The laboratory was originally established as a development center for next-gen sequencing and has been expanded to provide next-gen sequencing-based clinical testing to support clinical trials.

The firm's Portland, Ore.-based laboratory received CLIA certification in 2006.

"We are working productively with several top pharmaceutical clients to meet their biomarker evaluation and companion diagnostic requirements, supporting early stage proof-of-concept as well as drug/diagnostic co-development programs for FDA approval," Chief Technology Officer Glenn Miller said in a statement.

MolecularMD has developed a number of NGS-based cancer panels that target genomic regions containing genes that are the target of drugs or related to drug response or resistance.

The company has proprietary chemistry and data analysis pipelines that enable it to detect insertions and deletions up to 50 base pairs and to phase the mutations.

Cleanroom Benefits from Grant in Massachusetts

Governor Deval Patrick and the Massachusetts Life Sciences Center have announced $7 million in capital grants for UMass Lowell and Middlesex Community College.

Through the MLSC, Massachusetts is investing $1 billion over 10 years in the growth of the state’s life sciences supercluster. These investments are being made under the Massachusetts Life Sciences Initiative, passed by the state Legislature and signed into law by Patrick in 2008.

“In order for Massachusetts to continue to create jobs and prosper, we must train our workers for the jobs of the 21st century global economy, and provide spaces where early-stage companies can succeed,” says Gov. Patrick. “Our innovation economy relies on a well-educated, well-skilled workforce, and these grants will expand opportunity and grow jobs in the Merrimack Valley.”

UMass Lowell has been awarded $4 million to create the Big Company/Little Company Innovation Hub where medical-device and bio-tech startup companies will benefit from the Massachusetts Medical Device Development Center (M2D2) incubation services while receiving funding and mentoring from larger, established medical-device companies. M2D2 is a joint initiative of UMass Lowell and UMass Worcester that serves as a lifeline for medical-device entrepreneurs, providing easy, affordable and coordinated access to world-class researchers and resources. The success of medical-device companies participating in the current M2D2 ecosystem has attracted the attention of investors and larger medical-device companies. However, M2D2’s incubator is now operating at physical capacity and cannot accommodate additional startup clients. The funding will allow M2D2 to dedicate 11,000 square feet of new incubator space to medical-device and bio-tech startup companies. In addition, this will provide “soft landing” incubation space for European startup companies looking to enter the Massachusetts medical-device market.

Middlesex Community College (MCC) will receive $3 million for the purpose of constructing and equipping a new biotechnology facility to replace the college’s current, outdated facility. Comprehensive planning for the new facility was completed with the assistance of a planning grant from the Massachusetts Life Sciences Center and MCC funding. The multi-phase planning process included conforming the current and emerging workforce skills required by the life sciences industry through a workforce needs and curriculum analysis and identifying the most feasible facility option for enhancing the education and training of MCC biotechnology students through an architectural study. The proposed facility, to be located on the fifth floor of the Talbot Science Building, will include a combined lecture room and laboratory, a Class 10,000 cleanroom, gowning area, and prep room.

The addition of a cleanroom, which is not part of MCC’s current facilities along with the other proposed equipment and facilities upgrades, will significantly expand the capacity of MCC to prepare its students in the best possible way to meet the workforce needs of the life sciences industry.

Middlesex Community College President Carole Cowan says the life sciences grant will allow the college to invest in one of its burgeoning industries and to upgrade and supplement facilities that support the critical lab functions of the program. Specifically, the grant will allow for an investment of a cleanroom and combined lecture and laboratory space in its science properties.

Middlesex has previously been awarded the gold level designation by the Massachusetts Life Science Education Consortium and Cowan says this investment in infrastructure will only serve to bolster the college’s offerings.

The Massachusetts Life Sciences Center (MLSC) is an investment agency that supports life sciences innovation, research, development and commercialization. The MLSC is charged with implementing a 10-year, $1 billion, state-funded investment initiative.

The Massachusetts Life Sciences Center Expands

North Shore InnoVentures a $1.65 million capital grant to expand its laboratory facilities and purchase analytical instruments.

The Massachusetts Life Sciences Center awarded technology incubator and business accelerator North Shore InnoVThe Massachusetts Life Sciences Center awarded technology incubator and business accelerator North Shore InnoVentures a $1.65 million capital grant to expand its laboratory facilities and purchase analytical instruments. North Shore InnoVentures will use the funding to build out two new laboratories and add to an existing lab to accommodate four or five additional companies, it said. It added that it plans to acquire new capabilities in next-generation sequencing, mass spectrometry, digital PCR, flow cytometry, and cell imagingentures a $1.65 million capital grant to expand its laboratory facilities and purchase analytical instruments. North Shore InnoVentures will use the funding to build out two new laboratories and add to an existing lab to accommodate four or five additional companies, it said. It added that it plans to acquire new capabilities in next-generation sequencing, mass spectrometry, digital PCR, flow cytometry, and cell imaging

Gerresheimer to Extend Medical Devices Operation

Gerresheimer, a leading manufacturer of glass and plastic packaging and products, is extending its production capacity for medical plastic systems at its plant in Peachtree City, Georgia, US in a 'double-digit million dollars' project that will create more than 100 jobs going forward.

The production area will be increased by an additional 5,600m2 60,256 sq. ft.). Two-thirds of the extra capacity will be ISO Class 8 cleanroom. The new jobs will be administrative, supervisory and production positions.

'We’re experiencing worldwide growth in demand for user-friendly, safe and easy to use medical devices such as inhalers and insulin pens,' said Andreas Schütte, Head of Gerresheimer's Plastics & Devices Division. 'As a result of this growth, and new customer projects, our plant in Peachtree City will be significantly increasing its production capacity.'

He said there were many opportunities for Gerresheimer in this business segment in the US and the Peachtree City facility would 'play a crucial role in helping us to exploit them'.

Gerresheimer established its first Peachtree City production facility in 1993 and expanded it in 2009 with the establishment of a Technical Competence Centre (TCC). The plant is part of the company's Medical Plastic Systems business unit, which develops, manufactures and assembles customer-specific devices such as inhalers, insulin pens, lancets and various diagnostic systems.

Brown's Compounding Center Opens Solar-Powered Facility

Brown’s Compounding Center, a Colorado pharmacy that creates customized prescription medications to meet individual patients’ needs, recently hosted the ribbon-cutting ceremony for its brand-new, state-of-the-art lab near Denver. The 38,000-square-foot facility, one of the largest of its kind in the country, will serve as the U.S. headquarters for Brown’s, which serves patients in 38 states and counting.

“For the last 10 years, Brown’s has proudly served patients across the country from our home here in Colorado,” says Darby Brown, founder and CEO of Brown’s Compounding Center. “This new facility will enable us to meet the growing demand for prescription medications tailored specifically to individual patients’ needs, while maintaining our strict standards for safety, quality and patient care.”

One of the highlights of the new facility is its $2 million cleanroom, a world-class, 7,000-square-foot aseptic lab for production of sterile medications. Brown’s adheres to comprehensive safety standards for all medications produced in its lab, including frequent, meticulous quality testing. The new facility draws 100 percent of its energy needs from solar power, enabling the lab to continue operations uninterrupted — even in the event of local power outages.

Brown’s current staff of 95 employees, including licensed pharmacists, pharmacy technicians, customer care representatives and support staff, is expected to nearly triple in the new facility, which is nearly 10 times larger than Brown’s previous facility in nearby Parker, Colo. The new facility will allow Brown’s to expand its capabilities and continue to meet rigorous safety and cleanliness standards that exceed industry norms.

Doctors and patients across the country turn to Brown’s to address a wide variety of prescription needs, including pain management and sports medicine, hormone therapy, pediatric medications, adrenal and thyroid dysfunction, dermatology, ophthalmology and podiatry, among many others. Compound medications are tailored to meet individual patients’ needs that can’t be met by the commercial pharmaceuticals market.

Texas A&M Center Adds Mobile Cleanrooms

Walker Barrier Systems, a producer of isolation and containment equipment, has built and delivered the first of eight mobile cleanrooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM).

The Texas A&M Center for Innovation is home to the National Center for Therapeutics Manufacturing (NCTM), which provides a facility for the development and production of vaccines and therapeutics for use in clinical trials. The addition of eight new mobile clean rooms to theNCTM will increase the development and manufacturing capacity of the CIADM.

The Walker Barrier Systems mobile cleanroom design will allow the NCTM to manufacture clinical grade materials at increased levels of compliance. Walker Barrier Systems units are built to support a wide range of processes and platforms that will be required by CIADM to manufacture biosecurity medical countermeasures.

Construction of the mobile cleanrooms began in May 2013, and all eight are expected to be in operation at the NCTM by early 2014. The first unit was delivered in January 2014.

