Baxalta focuses on the development of therapies in hematology, immunology and oncology, as well as expanding its pipeline through an external innovation model, sourcing compounds externally through in-licensing or acquisitions. Baxalta has approximately 40 programs in development, and plans to launch 20 new products by 2020. The Cambridge center will provide Baxalta access to a range of innovations and collaboration partners to advance new treatments.

The Center supports cross-functional, co-located teams including R&D, oncology, biosimilars, business development, corporate strategy and customer operations, along with others that support or work closely with R&D. By the end of 2015, Baxalta expects to employ approximately 500 people at the Global Innovation Center. The company also operates a hemophilia treatment manufacturing facility in Milford, MA.

“We are honored to join this robust biotech community in Cambridge,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. “Kendall Square was a natural choice for the location of our Global Innovation Center. Here we are surrounded by some of the top minds in the industry, immersed in a biotech community that is unparalleled by any other in the world. Our goal is to become a leading development powerhouse to deliver innovative treatments for patients with unmet medical needs.”

Sterigenics Expands Fort Worth Facility

Sterigenics International is expanding its Fort Worth, TX location with a new gamma cell that will increase capacity by 30 percent.

“We have committed more than $80 million in capital investments in the past year to support our customers’ growth strategies,” said Michael Mulhern, chief executive officer of Sterigenics. “In addition to our Fort Worth expansion, we tripled sterilization capacity at the Sterigenics West Memphis, Arkansas location; significantly expanded our Gurnee, Illinois irradiation facility and increased our global service capabilities with the acquisition of leading Latin American sterilization firm Companhia Brasileira de Esterilização (CBE).”

“The Fort Worth expansion is the direct result of increased regional demand for Sterigenics irradiation services,” said Philip Macnabb, President of Sterigenics International LLC. “We are adding gamma processing capacity of up to 5 million cubic feet per year in Texas, with a product overlap system which will provide the capability to process numerous dose ranges and a wide variety of densities.”

Sterigenics Fort Worth provides routine gamma, GammaStat rapid processing, process validation and SteriPro laboratory testing. The expansion will be complete by 2Q17.

Takeda Buys Baxalta Minnesota Biologics Plant

Takeda has snapped up Baxalta’s mammalian cell culture plant in Minnesota for the production of its monoclonal antibody Entyvio (vedolizumab).

The 215,000 sq. ft. Brooklyn Park facility in Minnesota was sold by Genmab to Baxter International in 2013 for $10m (€9.2m), and in September spinout company Baxalta said it was looking to offload the site as part of its move away from in-house production.

Four months on and Japanese biopharma firm Takeda says it has bought the plant for an undisclosed amount, in order to manufacture its ulcerative colitis and Crohn's disease treatment Entyvio and other unnamed biologics in its portfolio.

The monoclonal antibody was approved by the European Medicines Agency (EMA) in March 2014 and by the US Food and Drug Administration (FDA) two months later, and is considered a major growth driver for Takeda with expected worldwide sales expected to surpass $2bn.

“Acquiring the state of the art Brooklyn Park facility and gaining access to a highly experienced and dedicated team is a very important strategic benefit for Takeda that reinforces and expands upon our global operations for Entyvio and future biologic products,” Thomas Wozniewski, Global Manufacturing and Supply Officer at Takeda, said in a statement.

The mammalian cell culture facility boasts a total capacity of 22,000L, consisting of two segregated manufacturing trains with 2 x 1,000L and 2 x 10,000L bioreactors. There is also flexibility to operate the 1,000L reactors at 400L and the 10,000L reactors at 5,000L.

After Baxter acquired the site, it invested in improving the facility’s quality, QC and IT systems, but has not recently been supporting any clinical projects or manufacturing any products.

Takeda has a biomanufacturing facility in Tokyo, Japan, as well as vaccine manufacturing plants in Germany and North Carolina. The firm also has a vaccine cell culture plant in Hikari, japan, set up in a joint venture with Baxter in 2010.

Astorino Reveals Plans for a New County Biotech Hub

Westchester's quest to solidify itself as a biotech powerhouse took another step forward today with County Executive Robert P. Astorino’s announcement this morning of a $1.2 billion private investment to create a bioscience and technology center on a county-owned site in Valhalla. Called the Westchester BioScience & Technology Center, the nearly 3-million square foot, mixed-use complex would make its home on the long vacant property known as North 60, on the Grasslands Reservation, adjacent to Westchester Medical Center and New York Medical College.

Astorino, who made the announcement at the Westchester County Association’s 2016 Economic Forecast Breakfast in Tarrytown, noted that the project “positions Westchester to grow smartly in the future. It creates jobs that play to the strength of the county’s highly skilled and educated workforce.” He also pointed to project benefits including an expanded tax base (some $9 million in estimated new real estate taxes annually to the County, the Town of Mount Pleasant, and the Mount Pleasant School District); creation of approximately 4,000 new construction jobs and 8,000 permanent jobs; and the ability to “expand the county’s growing leadership in the fields of biotechnology and medical science.”

The project would be developed by Fareri Associates, a well-known Westchester and Fairfield County developer, on a combined 80 acres of land (Fareri owns 20 acres adjacent to the county’s 60-acre North 60 plot, which it would rent from the county under a long-term lease). The plan proposes three multi-phase components: West Research Village, Central Village, and East Research Village; at full build-out, it would comprise more than 2 million square feet of biotech/research space; 400,000 square feet of medical offices; a 100-room hotel; 114,000 square feet of ground-level retail space; and a 34,000 square foot Children’s Living Science Center, which will seek to “promote the improvement of the health of children in the region” through educational programming. The plan will also include sustainable features such as green roofs, demonstration gardens, and preservation and improvement of on-site wetlands, as well as some 40 acres of open green space.

