickly leave the body. C dots are being tested in human clinical trials, opening the door to transformative research and the development of new clinically promising classes of nanoparticles and their applications in cancer diagnostics, surgery and targeted drug delivery.

Work in the MSKCC-Cornell Center will include development of intraoperative optical detection tools to improve cancer localization, staging and treatment, as well as optimized therapeutic platforms that enhance delivery relative to existing technologies.

‘We couldn’t be more proud to have this center supporting the partnership between Cornell and MSKCC,’ said Lance Collins, the Joseph Silbert Dean of Engineering. ‘This moment is the culmination of many years of innovative work by many exceptional researchers at both institutions. Without the foundational success of C dots, we probably wouldn't have been successful with the grant.’

Uli Wiesner, C dot creator and the Spencer T. Olin Professor of Materials Science and Engineering, stresses collaboration as key to the success of the center, which he will co-direct with Dr. Michelle Bradbury, Director of Intraoperative Imaging at MSKCC and Associate Professor of radiology at Weill Cornell Medical College. ‘You can’t do this alone,’ Wiesner said. ‘The medical community doesn’t have enough nanomaterial know-how, and we, the scientists and engineers, don’t have enough experience in the medical area. But to keep a team together for more than 10 years to successfully translate an idea from conception to human clinical trials is not easy.’

The MSKCC-Cornell Center for Translation of Cancer Nanomedicines will focus on four main areas: foundational science; multiplexed optical diagnostic applications in the surgical setting; particle radiotherapeutics; and the assessment of particles in brain tumors for cancer therapy.

Although the MSKCC-Cornell Center will focus solely on preclinical research, it is partnering with two companies, one of which will focus on clinical applications. The yet-to-be-named start-up will seek funding to help translate the center’s research into more human clinical trials.

IDT Biologika Launches US Manufacturing Operation

German life science firm IDT Biologika has commissioned its first US vaccine manufacturing facility in Rockville, Maryland. The state-of-the-art facility provides the translational bridge between pre-clinical development and phase II clinical trials with end-to-end capabilities, including process development, cell banking, cGMP manufacturing, purification and formulation, and fill and finish.

The Rockville facility is BSL-2 compliant and meets all US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards.

IDT Biologika shares the 75,000ft2 (around 7,000m2) building with Aeras, a nonprofit, global biotech organization developing new tuberculosis vaccines. The two companies will work together on process development and manufacturing of candidate tuberculosis vaccines.

'The Rockville facility marks a milestone for IDT Biologika as we expand our worldwide operations into the U.S. and continue our commitment to meet the vaccine development and production needs in key markets,' said IDT Biologika Corporation President Dr. Ralf Pfirmann. 'With the new facility, we provide US companies with a highly capable and experienced CMO partner for phase I and phase II clinical vaccine projects right from the heart of the BioMaryland corridor.'

Ben Wu, Deputy Secretary of the Maryland Department of Business and Economic Development, added: 'IDT Biologika’s decision to locate here is another example of how international companies are viewing Maryland as a prime location for their cutting-edge research and discoveries that are improving the lives of people across the globe. Our state is home to many vaccine, biotechnology and pharmaceutical companies, to renowned academic institutions, and to government agencies vital to the development of vaccines.'

U.S. Hospitals Pioneer Mobile Compounding Cleanroom

Duke Raleigh Hospital in Raleigh, North Carolina in the US, recently became the first healthcare facility to use a certified USP 797 mobile cleanroom to assure uninterrupted pharmacy services.

The advanced pharmacy unit, created by Germfree Labs of Florida, allowed the hospital, an acute-care facility, to maintain separate, on-site sterile drug compounding operations during a major renovation project.

During building renovations it is vital that IV compounding operations are not interrupted or otherwise disturbed. Full compliance with all regulations is critical to ensure an environment for safe and aseptic compounding of pharmaceuticals.

Duke Raleigh worked with Germfree, the manufacturer of a turnkey mobile USP 797 pharmacy-cleanroom. The fully equipped unit was engineered to provide the advanced functionality and ample capacity required for operation in a hospital. 'The mobile pharmacy was the perfect platform to continue all operations on-site,' said Gene Woodall, Duke Raleigh's Director of Pharmacy. 'We were able to deliver vital sterile compounded preparations without interruption while maintaining our extensive quality assurance protocols and rigorous standards for product sterility. Concurrently, renovations to improve our main facility commenced with absolutely no impact on compounding services.'

Germfree Labs of Florida, US, supplied the advanced pharmacy unit to Duke Raleigh Hospital

The remodeling of a hospital pharmacy presents a number of challenges to maintaining sterile drug compounding operations. 'Traditional approaches are cumbersome and costly,' said Sal Golfo, General Manager of Germfree's Pharmacy Division. Some facilities are forced to renovate one section at a time, extending and complicating the project. Other hospitals resort to outsourcing their compounding, which adds cost and impedes workflow.

'Our challenge was to design and deliver a complete mobile pharmacy that would be immediately operational. It was imperative that the unit provide a comfortable workspace equipped to facilitate all sterile or hazardous drug services conducted in a traditional building,' said Golfo. The mobile pharmacy has distinct, controlled work zones engineered as ISO 7 environments.

The Hazardous Drug Preparation Room operates under negative pressure and is equipped with Class II Biological Safety Cabinets. The Sterile IV Preparation Room operates under positive pressure and is equipped with Laminar Flow Workstations.

Woodall added: 'During the initial planning of our renovation project, we knew we needed an innovative plan to maintain the output levels and quality standards required for our sterile compounding services. 'Germfree's mobile pharmacy provided an advanced, comprehensive unit with all the resources we needed to provide seamless sterile compounding during the renovations at Duke Raleigh Hospital.'

UPM Opens Solids Formulation R&D Facility

UPM has announced the opening of its newly designed and qualified Solids Formulation R&D Facility. The facility is comprised of 4,000 square ft. with capabilities for a wide range of pharmaceutical formulation development, including four processing suites fitted with down flow booths, a wash room, dedicated feasibility materials storage, humidity controlled capsule shell storage, and an in process testing room. The facility contains dedicated R&D equipment that is state of the art and scalable to clinical processing, including wet and dry granulation, particle size reduction, encapsulation, multi-layer tableting, granules, coating, hot melt extrusion and liquid fill into hard shell capsules. Batches can be processed with as little as a few hundred grams of powder allowing clients to evaluate a broad range of processes before selecting one to scale up. Additionally this saves API that is often expensive or in limited supply.

