BioPharm International Editors

Aushon BioSystems, Inc. (Billerica, MA), a provider of multiplex immunoassay products and services for biomarker discovery, development, and analysis, will partner with LightArray Biotech Company, Ltd. (Shanghai, China) to provide Aushon?s suite of multiplex biomarker products and services to pharmaceutical, biotechnical, and academic research institutions located in mainland China.

GE Healthcare (Uppsala, Sweden) and G-Con Manufacturing LLC (College Station, TX) will develop a modular portable bioprocess manufacturing solution for vaccines and therapeutics. This collaboration combines GE Healthcare?s global presence and expertise in biopharmaceutical manufacturing technology with G-Con?s modular portable cleanroom technology.

Tolerx, Inc. (Cambridge, MA), a biopharmaceutical company developing novel therapies by modulating T cell activity, and the Cancer Vaccine Acceleration Fund (CVAF, New York, NY)?a nonprofit program of the Cancer Research Institute established in partnership with the Ludwig Institute for Cancer Research?have signed a research agreement to support the development of Tolerx?s drug candidate, TRX518. TRX518 is a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells. It is the first anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) drug candidate to enter human clinical trials.

Approvals, politics, and user fees are among the issues that make for an uneasy relationship between the US Food and Drug Administration and the life sciences industry, according to findings from a recent PricewaterhouseCoopers (PwC) survey of the industry. This survey, ?Improving America?s Health V,? the fifth such survey performed since 1995, found that although relations between the FDA and the life sciences industry have improved over time, there is still much progress to be made.

Wassim Nashabeh, PhD, the global head of technical regulatory policy and strategy at Genentech, has joined the Editorial Advisory Board of BioPharm International.

ZRG Partners (Westborough, MA) has released its analysis of overall life sciences hiring trends for Q3 2010 and if you live outside of the Americas, hiring trends are generally up.

Boehringer Ingelheim (Ingelheim, Germany) and MacroGenics (Rockville, MD) have entered into a global alliance to discover, develop, and commercialize antibody-based therapeutics that may span multiple therapeutic areas, including immunology, oncology, respiratory, cardiometabolic, and infectious diseases. These developmental drug candidates will be based on MacroGenics?s dual-affinity re-targeting (DART) platform and will be directed against up to 10 combinations of molecular targets.

Medicago Inc. (Quebec City, Canada) a biotechnology company focused on developing vaccines based on proprietary manufacturing technologies and virus-like particles (VLPs), has received clearance from Health Canada to commence a Phase 2 human clinical trial for its H5N1 avian influenza vaccine. Enrolment of volunteers is now underway.

LigoCyte Pharmaceuticals, Inc. (Bozeman, MN) has announced positive results from a Phase 1?2 challenge study of its norovirus virus-like particle (VLP) vaccine candidate. Baylor College of Medicine?s Robert Atmar, MD, the study's principal investigator, shared data from the trial via an oral presentation at the Infectious Diseases Society of America (IDSA) 2010 Annual Meeting on October 23 in Vancouver, British Columbia.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Paragon Bioservices, a Baltimore-based CMO focused on the contract research, process development, and manufacturing of biologics, has been awarded a $4.99 million contract to assist the US Army Medical Research Institute for Infectious Diseases (USAMRIID) in its vaccine development efforts.

Laureate Pharma, Inc. (Princeton, NJ) has entered into a development and manufacturing agreement to produce AV-203, AVEO Pharmaceutical?s (Cambridge, MA) monoclonal antibody targeted against ErbB3. Laureate?s services will include process development, protein production, purification, and aseptic filling of AP-203 for AVEO. Laureate expects to supply AVEO with clinical product in the second quarter of 2011. Terms of the manufacturing agreement were not disclosed.

In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA's plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.

The US Department of Health and Human Services? (HHS) Biomedical Advanced Research and Development Authority (BARDA) is providing three sets of grants totaling $10.4 million to help the World Health Organization (WHO) strengthen developing countries? ability to produce flu vaccines, potentially reducing the global threat from influenza.

Laureate Pharma, Inc. (Princeton, NJ) has secured $20 million in debt and equity financing to grow its business. The new funds will be used to expand existing capacity in protein production and aseptic filling and to expand its service offerings in analytical testing and cell line development.

US Health and Human Services Secretary Kathleen Sebelius has predicted that a cell-based seasonal flu vaccine could be on the market by the 2011?2012 flu season, as reported by CIDRAP of the University of Minnesota.

ARTES Biotechnology (Langenfield, Germany) has acquired the Anavax virus-like particle (VLP) technology from Select Vaccines Ltd. (Melbourne, Australia). Anavax is a patent-protected VLP technology that can be applied to develop vaccines for the prevention of several infectious diseases.

IDT Biologika, GmbH (Dessau-Rosslau, Germany), a contract manufacturer of vaccines and biopharmaceuticals, will expand its viral vaccine production capacity with the addition of a new high-speed filling line and additional lyophilization capacity. The company also will add 80 employees to its workforce?an increase of approximately 11%?to meet growth in demand for its biologics production.

SP Scientific (Gardiner, NY) has signed a license agreement to use Praxair's (Danbury, CT) ControLyo nucleation-on-demand technology, which provides pharmaceutical and biotechnology companies with control over the freeze-drying process for drug developmental efforts.

President's Council and HHS Call for Overhaul of Pandemic Response Programs

Lonza Expands Service Platform to Viral Vaccines, Gene Therapy Vectors

Medicago Awarded $21 million from the US Department of Defense

Nabi Receives Key Patent for Nicotine Vaccines, Enters Manufacturing Agreement with Diosynth

Temasek Life Science Ventures Pte, Ltd. (TLV, Singapore) and Emergent BioSolutions Inc. (Rockville, MD) will form EPIC BIO Pte Ltd, a joint venture to develop, manufacture, and commercialize a multivalent, cross-protective human vaccine to protect against influenza caused by a broad range of circulating H5 influenza strains.

RecipharmCobra Biologics Receives Patent for Antibiotic-Free Plasmid Maintenance System

ISCT Joins Forces with Roche and Genzyme to Launch Cell Therapy Industry Partnership

Genzyme Corporation (Cambridge, MA) has reported that production of its Gaucher treatment, Cerezyme is now up to historical averages and they began increasing shipments in August.

The Maryland Technology Enterprise Institute (Mtech, College Park, MD) Bioprocess Scale-Up Facility (BSF) will double its facilities and staff, expand into Shady Grove, acquire new equipment, and create a pilot plant for biofuels in College Park through the support of a $200,000 shared resource grant from the Maryland Biotechnology Center (MBC).

The UK?s Engineering and Physical Sciences Research Council (EPSRC) has awarded a Knowledge Transfer Secondment grant to BioPharm Services (Chesham, UK) and University College London?s Innovative Manufacturing Research Centre (IMRC) for Bioprocessing.

The US Food and Drug Administration has approved vaccines for the 2010?2011 influenza season in the United States.