Projects of this scope are never a sure thing, of course. The announcement itself comes after two years of negotiating, and the project heads next for review by the Westchester County Board of Legislators and the Town of Mount Pleasant. Fareri Associates will also need to conduct a full environmental impact study, which can take one to two years. Answering questions about the timeline at a press conference, Astorino said, “The best-case scenario for approval process is probably two years. Once an approval is obtained, we’ll immediately go to work, and we expect the first phase of construction will take about 18 months.”

That first phase—consisting of $40 million worth of infrastructure improvements (the totally unimproved piece of property requires sewer, water, and road work) and then approximately $200 million in construction costs—will include portions of the biotech/research space, medical space, retail, and the hotel. As Astorino pointed out, “the developer is investing more than $1 billion in this project, and the first phase is on county property, so the county gets its revenues first.”

As for prospective tenants, Fareri Associates says it is too soon to list names, but is confident that if the Board of Legislators gives the project a go-ahead, they will have plenty of companies interested in the space.

So too is Astorino. “Westchester County is a growing market with a workforce that is desirable; that makes it attractive for companies to come to a project like this, they are not rolling the dice,” he said. He also cited the project’s proximity to other biotech companies like Regeneron, as well neighboring healthcare and educational centers like Westchester Medical Center, New York Medical College, Westchester Community College and Pace University, as additional draws for health science and biotech companies looking for office and lab space.

Novartis Opens Facility in Cambridge, MA

Novartis (NVS) is looking at a new $600 million facility in Cambridge to expand development of its treatments for malaria, autism, rheumatoid arthritis and bipolar disorder.

Last week Novartis held a ribbon cutting ceremony for the long-awaited 550,000 square-foot facility that will offer laboratory, office and retail space. The new facility places Novartis in the heart of Kendall Square, one of the densest developments for the biotech and pharmaceutical industries in the United States. Novartis’s site has been in development since 2013. The new site is expected to house about 1,000 people. Novartis currently employs about 2,000 people in the Cambridge area.

“The addition of two new buildings and renovation of an existing building will allow us to create an ideal work environment for communication, exchange of knowledge and interdisciplinary collaboration. This campus will be a life sciences gateway and will provide an important connection between Kendall and Central Squares. It will bring vibrancy to the area with ample green space, pedestrian connection and street level retail space,” Novartis said in a statement on its website. “Over the coming months, you will see about 1,000 associates move into these new labs and offices to work on discoveries in aging, neuroscience, ophthalmology and cardiovascular and metabolic diseases.”

The new facility could become a major research base for Novartis’s investigational leukemia treatment CTL019, which wiped out the blood cancer in 93 percent of patients participating in a mid-stage trial, the company announced during a session of the American Society of Hematology in Florida earlier this month. Novartis is developing a chimeric antigen receptor T cell (CART) therapy for the treatment of children with relapsed/refractory acute lymphoblastic leukemia. During an ASH panel, Novartis announced that 55 of 59 patients, or 93 percent, experienced complete remissions with CTL019. The study did show that at the end of one year, 55 percent of patients had a remission-free survival rate and that 18 patients continued to show complete remission following one year.

The Kendall Square area of Cambridge is home to dozens of pharmaceutical and biotech companies. As the density of pharmaceutical work grew, so did interest from other companies looking to find a new home close to collaborative opportunities.

One of the reasons for the greater Boston area becoming such a major hub in the biotech and pharmaceutical industries is the plethora of research universities in the area. Boston also has one of the highest educated workforces in the nation. Not only are smaller companies calling the Boston area home, but many larger and established pharmaceutical companies, such as GlaxoSmithKline (GSK), TKPYY), Sanofi (SNY), and Biogen Idec (BIIB) have presences in the city. The close proximity of so many pharmaceutical and university laboratories provides researchers and scientists easy access to clinical studies and building partnerships between companies.

Cambridge’s Kendall Square area, which makes up approximately one square mile, is packed with biotech representatives. In May, Indianapolis-based Eli Lilly & Co. (LLY) announced it will build a new drug delivery and device innovation center, the Lilly Cambridge Innovation Center, in Kendall Square.

In April, Amgen (AMGN), headquartered in Thousand Oaks, Calif., announced it was going to expand its presence in its Cambridge facilities, as well as in South San Francisco, part of a 100-person staff expansion. It indicated 75 new hires would be at its Kendall Square location.

BioMarin (BMRN) rebranded almost 350,000 square feet of former Vertex (VRTX) space over three buildings in Boston as the Sidney Research Campus. Vertex vacated the space in 2013 when it moved a few miles into Boston.

Catalent has Newly Expanded Facility in Kentucky

Catalent will manufacture a heartburn OTC treatment for Pfizer from its newly expanded facility in Kentucky.

The contract development and manufacturing organization (CDMO) announced it will be formulating and manufacturing Nexium (esomeprazole) for Pfizer from its complex tablet site in Winchester, Kentucky which recently underwent a $52m (€48m) expansion.

Catalent spokesman Chris Halling said they awarded the contract “as a result of the expansion” but was not the motivation behind that investment.

In 2013, Catalent broke ground on the new 80,000 sq. ft. capacity at Winchester, pledging $35m worth of investment and around 90 manufacturing jobs. By the time the expansion was completed in April, a further $17m had been invested and the headcount increased by a total of 140.

The company added fluid bed capacity, expanded its analytical laboratories, and built an open facility design to provide flexibility in supporting the requirements for new customers.

Under this agreement, Catalent will make Pfizer’s 20 mg Proton Pump Inhibitor drug into enteric coated, delayed release pellets using fluid bed technology, as well as encapsulate these pellets into two-piece, hard-shell capsules.