Jim Gregory, UPM's CEO says, "At UPM we have a strong history of formulation development expertise, now combined with state of the art R&D facilities and equipment. We are your partner from concept to commercial on your journey to market."

Covance to Open Second cGMP Pharmacy in U.S.

Covance Drug Development is set to open a cGMP-compliant pharmacy at its clinical research unit in Madison, WI, allowing for on-site production of high quality, customized pharmaceutical products for clinical trials.

Covance, which opened its first cGMP pharmacy at its Dallas, TX facility earlier this year, is the only CRO to implement cGMP standards for Phase I manufacturing of investigational drug products in a U.S. Phase I clinical research unit.

The Madison cGMP pharmacy will be available for client audits beginning in October. Small-scale cGMP manufacturing meets the highest regulatory and safety standards and lowers the cost to manufacture pharmaceutical products for clinical trials.

Covance’s facilities offer certified cleanrooms that support a full range of sterile manufacturing, including aseptically prepared sterile parenteral investigative drugs and radio-labelled doses, as well as non-sterile investigational drug products.

“With dedicated pharmacists, production teams, and direct cGMP quality assurance oversight, Covance provides industry-leading quality and cost-effective manufacturing services with greater flexibility to help clients meet their Phase I clinical trial needs,” said Herman Scholtz, vice president and general manager, early clinical services, Covance. “These new drug development solutions demonstrate our commitment to providing innovative and differentiated solutions to streamline and enhance clinical trials, bringing innovative medicines to patients faster, and helping change the way care is provided.”

Hovione to Expand New Jersey Facility

Hovione is expanding its facility in East Windsor, NJ, increasing its global development and commercial capacity with an additional 30,600 ft² of space. The company will introduce a new commercial spray dryer unit specifically designed to handle potent drug substances (APIs). The expansion will more than double the drug substance capacity at the site and is expected to add approximately 60 new jobs.

“Expanding our manufacturing presence in the U.S. highlights our commitment to our customers that want to manufacture their products in the U.S. and to support the development needs of our ever expanding local customer base. The additional capacity will give us more flexibility and make us more agile to deal with our customer’s fast paced projects.” said Dr. Marco Gil, general manager, Hovione New Jersey.

Frontage Doubles Bioanalytical Lab Capacity in USA

Frontage, a full service contract research organization (CRO) located in the USA and China, has announced the expansion of its bioanalytical laboratories to meet increased demand for its services from existing and new biopharmaceutical clients.

As one of the leading providers of bioanalytical services for small molecules, large molecules and biologics, including the bioanalysis of Antibody Drug Conjugates (ADCs) by Mass Spectroscopy and Ligand Binding platforms, Frontage has completed an expansion of their Exton, PA operations.

With an additional 10,000 square feet of laboratories, this expansion allows for the installation of 20 additional state-of-the-art mass spectrometers, including the SCIEX TripleTOF® 6600 System for the measurement of peptides, antibodies and ADCs, and four (4) SCIEX Triple Quad™ 6500 Systems, bringing the number of MS systems to more than 50 globally. Frontage’s expansion increases the site’s deep freezer capacity to thirty-two (32) -70 °C freezers, equipped with emergency backup power generation. The company also added laboratories that expand its Biologics service offerings for ECL and ELISA-based assays, as well as its growing DMPK operations supporting discovery-stage pharmacokinetics and development-stage metabolism studies.

Frontage has complemented the facility expansion with the hiring of 21 additional, highly-talented scientific personnel, including eight (8) Ph.D. chemists. With new equipment, lab space and scientific team members, Frontage is continuing its efforts to improve client satisfaction and turn-around times for method development, validation and analysis of regulated bioanalytical samples with an increased capacity of 50,000 samples per month.

“Frontage’s expansion of our bioanalytical and DMPK operations is an essential step of meeting our client’s expectations to provide high quality services efficiently and economically. It is very exciting to see our company grow to meet these demands and have the ability to add some great people to our teams. We have also invested in equipment that will allow us to remain at the forefront of drug development and enable us to analyze increasingly complex new drug candidates. We are thankful for all of the clients that have put their trust in Frontage and for our team members who continue to perform at a high level,” said Dr. Song Li, CEO of Frontage.

Expanding Texas Bioprocessing Industry

The US National Science Foundation grant has been awarded to Austin Community College.

Austin Community College has received a Government grant to establish a center for biotechnology technicians it hopes will provide skilled workers for the Texas biomanufacturing industry.

The $2.9m (€2.6m) Undergraduate Education grant from the National Science Foundation (NSF) will be used to set up the center at Austin Community College (ACC), with aims to grow the number of well-trained technicians in the workforce and meet the needs of the bioprocessing industry throughout the state.

“Biotechnology is a rapidly growing industry in Central Texas and across the nation,” said Linnea Fletcher, ACC biotechnology department chair. “Our goal is to establish best practices and share resources such as curriculum, equipment, and teaching methods with other community colleges and universities across the state.”

The grant will also be used to create internship and externship programs to help bring academia closer to industry in the State.

“We’re developing the workforce that will meet the growing biotech demands from regulatory affairs, and stem cell maintenance to biotechnology-related renewable energy technology and biopharming,” Fletcher added.

Earlier this month, Texas A&M announced it was looking to recruit bioprocessing students and was seeking former military personnel who it deemed would be “particularly suited to the work.”

The growth of the bioprocessing industry is reliant on having skilled workers available, and therefore a number of Governments and companies have been investing in biomanufacturing education and training programs.

Ireland, for example, has always been a global hub of small molecule manufacture but has dealt with a shifting emphasis towards biologics in part through the Government’s €60m creation of the National Institute for Bioprocessing Research and Training (NIBRT).