UC Berkeley, UCSF to Launch CRISPR Center

The University of California, Berkeley and UC San Francisco will use a $10 million donation and $2 million of their own resources to launch an initiative and center that will apply a new DNA-editing technology to pursue wide-ranging genome research and engineering projects.

The Li Ka Shing Foundation has provided $10 million to fund the Innovative Genomics Initiative (IGI), which will establish the Li Ka Shing Center for Genomic Engineering and an affiliated chair at UC Berkeley.

UC Berkeley Professor Jennifer Doudna developed the DNA-editing technology — dubbed CRISPR/Cas9 or "DNA scissors" — and unveiled it less than two years ago. Doudna will serve as executive director of the IGI and hold the new faculty chair post, the university said.

The technology has garnered much attention since its arrival; more than 125 papers have been published using the technique, it has led to the launch of three startup companies, and it is being used in a wide range of applications to explore the genetic basis of diseases and to reprogram stem cells, according to UC Berkeley.

"We now have a very easy, very fast, and very efficient technique for rewriting the genome, which allows us to do experiments that have been impossible before," Doudna, a professor at the California Institute for Quantitative Biosciences (QB3), said in a statement.

She said the main goal of the IGI is to develop this technology, which was derived from a "DNA snipping" system that bacteria use to destroy viruses, for human health applications, and to build a library of resources that will make it available for wider use by other investigators.

"This is an exciting time in science right now, when the cost of sequencing a genome is going way down, to around $1,000 for a complete human genome sequence," Doudna said. "Cas9 technology will take genomics to the next level, to enable editing of the genome." She noted that the editing technique has already been used to make discoveries about human diseases in model organism studies, and that it will enable scientists to advance beyond the use of animal models to testing in human cells and tissue, and eventually into clinical medicine by making gene therapy simpler.

As part of the new initiative, Doudna and her colleagues are building an Entrepreneurial Fellows program, which will coordinate with QB3's Startup-in-a-Box program to provide resources and infrastructure for an incubator to help researchers create spin-off companies.

Doudna's fellow UC Berkeley Professor and IGI Co-director Michael Botchan said the initiative also will aim to fuel efforts to explore the "thousands of bacteria and Archaea out there with similar genome-editing systems" to discover other new tools that could be used in genome engineering. Because the CRISPR/Cas9 method enables researchers to disrupt multiple genes or regulatory sequences at the same time to study their functions and interactions, it is likely to lead to new targets for drugs, Botchan added.

The Hong Kong-based businessman and philanthropist Li Ka-shing previously provided $40 million to UC Berkeley to establish the Li Ka Shing Center for Biomedical and Health Sciences, which opened in 2012.

Biomet Plans Indiana Upgrade

Medical device maker Biomet Inc. is planning a $40.5 million expansion company officials say would create 150 high-paying new jobs at Biomet's northern Indiana operations by 2018.

Biomet's project calls for building renovations and adding 3-D printing and optical scanning technology. The Warsaw-based company would also upgrade a center where surgeons interested in introducing a new product, technology or technique can explore the idea with an expert.

The Journal Gazette reports Biomet's global vice president of finance presented the project Thursday to the Kosciusko County Council, which voted unanimously to move the company's request for incentives to the next stage.

Paperwork prepared by the company says the jobs the expansion would bring are projected to pay $75,000 a year on average and will be added in stages.

Alvotech and Finesse Announce Biomanufacturing Collaboration

Alvotech, a new company in the field of biopharmaceuticals and Finesse Solutions, Inc. announced that they have entered into a partnership that will provide Alvotech with world-class, scalable, flexible and cost-efficient manufacturing and laboratory technology through the Finesse turnkey SmartFactory® GMP manufacturing platform suite. SmartFactory® is a single-use cGMP bio-manufacturing capacity, which will allow Alvotech to rapidly expand its biosimilars business. Finesse’s customers will benefit from unprecedented access to Alvogen’s commercial, FDA approved, biomanufacturing facility.

Dr. Andreas Herrmann, CEO of Alvotech, said: “This partnership allows us to leverage Finesse’s single-use bio-manufacturing automation platform, combining best-of-breed bio-process equipment from upstream through downstream. This strategic relationship provides us with much-needed additional manufacturing capacity and scale-up capabilities which will allow us to expedite our ambitions to become a global leader in the high-growth biopharmaceutical industry. The first manufacturing suite will be in place by the end of 2015.”

Dr. Barbara Paldus, CEO of Finesse, added: “Alvotech is capitalizing on the extraordinary flexibility afforded by SmartFactory, and together we will be ableto implement cutting-edge, innovative solutions for established and development-stage biosimilars processes. The Alvotech facility will showcase our latest SMART technologies in process control, batch automation and data management. This partnership will also provide us with an important path to offer full-scale commercial manufacturing to our customers,”

Alvotech is a sister company of the multinational pharmaceutical company, Alvogen.

Progenitor Cell Therapy Announces Bi-Coastal Facility Expansions

NeoStem, Inc., a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced that PCT has expanded both its Allendale, NJ and Mountain View, CA current Good Manufacturing Practice ("cGMP") facilities to significantly increase its engineering and process development laboratories, and controlled environment ("clean room") space available for client needs. Furthermore, the expansion in the Allendale, NJ facility features an ISO Class 6/1,000 cleanroom, enabling PCT to manufacture products intended for European distribution.

"The expansion of our facilities is well in line with the growing demand for PCT's contract development and manufacturing services," said Dr. Robert A. Preti, Chief Scientific Officer of NeoStem and President of PCT. "PCT has always prided itself on delivering excellent customer service and now we can offer our clients more capacity and options for solutions at our facilities to expedite the development and manufacture of their cell therapy products. The non-clean room expansion activities will both improve our capability to provide product development support, and importantly provide room for PCT's Engineering and Innovation Center to grow."

PCT's Allendale facility added two cleanrooms for a total of five, an increase of 67%. One of these new cleanrooms is ISO Class 7/10,000 and the other is ISO Class 6/1,000, meeting certain compliance requirements for product distribution into the European Union. Additionally, the facility expansion added a process development laboratory and effectively doubled available office space. At this point, approximately 22,000 of the Allendale facility's approximate 30,000 sq.ft. of space has been developed, allowing for the possibility of additional future expansion.

The Allendale facility expansion was designed by Poskanzer Skott Architects of Ridgewood, NJ, an award-winning design and planning firm recognized for its innovative and workable design solutions. "Our work for PCT has taken our firm's involvement in the high-tech/sciences sector to a new level," said the firm's co-founder, Barry Poskanzer, AIA. "We take great pride in the quality and longevity of our relationship with PCT, an exciting company doing cutting-edge work in support of medical advancements."

PCT's Mountain View facility expansion added a cleanroom for a total of six, an increase of 20%. The new room is a 250 sq. ft. ISO Class 7/10,000 cleanroom. This expansion brings the production area of the facility to approximately 17,000 sq. ft., reserving approximately

8,000 sq. ft. for future development.

"This investment into PCT's manufacturing facilities and the expansion of its capabilities demonstrates our commitment to support the significant growth and advancement of the regenerative medicine industry, both in the U.S. and in Europe," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

Friedreich's Ataxia Center of Excellence Created

The Penn Medicine/CHOP Friedreich's Ataxia Center of Excellence has been created with a $3.25 million gift from the Friedreich's Ataxia Research Alliance (FARA) in partnership with the Hamilton and Finneran families.

Friedreich's Ataxia (FA) is a progressive neurogenetic condition found in about one in every 50,000 people worldwide. No approved drugs currently exist for the condition, which is characterized by a progressive loss of coordinated movement and a loss of balance.

The goal of the new center is to work with pharmaceutical industry partners to develop drug candidates. Additionally, it will establish a biomarker development program; add cardiac expertise in FA research and clinical care; increase the capacity for and open more clinical trials; and create a dedicated drug discovery unit, the partners said.

The Friedreich's Ataxia Center of Excellence is co-directed by David Lynch, FA program director at Children's Hospital of Philadelphia, and Robert Wilson, a professor of pathology and laboratory medicine at the Perelman School of Medicine at the University of Pennsylvania.

The center continues a 16-year collaboration between Penn Medicine, CHOP, and FARA to improve FA patient care. In that time they have collaborated in research and clinical trials that have shed light on the metabolic dysfunction that underlies FA. Their work has also resulted in a database of well-document patients and more than 20 drug candidates. The FA clinical program at CHOP is the largest in the world, they said.

"Achieving a more holistic approach to both research and care is one main intent of our gift," FARA board member and donor Tom Hamilton said in a statement. "The Center will allow scientists and physicians to exchange insights regularly, not just as projects allow."

Vertex Pharmaceuticals Expanding in Boston

Massachusetts-based biotechnology company Vertex Pharmaceuticals (Vertex) is currently relocating its headquarters from Cambridge to Fan Pier, on the Boston Waterfront. The company is currently headquartered at 130 Waverly Street and operates ten different facilities in and around Cambridge. The relocation is expected to be completed by mid-2014.