Ropack Purchases Two Pharmaceutical Facilities in Long Island, NY

Ropack Inc., a provider of contract manufacturing and packaging services for the pharmaceutical and nutraceutical industries, has announced the purchase of two pharmaceutical facilities in Long Island, New York. The acquisition significantly expands the company’s capabilities which will now include research and development, formulation, lab analysis and commercial and clinical manufacturing, complementing its well-established solid oral dosage packaging and clinical study distribution.

The buildings, formerly operated by Forest Laboratories, LLC, and total 213,700 square feet and are a realization of Ropack Inc.’s strategic expansion plan. “It has been a longstanding goal to broaden our service offerings,” noted Yves Massicotte, President and CEO. “To establish a presence in the United States at the same time makes this acquisition ideal.” Activities in the US territory will be managed through Ropack USA Inc. Mr. Massicotte added that Ropack Inc. and Ropack USA Inc. will now be known as “Ropack Pharma Solutions.”

“The purchase of these two state-of-the-art pharmaceutical facilities on Long Island will enable Ropack Pharma Solutions to provide its current and future customers with comprehensive solid oral dosage development, manufacturing and packaging solutions,” remarked Paul Dupont, Vice President of Marketing and Business Development. “This acquisition will add considerable capacity and key technologies to support projects from formulation development through commercialization.”

Ropack, celebrating its 40th anniversary in 2016, operates four facilities in Montreal, Canada, for the packaging of solid oral dosage in bottles, flip-top vials, blister packs, stick-packs and sachets.

New Single-Use Bioproduction Plant for Avid Bioservices

A new single-use bioproduction plant will bring in annual revenues of $40m, says Avid Bioservices which is already eyeing up additional capacity to cope with contract manufacturing demand.

CDMO Avid’s parent company Peregrine Pharmaceuticals announced its new mammalian cell culture facility in Irvine, California is ready for the initial phase of GMP manufacturing while presenting its Q2 FY results yesterday.

The site was constructed to support the growth of the contract manufacturing business, while also providing capacity for a potential launch of Peregrine’s own lead candidate bavituximab, a monoclonal antibody for non-small cell lung cancer.

“This facility, currently named the Myford facility, is state-of-the-art and its construction was completed for a fraction of the cost of building of comparable facilities,” Head of Regulatory Affairs Robert Garnick said.

“This in and of itself is a major accomplishments and I am very proud of our team for their success of this achievement.”

The reason for this was attributed to the plant being fully disposable, being equipped with single use bioreactors up to 2,000L in scale. Furthermore the firm predicts the new capacity has the potential to generate around $40m (€36m) of contract revenue annually for Avid.

For the second quarter, Avid saw a 52% increase in sales year-on-year to $9.5m, but said current backlog now sits at $49m which is leading the company to assess future expansions.

“Although, we have just opened the doors at Myford we are already contemplating our options to increase further manufacturing capacity,” Garnick said, while Peregrine’s CEO elaborated further:

“The expansion really is driven by our existing and new clients that have come in and so obviously primarily that’s driven in the bulk drug substance area,” said Steven King.

“There’s space in the current buildings that we’re in, but we’re also looking at other opportunities nearby with the same model as we did for the Myford facility and allowed us to most efficiently grow the business.”

Grand River Expands Disposable Technology Capabilities

Grand River Aseptic Manufacturing, Inc. (GRAM) has expanded its disposable technology capabilities at its FDA-approved manufacturing facility in Grand Rapids, MI.

With the expanded single-use systems, the company aims to offer clients cost and time savings, and improved safety and quality standards, as compared to stainless steel system alternatives. Additionally, there is greater flexibility in process design and risk of client cross-contamination is greatly mitigated. By utilizing disposable technology, manufacturing downtime is also reduced due to the elimination of validation activities that come with the cleaning process.

Steve Nole, GRAM’s director of manufacturing, said, “We’re excited to offer expanded disposable technology capabilities. This will enable us to respond more quickly to client needs and ultimately reduce their costs.”

AMRI has opened a Drug Discovery Center

AMRI has opened a drug discovery center, citing growing customer demand for biology, high-throughput screening, in vitro pharmacology, and medicinal chemistry at a single site.

The center, located on the Buffalo Niagara Medical Campus in Buffalo, NY, was launched with the goal of creating a transitional science center leveraging infrastructure from AMRI’s partner institutes, and is part of a larger commitment by the state of New York with SUNY Polytechnic Institute.

"We are excited to launch a realigned and upgraded discovery service offering for our customers through our new center for global drug discovery in Buffalo," said Christopher Conway, Senior Vice President, Discovery and Development, AMRI.

"AMRI is the only North American based Discovery CRO with biology, pharmacology, HTS and chemistry located in one building, in the center of a hub of complimentary biotech, major medical and academic centers. This hub for drug discovery provides our customers and partners with the speed in decision-making and depth of collaboration need to accelerate speed of data and maximize results."

Other partners in the project include the University at Buffalo School of Medicine, University at Buffalo Clinical and Translational Research Center, Buffalo General Hospital, Jacobs Institute, Roswell Park Cancer Institute, and the Hauptman Woodward Institute.

According to Rory Curtis, Vice President, Discovery Biology and Pharmacology, and Site Head of AMRI Buffalo, “The ultimate aim of this site is to provide a suite of discovery services, from assay development and HTS to medicinal chemistry and in vitro pharmacology, that will reduce data cycle times in order to improve the value of our customers' discovery programs, as well as offer ease-of-communication with project teams and functional groups."

AMRI is a founding member of the Buffalo Medical Innovation and Commercialization Hub (BMIC). By combining the expertise of academic and industrial partners the hub will offer opportunities for collaborations to develop new approaches to discover life-saving therapies.

