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…
Monday, September 1, 2008 Daily Archives
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…
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…
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…
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…