Vertex Pharmaceuticals signed agreements in May 2011 to lease two buildings at Fan Pier for a period of 15-years. It is the largest commercial lease in Boston, amounting to $1.1bn. The move will consolidate the company's headquarters and entire operations at Fan Pier.

Vertex Pharmaceuticals was founded by Joshua Boger in Massachusetts in 1989. The company is focused on discovering, developing and commercializing new medicines through research.

It is engaged in the development of medicines for life threatening diseases such as hepatitis C, epilepsy and cystic fibrosis through worldwide research programs.

Vertex currently has a workforce of 1,300 employees in the state. About 500 more employees are expected to be hired by 2015, to support the continuous growth of the company. Other office locations are in San Diego and Coralvillein the US, Abingdon in the UK and Laval in Canada, with a total workforce of about 1,800.

The first drug of the company, INCIVEK (telaprevir) was approved by the US Food and Drug Administration (FDA) in May 2011 for the treatment of hepatitis C. Vertex developed Kalydeco (VX-770) for the treatment of cystic fibrosis and obtained FDA approval for the drug for the treatment of cystic fibrosis in January 2012. Several other medicines are in the mid-stages of development.

Fan Pier, also called Innovative District, is a 21-acre mixed-use waterfront development spanning about nine blocks along the edge of the Boston Harbor. It has about three million square feet of commercial, hotel, retail, residential and public green space. It includes a six-acre marina, harbor walk and a public park and has a well connected transportation infrastructure.

Fan Pier is home to the Institute of Contemporary Art, Salon Mario Russo, LOUIS and other commercial tenants. ONE Marina Park Drive is the first and LEED Gold certified development at the Innovative District.

The relocation of Vertex Pharmaceuticals to Fan Pier is expected to promote establishment of other academic institutes and technology companies.

The project includes construction of two 16-storey buildings for Vertex headquarters. The biomedical research laboratories and offices in the two buildings will occupy a total area of 1.1 million ft2. The ground floor development includes retail and restaurant spaces in an area of 60,000ft2. It also has underground parking garage for 725 vehicles.

The two buildings are distinctive and differ in design. A contemporary design building, 50 Northern Avenue was designed by the architectural firm Tsoi/Kobus & Associates of Cambridge. It has floor to ceiling glass exteriors.

The light blue façade has sloped floor heights along the Northern Avenue. It offers panoramic views of the Boston skyline and the waterfront.

Elkus Manfredi Architects of Boston designed the other building, 11 Fan Pier Boulevard. The building has a metallic framework façade with floor to ceiling green glasses. The facade is curved in the east.

All the building corners facing the city feature glass. Both the buildings are designed to achieve LEED Gold certification.

Construction of the new headquarters was started in June 2011 and inauguration was held in February 2014. The total cost of construction of the project was about $850m, making it one of the largest private-sector projects in the US. The project created about 2,000 construction jobs. Turner Construction was the general contractor of the project.

Public-private funds supported the construction of the pharmaceutical buildings, refurbishment of the public accessibility, landscaping, utilities, sidewalks, and construction of a new water public transpiration dock.

The Fallon Company is the owner and developer of the Fan Pier facility. Cornerstone Real Estate Advisers and Massachusetts Mutual Life Insurance were the financial advisors for the project.

A loan of $355m was secured in July 2011 by HFF towards the construction of the Vertex Pharmaceuticals Campus on behalf of the Fallon Company and investors. In October 2011, the state-run public-private program, Innovative Infrastructure Investment (I-Cubed), committed to fund $50m towards the development of the Fan Pier facility.

Intertek Microbiology Laboratory Achieves Bio-Safety Level 2

Intertek, a leading provider of quality and safety solutions serving a wide range of industries around the world, announces its Cortland, NY, personal protective equipment (PPE) microbiology laboratory has increased its microbiological testing capabilities to Bio-Safety Level 2 (BSL-2). With this achievement the lab provides testing with a broad spectrum of bacteria, fungi, viruses and other microorganisms.

In the United States, microbiology labs are classified by the Centers for Disease Control and Prevention within four Biological Safety Levels (BSLs), which are segmented according to the safety measures needed to mitigate risk to personnel or the environment. BSL-1 is considered to be of little or no risk to human health, whereas, BSL-4 is high risk and may include weaponized biological warfare agents like Anthrax.

To meet the BSL-2 requirements, Intertek invested in state-of-the-art engineering safety controls and conducted extensive training for an already highly experienced staff. “We invested in expanding our chemistry, microbiology, flame, impact, fall from height and physical capabilities to provide a complete solution for our customers. This creates efficiencies for our customers and ultimately works to shorten their time to market,” said Intertek senior microbiologist Adrian Buzea. “This lab allows us to provide unparalleled service to the market as we can deliver on a diverse set of performance requirements.

”With the enhanced capabilities, the products tested at the lab have also become more diverse. Projects are already underway to test blood-borne pathogen-resistant gloves, hypoallergenic air filters and Bacterial Filtration Efficiency (BFE) of medical face mask materials.

Metrics Expands

Metrics Inc. is making significant investments in its facilities and equipment for the benefit of contract services clients by opening a new laboratory to better support fast-track development of pharmaceutical products.

Also in its Greenville facility, the company is adding to its equipment portfolio a Gerteis Mini-Pactor, a high pressure-precise roller compactor that provides Metrics’ formulation development scientists even greater flexibility in batch sizes and throughput. The fast-track development laboratory and Gerteis Mini-Pactor represent continuing investment efforts at Metrics to support the changing needs of its contract services clients, said Stefan Cross, president of Mayne Pharma USA, the parent company of Metrics.

The $1.6 million, 4,524-square-foot facility – located on the company’s main campus in Greenville, N.C. – provides maximum flexibility for early formulation and analytical method development.

The facility is designed for pre-clinical development of early formulation prototypes and related analytical methods. In this laboratory setting, formulators and chemists will have significant autonomy to conduct development activities more quickly, explained Dr. Brad Gold, vice president of pharmaceutical development.

Segregated from the main Metrics operations and containing fully dedicated equipment, these new processing suites have independent HVAC systems and state-of-the-art engineering controls such as interlocking airlock doors, room air pressure differentials, high-volume room air turnover, and 100-percent HEPA air filtration.

“These suites offer our scientists tremendous flexibility, which will support the fast-track development of drug products,” Gold said. “Prototype formulations and methods developed in this lab will be transferred to the adjacent facility for further development and manufacture of clinical trial materials and registration batches. There, they will be manufactured under the exacting auspices of current Good Manufacturing Practice so that Metrics will continue to deliver proven scientific and operational excellence in oral solid dosage forms.”

The ground floor of the new facility consists of five processing rooms and one analytical laboratory. The second floor consists of workstations, office space and a conference room. This project increases to 16 the total number of processing rooms, which are in addition to the extensive analytical laboratories and large-scale manufacturing and packaging operations that Metrics has available. The new facility is expected to be fully operational by mid-February, Gold said.

Metrics’ capabilities include highly potent, cytotoxic and unstable compounds, Schedule II-V controlled substances, and products with poor bioequivalence – for which we offer an impressive portfolio of advanced delivery methods.

Metrics proudly operates as a subsidiary of Mayne Pharma Group Limited.

OTHER COUNTRIES

Alexion Announces Third Irish Facility

Soliris manufacturer Alexion has announced its €75m ($103m) third Irish plant will create 200 new jobs.

The planned 15,000m2 (161,400 sq. ft.) laboratory, office, packaging and warehouse facility in Blanchardstown, Dublin will become the third Irish facility for the Connecticut; US-headquartered biopharma company after it announced it was buying the ex-Elan Drug Technologies vialling plant in Athlone, County Roscommon in February.

The firm manufactures the humanized monoclonal antibody drug Soliris (Eculizumab) which has orphan drug status for the treatment of atypical hemolytic uremic syndrome (aHUS), and paroxysmal nocturnal hemoglobinuria (PNH).

Worldwide net sales of the drug clocked $1.13bn for 2012, according to the firm’s annual report, but Soliris’ $567,000 annual price tag per patient has received scrutiny of late from the UK’s National Institute for Health and Care Excellence (NICE) Committee who asked the firm last month to justify the cost .

To place into context, Soliris costs over 30 times that of other monoclonal antibodies.

The creation of 200 jobs - praised by Ireland’s Head of government, Enda Kenny – will be on top of the 60 staff currently employed at the firm’s Park West manufacturing facilities, also in Dublin.

“Our choice of Ireland reflects the caliber of the workforce and the country's culture of innovation, and we look forward to an ongoing partnership with the Irish Government, IDA Ireland and local communities in the years to come,” said CEO Leonard Bell following the announcement.