REST OF WORLD

Wuxi AppTec to Invest in Discovery and Development Lab

Newly private WuXi AppTec has announced plans to invest $120m in a biopharmaceutical development laboratory and clinical-scale manufacturing facility in Shanghai, China.

The facility – which is due to be operational in 2017 – will provide discovery, development and clinical trial supply manufacturing services.

Early development services available at the site will utilize the antibody generation OmniRat platform – which Wuxi accessed in 2012 in a deal with Open Monoclonal Technology – and phage display libraries developed by the Chinese contract research organization (CRO).

Manufacturing operations at the new facility will use a proprietary Chinese Hamster Ovary (CHO) cell line. The site will house three 2,000L fed batch bioreactors and two 500L perfusion reactors.

Wuxi said that when operational the facility will employ 800 staff.

A spokesman said "The decision to build the lab was driven by strong past, present, and expected future demand for WuXi’s integrated platform of biologics services" adding that "WuXi’s biologics services are and will be offered to both international and Chinese companies."

The facility is the second Wuxi has announced in less than a year.

In May 2015, the CRO's subsidiary Wuxi Biologics started work on a biopharmaceutical manufacturing site.

The facility - in Wuxi city - will "be the largest mammalian cell culture manufacturing facility using disposable bioreactors in the world" according Wuxi, which expects it to be fully operation in 2017.

News of the Shanghai laboratory investment also comes just weeks after Wuxi AppTec completed a $3.3bn (€3.04bn) transaction to leave the New York Stock Exchange (NYSE) and became a private company.

Lonza Expands Single-Use Capacity in Slough Facility

Lonza has announced the expansion of mammalian production capacity at its Slough, UK, facility.

Based on increased demand for biopharmaceutical development and clinical manufacturing services, two 1,000l single-use bioreactors will be installed at the site.

The expansion will increase the existing single-use manufacturing capacity in Slough, while allowing current operations to continue without interruption. The additional mammalian manufacturing capacity is available to customers.

Lonza's cGMP facility in Slough is a center of excellence for development and clinical supply. The site provides cell line construction, process development and clinical manufacturing services for mammalian-derived biotherapeutics.

The increase in bioreactor capacity continues the implementation of single-use technologies at the Slough site and complements existing single-use equipment for seed train systems and downstream processing, including chromatography, filtration and ultrafiltration unit operations.

New reactors are equipped with controllers that enable parallel reactor operations, expanded process capabilities with flexible operating scales and bioreactor types.

Use of these technologies supports Lonza's ability to accommodate a variety of customer projects and processes across scales and clinical phases.

Lonza Pharma and Biotech Clinical Development operations head Michael Brown said: "The ease of installation, commissioning and validation of single-use bioreactors allows us to meet the increased market demand for clinical manufacturing."

AAI/CML has Upgraded Capabilities in Weert, Netherlands

AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML), has upgraded its small molecule manufacturing capabilities in Weert, Netherlands with the installation of a DE Dietrich Agitated Filter Dryer for controlled isolation of Intermediates and APIs. The new filter dryer provides a closed system unit for isolation and drying, designed to minimize operator exposure and provide a safer manufacturing environment.

The DE Dietrich Agitated Filter Dryer also has the ability to re-dissolve using a second solvent within one system with volume of 490 Liters, cake volume of 180 Liters and nominal filtration area of 0.6m2.

"The investment in this technology has improved containment around isolation, enhanced the safety of our operating environment, and helped increase yields. Our highly active compounds can also be processed using this filter dryer with ancillary equipment, for customers that need additional protection for Occupational Exposure Limits (OELs)," said Ted Dolan, chief operating officer. "We are pleased to continue to offer more options for customers with our expanding capabilities."

Kalbe Farma to Build Indonesian Facility

Kalbe Farma has launched construction plans for a local raw materials facility in a bid to tackle import challenges.

The Jakarta-based company announced its facility will be opened in West Java by 2018 and will focus on biopharmaceutical raw materials.

In a press statement, Director Vidjongtius said importing raw materials in Indonesia is a challenge.

According to the Global Business Guide Indonesia website, a major weakness in the sector is the lack of locally available raw materials leaving producers battling with fluctuating global prices. An estimated 90 - 98% of pharmaceutical raw materials in Indonesia are imported, largely from China but also from the US and India.

Average drug prices in Indonesia are 25 - 30% higher than the global average, and around 35% of the total selling cost for drug companies is down to raw materials and high energy prices in Indonesia, the Global Business Guide states.

In its Q3 2015 financial report, Kalbe referred to a "foreign currency risk" due to the fact it purchases raw materials and equipment from international markets in the relevant currencies (ie US dollar or the Euro).

State-owned pharmaceutical company Kimia Farma also noted in its FY15 report that reliance on importing raw materials from countries like China, India and the US coupled with the depreciation of the Indonesian Rupiah (IDR) against other currencies is adding strain to production costs.

In December, Kimia announced plans to build an IDR 110 billion [$79.4 million] raw materials factory in West Java within 2016 in partnership with South Korean firm Sungwun Pharmacopia. Like Kalbe, Kimia said the Indonesian plant is being constructed in response to the growing import challenges.

Kimia currently imports around IDR 350bn [$25.3m] worth of chemicals (the majority of its materials) annually, Rusdi Hosman told Deal Street Asia in December.

In December, Indonesia's Coordinating Economic Minister Darmin Nasution backed investment in the local pharmaceutical sector, branding the government "not smart" if it does not support its growth.

In this week's press statement on Kalbe, it was also noted that Indonesia's investment board Badan Koordinasi Penanaman Modal (BKPM) plans to increase foreign investment potential in local companies from the current 85 to 100 percent.