The center, located in Dublin, has been described as “a flight simulator for biopharma manufacturing” and is backed by industry which is benefitting from the local talent trained there.

Meanwhile in India – another region synonymous with small molecule API manufacture - there has been some concern that a lack of skilled workers is holding back a burgeoning biomanufacturing industry.

India-based biopharma firm Biocon formed, therefore, an academy devoted solely to bioscience education and discovery to help bridge the gap between a lack of lack talent and industry’s future needs.

Plough Center for Sterile Drug Delivery Systems Facility, USA

A new drug manufacturing facility for the University of Tennessee Health Science Centre in Memphis, Tennessee is expected to begin construction in September 2015.

The new facility, which will be known as Plough Center for Sterile Drug Delivery Systems, will house pre-manufactured cleanroom pods for the manufacture and filling of clinical trial drugs. It will provide aseptic formulation and clinical trial drug compounding services on a contractual basis for the private sector.

It will be built in compliance with current good manufacturing practices (cGMP) to produce small-batch drugs in injectable and semi-solid dosage forms for preclinical Phase 1 and Phase 2 clinical trials.

"Pre-fabricated pods will include temperature-controlled and smaller spaces, which will give control over sterilization while preparing, compounding and filling pharmaceuticals."

The facility will be constructed by replacing the 32,000ft² warehouse located at 208 S Dudley Street, which was purchased from Dudley Properties for $750,000 in June 2011. The University of Tennessee filed a $3.7m permit application for the project with the Shelby County Department of Construction Code Enforcement in July 2015.

Adaptimmune Therapeutics announces Expansion Plans in Philadelphia

Adaptimmune Therapeutics plc. announced plans to locate its U.S. headquarters and clinical operations in a newly developed facility to be constructed at The Navy Yard in Philadelphia.

The 47,400 square foot facility, located at 351 Rouse Boulevard in The Navy Yard’s Corporate Center, will house a state-of-the-art cGMP manufacturing facility designed to support the clinical development and initial commercialization of the Company’s novel engineered immunotherapies for cancer.

Adaptimmune, represented by CBRE, has entered into a long-term lease agreement for its U.S. headquarters building being developed by Liberty Property Trust and Synterra Partners. CBRE’s Project Management Group will also advise Adaptimmune in the construction phase of the project. The building is expected to be delivered in late 2016.

“Adaptimmune is in a period of rapid growth on both sides of the Atlantic, and we are putting in place the facilities to enable us to deliver our promising pipeline into the clinic and beyond,” said James Noble, Chief Executive Officer of Adaptimmune. “This exciting new Philadelphia facility allows us to expand our clinical and early commercial manufacturing and control associated costs in anticipation of the commercialization of our product candidates. We are delighted to be working in partnership with key players in Pennsylvania and we regard our commitment to The Navy Yard as a vote of confidence in the city and the region as a powerhouse for scientific and medical achievement. We started Adaptimmune in 2008 through a partnership with the University of Pennsylvania, and we have had roots in Philadelphia ever since. The location provides us with an environment that promotes strong business growth and innovation, as well as access to a rich pool of scientific and clinical talent that we will use to place more than 110 new jobs to the area in the near future.”

Adaptimmune has also announced the construction of a major new laboratory and office building in Milton Park, Oxfordshire providing approximately 67,000 square feet of rentable area. The U.K. facility will support Adaptimmune’s expanding research and development operation and is also scheduled for delivery in late 2016, complementing its U.S. clinical and manufacturing plans.

By leveraging its integrated T-Cell Receptor (TCR) engineering platform, Adaptimmune has established an enviable pipeline of immunotherapy candidates and is already generating promising early data in both solid and hematologic cancers. The company has five phase I/II clinical trials ongoing with its NY-ESO therapeutic candidate, an IND open with its second therapeutic candidate, MAGE-A10, and a third candidate in planning for IND submission in 2016.

Nestlé Health Science to Invest in U.S. Product Technology Center

Nestlé Health Science is investing $70M to create a Nestlé Product Technology Center (NPTC) at the New Jersey Center of Excellence in Bridgewater, New Jersey. The Center will be dedicated to developing innovative nutritional solutions and will open in 2016.

Nestlé Health Science, established four years ago, focuses on deepening the role of nutrition in healthcare, an area that is rich in innovation potential as we learn more about the roles of nutrients in addressing health needs.

The NPTC in Bridgewater will benefit from and contribute to the global R&D network of parent company, Nestlé S.A., the world’s leading nutrition, health and wellness company. It will focus on applied research and innovative product development, sensory perception, engineering and provide technological know-how in packaging.

The activities and teams of the company’s R&D Center in Minneapolis will relocate to the new NPTC, as will the U.S. headquarter functions of Nestlé Health Science, currently based in Florham Park, NJ. The new facility will reinforce Nestlé Health Science’s presence in the Northeast, where its Novel Therapeutic Nutrition business will also open offices in Cambridge, Massachusetts (USA).

Nestlé Health Science CEO Greg Behar said, “This investment reflects our commitment to leading the development of innovative nutritional therapies that change the course of health for people and patients in the U.S. and globally. The new facility will house the latest technologies and people in the field, uniting our R&D and business teams in a region with strong life-science activity; it will enhance and accelerate the quality and speed to market of Nestlé Health Science’s innovations that improve nutritional status and health outcomes.”

Stefan Catsicas, Chief Technology Officer, Head of Innovation, Technology & Research and Development, Nestlé, stated: “The field of nutritional therapy is vibrant with scientific and clinical advances, and this new facility will be dedicated to Nestlé Health Science’s quest to advance the therapeutic role of nutrition, a central part of Nestlé’s wider commitment to Nutrition, Health and Wellness.”

Lilly to Expand NYC Labs

Eli Lilly announced plans to expand its presence in New York City, with an addition of 30,000 square feet of space and about 50 new jobs to its R&D site at the Alexandria Center for Life Science.

Lilly, based in Indiana, said the expansion will strengthen its collaboration with local academic institutions and medical schools. When completed next year, the new space will include a translational immuno-oncology hub and a Lilly platform designed to promote collaboration by allowing scientists access to drug discovery capabilities, including chemistry and lead optimization expertise.