Alexion’s interest in Ireland adds weight that the country is becoming a hub for biomanufacturing companies, following some major pull-outs in small molecule production.

Bristol-Myers Squibbs earmarked a Dublin API plant to close last month, adding to recent closures and divestitures from Merck & Co. and Pfizer . However, on the biopharma side Regeneron has bought an ex-Dell computer plant and is converting it into a bioprocessing facility, whilst Pfizer , Eli Lilly and Amgen have all invested in biopharma capacity in the last few years.

Alexion’s “choice of Ireland as a location for their business is an endorsement of the strong infrastructure we have available for pharma companies,” said Barry O'Leary, CEO of IDA Ireland. “The strong flow of investment into Ireland from biopharmaceutical companies is due to our flexible workforce and dedicated training programs.”

UK Awards $19.9M for Synthetic Biology Centers, Training

The UK is investing £12 million ($19.9 million) to establish new synthetic biology facilities and provide training in the field, the Biotechnology and Biological Sciences Research Council announced.

The UK Research Councils, led by BBSRC, will award £10 million to create five DNA synthesis centers "to further develop the UK's research base in synthetic biology," BBSRC said.

Additionally, £1 million is being provided to the BBSRC and Engineering and Physical Sciences Research Council (EPSRC) Centre for Doctoral Training at the universities of Bristol, Oxford, and Warwick, and £1 million is going to the EPSRC Centre for Doctoral Training at University College London for equipment in order to enhance student training.

"Synthetic biology is one of the eight great technologies of the future with the potential to underpin growth and create jobs in a low carbon economy," Willets said in a statement. "This investment in [synthetic biology] will hopefully stimulate even more interest and financial support and reinforce our efforts to develop a leading synbio community in the UK."

The five DNA synthesis centers being established with the funding are located at the University of Edinburgh; Imperial College London; University of Liverpool; MRC Laboratory of Molecular Biology; and the Genome Analysis Centre in Norwich.

The University of Edinburgh will use its £1.8 million award to establish the Edinburgh Genome Foundry, "which will provide end-to-end design, construction, and validation of large gene constructs for academia and industry."

A £2 million award will be used to create the DNA Synthesis and Construction Foundry at Imperial College. The foundry will develop a platform to enable a standardized framework for DNA synthesis, gene and genome assembly, and assembly verification, BBSRC said.

In a separate statement from the college, Richard Kitney, co-director of the Centre for Synthetic Biology and Innovation, said, "The new DNA Synthesis and Construction Foundry will not only scale up DNA synthesis to an industrial level, it will also provide much needed new infrastructure and facilities to collaborate with and train other academics and UK companies interested in synthetic biology."

Another £2 million will go to the University of Liverpool to create the Liverpool GeneMill, focused on developing a high-throughput, automated workflow for synthesizing genes and DNA parts in bacteria, fungus, plant, and mammalian cells.

The MRC Laboratory will invest its £2 million award into a robotic platform to automate the assembly of short DNA fragments into expressible genes, "including the picking, growth, and analysis of DNA from bacterial colonies."

The Genome Analysis Centre will use £1.9 million to set up a DNA synthesis facility at the Norwich Research Park to support the design, generation, and exploitation of high-value compounds and bioactives obtained from plants and microbes.

According to BBSRC, a major hurdle in synthetic biology is creating and assembling starting material, the modular bits of DNA that code for a specific function and which are synthesized in a laboratory. The centers being established with the new funding "will build on existing investments to further establish capability of DNA synthesis for synthetic biology in the UK to help tackle this problem."

The funding is derived from the Roadmap for Synthetic Biology in the UK laid out by the government in 2012. At the time, an independent group advised the government to establish a synbio resource network, support the synbio research community, invest in new technologies, and establish a leadership council focused on synbio activities as an economic growth strategy.

Since then, the UK has invested heavily into building out its synbio infrastructure. About a year ago, the UK said it planned to award as much as £80 million to create a network of multidisciplinary synbio research centers to serve as cores for research projects and to provide researchers with training and resources.

In February, the government announced £40 million in funding to create three new synthetic biology research centers.

GSK to Invest in Manufacturing in Sub-Saharan Africa

GSK says it intends to build five new drug manufacturing as part of a £130m ($215m) investment in sub-Saharan Africa.

The UK-headquartered pharma giant intends to increase its presence on the continent by increasing its manufacturing capacity, expanding its current facilities in Nigeria and Kenya, and – through partnerships with Governments – building up to five new GMP facilities, with locations currently under review in Rwanda, Ghana and Ethiopia.

The firm announced its plans as part of the EU-Africa Business Forum in Brussels, with CEO Sir Andrew Witty telling the meeting GSK’s long-term goal was to equip Africa to “discover, develop and produce” medicines for itself.

The firm will spend £100m to expand its manufacturing capacity for products such as antibiotics, respiratory and HIV medicines which it says are locally relevant, with an aim to “transfer the technology, skills and knowledge needed to enable the local manufacture of more complex products over time.”

A further £25m will be spent on building an Open R&D Laboratory for non-communicable diseases, allowing independent researchers access to GSK resources and knowledge, in collaboration with its R&D hub in Stevenage, UK.

“With global attention focused on how we support development beyond 2015, now is the moment for business to play a more active role in contributing to a more prosperous future in Africa, investing in infrastructure, building skills and capability to unlock human potential and create jobs,” said Witty.

GSK’s interest in Africa was boosted in 2009 when it took a 16 percent stake in South Africa-based pharma firm Aspen. As part of the deal, the two firms looked to collaborate in commercializing their portfolios across the continent, especially with regards to generics.

Novartis subsidiary Sandoz forged a pact with Cameroonian generics firm Cinpharm in 2012 as part of what it said would be bigger plans for the region.

At the time the firm’s operational Head of Western Europe, Middle East and Africa Nick Haggar said sub-Saharan Africa was “a promising emerging market.” He added: “There is a growing population in the region, as well as a growing awareness among policy makers that generic medicines have the potential to make a significant impact on public health outcomes in Africa.”

Philips to Establish Research & Innovation Hub in Africa

The Philips Africa Innovation Hub in Kenya will be the center for developing innovations “in Africa-for Africa” in the areas of healthcare, lighting and healthy living

Royal Philips has announced the establishment of its Africa Innovation Hub in Nairobi, Kenya, which underlines the company’s commitment to invest in Africa. The Philips Africa Innovation Hub will work both on the creation of new inventions, as well as bringing these inventions to the market.

The Philips Africa Innovation Hub will do application-focused scientific and user studies to address key challenges like improving access to lighting and affordable healthcare as well as developing innovations to meet the aspirational needs of the rising middle class in Africa.

The Philips Africa Innovation Hub will be located at the Philips East African Headquarters in Nairobi, where African talents and international researchers will operate on the concept of “open innovation” and will work in close collaboration with the R&D ecosystem of Kenya and Africa. Philips is in discussions with local organizations and Universities on R&D collaborations to co-create meaningful solutions for Africa.

“We welcome the establishment of Philips’ Innovation Hub in Kenya; Philips is a globally recognized innovation powerhouse and their selection of Nairobi as the site to establish their African Innovation hub is a testament to the Kenyan government’s commitment to nurture the drive for research and innovation in the region”, says, Hon’ble Adan Mohammed, Cabinet Secretary for Industrialization. “We lend our full support to the investment being made by Philips and look forward to the outcomes of their Africa-specific research and projects that can contribute to transforming society, business and government across the continent”.

JJ van Dongen, Senior Vice President & CEO Philips Africa states: “Philips is passionate to invent, apply technology and partner to help people succeed. Our ambition is to create impactful innovations that matter to people and address the key challenges that confront society. With Kenya as a leader in the continent in science and entrepreneurship as well as a hub of collaboration on technology and innovation, Nairobi, is the ideal location to establish Philips’ African research presence. We want to tap into the city’s vibrant R&D eco-system and contribute to the process of co-creating new solutions, new business models and meaningful partnerships to provide innovations that make an impact.”

Enhancing people’s lives in Africa though meaningful innovations Some innovations that Philips was already working on have now become part of the Innovation Hub, hence, the Philips Africa Innovation Hub will kick-off with ventures that are under development as well as in the pilot phase; these include:

Respiratory rate Monitor to support pneumonia diagnosis: Pneumonia is the leading cause of death among children under the age of five, resulting in 1.1 million deaths worldwide annually . Of these, 99% of deaths occur in developing countries in low-resource settings, which typically entail rural areas with very limited or poor healthcare facilities or with low-skilled health workers. The current diagnostic tools in such settings are not easy to use, can easily distract the workers from an accurate conclusion, and thus lead to a poor diagnosis.

The Innovation hub is working on the development and clinical testing of a robust and affordable Automated Respiratory Rate Monitor that aims to support the diagnosis of pneumonia among infants and children, using smart sensing technology on the body which is intended to be more accurate and reliable compared to manual processes being currently observed. This device will be specially designed for use by community health workers and nurses in rural areas. In Kenya, discussions are on with the Kenya Medical Research Institute (KEMRI) to further develop this project and co-create an effective solution tailored to circumstances in rural Africa.