Recipharm Acquires Facility in France

Recipharm has entered into the previously announced strategic collaboration with Alcon, a Novartis company, and has signed a long term supply agreement whereby Recipharm will manufacture a range of ophthalmic products using Blow Fill Seal technology.

As part of this collaboration, Recipharm will also acquire from Alcon, Kaysersberg Pharmaceuticals, a company whose main asset is a manufacturing facility located in Kaysersberg, France which currently supplies this product range.

Highlights:

Long term manufacturing agreement will add annual sales in excess of EUR 36 million and EBITDA-margin well in line with the Group’s average.

Adds a new important relationship with Alcon and further strengthens the current relationship with Novartis.

100 percent of the shares in Kaysersberg Pharmaceuticals will be acquired for a total consideration of EUR 18 million.

Extends Recipharm’s manufacturing services offering with the growing technology of Blow Fill Seal.

Provides potential synergy with Recipharm’s three other French facilities.

Approximately 260 people currently employed by Kaysersberg Pharmaceuticals will continue their employment under Recipharm ownership.

Closing is expected to take place on 31st December 2015. There are no material conditions to closing.

Thomas Eldered, CEO Recipharm AB commented “We are looking forward to extending our relationship with Alcon and Novartis and I am very pleased that they have had the confidence in Recipharm to make this commitment of a long term manufacturing agreement and sale of Kaysersberg Pharmaceuticals. Blow Fill Seal technology is a very interesting area which we believe will grow and it therefore forms an important addition to our portfolio. The high skill levels and dedicated employees in Kaysersberg will be a welcome addition into Recipharm and we look forward to working with them to further develop and grow the business”.

Financing and payment terms:

The consideration of EUR 18 million will be paid in cash with 75% in 2015 and 25% in January 2016.

In addition, Recipharm will acquire working capital for approximately EUR 4.2 million.

The acquisition will be financed will already available funds. No further financing will be required.

Boehringer Plans Biopharma Expansion in Austria

German pharma group Boehringer Ingelheim is planning to open a new biopharma production facility in Vienna that will create 400 jobs when it comes online in 2021.

The massive project - which will cost around €500m - will be centered on the construction of a new large-scale facility for the production of biologic drugs in cell culture that Boehringer says will “enhance its leading position in the market”.

The new plant will mark a significant expansion of Boehringer's cell culture production capabilities, which are currently concentrated at its Biberach site in Germany, which houses Europe's largest biopharmaceutical unit for therapeutic proteins and antibodies from mammalian cells.

The decision to add further internal production capacity stems from the number of projects coming through Boehringer's biologics pipeline as well as "heavy market demand for contract manufacturing".

In addition to developing and producing its own drugs, Boehringer's BioXcellence unit is one of the largest contract manufacturing companies in the world. The company recently took control of a facility in Shanghai that will spearhead its contract manufacturing operations in China.

Biberach will remain the company's primary location for commercial manufacturing, with the new Vienna facility providing additional capacity for Boehringer's pipeline projects. Until now, the Vienna site has been focused on making active pharmaceutical ingredients (APIs) using microorganisms, but cell culture technology will be transferred there over the next few years.

"This is a decision for Europe as a pharma location," said Boehringer chairman Andreas Barner, who noted that the company had looked at various international locations for the new facility.

"The clincher for Vienna was ultimately the company's desire to additionally secure the market supply of biopharmaceutical products and to balance the risk by establishing a further independent facility," he added.

Waters to open Analytical Lab in UK

Former AstraZeneca R&D site in Alderly Park, Cheshire, is now home to over 1,076,000 sq. ft. (100,000 sq. m.) of scientific laboratory space.

Waters Corporation will offer an open access analytical laboratory and technology support to biotechs based at a former AstraZeneca site in the UK.

Alderly Park, near Manchester, UK, was sold off by AstraZeneca to Machester Science Parks – a public-private partnership – in 2014 , and analytical equipment and technology firm Waters announced it has struck an agreement to launch an open access analytical laboratory there.

“This laboratory is a dedicated Open Access Laboratory, for the benefit of all companies located in the BioHub at Alderley Park [known as BioCity],” said company spokesman Chris Orlando.

“Scientists on the site will gain access to cutting edge Waters capabilities through the Open Access facility which will be managed and run by BioCity, on a fee-for-sample/time/service basis. Support on the use of the facility, and the technology available, will be provided by an experienced laboratory manager.”

The firm already has its mass spectrometry headquarters and demonstration laboratory in nearby Wilmslow, but this new facility will focus on providing “cost-effective access to the kinds of cutting edge analytical technologies which underpin modern life and health sciences research,” he continued.

“Many, if not all, the companies at BioHub are engaged in cutting edge, and diverse, research and development. Close engagement with companies using the facility will give Waters a deeper insight into their needs and challenges.”

The firm’s Ultra Performance Liquid Chromatography (UPLC) systems, mass spectrometry (MS) and informatics technologies will be available at the new laboratory when it opens early this year, as will a nuclear magnetic resonance (NMR) system provided by Manchester Science Partnerships.

Medicago to Help Establish Class 3 Containment Laboratory at Université Laval

Medicago, a Canadian developer of plant-based therapeutic proteins and vaccines, will contribute one-third of the CA$1.5m financing for a new Class 3 containment laboratory to be located at Université Laval's Infectious Disease Research Centre.

The City of Quebec and the research center’s foundation will provide the remaining funds required to launch laboratory operations.

'We are very pleased to support this local project of importance for Quebec City,' said Andy Sheldon, President and CEO of Medicago. 'This laboratory will contribute to the development of a center of excellence of an international caliber, and create significant value for the biotechnology sector.'