“Searching for the next breakthrough is not a one-person job. In fact, it’s not a one-company job either,” said Jan Lundberg, Ph.D., president of Lilly Research Laboratories. “Discovering life-changing medicines requires a diverse team of dedicated experts from different places and with different viewpoints and approaches. Collaboration, even if the term seems overused, is what allows us to discover medicines more efficiently and successfully.”

Lilly opened a 90,000-square-foot office/lab site for 140 scientists at the Alexandria Center in 2010, a couple years after the company entered the New York City area via the acquisition of ImClone.

This is Lilly’s third strategic R&D expansion this year. In May, Lilly said it will establish the Lilly Cambridge Innovation Center in Cambridge, MA, to focus on new drug delivery and device approaches. And in July, Lilly said it would expand its staff and space in San Diego, at its Lilly Biotechnology Center.

Dale Ludwig, Ph.D, vice president of biologics technology, oncology research, provides a tour of Lilly's NYC labs. Dale Ludwig, Ph.D, vice president of biologics technology, oncology research, provides a tour of Lilly's NYC labs. First stop: MBC Lab, where reagent proteins and antibodies are cloned and engineered for research use. First stop: MBC Lab, where reagent proteins and antibodies are cloned and engineered for research use.

Lilly is focused on developing patient-tailored therapeutics, and key to this approach is a catalogue of biomarkers, said Michael Kalos, Ph.D., chief scientific officer, cancer immunobiology, at Lilly. R&D efforts will focus on three key areas: tumor signaling, tumor microenvironment, and the immune system.

“We and others have recognized that despite the incredible results that have been seen so far in immunotherapy, these agents only work in a subset of patients, about 20 to 30 percent,” said Kalo. “Why and how they don’t work in some patients is a critical component discovery.

“So far, the field has been doing combinations like throwing spaghetti on a wall,” Kalos told Drug Discovery & Development. “We have these molecules, let’s test them with everything else and see if something works.

“Cancer is a complex disease,” said Kalos. “Lilly’s strategy is to obtain a deep mechanistic understanding in our models in NYC about why molecules might be working and why they might not be working so that we can appropriately develop and tailor our strategies, moving forward — and that’s our strong commitment in the immune-oncology hub.”

The 700,000-square-foot Alexandria Center for Life Science also houses pharmaceutical companies, Pfizer and Roche.

Lilly oncology labs at the Alexandria Center for Life Science

The Molecular Biology and Cloning Lab (MBC): the site where reagent proteins and antibodies are cloned and engineered for research use.
The Cell Culture and Recombinant Protein Production Suite: the location where DNA that has been engineered in the MBC lab is introduced into living cells, then cultured to produce recombinant protein, including antibodies, for research use.
The Protein Purification Lab: the place where proteins produced in the production suite are purified away from cells, media proteins and other materials.
The East and Northeast Labs: where recombinant proteins are checked for yield, purity and product quality. In the East lab, antibodies are assessed to confirm whether they can be generated at a commercial manufacturing scale.

Sterigenics to Triple Sterilization Capacity

Sterigenics International, a leading global provider of contract sterilization, gamma technologies and medical isotopes, and a portfolio company of Warburg Pincus and GTCR, has announced a US$15m expansion at its West Memphis (Arkansas, US) facility that will triple the company’s gamma sterilization capacity.

Opened in 1999, the West Memphis Sterigenics facility currently offers 2.5 million cubic feet of gamma sterilization capacity. The installation of a new gamma cell will triple its capacity to 7.5 million cubic feet and, on completion in early 2017, will result in approximately 20 additional jobs at full capacity.

‘As the demand for medical devices grows globally, our customers can be assured that we will add sterilization capacity to meet their needs,’ said Michael Mulhern, CEO of Sterigenics International. ‘The expansion at West Memphis is just one more example of our ongoing commitment to customers.’

‘Our West Memphis location is experiencing increasing demand for sterilization services,’ said Philip Macnabb, President of Sterigenics International. ‘Given the importance of Memphis as a major US logistics hub, it is a critical piece of our global network that we will continue to build on and expand.

The Deerfiled, Ill.-based Sterigenics International, operates 47 facilities in 13 countries in the Americas, Europe and Asia, Sterigenics provides contract sterilization and ionization services for the medical device, pharmaceutical, food safety, and high-performance materials industries.

The company is owned by private equity firms Warburg Pincus and GTCR.

Steris Isomedix Services to Expand Ethylene Oxide Sterilization Facility

Steris Isomedix Services is expanding its existing ethylene oxide sterilization facility in Temecula, Calif., to include small-volume processing. The expansion will add four small ethylene oxide chambers of various sizes to the existing medium-sized chambers already in use at the Temecula facility. Temecula is in Southern California, close to San Diego.

“With the addition of small-volume processing, we are better positioned to support the processing needs of both established medical device manufacturers and regional startup firms,” said Thad Wroblewski, vice president of sales for Steris Isomedix Services. “Not only are we able to offer customers a variety of chamber sizes, the new equipment includes specialty processing options such as low-temperature cycles, parametric release and EOExpress expedited processing.”

In addition to the new chambers, the facility also has updated its existing ethylene oxide processing equipment, including the boilers and chillers. The new chambers will be operational in early 2016, according to the company.

Steris Isomedix Services provides contract sterilization and laboratory services with 19 facilities located in the United States, Canada and Puerto Rico. The company uses gamma, ethylene oxide and steam sterilization for medical device, pharmaceutical and biotechnology customers.

REST OF THE WORLD

ABEC Opens Irish Bioprocessing Equipment Plant

ABEC has begun supplying the Irish biopharma industry bioprocessing equipment from an ex-electronics facility in County Cork, acquired earlier this year.

The firm bought the 87,000 sq. ft. site in Fermoy, Ireland from French Firm FCI in January and has spent the past ten months converting the facility from one that made electronic components for the automotive industry to a bioprocessing equipment plant.

“We are able to engineer, design, manufacture, and test the entire bioprocess and clean utility equipment set,” an ABEC spokesperson said. This includes: “bioreactors, filtration and chromatography systems, single use systems, media and buffer prep/hold systems and CIP systems.”

