Manufacturing

Genentech has been notified that their Cabilly patent claim has been rejected by the US Patent and Trademark Office.

Two case studies illustrate a systematic approach.

The use of disposables has changed significantly in the biopharmaceutical industry.

Best practices from Big Biotech, including how to handle new product introductions.

The key to a good graphical presentation is to select the method that best fits the data.

The automated NucleoCounter from New Brunswick Scientific use disposable cassettes, pre-filled with propidium iodide for accurately counting cells.

The replacement of a IgG ELISA assay with an SPR-based test can shorten the production workflow by one day.

The recombinant approach lends itself to the production of an inexpensive and effective vaccine at large scale.

Potential interference with maternally-derived antibodies makes most vaccines less effective in the neonate.

Human HBV can be grouped into eight genotypes, which differ by at least 8%.

Microstructured transdermal systems can deliver a vaccine in close proximity to the antigen-presenting cells in the epidermis.

The second of a two part article.

A solution for the problems of a "bag in a can" system would be a fully jacketed and insulated container, similar to a traditional freeze tank.

One of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.

Disposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.

Comparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.

Single-use systems reduce maintenance and capital expense by eliminating expensive vessels, valves, and sanitary piping assemblies.

The approval of a new seasonal influenza vaccine has further diversified the supply to the US market.

The US Food and Drug Administration has approved the use of the nasal influenza vaccine FluMist in children ages 2?5.

Bayer Schering Pharma AG, (Berlin, Germany) has completed the acquisition of a biologics manufacturing facility in Emeryville, CA, from Novartis.

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

Sanofi Pasteur (Lyon, France) has announced positive results from Phase 2 trials of its dengue vaccine candidate based on technology licensed from Acambis plc (Cambridge, UK).

Crucell N.V. (Leiden, the Netherlands) has discovered a set of human monoclonal antibodies (MAbs) that work to neutralize and protect against H5N1.

Sanofi Pasteur (Lyon, France) has produced data showing that its new investigational H5N1 pandemic influenza vaccine containing a proprietary adjuvant achieved a high immune response at the lowest dose of H5N1 antigen reported to date.

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.

SAFC (St. Louis, MO), a member of the Sigma-Aldrich Group, has announced a $29-million investment to significantly expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel

The US Patent & Trademark Office has issued the fifth US patent to MorphoSys AG (Munich, Germany) stemming from MorphoSys’s base HuCAL (human combinatorial antibody library) patent family, providing extended protection to MorphoSys’s core technology.

Bristol-Myers Squibb (Princeton, NJ) will acquire privately held Adnexus Therapeutics (Waltham, MA), the developer of a new therapeutic class of biologics called Adnectins.

Five European organizations, including three companies and two hospitals, have joined forces to develop a novel pandemic influenza vaccine as a potential emergency vaccination.