BioPharm International Editors

The pharmaceutical and medical device industries can learn from Toyota's recalls to avoid their own "runaway" quality problems.

Althea Technologies, Inc. (San Diego, CA), a provider of services for biopharmaceutical development and manufacturing will acquire the assets and IP portfolio of Altus Pharmaceuticals (Cambridge, MA).

Archivel Farma's (Badalona, Spain) treatment for tuberculosis (TB) will shortly start Phase 2 clinical trials.

DSM Biologics (Parsippany, NJ), a business unit of DSM Pharmaceutical products, has reached an agreement for the acquisition of the assets and associated business of the Rhobust technology from Upfront Chromatography A/S (Copenhagen, Denmark) for pharmaceutical and other applications.

Crucell N.V. (Leiden, the Netherlands) has been awarded $110 million from UNICEF to supply its pediatric vaccine Quinvaxem to the developing world.

Delaware-based, iBio, Inc. has been awarded a grant of rights to use its proprietary technology, the iBioLaunch platform, in support of a $5.3 million government-funded project for the development of a single vaccine to protect against both anthrax and plague.

Ernst & Young has released its annual report on the state of the biotech industry, Beyond Borders: Global Biotechnology Report 2010, and overall, things are looking good for the industry.

Waters Corporation (Milford, MA) and Ireland's National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) have formed a collaboration that will create the world?s first database for glycan analysis by UltraPerformance liquid chromatography (UPLC).

Dutch biopharmaceutical company Crucell N.V. (Leiden, the Netherlands) and GlaxoSmithKline Biologicals (GSK, London, UK) will collaborate on developing a second-generation malaria vaccine candidate.

Sinovac Biotech, Ltd. (Beijing, China), a vaccine manufacturer, has signed an exclusive license, supply, and distribution agreements with Parenteral Biotech Ltd., a subsidiary of Parenteral Drugs (India), Ltd., an India-based pharmaceutical company.

Millions of infants and young children in the world?s poorest countries will receive potentially life-saving vaccines that help protect against pneumococcal disease, including pneumonia?the world's biggest childhood killer, through agreements made through the GAVI Alliance with GlaxoSmithKline (London, UK) and Pfizer Inc. (New York, NY).

Ranbaxy Laboratories Limited (Gugaon, India) will develop an undisclosed biosimilar therapeutic produced in the Pfenex platform, a Pseudomonas-based recombinant protein expression technology developed by Pfenex Inc. (San Diego, CA).

The US Food and Drug Administration has notified Genzyme Corporation (Cambridge, MA) that it intends to take enforcement action to ensure that products manufactured at its Allston, MA, plant are made in compliance with good manufacturing practice regulations.

The US Food and Drug Administration is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine, manufactured by GlaxoSmithKline (GSK) for rotavirus immunization in the US, while the agency learns more about components of an extraneous virus detected in the vaccine.

On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant.

The Texas Plant-Expressed Vaccine Consortium launched Project GreenVax, a biotherapeutic manufacturing initiative that is designed to show proof-of-concept for a technology that could reduce the time to produce vaccines for infectious disease.

Sanquin Blood Supply Foundation (Amsterdam, the Netherlands), the Netherlands Cancer Institute (Amsterdam, the Netherlands), and the Netherlands Vaccine Institute (Bilthoven, the Netherlands), have launched the AmpVacs project, which aims to develop a broadly protective synthetic influenza A vaccine component.

The US Food and Drug Administration has issued final guidance to help manufacturers who are developing cell-based viral vaccines to address emerging and pandemic threats.

Humacyte, Inc. (Research Triangle Park, NC) and Xcellerex, Inc. (Marlborough, MA) have entered into an initial strategic collaboration for Xcellerex to develop a manufacturing process that will enable the production of Humacyte?s lead regenerative medicine product using Xcellerex?s XDR single-use bioreactor system in its FlexFactory.

The US Food and Drug Administration and the European Medicines Agency (EMA) have agreed to a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMPs) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium.

Repligen Corporation (Waltham, MA) has acquired the assets of BioFlash Partners, LLC (Marlborough, MA), including a technology platform for producing prepacked plug-and-play chromatography columns.

Waters Corporation (Milford, MA) and Daiso Co., Ltd. (Osaka, Japan) have entered into a collaborative agreement to globally market and supply Daisogel bulk packing materials for process chromatography.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages six weeks through five years, manufactured by Wyeth Pharmaceuticals, Inc. (Collegeville, PA), a wholly owned subsidiary of Pfizer, Inc.

The US Food and Drug Administration has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia.

Sanofi Pasteur (Lyon, France) has recalled an additional six lots of its Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes after routine testing found that the antigen content had declined below the specification limit.

The US Food and Drug Administration will collaborate with PATH to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.

Vivalis (Nantes, France) has acquired Humalys SAS, a private French biotech research and development company based in Lyon, specialized in the generation of human MAbs.

Workshops Based on the A-MAb Case Study