2008

Optimizing Vaccine Supply Chains Through Quality Management in Manufacturing

The recent product recalls of PedvaxHib and Comvax vaccine batches are a reminder that the control of vaccine manufacturing processes is of the highest importance. This rings especially true because the target population for these two products is children under the age of five. The Hib vaccine guards against meningitis and other serious infections caused by the bacterium Haemophilus influenzae. In this particular recall, type b vaccine was tested and determined to be free of contaminating microorganisms before being released…

Data Management in the Supply Chain

Adopting an effective strategy for data and knowledge management throughout the drug development and clinical manufacturing lifecycle is key to maintaining a competitive edge. Significant challenges face each organization seeking to improve efficiency in this area, and they can mostly be attributed to the complex nature of pharmaceutical drug development. Managing both data and knowledge is complicated by the different groups, sites, and partner organizations involved with developing and manufacturing a new drug product. To further compound the problem, a…

The Next Generation of Biologicals and Their Production Systems

Combined advances in molecular biology, cell biology, and genomics have led to a wealth of new information about cellular processes. A growing understanding of the fundamentals of cell biology is now being translated into products that use an approach to exert a biological effect that is different from that of most biologicals currently on the market. To date, most biological products consist of highly purified proteins with a specific activity that alleviates or stops the symptoms of a certain condition.…

Higher-Order Structure Comparison of Proteins Derived from Different Clones or Processes

Biological product manufacture is a complex process that constantly evolves throughout the lifecycle of each product even after its approval. A number of constraints (such as increased yield, scale-up, or a need for greater purity) can necessitate the redesign or optimization of a given process. Heterogeneity of a biopharmaceutical product at the beginning of its shelf life comes from inherent variations in its production process that lead to various forms of posttranslational modifications and degradation products. Clearly, the foremost aim…

Third International

Over the past 25 years, the biopharmaceutical industry has transformed itself from a largely R&D enterprise to a global product economy with rapidly growing sales and regulatory approvals worldwide. Some 125 new biologics are expected to hit the market in the next 10 years. This transition from R&D to manufacturing has placed an enormous strain on existing biomanufacturing expertise and production capacity. India presents a huge opportunity for biopharm companies trying to meet this challenge with its competitive labor cost,…

Products, Services, and Literature

Automated Welding Product: M200 orbital welding system Application: Welding power supply Features: The orbital welding system M200 power supply offers ease of use, portability, and 200 amp capability, all at a weight of less than 50 lbs (23 kg). A high-resolution, 12.1-in. (307-mm) color industrial touch screen gives users a simple, intuitive pathway to enter weld programs. Users can choose from one of three forms to enter weld programs, including automatic weld schedule programming. Contact: Swagelok Company www.swagelok.com RNA Purification…

Recovery and Purification

Q&A with the Scientific Advisors CHARLES SCHMELZER senior scientist in late-stage purification at Genentech, Inc. How long have you worked for your current employer, and where did you work before that? What degrees do you hold, and from where? I have been working at Genentech since September 1987. I have a BS degree (chemistry) from Rutgers University (Cook College) and a PhD degree (biochemistry) from North Carolina State University. UWE GOTTSCHALK vice president of purification technology at Sartorius Stedim Biotech…

The Orphan Drug Program

It’s been a quarter-century since the Orphan Drug Act became law in 1983. An orphan drug is any therapeutic, vaccine, or blood product that treats a rare disease or condition (one with fewer than 200,000 US patients). Such drugs may be new products or those already approved for other diseases but discovered to treat a rare disease. Drug sponsors must apply for orphan drug designation through the US FDA (1). Similiar status may be obtained in Europe through the EMEA’s…

An Inoculum Expansion Process for Fragile Recombinant CHO Cell Lines

Development of robust inoculum expansion procedures from cell banks is crucial to successful upstream manufacturing processes. Typically, vial thaw and cell culture expansion processes follow well-established procedures. Certain recombinant cell lines, however, need extra attention and development efforts to optimize conditions for robust and reproducible vial thaw and further subculturing. Difficulties in thawing frozen cells might be clone specific or could originate from suboptimal conditions during freezing. Such conditions might not be known initially and could need further optimization at…

Poster Presentations

Production and Economics Friedrich Nachtmann, head of biotech cooperations in biopharmaceuticals at Sandoz GmbH NAFT: Npro Autoprotease Fusion Technology Microbial expression systems play an important role in the biopharmaceutical industry. A robust, scalable, and well-understood process, reduced development times, and competitive costs are requirements for successful manufacturing. In cooperation with the Austrian Center of Biopharmaceutical Technology, Sandoz has developed a platform Escherichia coli expression technology that provides high expression levels and rapid process development for a broad range of peptides…