News

When the CMC Biotech Working Group began developing a case study on applying Quality by Design (QbD) to biotech products, the goal was to challenge conventional thinking on the subject.

Gyros AB (Uppsala, Sweden), a provider of automated micro-immunoassays for therapeutic protein development, has signed a distribution agreement with DI Biotech (Seoul, Korea), a supplier to the Korean life sciences market.

A ground breaking ceremony for the commencement of construction of the National Institute for Bioprocessing Research and Training (NIBRT) at Belfield Innovation Park in Dublin was held on November 29.

Sinovac Biotech Ltd. (Beijing, China), a developer and provider of vaccines, has executed a joint venture agreement to establish Sinovac (Dalian) Vaccine Technology Co., Ltd. (Sinovac Dalian).

Genzyme Corporation (Cambridge, MA) has begun shipping vials of newly produced Cerezyme (imiglucerase for injection) manufactured at its plant in Allston Landing, MA.

The German fill-finish provider Vetter inaugurated a new US facility in Skokie, IL, just outside Chicago, along with a new subsidiary, Vetter Development Services USA Inc.

The US Food and Drug Administration has approved Agriflu, a new seasonal flu vaccine manufactured by Novartis Vaccines and Diagnostics (Siena, Italy), for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

The Swiss pharmaceutical company Novartis has opened a new vaccine manufacturing facility in Holly Springs, NC.

Following a five-week inspection of Genzyme's plant in Allston Landing, MA, the US Food and Drug Administration is still not satisfied with the company?s large-scale manufacturing of Lumizyme.

Abraxis Biosciences, a Los Angeles-based biotechnology company, unveiled a $70-million biopharmaceutical manufacturing plant in Phoenix, to serve as the company's manufacturing site for its pipeline of biologics.

FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

Morphotek, Inc. (Exton, PA), a subsidiary of Eisai, Inc., has entered into a license agreement with Centocor Ortho Biotech, Inc. (Horsham, PA), for the development and commercialization of an antibody that targets a tumor-associated antigen over-expressed in many solid tumors.

SAIC-Frederick, Inc. (Frederick, MD), has signed a contract with GenVec, Inc. (Gaithersburg, MD), for the development of influenza and HIV vaccines in support of the Vaccine Research Center (VRC, Frederick, MD).

Octapharma Group (Bad Homburg, Germany) and Fresenius Kabi (Lachen, Switzerland) have signed a license, development, and supply agreement for the use of Fresenius Kabi's HESylation technology to develop a HESylated recombinant protein.

The US Food and Drug Administration has granted priority review for Shire plc's (Cambridge, MA) New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

Brain drug delivery company to-BBB, (Leiden, The Netherlands) has entered into a research collaboration with Genzyme Corporation (Cambridge, MA) to evaluate to-BBB?s proprietary G-Technology to enhance delivery of biologics for neurodegenerative diseases.

In an attempt to save around $60 million annually, the Danish biopharmaceutical company Genmab is planning to sell its manufacturing facility located in Brooklyn Park, MN, and reduce headcount by approximately 300 positions.

The US Food and Drug Administration has granted orphan drug designation to GenVec, Inc.'s TNFerade for the treatment of pancreatic cancer.

In a ribbon-cutting ceremony held on October 30, 2009, Sartorius (Goettingen, Germany) inaugurated its new plant at the Sartorius Group's location in Bangalore, India.

CPL Biologicals Pvt. Ltd. has begun construction of a state-of-the-art manufacturing facility in India that will be used to produce pandemic and seasonal influenza vaccines.

In keeping with the growing trend of iPhone applications for every conceivable convenience, DASGIP AG (Juelich, Germany), a provider of parallel bioreactor systems at benchtop scale, has launched an iPhone application for accessing bioprocesses online.

SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics.

The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.

The US Food and Drug Administration?s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline?s (GSK, Middlesex, UK) candidate cervical cancer vaccine.

Neoprobe Corporation (Dublin, OH) and Laureate Pharma, Inc. (Princeton, NJ) have entered into a Biopharmaceutical Development and Manufacturing Agreement.

The US Food and Drug Administration today approved Stelara (ustekinumab), a biologic manufactured by Centocor Ortho Biotech, Inc. (Horsham, PA),for adults who have a moderate to severe form of psoriasis.