Community care services: The development and testing of a work-flow innovation designed to reduce the number of avoidable maternal and child deaths. The purpose of the workflow is to enable remote area health centers to diagnose, triage, treat, stabilize and (prepare for) transport expectant mothers that come in for a check-up and treatment.

Smokeless cook stove: Philips has designed and is manufacturing this innovative stove to improve the lives of those who rely on wood or biomass for their daily cooking. These specially designed stoves are extremely efficient and significantly reduce the use of wood as fuel. The cook stove can reduce smoke and carbon monoxide emissions by more than 90% compared to an open fire thus reducing the health risks of indoor cooking. The contribution of the innovation hub is to create new go-to-market models for these stoves.

Consumer solar solutions: Today an estimated 560 million Africans live without electricity; Philips is committed to improving access to lighting in Africa, for the majority of the population that lives in off-grid communities. The Innovation hub is designing and developing new consumer products using the combination of solar power and energy efficient LED technology. New go-to-market models are also being established to ensure these solutions become accessible to people that would not be able to afford them otherwise.

The Philips Africa Innovation Hub while headquartered in Kenya, will be responsible for pan-African research and projects and will have operations across Africa, linked to the Philips regional offices across the continent; the hub will be headed by Dr. Maarten van Herpen and will work in close collaboration with the Philips research labs in Bangalore, Shanghai and Eindhoven.

GlaxoSmithKline Teams with EMBL-EBI, Sanger Institute to Launch Center

In an effort to address the high failure rate of drug candidates in clinical studies, the Wellcome Trust Sanger Institute, the European Bioinformatics Institute, and GlaxoSmithKline have partnered to create a new center that will use genomics and big data technologies to validate drug targets, EMBL-EBI said.

Based at the Wellcome Trust Genome Campus near Cambridge, the Centre for Therapeutic Target Validation (CTTV) will launch with a £1 million ($1.7 million) investment from GSK that will fuel its initial research projects.

The center will seek to use advances in genetics research to address one of the most formidable problems facing drug developers: an estimated 90 percent of compounds that enter clinical trials fail, either because they do not work or because they are unsafe. The failure rate is so high primarily because the biological targets for drugs are not well understood, EMBL-EBI said.

The staff of an estimated 50 scientists at the CTTV, pooled from the three partners, will combine their expertise in genomics, proteomics, chemistry, and disease biology to study large volumes of data and published research to enhance existing target validation capabilities.

Wellcome Trust researchers will contribute their knowledge of genetics in health and disease, EMBL-EBI scientists will use bioinformatics methods to analyze large amounts of data, and GSK investigators will contribute their expertise in disease biology, drug discovery, and translational medicine.

The CTTV will initially be led by Interim Head Ewan Birney, associate director and senior scientist at EMBL-EBI, who will develop a work program to guide the center's research projects.

Birney said in a statement that the pre-competitive nature of the CTTV will enable the partners to "make the most of commercial R&D practice, but the data and information will be available to everyone."

"Target validation is one of the greatest challenges in drug discovery," added Patrick Vallance, president of pharmaceuticals at GSK. "By changing our business model, taking a more open-minded approach to sharing information and forging collaborations like the Centre for Therapeutic Target Validation, we believe there is an opportunity to accelerate the development of innovative new medicines."

Genomics research has increased the availability of drug targets, Wellcome Trust Sanger Institute Director Mike Stratton said, but it also has presented a problem of how to convert these research findings into medicines. "The challenge we now address is to identify those new targets with the greatest relevance to human disease which, in turn, will undoubtedly increase the speed and efficiency in which new medicines can be developed."

GSK, Wellcome Trust, and EMBL-EBI have agreed that the sequence data and information gathered within the center will be shared with the larger scientific community, and researchers associated with the center will seek to publish their findings in peer-reviewed journals. The CTTV partners also will seek to bring in new corporate and academic partners to expand its activities, EMBL-EBI said.

FONA Opens Innovation Centre in Guangzhou

Flavors manufacturer FONA International has opened new innovation centre in Guangzhou, China.

"Our presence in the area allows us access to local consumer novel sensory technologies and regional application expertise we can share with our customers around the world," said Luke Slawek, President of FONA International.

The facility features labs, a learning centre and gardens. "We want to work side-by-side with our customers in an inspirational environment, and this facility is truly an awesome place to think, build, innovate and learn," said executive vice-president TJ Widuch, who has been overseeing the development and launch of the new facility.

"Our Guangzhou facility is part of our larger vision of expansion throughout Asia-Pacific to be onsite where our customers need us," added Slawek.

New Danish Purification Pilot Plant

Novo Nordisk is increasing its drug development capacity by investing 550 million Danish kroner in a new research and development facility in Bagsværd, Denmark.

The purification plant will expand the company’s capacity to produce active pharmaceutical ingredients for a growing number of diabetes drugs under development.

The pilot plant will be fully operational by late 2016 and will be run by CMC Supply (Chemistry, Manufacturing and Control Supply); a unit within Novo Nordisk R&D. CMC Supply develops, produces and formulates all new protein and peptide processes in Novo Nordisk.

"The new purification pilot plant will significantly increase our capacity for early-phase diabetes projects. It will create up to 35 new jobs over a two-year period in addition to the 100 new employees CMC Supply will hire in Denmark in 2014", said Jesper Bøving, senior vice president, CMC Supply.

The project initially involves establishment of a pilot plant with one purification line. The facility can be expanded to the double size to further increase the capacity. In total 5 kilometers of steel pipes will be used in the purification pilot plant with a total area of 2,700 square meters

(29,052 sq. ft.).

Interserve to Build UK's National Biologics Manufacturing Centre

The design and build contract for the £38m National Biologics Manufacturing Centre (NBMC), to be based in Darlington, UK has been awarded to Interserve Construction.

The contract will create new jobs for the area helping to boost the local economy as well as delivering a state-of-art centre to improve the competitiveness of the UK biologics sector.

Work is expected to begin on the site in April with completion at the end of March 2015.

Interserve is a Twyford, UK-based support services and construction company, which offers advice, design, construction, equipment, facilities management and front-line services.

David Flewker, Regional Director, said: 'Interserve is delighted to be involved in the delivery of the National Biologics Manufacturing Centre. We have operated in the Tees Valley for nearly 60 years and this strategically important facility will enhance the reputation and status of the region as a world leader in this field.'

This strategically important facility will enhance the reputation and status of the region as a world leader in the biologics field.

The 5,000m² (53,800 sq. ft.) NBMC, to be operated by the Centre for Process Innovation (CPI), the process industry element of the government’s national manufacturing strategy called the High Value Manufacturing Catapult, will be a large open access facility that will help companies of all sizes to develop, prove, prototype and scale up the next generation of biologic products, processes and technology.

Located at Central Park, Darlington, it will support the commercialization of research by promoting collaboration between academia, the National Health Service and industry.

The facility will provide flexible laboratory and pilot plant areas for process, analytical and technology development, cleanrooms for GMP process and equipment proving and flexible, open-plan areas where new facility design concepts can be developed and tested. It will also provide training and conference facilities and office and meeting spaces.

Intertek Opens New UK Laboratory

Intertek, a UK testing and certification company, has opened a new UKAS accredited food laboratory in Derby. The laboratory will offer a range of testing and analysis services, as well as expertise and support, to local, regional and global clients. It will provide high quality results and quick turnaround times for all microbiological testing requirements.

'We are delighted to be increasing our operations here in the UK where we can provide additional support to our clients within the food industry. Our experts have a wealth of knowledge and experience and can offer practical solutions to customers around the world,' said Chetan Parmar, Senior Vice President for Food Services and the Managing Director for UK and Ireland at Intertek.

The Derby facility is part of a global network of laboratories and will work with other Intertek laboratories to provide clients with extended expertise, services, and quality results. In-house expertise and analytical resources provide clients with the testing, auditing, certification, advisory and training services that they need.

Applikon's China Plant Up and Running

Applikon Biotechnology BV has already made 50 bioreactor systems at a new plant in China, which it plans to expand into its Asian manufacturing HQ.

The facility in Guangzhou, a city on China's southern coast, is due to be opened officially in April.

However, the site actually started producing and assembling Applikon’s range of bioreactors last summer according to spokesman Erik Kakes.

“The plant has gone on-line in August of 2013 and we have already produced over 50 units in our new facility,” said Kakes.

He added that “at first the plant will be assembling for China only. On the longer term we envision this plant to become the hub for Asia.”

The firm currently employs a staff of 25 people at the site but plans to double its workforce by the end of the year according to Kakes.

At present, Asian customers generate about a third of Applikon’s global turnover, with China being the largest market.