The site “builds on our capability to deliver complete bioprocess solutions globally,” the firm added. It also has a large local customer base, to which it has already begun supplying, due to Ireland being somewhat of a biomanufacturing hub.

When Merck & Co. (known as MSD outside of North America) recently announced it was upping capacity at its Keytruda plant in Carlow, the news came as part of an ongoing trickle of expansions and investments from Big Biopharma in Ireland.

Last November, Bristol-Myers Squibb – a firm which says it expects 75% of its future product portfolio to be biologics – announced it was investing $900m into a new 30,000 sq. ft. large-scale biologics facility in County Dublin.

Meanwhile, Pfizer has spent upwards of $130m at its Grange Castle, Dublin biologics site, while the country has also seen Eli Lilly, Regeneron and Alexion invest in biomanufacturing capacity.

The new ABEC facility has 50 employees and with the firm recently announcing it is acquiring Kell Stainless in County Meath, total Irish headcount will reach over 100.

Cleanroom Construction in Africa and Middle East

Cleanroom design and build specialist Clean Room Construction (CRC) has broken new ground after being awarded its first contracts for cleanroom projects in Hong Kong and Qatar. CRC’s involvement in the 'world-beating' Cell Therapy Catapult center in Guy’s Hospital in London brought it to the attention of China Regenerative Medicine International Limited (CRMI) in Hong Kong through its collaboration with the University of Oxford.

CRC has been contracted to produce the detailed design for a cleanroom suite at a new stem cell research facility for CRMI, working alongside consultants eXmoor pharma. The design for the 22,596 sq. ft. (2,100m2) facility, which will form part of the China Stem Cell Clinical Applications Centre on the Hong Kong Science Park, is expected to be completed by Christmas.

Over in the Middle East, CRC is starting work this month on building a cleanroom facility for Petrotec in Qatar.

This will be used for the assembly and testing of devices for the petrochemical industry. Petrotec supplies equipment and provides related engineering support to the oil and gas industry in Qatar. All supplies and equipment have been shipped out to Qatar in four High Cube containers in advance of the CRC team flying out to carry out the installation.

'These two ground-breaking contract wins in Qatar and Hong Kong are testament to CRC’s cleanroom design and build experience and expertise built up over the last 50 years,' said Steve Lawton, CRC’s Managing Director. 'Our proven track record in engineering world-class facilities for high profile, industry-defining projects is second to none and we are proud to fly the flag for the UK on this international stage.'

AstraZeneca Opens New Russian Manufacturing Facility

AstraZeneca has announced the opening of its new state-of-the-art manufacturing and packaging facility in Kaluga, Russia, dedicated to the local supply of innovative medicines.

In 2011 AstraZeneca was one of the first multinational pharmaceutical companies to announce plans to invest in the construction of a dedicated manufacturing facility in Russia. Four years on, the company has invested $224m in the development, which is the largest foreign investment in the construction of a new pharmaceutical facility in the country.

Commenting from Russia on the opening of the Kaluga facility, Pascal Soriot, Chief Executive Officer, said: “Our new dedicated production facility will support our efforts to bring innovative medicines from our exciting pipeline to patients in Russia. This opening builds on our investments in clinical research and scientific collaborations in this important country and serves to reinforce our long term commitment to Russia.”

Commercial production will begin early next year and will focus on final-stage manufacturing, packaging and quality control. The site will become fully operational in 2017 and will produce around 40 million packs and 850 million tablets of some 30 innovative medicines every year. This represents more than 60% of AstraZeneca’s medicines marketed in Russia to treat diseases across the company’s therapy areas.

The new facility adds to the expansion of AstraZeneca’s global manufacturing capabilities to support the company’s expanding portfolio of medicines and growing demand, following on from the planned biologics manufacturing investments in Sweden (announced in May 2015), the acquisition of a new site in Boulder, Colorado, US (announced in September 2015) and the expansion in Frederick, Maryland, US (announced in November 2014).

Hovione Refurbishing Site in Portugal

Hovione will spend $10m refurbishing a plant acquired from a Portuguese generics company to create an oral and inhalation formulation site.

The API and ingredients maker says as part of an expansion plan to grow its specialized formulation capabilities, it has bought a facility in Loures, Portugal from generic pharmaceutical company Generis, which it intends to refurbish and incorporate with its ongoing operations.

“The overall investment which includes the acquisition, refurbishment and new equipment will amount to $10m (€8.8m),” said António Dinis, Hovione’s Director of Marketing and Communication.

“We plan to totally refurbish the facility and create new oral and inhalation formulation development labs, analytical labs and production areas.”

While the site will be mostly fitted with existing Hovione production equipment, Dinis said the most important addition will be a small volume precision capsule filling machine with appropriate containment systems to handle highly potent compounds.

“This facility will be integrated into our Loures site in Portugal, Hovione’s largest,” he continued. “With this investment Hovione wants to offer its customers the option to get their clinical supplies or small volume commercial supplies from the same site where they already produce their API or solid dispersion.

“This facility will also complement our inhalation franchise allowing us to go end to end from the device to the final dosage.”

The news is the latest in a series of expansions for the Portuguese ingredient maker. Earlier this month, the Portugal-based ingredient supplier announced it was investing in its API facility in New Jersey, adding capabilities to handle highly potent compounds.

And in July, the firm increased its spray-drying capacity at the Loures plant by 20% through the addition of a new unit capable of producing between 50 and 200 metric tons per year.

Regeneron Expanding Irish Biologics Plant

Regeneron's investment is a further boost for Ireland's biopharma industry.

A $350m investment will make Regeneron’s Limerick plant “the largest-scale bulk biologics production facility in Ireland,” the firm says, and add a further 200 jobs.

Biopharma firm Regeneron acquired a 400,000 sq. ft. plant from computer manufacturer Dell in Limerick back in July 2013 investing $300m (€265m) to convert it into a biomanufacturing site for biopharmaceuticals, including monoclonal antibodies.

Now the firm is looking to expand the site further by investing an additional $350m and adding a further 200 jobs to create by the end of 2017 a campus it says will “house the largest-scale bulk biologics production facility in Ireland.”

