September 2008

Managing the Analytical Lifecycle for Biotechnology Products

Biotechnology pipelines have demonstrated significant growth over the past decade, with many therapeutic candidates evolving in a single class of protein molecules: the monoclonal antibodies (MAbs). To develop such therapeutic candidates, a scalable drug development process must leverage in-house and industry-wide knowledge so biotechnology companies can address the economic and medical needs of 21st-century medicine. Biotherapeutics development is complex, resource intensive, and time consuming, taking some 10 years of effort to go from target validation to commercialization. This reality, coupled…

Cell Culture and Upstream Development

Q&A with Scientific Advisor Dennis Kraichely How long have you worked for your current employer, and where did you work before that? When and why did you get involved in the biotechnology industry? What interested you the most about it? Since 2001, I have worked for Centocor R&D, Inc. (a Johnson & Johnson Company) located in the greater Philadelphia, PA area. Prior to that I worked in cardiovascular discovery research at Procter & Gamble Pharmaceuticals in Cincinnati, OH. Being trained…

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…

Reducing Microbial Contamination Risk in Biotherapeutic Manufacturing

The risk of contamination (especially microbiological) is always an area for special attention in biopharmaceutical processes. No matter the process stage, whether upstream of a bioreactor or in the final filling of a sterile product, effective contamination control continues to be a critical requirement, so any opportunities for improvement may justify further investigation. Even with established validated processes, demands for higher purity and increased sterility assurance may require manufacturers to reassess their procedures and technologies. New processes present an even…

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,…

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…