Kakes said that: “We decided to setup our plant in China to be able to offer better and faster support to this significant market. Our customers benefit from Chinese Government investment and this increases the size of the market for us.”

The Chinese Government has been investing in the country’s biopharmaceutical manufacturing industry for more than twenty years, beginning in the 1990s with the launch of a national vaccine production program in which Applikon was involved. Since then support for the biopharmaceutical industry has increased.

The country’s 12th five-year plan – published in 2009 – highlighted the biotechnology sector as one of seven “emerging strategic industries” deserving of Government support.

Applikon already counts CNBG, Qilu pharma, Wuxi Aptech, Wison pharma and Recomgen among its customer base, many of which have received government support.

Prima BioMed Plans to Scale Up

After making significant investments in its personalized immunocellullar manufacturing technology, Prima BioMed is looking to scale up the platform as the company’s lead product enters Phase II trials.

Matthew Lehman, CEO of Prima, told BioPharma-Rerporter.com in an exclusive interview that the production of a personalized treatment like CVac, which is the company’s lead product, presents “a number of manufacturing challenges” as the company looks to scale up to a commercial offering.

Prima has to ensure “everything from how to collect cells from patients, how to automate scheduling, labeling the cells, how to ship those frozen materials, to how the actual process of making the product in the lab works,” Lehman said. This is a process done in three sites in Australia, US, and Germany, which is the company’s flagship site.

The manufacturing process is a combination of semi-automated cell separation and characterization and mostly single use bags for cell culture, Lehman explained. “The cells are in single-use bags and automated separation and culture the cells in single-use bags and then semi-automated steps for washing the cells at the end of the process and then fill and finish,” he added.

The first time the product was made was 12 years ago, and for several years it was all done at a single site in Melbourne, Australia, and then the company began scaling up in 2009.

CVac is a personalized immunocellular therapeutic under investigation for the treatment of epithelial ovarian cancer. The CVac treatment is a targeted cancer immunocellular therapeutic that stimulates the patient‘s own immune system to target and destroy tumors.

Lehman noted that the manufacturing platform could be applied to other developing biologics. There are “a number of applications for this immunocellular manufacturing platform and we’ve done a lot of work on this for years – other companies and groups could benefit from this product development process as it’s not just a process of taking and manipulating cells,” he added.

The company is now beginning a larger Phase II trial that will begin “in a matter of weeks,” Lehman noted. The company will investigate the possibility of more trials over the next two years “as we continue to scale up manufacturing,” he said.

Therapure Biopharma — Development, Scale Up and Manufacture of Complex Biologics

Therapure Biopharma is a contract development and manufacturing organization (CDMO) that specializes in the development, scale up and manufacture of complex biologics. Therapure operates a modern 130,000ft² cGMP facility in the Greater Toronto area that is equipped with Class A to C clean rooms, QC and analytical labs, clinical and commercial-scale manufacturing suites, mammalian cell culture production capability with upstream and downstream processing, and aseptic fill/finish capacity.

Therapure has over 20 years of experience manufacturing a variety of sources of API, including:

·       Whole blood and plasma

·       Mammalian cell culture

·       Primary cell culture

·       Protein manufacturing services

Therapure is highly experienced in protein scale up and cGMP manufacturing. When batch manufacturing starts, we encourage clients to be on-site, observing the manufacturing runs with us. Upon completion, we review the run with the client, going through every technical aspect of the batch records in order to fine tune the process for the next run.

Our protein manufacturing capabilities include:

Upstream: mammalian cell culture processes (CHO, HEK-293, Hybridoma, etc.); microbial processes (through strategic partnerships); master cell bank (MCB) creation; seed train from 5l to 500l single use bioreactors (SUBs); media preparation up to 6,000l batches

Midstream: harvest by nominal flow filtration, tangential flow filtration or centrifugation; viral inactivation tanks (pH, solvent-detergent, temperature); nanofiltration

Downstream: dedicated 'non-live' processing area; chromatographic volumetric rates from 10ml/min to 10l/min; ultrafiltration / diafiltration up to 100m² of membrane; protein modification (conjugation, refolding, enzymatic conversion, etc.); buffer preparation up to 6,000l batches; bulk filling

Glass vial filling

Therapure has experience filling and finishing both therapeutic proteins and small molecules into glass vials, preformed IV bags and prefilled syringes.

For glass vial filling Therapure uses Bosch TL equipment and can fill 3,000 x 2ml vials per hour. Container volumes can range from 2ml to 200ml.

Lyophilization services include:

Clinical-scale lyophilization:

Chamber size: 1.1m² (12ft²)

Number of shelves: six shelves (114mm)

Temperature range: -70°C to +65°C

Batch to vial size: 4,300 units x 2ml; 2,000 units x 10ml

Commercial-scale lyophilization:

Chamber size: 7.5m² (81ft²)

Number of shelves: seven shelves (100mm)

Temperature range: -70°C to +80°C

Batch to vial size: 35,000 units x 2ml; 16,000 units x 5ml; 3,700 units x 50ml

cGMP contract manufacturing services for biologics

Therapure offers integrated lyophilization capabilities at both the clinical and commercial scale.

Therapure operates a world-class 130,000ft² facility with over 28,000ft² of cGMP manufacturing space. Their cGMP contract manufacturing services are designed to help every step of the way - from technology transfer and process development, to analytical development and testing, to the scale up and cGMP manufacturing phases and then on to aseptic fill/finish and lyophilization and, finally, a range of support services, including GMP-compliant warehousing, distribution services, validation support, and stability testing services.

Applikon Biotechnology to Open New Facility in Guangzhou, China

Applikon Biotechnology opened a new production facility on Wednesday March 19th in Guangzhou, China. This new facility is located in “science city” a newly developed high tech science park in Guangzhou. The grand opening was attended by (inter)national customers, business relations, (inter)national officials, scientific relations and a large team of the Applikon Biotechnology in the Netherlands.

The new production facility has been operational for several months and the festivities planned on March 19th are to celebrate this achievement and to officially mark this further step in the development and growth of the company. Arthur Oudshoorn, Managing Director of Applikon Biotechnology, and his dedicated team are proud and happy with these large new premises which consists of offices, a warehouse, production facilities, QA/QC testing section and a technical support department.

In this new facility, Applikon Biotechnology will be able to provide a complete range of bioreactor systems ranging from micro liter research volumes up to production systems for pharmaceutical and biotechnological applications in the Chinese market. Being closer to the customers in china will decrease response time and improve the local technical support for users of advanced bioreactor systems.

Yili Expands with European Research Centre

Chinese dairy group, Yili, has launched a European research and development centre at Wageningen Campus in the Netherlands.

The company wants to extend its activities outside China into Europe, and the Yili Research and Development Centre is its first research centre in the region. It also has plans to expand into North America.

Ben Geerlings, manager international communications, Wageningen University and Research Centre (Wageningen UR), said Yili and the university will work together on dairy farm management, processing of dairy products and food safety.

“Eight projects will be discussed with Wageningen UR staff once the centre is manned,” he said. “At the moment they are recruiting researchers. In June 2014 we expect to start working on the eight subjects, plus new ones brought forward by Wageningen UR.”

In September 2013, Yili visited Europe and Wageningen UR, where food and food production is a core area of study.

The company chose the site because of its interest in Wageningen and the ‘food valley’ area – a region where a number of international food companies and research institutes are based, according to Geerlings.

“Food Valley stimulates growth in the Dutch agro-food sector, with demand as its driving force. It acts on the needs of the business community,” said Geerlings.

“By partnering knowledge with enterprise, Food Valley ensures the wealth of knowledge in the Netherlands is put to optimal use. Much agro-food expertise can be found in the area around Wageningen.”

The research centre was opened by Pan Gang, president, Yili Group; Chen Xu, Chinese ambassador to the Netherlands; Aalt Dijkhuizen, president and chairman, Wageningen UR; and Geert Van Rumund, mayor, Wageningen.

A total of 10 employees from China will be working at the research and development centre.

The Yili Group is a privately owned company that processes and manufactures dairy products, including milk powder, sterilized milk and fresh milk.

It is 12th in the ranking of dairy companies worldwide. FrieslandCampina, fifth in the ranking, opened its research and development centre at Wageningen Campus last year.

Bayer Invests in Production

Bayer says it is going to invest more than 500 million euros at two of its manufacturing sites in Germany to prepare for the production of two investigational haemophilia A treatments.

The cash will be spent at its Wuppertal and Leverkusen facilities to establish additional capacity for the recombinant factor VIII (rFVIII) products — a plasma protein-free rFVIII (BAY 81-8973) and a long-acting rFVIII (BAY 94-9027). Both are currently in Phase III trials and last month Bayer presented data showing that the latter demonstrated protection from bleeds comparable to standard therapy (which requires that patients infuse themselves two to three times a week) with infusion intervals of up to seven days.