In March 2014, Regeneron denied rumors it was building a fill/finish plant in Limerick to support the biologics facility, but a spokesperson from the firm said this latest investment would not be for fill/finish operations.

Instead, Hala Mirza said, the $350m will be used for “continued growth and expansion of the Industrial Operations and Product Supply (IOPS) bioprocessing site,” supporting the firm’s ever-growing portfolio through additional capacity.

Manufacturing “will include products from our marketed and innovative pipeline of therapies,” such as its mAb Praluent (alirocumab), which became the first anti-PCSK9 approved in the US in July.

Regeneron also makes the recombinant protein for (wet) age-related macular degeneration (AMD), Eylea (aflibercept), and has a number of mAb candidates in Phase II and III studies.

The news comes as a further boost for Ireland, which has become quite the hub for biomanufacturing.

Earlier this month, ABEC opened a facility making bioprocessing technologies citing demand from an Irish biopharma industry which has seen hundreds-of-millions of dollars’ worth of

investments over the past few years from the likes of Pfizer, Merck & Co., and Bristol-Myers Squibbs.

“We believe Ireland is a unique and important market for the expansion of our IOPS organization,” Regeneron’s Mirza told us, due to the “English language, close proximity to our European collaborators and a high-quality, talented workforce.”

Martin Shanahan, CEO of the Irish IDA (Industrial Development Agency), said: “This $350 million investment announcement from Regeneron is a huge boost for Ireland’s Mid-West Region.

“Biopharma is thriving as an industry in Ireland right now, and Regeneron is a prime example of this. This new facility will provide employment to people at all levels from science, engineering and admin backgrounds.”

Novo Nordisk to Build Plant in Iran

Novo Nordisk is to build a €70m manufacturing plant for FlexPen prefilled insulin devices in Iran in a five-year project.

The Danish insulin specialist already employs around 130 people in the country and said the new facility will create 160 jobs. Once completed, it will function in compliance with Good Manufacturing Practices (GMP).

The new plant 'signals our long-term commitment to Iran, a country where close to five million people have diabetes according to the International Diabetes Federation', said Ole Moelskov Bech, Corporate Vice President of Novo Nordisk Business Area Near East.

'This investment will ensure availability of our modern insulins and will bring us a step closer to the people who rely on our products.'

Adaptimmune to Open New R&D Facility in Oxfordshire, UK

Adaptimmune Therapeutics, a biopharmaceutical company, has announced plans to expand its R&D operation with investment in a new facility at Milton Park, Oxfordshire, United Kingdom.

Construction of Adaptimmune’s 67,000 square foot ‘Enterprise Zone’ building is already under way. The facility will provide laboratory space with associated offices and meeting rooms to accommodate a team of approximately 200 R&D specialists. The new building is designed to support the company’s continuing R&D growth and is scheduled for launch in late 2016.

Adaptimmune has signed a 25-year agreement with break options to lease the building from developer MEPC, which owns Milton Park, one of Europe’s largest business parks and home to over 7500 employees and 250 organizations.

Established in the UK, Adaptimmune launched operations in the United States in 2011 after a long-standing research collaboration with the University of Pennsylvania. The company has rapidly expanded its clinical programs and is currently running five Phase I/II trials in multiple cancers across the US, targeting the NY-ESO-1 cancer antigen in both solid and hematologic cancers with promising early results. Adaptimmune also has an IND open with its second therapeutic candidate, MAGE-A10, and a third candidate in planning for IND submission in 2016.

In May 2015, the company achieved a successful IPO on NASDAQ, generating net proceeds in excess of $176 million, and is advancing a pipeline of therapeutic candidates based on its proprietary T-cell engineering platform.

M+W Contracted to Build Cell Therapy Facility

M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.

The new center – which will be built in Stevenage – is intended to provide small and medium sized developers with the capacity to manufacture therapies for clinical trials and commercial supply.

Cell Therapy Catapult received planning approval for the 77,472 sq. ft. (7,200m2) plant in August when Stevenage Borough Council predicted the facility would "generate £1.2bn of revenue by 2020."

Cell Therapy Catapult announced it had selected Chippenham, UK-based M+W as the main contractor after a tendering process.

The contract specifications state the facility is likely to feature Grade B Clean Rooms

(ISO Class 5), which are suitable for aseptic preparation and filling – as well and manufacturing and administration space.

The document also specifies that Cell Therapy Catapult invite a minimum of six engineering firms to bid for the work, stipulating that only companies that have had annual turnover of at least £50m a year for the past three years would be approached.

Cell Therapy Catapult did not respond when we asked which other engineering contractors had been approached.

The aim is that the Stevenage site will be operational by the end of March 2017 and employ a full time staff of 150 people.

Plans for the facility were announced by UK chancellor George Osborne in his March 2014 budget. The idea is to provide smaller cell therapy developers with a way of producing their products for trials.

At the time, Osbourne justified his decision to use public money to support private sector developers – in a budget that also introduced public spending cuts – on the basis that a cell therapy sector would create jobs and attract investment.

Scientia Clinical Research (SCR) Facility, the University of New South Wales (UNSW), Australia

The facility will be located within a major research precinct that also includes the Prince of Wales Hospital, the NCCC, and the Lowy Cancer Research Centre.

Construction of the Scientia Clinical Research (SCR) facility at the Randwick Hospitals campus in the University of New South Wales (UNSW) began in November 2014.

The facility will accommodate early phase clinical trials to provide a full-range of specialties in cancer, ophthalmology, neurology, addiction medicine, rheumatology and pediatrics.

It will also provide investigation of medicines, biomedical equipment, devices and other procedures and treatments.

The clinical research facility is being constructed under stage two of Nelune Comprehensive Cancer Centre (NCCC) and Scientia Clinical Research (SCR) project as a member of the Bright Alliance, a partnership between Prince of Wales Hospital and UNSW Australia.

The Department of Planning and Environment gave planning approval for stage two of the building construction on 15 May 2014. The SCR facility is expected to be ready for operations by mid-2016.