Medicago says a CL3 lab is an indispensable tool for conducting pre-clinical studies to advance the research and development of vaccines and other pharmaceuticals.

The difficulty of access to CL3 laboratories frequently requires researchers to use resources located outside Quebec and Canada, often in Europe or the US. Sheldon made the commitment, on 24 October 2014, on Medicago's behalf, to provide one-third of the amount required to launch the laboratory's operations.

Proxy Biomedical Expands Medical Implants Facility

Europe Proxy Biomedical, a manufacturer of biomaterial-based products for medical implants, has announced a 'substantial' facility expansion at its premises in Spiddal, Co. Galway, Ireland.

The firm says the expansion is a direct result of new business and continued revenue growth supported by new products launched during 2015. These new products include reabsorbable and non-reabsorbable biomaterial solutions for vascular indications.

The company says it is now a leading supplier of PTFE encapsulation for stents, in addition to offering biomaterial coatings for structural heart implants, as well as occlusion and retrieval devices. Other new products include Proxy Bio-XT, a proprietary process that reinforces resorbable implants for applications such as soft tissue fixation in sports medicine and orthopedics, and ProTEX Med polypropylene for use in the manufacture of implantable textiles, facilitating the approval process for products, such as hernia mesh, used in general surgery. To accommodate these additional technologies and services and to meet growing demand, Proxy Biomedical will expand its facility, which is due for completion in the second quarter of this year.

The company will double its cleanroom manufacturing facilities, introducing a suite of new technologies and biomaterial conversion processes. The firm also expects to expand its solutions portfolio for resorbable biomaterials in both textiles and solid implants. Pre-clinical trials are scheduled to evaluate innovative antimicrobial implantable materials, while the company’s coating capabilities are set for further expansion, to accommodate an ever greater range of indications.

Samsung BioLogics to Build Biopharma Plant Asia

Pharmaceuticals Samsung BioLogics has broken ground on the construction of its third plant in Incheon Free Economic Zone, Songdo, Korea. The KRW850bn (€663m; US$725m) plant will be a world-leading facility both in terms of its 180,000 liter capacity and its production efficiency. It is expected to be completed by 2017 and begin operation in the fourth quarter of 2018 after validation. Once it begins operation, Samsung BioLogics expects to become the world's largest biologics contract manufacturing organization with a total production capacity of 360,000 liters.

'We are investing in a third plant to provide a stable supply of biopharmaceuticals, a market which is growing exponentially, and to meet the manufacturing demands from global biopharmaceutical companies,' said Dr. TH Kim, CEO of Samsung BioLogics. 'With the world's largest capacity and the capability to operate 365 days a year non-stop, the third plant will boast world-class quality and productivity.' In the longer term, the company plans to continuously expand its CMO business with further investments planned for a further two plants. Samsung BioLogics' first plant has recently received official approval for production from the US Food and Drug Administration, and its second plant is scheduled to begin operation in early 2016.

ShangPharma’s Manufacturing and Pre-Clinical Research Facility, Shanghai, China

ShangPharma’s new biologics manufacturing and pre-clinical research facility will be located in the Qidong Biopharma Industrial Zone.

ShangPharma, a leading outsourcing partner in pharmaceutical and biotechnology research and development based in China, signed a deal with Qidong Biopharma Industrial Zone to build a biologics manufacturing and pre-clinical research facility in the Qidong Biopharma Industrial Zone, China.

It will be the first tenant for the biopharma zone in Qidong.

ShangPharma comprises a family of companies, which include China Gateway Biologics, China Gateway Pharmaceutical Development, ChemPartner, ShangPharma Technology and ShangPharma Investment.

The company will invest $60m in the project through a new subsidiary that will be established to provide and develop cutting-edge science and technology aimed at expanding its biologics service portfolio.

China Gateway Biologics, the contract manufacturing wing of ShangPharma, will operate the manufacturing facility, while the pre-clinical research facility will be operated by ChemPartner, ShangPharma's contract research wing.

The manufacturing and research facility is expected to be operational in early 2018. It aims to develop Qidong as China's bio-technology hub and ShangPharma t grow as a distinguished outsourcing and biopharmaceutical service provider.

The facility is being built in the Qidong Biopharma Industrial Zone in Lianyungang, Jiangsu Province.

The project is being jointly financed by ShangPharma and the Qidong Biopharma Industrial Zone.

ShangPharma's manufacturing and pre-clinical research plant details:

"The manufacturing and research facility is expected to be operational in early 2018."

The plant is aiming for high commercial-scale operations with an international focus and overall biopharmaceutical development of ShangPharma.

The facility will be equipped with a 500l single mammalian cell culture unit for clinical phase supply to be handled by ChemPartner and two 2,000l units for commercial manufacturing to be handled by China Gateway Biologics.

The clinical supply and manufacturing units will be complemented with fill and finish capabilities of an appropriate scale.

The investment is expected to grow China Gateway Biologics' biopharmaceutical services by transforming it into a full biopharmaceutical service provider, from pre-clinical development to commercial-scale. ChemPartner will be able to expand its clinical research abilities through the investment.

The state-of-the-art plant will comply with Western standards in order to support and meet expectations of international clients.

ShangPharma has established extensive research and development (R&D) partnerships within the healthcare industry and with organizations.

ShangPharma provides customized services to international pharmaceutical, biotech, agrochemical, chemical, biology, biologics, and pre-clinical development. It also provides high-quality, cost-effective, integrated services in drug discovery and development processes to help international and Chinese pharmaceutical companies efficiently discover and develop drugs.

China Gateway Biologics provides biologics manufacturing services for the biopharmaceutical industry for Chinese and international customers.