As for BAY 81-8973, it is an upgrade of Bayer's currently-marketed rFVIII blockbuster Kogenate, which is manufactured exclusively in Berkeley, California. It will be filed with regulatory authorities in the second half of 2014 and the company noted that "establishing an additional supply source in Germany will help…prepare for production of the anticipated new therapy options and address the growing demand in this therapeutic area".

The investment "will be one of the largest in the history of Bayer HealthCare and reflects our strong commitment in the field of haemophilia A," said Olivier Brandicourt, chief executive of the division. It will also create 500 new jobs at Leverkusen and Wuppertal by 2020.

Cancer Treatment Partnership Established

Start-up biotechnology company TC BioPharm Ltd has established a collaboration with MEDINET, a Tokyo-listed immuno-cell therapy company, to develop a treatment for various different types of cancer.

MEDINET will exclusively license its cell therapy technology to TC Biopharm for clinical development in the U.K. and Europe. According to The Scotsman, TC BioPharm, which is based at the Pentlands Science Park outside Edinburgh, has leased a site at Maxim Office Park in Lanarkshire, where it will establish a new cleanroom, lab, and administration facility which will become a Scottish hub for immuno-cell therapy research to benefit cancer patients.

TCB’s technology uses patients’ own immune cells grown in culture to target cancer, and has a safe history based on the treatment of numerous patients in Japan. TCB has obtained Scientific Advice from the U.K. Medicines and Healthcare Products Regulatory Agency which has provided a clear roadmap to clinical studies. Under expert guidance from Principal Investigator Professor Jeff Evans of the University of Glasgow, TCB plans to treat the first cohort of patients early in 2015, working alongside established cancer clinics in Glasgow and Southampton.

Combining grant support with equity finance from MEDINET and Scottish investors, TCB has an initial funding commitment of $2 million, with additional major venture investment anticipated to support further clinical studies.

TCB is working with Scottish Enterprise, through its account management approach, to assist with the company’s strategic business planning, investment strategy and international growth opportunities through SDI. The account team comprises specialist advisors in these areas and from SE’s High Growth Start Up team. An $830,000 Regional Selective Assistance award from SE will enable the creation of 35 new highly skilled jobs over the next three years as the company grows. Additional funding for academic collaborations has been provided by Glasgow City Council.

Kunihiko Suzuki, chief executive officer of MEDINET (Japan), says, “It is encouraging to have an excellent business partner in the UK, headed by Dr. Michael Leek, who has a well established reputation in the biotechnology and regenerative medicine industry. Over the next few years I believe our partnership with TC BioPharm will successfully obtain marketing approval of this exciting immuno-cell therapy for cancer patients in the U.K. and Europe.”

First Minister of Scotland Alex Salmond says, “Scotland is at the cutting edge of technological advances in a whole range of different fields and I welcome the collaboration between TC BioPharm Ltd with MEDINET in what is a hugely important area of research. Today’s announcement reinforces our position of outperforming the UK for securing inward investment and is testament to the confidence international companies have in Scotland as a country to invest in."

Pfizer Invests in Indonesian Facility

Pfizer’s $3.5m expansion of an Indonesian solid oral dose plant will increase capacity by 76%, the company says.

The Pfizer Global Supply (PGS) facility in East Jakarta manufactures formulated drugs for the treatment of cardiovascular diseases, inflammation, infectious diseases and analgesics, and primarily serves the Indonesian market.

The pharma giant is set to increase production of its solid oral dose products, spokesperson Allyanna Anglim said in order to bolster supply both locally and in Southeast Asia.

“With a total investment of IDR 40 billion [$3.52m], this factory expansion will increase the production capacity of solid oral dose products by 76%, or from 170 million tablets to 300 million tablets per year,” she said.

“Currently, the PGS factory distributes 80% of its products to the Indonesian market and 20% is exported to various countries in Asia, including South Korea, Hong Kong, Thailand, Vietnam, Philippines, Malaysia and Singapore,” she added.

“This plant expansion will reinforce this commitment through the provision of quality and innovative products to meet the healthcare needs of our patients in Indonesia and the rest of Asia.”

Whilst Singapore has fast become the focus of a number of multinational pharma firms within Southeast Asia, especially in biologics, Indonesia was described as a “potentially very lucrative market” by managing director of Malaysia-based pharma firm Pharmaniagia Dato Farshila Emran in 2012.

During talks to acquire a $10m API plant in the country, he said, “Indonesia is the only country among pharmerging countries that has registered double digit growth [14% growth from 2009 to 2011] in the pharmaceutical sectors.”

Last August, Germany-headquartered drugmaker Fresenius Kabi staked its place in the market it expects to be worth over $9.5bn by 2018, acquiring a 51% share of local firm Ethica Industri Farmasi.

The world’s largest clinical research organization, Quintiles, also entered the region in 2011 and expanded its presence the following year in a partnership with Indonesian firm Prodia, citing – amongst other factors — the country’s 240 million strong population, ethnic diversity and growing incidence of infectious and non-communicable diseases.

Novartis Builds Research Capacity in Africa

Limited resources and other barriers have long stymied advances in medical research infrastructure in Africa. But the situation is starting to change. Many countries are making greater investments in science as part of broader efforts to tackle local health problems.

Novartis is working with local partners across Africa to build research capacity. Through the Novartis Institutes for BioMedical Research it has sponsored training programs in several African countries and is also partnering with academic institutions to build drug discovery and development capabilities.

In the area of education, the institutes worked together with the Novartis Pharmaceuticals Division and the Sandoz generic medicines division to sponsor training programs in six African countries in 2013, attracting more than 500 scientists and physicians. In addition, Novartis granted personalized training to more than 50 African scientists at its labs in Switzerland and the United States. The ties established during these exchanges often create enduring scientific collaborations.

Novartis also supports specific research initiatives. For example, bioequivalence studies are important to address the issue of drug quality in Africa where a significant portion of available medicines have been shown to be sub-standard.

In 2013, Novartis created a workshop to help African researchers construct safe and effective Phase I trial facilities for bioequivalence studies. These workshops were very successful in Kenya and Ghana, and Novartis is now responding to requests to bring this capability to colleagues in Tanzania, Ethiopia and other countries, including South Africa where Novartis helped set up a first-in-human study site to test new medicines in African populations.

Another partnership focuses on early stage drug discovery. In 2013 the Novartis Institutes for BioMedical Research and the University of Cape Town in South Africa launched a collaboration to expand research capabilities at the university’s Drug Discovery and Development Center. The center is the first research institution in Africa to successfully bring a new compound – an antimalarial drug candidate – from the screening phase to preclinical development. Under this partnership Novartis provides training grants and infrastructure upgrades, offers university researchers advanced research training at Novartis labs, and delivers on-site training by Novartis scientists.

Fresenius Invests in Australian Plant

Fresenius Kabi has announced plans for a new $47m (€34m) infusion products manufacturing and cancer drug compounding facility in Australia.

The German-owned medicinal products firm has chosen a site in the Melbourne suburb Derrimut for the new 40,000 square meter (428,000 sq. ft.) facility which it says will create 120 manufacturing jobs.

Company spokesman Mathias Link told in-Pharmatechnologist.com that when operational in 2015 “the plant will produce infusion solutions, irrigation solutions, IV generic drugs and compounded oncology products” for public and private hospitals Australia.

According to a report in the Herald Sun newspaper the plant will supply as many as 180 hospitals with 29m intravenous bags and drug delivery systems. Fresenius Kabi also stressed that the facility will run a 24-hour production schedule to ensure demand is met.

The new construction project is being supported by a grant from the Victoria State Government, which has A$55m ($49m) set aside to fund development of industrial biotechnology in the region.

Victoria is already one of Australia’s key drug manufacturing hubs as a result of a number of recent manufacturing expansions by suppliers based in the State.

In 2009, for example, generic drugmaker Sigma Pharmaceuticals expanded its Melbourne facility through a $9.6m investment designed to cement its already leading position in the Australian drug market.

More recently, in March last year, Mumbai-headquartered Cipla chose Victoria as the location for its first regional office outside India.

News of the investment in Victoria comes just a few weeks after Fresenius Kabi recalled compounded cancer drugs in the neighboring State of Queensland over safety concerns.

According to a recall notice on the Therapeutic Goods Administration (TGA) website the firm issued a class I recall of a range of cancer drugs it had compounded after environmental quality control analysis detected some high mould counts.

The firm said that: “A risk assessment by Fresenius Kabi concluded that there is a potential risk for patients as the sterility of product may have been compromised.

It added that it has “not received any reports of adverse events associated with this failure” and that further to the recall identified that there is no evidence for actual contamination of the compounded products and therefore there is no hazard to human health.”