The facility will promote New South Wales (NSW) as a prime location for clinical trials and provide an opportunity for fast tracking new medical discoveries.

Scientia Clinical Research (SCR) facility will be part of the ten level stage two building. It will be collocated within a major research precinct that includes the NCCC, the Prince of Wales Hospital and the Lowy Cancer Research Centre.

The research center will provide services to the biotechnology and the pharmaceutical industry. It will perform phase I to IV clinical trials for multinational and national pharmaceutical and biotechnology companies, as well as support small and medium trials initiated by co-operative trial groups and research investigators.

It will be connected to the Prince of Wales Hospital, Royal Hospital for Women and Sydney Children's Hospital through links at levels one and two of the building.

Athenex to Construct Two New Pharmaceutical Manufacturing Plants

Athenex announced the completion and execution of a definitive agreement with the Banan District in Chongqing, China to construct two separate pharmaceutical manufacturing plants on Banan sites already identified and selected by Athenex management. Under the terms of the agreement, Banan will provide the funding for the land and construction of the manufacturing plants according to Athenex specifications, and Athenex will equip the facilities.

Mr. Flint Besecker, Athenex Board Director and Chief Operating Officer commented, "This agreement accomplishes several important goals for the company. First, it allows us to materially expand our existing high potency oncology active pharmaceutical ingredient manufacturing capacity. The existing plant from our recent acquisition of Polymed/Taihao located in Chongqing, China is capacity constrained. The new API plant will be approximately five times larger and add significant capacity. This expansion is an important next step in assembling a world-class global pharmaceutical supply chain in the oncology area and will complement our U.S. based manufacturing strategy. Secondly, the government collaboration allows us to execute on a key aspect of our game plan delivering innovative oncology drugs into an important global market like China."

Dr. Manson Fok, Athenex board director, physician, and health policy advisor in China added, "This partnership will provide patients in China an opportunity to access very important and innovative oncology pharmaceutical products. China is expected to have the fastest growing healthcare market in the world and cancer impacts so many patients in the country."

The agreement also establishes a framework for a translational medicine collaboration with an existing Athenex R&D partner in Hong Kong, the Polytechnic University of Hong Kong. Athenex previously announced the in-licensing of the global rights to an innovative oral absorption technology from Polytechnic University in February 2015.

Symbiosis to Up Capacity at Stirling Sterile Injectables Site

Symbiosis has decided to increase manufacturing capacity at its sterile injectable drugs facility in response to increased demand.

The UK contractor plans to increase the size of its manufacturing area by 20% and add a temperature controlled storage area at its facility at the Stirling University Innovation Park in Scotland.

Symbiosis was set up to provide fill/finish services for biopharmaceuticals and small molecule drug products being examined in clinical trials.

However, in August last year Symbiosis was granted a manufacturer/importer license by the UK Medicines and Healthcare Regulatory Agency (MHRA), which enabled it to begin making commercial products.

The expansion reflects this and “the increased number of injectable drugs in development, increased biotech funding, and from more oncology and orphan drugs” Symbiosis said.

Global sterile drug contracting capacity has been hit by the closure of US contractor Ben Venue, which shut down for good in October 2013 after years of problems at its manufacturing facility in Bedford, Ohio.

In the UK capacity has also fallen. Last autumn Aesica pulled out of sterile injectables production – which was only ever a small part of its business – a few months after SCM Pharma lost its manufacturing license due to GMP violations at its site in Prudhoe.

Prior to that Moorfields Pharmaceuticals – a division of Moorfields Eye Hospital - was deemed to have breached GMP guidelines by the MHRA, which reduced UK capacity for ocular injectables.

Medical Air Technology Designs and Builds Cleanroom for Hospital in Malta

The project includes a new cytotoxic dispensing aseptic suite Medical Air Technology (MAT), a Manchester, UK-based specialist in the construction of cleanrooms, recently completed a complex design and build project at Malta’s state-of-the-art national hospital.

Mater Dei is an acute general teaching hospital, offering hospital and specialist services. One of these specialist services is a dedicated oncology center, funded in part by an EU grant, which offers world-class treatment from a new purpose-built block.

MAT was brought in to work on a new cytotoxic dispensing aseptic suite within the oncology center, designed for the preparation of medicines to treat cancer. This treatment is prescribed by a doctor and prepared by pharmacists trained in the aseptic handling of medicines. Such medicines, which are unique to each individual patient, have a short shelf life due to microbiological issues. The new facility enables the safe aseptic preparation of treatment and its subsequent administration to the patient.

MAT was recommended to the main contractor following its work on containment laboratories for the bacteriology and pathology departments in the main hospital. Everything required for the build was shipped out from MAT’s UK headquarters and assembled on-site by the local skilled workforce. MAT provided all the internal structure for the new aseptic suite, which was fully vinyled to give an impervious finish.

This and other services, including BMS controls, air-handling systems and ductwork, were all necessary to establish and maintain European standards concerning aseptic preparation of cancer medicines. All areas are fully air conditioned through a new air handling plant, and filtered using new terminal HEPA filters. Air change rates were calculated to meet the specific design conditions required to achieve the recommended background criteria. The suite has one isolator, with provision for a second unit, and has been built to comply with current European cleanroom standards.

The suite is designed to allow the safe transfer of the components of the cancer medicines as they progress from the starting material to the final preparation.

The pharmacy department at Mater Dei designed an appropriate workflow to ensure the risk of cross-contamination or dispensing errors are minimized as much as possible. The starting material is brought into the support area for unpacking and disinfection with alcohol. The preparatory materials enter the isolator room through a transfer hatch, to be compounded in the isolator cabinet. The final preparation leaves through a separate transfer hatch, and is returned to the support area for release by the releasing pharmacist before being taken to the holding bay ready for dispatch to the ward area. This complex, detailed procedure ensures the safe handling of these potentially dangerous medicines, and their timely dispatch to the patients who need them.

ADC Bio to Build Welsh Manufacturing Site

UK-based processing tech provider ADC Biotechnology will build a $10m plant for the GMP manufacture of antibody-drug conjugates (ADCs).

