September 2008

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…

Biotech Facilities Average a Batch Failure Every 40.6 Weeks

Gathering information about batch failure rates in the biopharmaceutical industry is about as easy as getting politicians to talk about their most embarrassing gaffes and indiscretions. Although it comes as no surprise that batches do fail, some readers may be surprised at how relatively well many organizations appear to be performing. Based on the results of our recently released annual report and survey (1), facilities are experiencing batch failures at an average rate of about one every nine months (40.6…

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…

Multicolumn Chromatography

Downstream processing is a sequence of unit process operations that purify biopharmaceuticals and prepare them primarily for bulk formulation (Figure 1). Typically, a large volume (hundreds to thousands of liters containing kilograms of therapeutic protein) is delivered from an upstream fermentation or cell culture process — and this ends up as a small volume (a few liters) of purified concentrate product after processing. Figure 1: () For many years, biopharmaceutical manufacturers have been working to increase capacity, address upstream production…

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…

Manufacturing Patient-Specific Cell Therapy Products

Several cellular therapies are currently progressing through clinical development with the potential to address unmet medical needs affecting millions of patients. As cell-based therapeutics receive regulatory approval and reach the market, the primary challenge will quickly become manufacturing such products in sufficient volume to meet demand. Aastrom Biosciences has developed tissue-repair cell (TRC) technology for use in autologous, patient-specific cellular therapy (PSCT) and is conducting late-stage clinical trials both in the United States and Europe. TRCs are derived from a…

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…

Scaling Up from Bench through Commercialization

Q&A with the Scientific Advisors THOMAS C. RANSOHOFF vice president and senior consultant at BioProcess Technology Consultants, Inc. How long have you worked for your current employer, and where did you work before that? I’ve worked for BioProcess Technology Consultants for six years (since 2002). Before joining BPTC as a senior consultant, I held senior positions in manufacturing, development, and operations for several biotechnology companies including Repligen, Dyax, and TranXenoGen. What degrees do you hold, and from where? I hold…

Proactive Debottlenecking

It wasn’t so long ago that people in the biotherapeutics industry talked about a “capacity bottleneck” to describe the difficulty faced by bioprocessors as their many products moved forth through development to require production at larger and larger scales (1). Expression technologies at the time were making proteins at levels suggesting that huge amounts of manufacturing capacity would be needed soon. Just after the turn of the century, product titers (in terms of protein present per liter of culture broth/supernatant)…

Production and Economics of Biopharmaceuticals

Q&A with the Scientific Advisors HOWARD L. LEVINE president of BioProcess Technology Consultants, Inc. How long have you worked for your current employer, and where did you work before that? I’ve worked for my current employer since 1994. Before BioProcess Technology Consultants, I worked as vice president of manufacturing operations for Repligen. What degrees do you hold, and from where? PhD in chemistry from the University of Chicago (1978); BS in chemistry from the University of Southern California (1975) Who…