Celerion Opens South Korea Operations

Celerion has expanded its clinical operations to South Korea through a partnership with Seoul National University Hospital (SNUH). The new office is located within the SNUH Clinical Trials Center and provides Celerion with access to the 80-bed clinical research unit specializing in clinical pharmacology, oncology, and pediatrics, as well as to the center’s staff. John Horkulak, executive director, Eurasian Site Operations will oversee the new office. Mr. Horkulak has more than 20 years of experience in managing clinical pharmacology studies in patient populations.

The SNUH Clinical Trials Center focuses on translational medicine and supports Celerion’s strategic objective to provide global services for the growing interest in complex early clinical studies, often involving patients. Additionally, Celerion has audited three other clinical trial centers in South Korea to support multi-site early clinical studies in patients.

“We are very pleased to have a presence in South Korea through our partnership with Seoul National University Hospital,” said Susan Thornton Ph.D., president and chief executive officer at Celerion. “They are a highly respected institution and among the global leaders in the conduct of quality medical research. Collectively, we are in a solid position to successfully conduct and analyze complex clinical pharmacology studies involving patients with access to specialized equipment and facilities.”

“It is an honor for us to partner with Celerion, a global leader in early clinical research,” said Prof. Yung-Jue Bang MD Ph.D., president of the Biomedical Research Institute at SNUH, who also serves as the Director to the Clinical Trials Center. “The partnership enables us to participate more actively in global drug development programs as well as supporting the early clinical research needs for the emerging Korean drug discovery industry.”

Boehringer Updates Plant

Boehringer Ingelheim says it will pump a further €330m ($453m) into a German manufacturing facility criticized by the US FDA in its rejection of the drug empagliflozin.

Developed as part of a joint venture between Boehringer and Eli Lilly , empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor intended to reduce blood glucose levels in patients with type 2 diabetes and was submitted to the US Food and Drug Administration (FDA) in March 2013.

However, the companies received a complete response letter this week for the New Drug Application (NDA) referencing previously observed manufacturing deficiencies at Boehringer’s facility near Mainz, Germany, where empagliflozin will be made.

The quality control issues resulted in a Warning Letter last May and included failure to thoroughly investigate critical deviations in the manufacturing of ingredients, and failure to conduct thorough complaint investigations after the presence of foreign particles were found in APIs.

The letter also “referenced findings related to commercial drug production that were observed during an inspection in November 2012,” Boehringer spokesman Dr. Ralph Warsinsky said, and “these deficiencies need to be resolved before the approval of the empagliflozin application.”

Following receipt of the Warning Letter last year, Boehringer has undergone a review of its manufacturing systems and processes, said Warsinsky, in order to optimize manufacturing and quality control, and to prepare for the FDA re-inspection that is currently underway.

“The goal is to implement appropriate and sustainable measures to optimize manufacturing and quality control and to prepare for the FDA re-inspection that is currently underway.”

Amongst the actions already carried out, he continued, was strengthening the quality management structure in the Operations Division and formalizing a “Culture improvement program” for all employees to encourage a more quality-focused mindset and behavior.

Moreover, the firm has invested over €100m ($137m) since receiving the warning “to address immediate issues and improve standards” and, according to Warsinsky, there is more investment to come at the site.

“In the last five years the company has invested more than €520m in modernizing different parts of the Ingelheim manufacturing site,” Warsinsky said, with a further €330m planned for 2014/2015 to upgrade the facilities.

The European Medicines Agency (EMA) also received the firms’ marketing authorization application (MAA) for empagliflozin in March 2013 but when contacted this morning the agency told us it did not comment on medicines that are still under evaluation.

Lilly, Novast Break Ground on China Expansion

Lilly and Novast Laboratories Ltd. announced that they have commenced the expansion of manufacturing and development facility capacities in Nantong, Jiangsu, China. The expansion is a result of Lilly’s strategic partnership signed in 2012 with Novast to create a platform of Lilly-branded generic medicines.

The facility will be located on a 22-acre campus located inside the Free Trade Zone of the Nantong Economic Technology Development Area (NETDA). The upcoming facility will be built employing a quality by design approach, designed by the world's leading engineering consultants and is a direct culmination of a synergistic teamwork between Lilly and Novast personnel. The facility will be state of the art and world class with emphasis on total quality and safety at each step of the design process.

“This day marks a new chapter for Novast as we are transitioning from commercializing quality prescription products in the United States to focusing on catering the same to the China domestic needs through the collaboration platform with Lilly,” said Dr. Zhang, president and CEO of Novast Holdings Ltd.

“We are delighted to see the facility expansion of Novast under the strategic partnership of Lilly-Novast on brand-generic medicine. In Lilly’s emerging markets business, we are focused on providing patients with innovative medicines from our own pipeline, as well as select Lilly-branded generic medicines that meet Lilly Global Quality Standards. The additional manufacturing capabilities provided by Novast will allow us to better deliver on that strategy," commented Alfonso Zulueta, senior vice president and president of emerging markets, Eli Lilly and Company.

The expansion will involve the addition of a 260,000 square foot manufacturing facility, enabling the production of both sustained release and containment solid oral dosage prescription pharmaceuticals with an annual additional capacity of more than 2.2 billion units. The company plans to invest $60 to $70 million and is anticipated to complete construction by the end of 2015. When the facility becomes fully operational it will not only provide quality products benefiting patients, but also help the local economy in the creation of more than 350 highly skilled additional jobs.

“As an expat living and working in the Nantong area for the past eight years I am extremely impressed and grateful to NETDA and Nantong Municipal Government for their never-ending support and continued cooperation during all these years," commented Prasad Pinnamaraju, senior vice president and COO of Novast Holdings, Ltd.

Andrew Hodge, president of Lilly China, indicated that the expanded manufacturing facilities in Novast will impose a strong support to Lilly China’s full value chain strategy, which is an integration of business presence including Lilly-owned manufacturing, sales and marketing, R&D and branded generics.

AAF Inaugurates New Cleanroom Facility

AAF inaugurated the new cleanroom facility for HEPA filter manufacturing at its main European production location in Emmen, the Netherlands. In the presence of the Management Team of AAF Air Filter Europe, delegates of the Municipality of Emmen and the invited regional press, the opening ceremony was performed by AAF’s COO Johan Langius. The official opening of the cleanroom facility marks a new milestone in AAF’s pursuit of continuously improving manufacturing productivity, product quality and therewith maximizing customer satisfaction.

It is commonly understood that the quality of the HEPA filter directly affects process performance and output quality of critical cleanroom environments, such as those found in the pharmaceutical and microelectronic industries. Even the smallest contamination here can make the difference between success or failure, especially when taking into account latest developments in nanotechnology. Not only does this mean that the particulate collection performance of the HEPA filter needs to comply with functional specifications, also contamination resulting from the HEPA filter itself is to be eliminated. This context requires manufacturing of HEPA filters under clean conditions for aligning with the strictest customer expectations. AAF has acknowledged this importance and has built a fully new cleanroom for its European HEPA manufacturing facility.

The new cleanroom is constructed as a separate area inside the largest European manufacturing facility of AAF, which is located in Emmen, the Netherlands. The total floor area covers 900 square meters (9,684 sq. ft.) and consists of four core process steps: media pleating, filter assembly, testing and packaging. For pleating the media, assembly into HEPA filters and filter testing according to the EN1822:2009 standard, an ISO 7 controlled environment has been designed. Packaging of the HEPA filters will be done in an ISO 6 controlled environment, through which AAF wishes to minimize any contamination risk from the filter itself, once entering the cleanroom at the customer’s site. Both cleanroom areas are designed, constructed and validated following the principles as defined in the ISO 14644 standard.

As a member of Daikin Industries Ltd, global market leader in air conditioning systems, AAF has the ambition to be the number one preferred supplier of clean air solutions. The construction of the new cleanroom represents the latest milestone in the continuous improvement of AAF’s manufacturing and value chain layout in Europe and Middle East. Johan Langius, Chief Operating Officer (COO) for AAF Europe and Middle East: “AAF has significantly upgraded its manufacturing facilities over the last few years with the aim to better meet customer expectations and simultaneously enhance operational excellence. The new cleanroom facility exemplifies the positive development of our organization and strengthens AAF’s leading position in the high-end air filtration market.”

The cleanroom is fully operational. Prior to the official opening, several customers from the pharmaceutical industry have already audited AAF’s new cleanroom area for ensuring alignment with their own internal quality procedures. The AAF cleanroom has convincingly passed these audits with very positive results, demonstrating a solid process design which is fully compliant with stringent customer requirements for clean manufacturing.

Next to the Emmen plant in the Netherlands, AAF has also implemented various upgrades to its other European manufacturing locations in France, the United Kingdom and Slovakia. All facilities follow the Six Sigma improvement principles and are ISO 9001, ISO 14001 and OHSAS 18001 certified. AAF believes that only this combination guarantees the highest quality levels in terms of process, product and the environment.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com