ChemPartner is a contract research organization serving the pharmaceutical and biotechnology industry. It provides integrated services across drug discovery and development, including discovery biologics, chemistry and biology, as well as pre-clinical development.

AstraZeneca to Expand Chinese Operations

AstraZeneca has entered two agreements in Japan and China as part of its aim to strengthen its operations in these regions to meet growing sales.

In Japan, the company agreed to buy Takeda Pharmaceutical's core respiratory business for $575m. The deal will give AstraZeneca the global rights to lung drug roflumilast, Alvesco and Omnaris (ciclesonide).

Roflumilast is sold under the name Daliresp in the US and as Daxas in other countries. It is for treatment of chronic obstructive pulmonary disease (COPD), while Alvesco is indicated to treat asthma and Omnaris for allergic rhinitis.

Upon completion of the acquisition, which will also include regional and local products, as well as several pre-clinical assets, around 200 Takeda employees will be transferred to AstraZeneca.

The British firm has been marketing Daliresp in the US since the acquisition of the product rights from Actavis in March.

The acquisition of worldwide rights will support AstraZeneca's respiratory franchise and complement its treatments portfolio for severe COPD, the company noted.

"Daxas in particular adds to our portfolio of treatments for patients with severe COPD."

AstraZeneca global portfolio and product strategy executive vice-president Luke Miels said: "The agreement with Takeda complements our respiratory business, one of our three main therapy areas, supports our return to growth and will be immediately accretive to earnings from 2016.

"Daxas in particular adds to our portfolio of treatments for patients with severe COPD."

Separately, AstraZeneca said it would invest up to $100m in Chinese biologics firm WuXi AppTec for the option to acquire the company.

The company also intends to invest $50m to build an additional development and launch facility alongside its existing manufacturing site in Wuxi City to support the development and manufacture of new small molecules discovered in China and its global R&D sites.

The alliance builds on an existing joint venture between MedImmune, the global biologics research and development arm of AstraZeneca, and WuXi AppTec. The alliance is to develop and commercialize biological treatment for autoimmune and inflammatory diseases, MEDI5117, in China.

BeiGene has Monoclonal Antibody (mAb) Plant in Suzhou

Nasdaq-bound Chinese biopharma BeiGene has chosen GE Healthcare’s Flexfactory platform for the monoclonal antibody (mAb) plant it is building in Suzhou.

The Beijing-headquartered cancer drug firm said the GE system will “significantly reduce the build-up and commissioning time and help to increase the speed to global markets, including the United States, Europe and China.”

BeiGene started building the facility in August after securing a plot at the Suzhou Industrial Park an hour outside Shanghai.

At the time the firm said the facility will support both clinical trials and commercial production of its candidate cancer biologics when operational in 2017.

BeiGene's most advanced candidate is BGB-283 - an RAF dimer inhibitor of solid tumors – that entered a Phase I trial in October after showing promise in preclinical studies conducted by Wuxi AppTec and Joinn Laboratories.

BeiGene has also announced its intention to go public and list on the NASDAQ in the US.

BeiGene will use the Flexfactory system to culture cell lines developed using a platform licensed from SAFC, the custom manufacturing business of recent Merck acquisition Sigma Aldrich.

That deal – signed in March – granted BeiGene rights to develop monoclonal antibody (mAb) production cell lines using SAFC’s CHOZN platform.

The platform combines zinc finger nuclease (ZFN) gene editing and the glutamine synthetase CHO cell line that SAFC launched in 2011.

Speed was also a driver for the SAFC deal according to BeiGene’s biologics head Kang Li.

He said at the time “our objective in selecting SAFC’s CHOZN Platform and services was to shorten bioproduction times in early development and to obtain a manufacturing clone quickly with the highest protein quality specifications.”

GE Healthcare acquired the FlexFactory system when it bought Xcellerex in 2012. Since then the General Electric division has sold the system to various drugmakers – including Patheon acquisition Gallus and China-based manufacturer JHL Biotech – and more recently Nanotherapeutics.

The firm welcomed BeiGene’s comments about set-up speed, telling us "the typical time to complete the installation of a FlexFactory is nine months. This includes a planning and design phase, construction and installation, and then validation. The key to compressing the timeline is working in parallel where possible. For example, the customer's initial acceptance testing of the single-use technologies that make up the FlexFactory begins at GE's sites in Marlborough and Uppsala, prior shipping to their own facility."

"The FlexFactory platform, which is comprised predominantly of single-use technologies, will incorporate a 500 L scale single-use bioreactor, the Xcellerex XDR 500, to meet BeiGene's pilot scale requirements. The platform comprises distinct unit operations connected via single-use tubing sets and is controlled by a centralized automation system."

MedImmune Expands Joint Venture with WuXi Apptech

MedImmune has the option to acquire a Chinese biologics manufacturing facility for around $100m in an expansion of its joint venture with WuXi Apptech.

The partnership between AstraZeneca’s global biologics R&D arm and WuXi commenced in September 2012 with a focus on the development of the former’s candidate MEDI5117, a monoclonal antibody initially investigated for autoimmune and inflammatory diseases in China.

A month after, the Chinese CDMO opened a fully single-use GMP biologics manufacturing facility in WuXi – about 50km west of Shanghai – which, according to an announcement today, MedImmune has the option to acquire through an investment of around $100m (€92m).

The AstraZeneca offshoot said the option forms part of an expanded joint venture which will look to address unmet patient needs in China across a range of therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic diseases, and oncology.

MedImmune’s EVP Bahija Jallal said she was “delighted” to broaden the collaboration with WuXi.

“This strategic alliance, alongside our accelerated investments will create a sustainable and strategic innovation platform in China and strengthen our leadership in developing next-generation biologics for both local needs and patients around the world.”