The 16,140 sq. ft. (1500m2) Welsh manufacturing facility is set to come online mid-2017, offering ADC process development, manufacturing and quality testing services to drug developers.

The company said the investment was driven by a shortage of clinical manufacturing capacity for such services as drugmakers look to bring more ADCs into the clinic, and comes as the first

stage of a two-part expansion strategy which will see the firm add a further 26,900 sq. ft. (2,500m2) of production space.

Over 60 new jobs will be created across the two expansion phases at the site in St Asaph, North Wales.

With the firm citing that the ADC clinical trial contract manufacturing industry could triple in size to $150m by 2018, CEO Charlie Johnson said: “ADC manufacturing at larger scales is a fast-emerging global market opportunity.”

He added ADC Bio was hoping to capitalize on this using its ‘Lock-Release’ enabling technology which can help reduce future production costs of these drugs.

The platform works by covalently ‘locking’ an antibody to solid polymer beads, prior to conjugation, releasing them as a clean drug substance. It can then be conjugated with a payload before being released from the bead bond using an additive acting as a chemical ‘key,’ leaving an ADC ready for downstream processing.

According to the company, the tech can help eliminate several steps in the conjugation process while reducing the amount of processing equipment and the process risks associated with ADC manufacture.

There are currently just two ADCs available in Europe: Roche's Kadcyla (trastuzumab emtansine) and Seattle Genetics's Adcetris (brentuximab vedotin).

Asterias Biotherapeutics Opens UK Subsidiary

California-based Asterias contracted CTC to develop manufacturing processes for AST-VAC2, a candidate lung cancer therapy made mature dendritic cells derived from pluripotent stem cells. CTC will also manufacture the product commercially if it is approved.

CEO Jane Lebkowski said Asterias’ UK division would allow it to collaborate effectively with the “Cell Therapy Catapult center at a low cost in the medium term while providing a base from which to grow our AST-VAC2 platform and maximize its value.”

CTC told us “the work will be done at our development laboratories in London, at Guys Tower.”

The organization – which is financially supported by the Government’s Innovate UK agency – confirmed that Asterias will be paying a commercial rate for its services but did not disclose how much.

CTC also made clear that if AST-VAC2 is approved, Asterias is not under any obligation to sell the immunotherapy product to the UK National Health Service (NHS) at a reduced rate.

“The Cell Therapy Catapult is a private sector organization, independent of the NHS. Companies work with the Cell Therapy Catapult because of its depth and breadth of expertise which allows it to create innovative solutions to industry needs.”

News of the contract comes just days after CTC announced it had hired engineering contractor M+W to construct a facility for large scale cell-therapy manufacturing at a site in Stevenage.

CTC told us that: “The contract and the establishment of a UK subsidiary by Asterias opens the possibility that in the future manufacturing could be done at Stevenage.”

AST-VAC2 is due to be examined in Phase I/IIa clinical trials in lung cancer patients under an existing collaboration with charity Cancer Research UK, which will be responsible for production of the therapy for the study.

Vetter to Upgrade Manufacturing Facilities

Vetter, a German contract development and manufacturing organization (CDMO), has unveiled plans to invest €300m for expanding and upgrading its manufacturing facilities over a five year period.

The firm started the first of its facility expansions at various locations in Germany, including its Ravensburg Vetter West center for visual inspection and logistics, in order to prepare them for future requirements.

According to the company, the upgrades are being driven by a changing healthcare market that is affected by issues such as complex molecules, smaller batch sizes, and increasing regulatory requirements.

Vetter completed structural work for the facility expansion, which will double the plant's existing capacity. The site is expected to begin operations in 2017.

The plans also include expansion of the Ravensburg Vetter South production site and the Ravensburg Schuetzenstrasse facility.

The site expansion will increase drug product manufacturing capabilities and offer additional logistic services.

Vetter will implement an in-house made enhanced restricted access barrier system (RABS) concept for increased operational excellence in aseptic manufacturing.

All planned activities are designed to meet future customer expectations and regulatory requirements at an early stage.

Vetter managing director Peter Soelkner said: "We are continuously monitoring and reacting to a changing marketplace and are pleased that we are in the position to be able to make these strategic investments to further develop our sites and meet these challenges.

"Individually and collectively, they will help us keep pace with the market and allow us to continue to build a successful future for Vetter and our customers."

In January, the company completed the first phase of a multi-functional building at its Ravensburg Schuetzenstrasse site.

The new facility, which is scheduled to be fully operational by the beginning of 2016, will feature high-tech laboratories and workplaces for Vetter's development service, as well as a secure data center and further office space with a total area of 91,460 sq. ft. (8,500m²).

Vetter is a contract manufacturer and specializes in the production of aseptically prefilled syringe systems, cartridges and vials.

The Centre for Process Innovation Launches Open-Access Biologics Manufacturing Site

As part of the United Kingdom's effort to be a premier research destination in the life-sciences sector, the UK's Department for Business Innovation and Skills has funded the construction of a new research and teaching facility to educate its residents. According to a promotional video released alongside the press release announcing the center's launch, the construction of the location will help companies “understand the technical feasibility of their new biologic process or technology.”

The £38-million center in Darlington, Co. Durham—launched by the Centre for Process Innovation (CPI), an organization that is part of the UK government’s High Value Manufacturing Catapault project—was built to “capitalize on the North East’s expertise in medicines manufacturing” and to “bridge the gap between business and academia,” said Jo Johnson, minister of state for universities and science, in a press release. Johnson, in collaboration with Fujifilm Diosynth Biotechnologies’ CEO Steve Bagshaw, opened the center to help the UK claim a stake in the rapidly growing biologics manufacturing sector. The addition of the new facility will help prepare the UK workforce for the challenges that complex bioprocessing techniques present, according to Bagshaw.

Specifically, the facility will “enable companies to test and trial new ideas cheaply and quickly with minimized risk,” which will help medicines get to the market more quickly, commented Nigel Perry, CEO of CPI. The initiative will bring together industry subject matter experts across the biopharmaceutical supply chain, noted Chris Dowle, who is director of biologics at CPI. He added that a number of projects are already underway to help UK life-sciences companies “prove their technologies in an industrially relevant environment.”

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