Manufacturing, Biologic Drugs

GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.

The authors describe a holistic and integrated approach to focus on the linkage of the prefilled syringe with the four phases of product design, development, operation, and control.

Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines.

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation.

A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.

America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report.

Vaccine development is benefiting from manufacturing advances and support for global health.

Protein Sciences announced that the Biomedical Advanced Research and Development Authority (BARDA) will continue to support the company?s influenza vaccines program.

The share of biologic-based drugs in the global pharmaceutical market is on the rise.

Quality assurance of biological products is central to India's good distribution practices guidelines.

A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world.

FDA has approved Protein Sciences's FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human flu vaccine. FDA approved Flublok for people 18–49 years old.

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October.

Janssen Pharmaceuticals, Inc. and GlycoVaxyn AG have entered into a three-year agreement to collaborate on the research and development of a multivalent bacterial vaccine utilizing GlycoVaxyn's bio-conjugation technology.

As 2012 comes to a close, Pfizer leads among Big Pharma companies for FDA approvals of new molecular entities and biologics.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

The Italian Medicines Agency lifted a temporary hold on the use of Novartis seasonal influenza vaccines in Italy after affirming the vaccines' safety and efficacy.

Policymakers must balance fundamental issues involving access to medicines and pricing.

A Q&A with James Ingebrand, Vice President and General Manager of 3M Drug Delivery Systems Division, on recent industry trends.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

MedImmune, the global biologics arm of AstraZeneca, announced that it is restructuring its infectious disease and vaccines R&D and operations. This will result in the closure of MedImmune's sites in Mountain View and Santa Clara, California.

Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

BIO is calling for a more patient-centric approach to user-fee reauthorization.

FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.