MEDI5117 was originally being investigated for osteoarthritic pain, but last year the firm dropped the programme and concentrated on developing the anti-IL6 mAb in rheumatoid arthritis (RA).

In March this year, the China Food and Drug Administration (CFDA) accepted the candidate for review. WuXi completed all CMC (chemistry, manufacturing and control), nonclinical, and clinical sections of the dossier, while the wholly owned subsidiary of the joint venture filed an IND for it with the Jiangsu provincial FDA as a Class 1 therapeutic biologic in December 2014.

The expanded alliance will also see the firms invest $50m into a new plant on the WuXi site to aid the development and manufacturing of innovative small molecule drug candidates.

AstraZeneca’s EVP Mark Mallon said the increased investment would further help bring medicines to Chinese patients while also making the firm “the first multinational biopharmaceutical company to create a dedicated R&D platform and manufacturing capabilities in China for local development.”

Clariant Invests in Healthcare Packaging Plant in India

Specialty chemicals company, Clariant plans to invest CHF10m (£6.5m) in a new Healthcare Packaging manufacturing plant in southern India. The plant is located in Cuddalore, Tamil Nadu, about 25km from the city of Puducherry. It will manufacture Clariant’s moisture control products to support the growing pharmaceutical packaging market in India.

'India is the largest provider of generic drugs globally, making it a key market for Clariant’s desiccant products,' says Ketan Premani, Head of Clariant Healthcare Packaging Sales in India. 'We want to ensure that we serve our customers here as directly and efficiently as possible.

When the plant is complete, they will now have the ability to procure Clariant’s global-standard products directly produced in India.' Clariant Healthcare Packaging, a member of the Masterbatches business unit, manufactures controlled atmosphere packaging solutions including pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers.

India is the largest provider of generic drugs globally, making it a key market for Clariant’s desiccant products The new plant will initially produce desiccant canisters and packets, which are inserted into pharmaceutical packaging to control moisture and protect the stability of the medicine during its shelf life.

The desiccant production area will be in a Class 100,000 (ISO 8) cleanroom. It will meet all relevant cGMP and US FDA standards. Clariant's Region President - India, Deepak Parikh, said: 'We are happy to announce our plans to invest in a new state-of-the-art manufacturing plant in India. This new manufacturing facility is in alignment with our overall growth strategy in the country.

The new facility will enable us to enhance our medical specialties business and offer end-to-end solutions to our existing as well as potential customers.' The new plant will primarily serve generic and branded pharmaceutical companies operating in India, as well as the domestic Indian pharmaceutical market. According to market research firm Markets and Markets, India’s pharmaceutical packaging market is projected to grow at a compounded annual growth rate (CAGR) of 10.2% from 2015 to 2020. India Ratings & Research, another research company with six offices across India, recently reported that Indian drugmakers accounted for 40% US generic drug imports. It forecasts a 20% CAGR for the overall pharmaceutical market to 2020. The new Healthcare Packaging plant in Cuddalore – together with its plant in Changshu, China and the recent acquisition of healthcare packaging specialist VitaPac, located in Dongguan, China – positions Clariant to take a major role in the expanding healthcare sector across Asia, the firm said.

CSL Behring Expands Operations to Russia

CSL Behring is opening operations in Russia to fulfill certain unmet needs for biotherapies and blood plasma products. CSL Behring is also investigating opportunities to contribute to the development of the Russian pharmaceutical industry, and identify the best ways to partner with the Russian government.

According to the company, the annual usage of certain classes of these medicines in Russia is much lower than it should be, with consumption of immunoglobulins in Russia 10 to 20 times lower than in the U.S. and some European countries.

CSL Behring has operations in more than 30 countries and focuses on developing protein-based therapies for the treatment of bleeding disorders, immune deficiencies, inherited respiratory disease and hereditary angioedema, and for neurological disorders.

CSL chief executive officer and managing director Paul Perreault said the new office enables CSL Behring to partner more closely with the Russian Federation, healthcare providers, patient groups and the scientific community. The company currently has seven products registered in Russia. He added that it will now be easier to launch products in Russia and offer new therapy options to doctors and their patients.

Because the amount of human plasma that is currently collected in Russia is insufficient to meet the growing demand for protein-based medicines, Mr. Perreault said it may be possible to transfer CSL's plasma collection technology to Russia, and initiate toll manufacturing in that country.

Over the last five years, CSL has invested more than $2 billion in R&D, employing more than 1,100 R&D experts.

Aptuit to Increase Capacity at Sites in the UK and Italy

Aptuit plans to up tabletting and encapsulation capacity at sites in the UK and Italy less than a year after it increased API output at the same facilities.

The US contractor announced it would invest $16m (€14.6m) at the sites in Oxford and Verona and hire and 90 more scientists, describing the move as the first part of an “aggressive expansion” plan for the two sites.

CEO, Jonathan Goldman, said increasing capacity would enable Aptuit “to deliver more high quality integrated CMC and help our customers increase their chances of successful IND filing.”

Aptuit cited increasing customer demand as the driver for the investment, but did not provide additional details.

News of the investment comes less than a year after Aptuit opened a 1600L/1000L reactor stream at its API facility in Oxford, UK, and increased throughput at its 400L reactors at its site in Verona, Italy.

In January Aptuit sold two manufacturing facilities to fellow contractor AMRI. The $60m deal saw it divest its injectable drug manufacturing facility in Glasgow, Scotland and its peptide testing services centre in West Lafayette, Indiana.

At the time Goldman said “The sale of these sites to AMRI is part of our strategy to divest non-core assets and invest in our core competency of integrated early discovery to mid-phase drug development.”

He also it would “facilitate reinvestment in our core competencies” citing the Glasgow and Verona facilities as examples.

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