Short time frames are a major challenge in developing alternative microbiological methods for autologous cell therapy products. Ideally, results are made available in under a day. Obtaining regulatory acceptance also can be a challenge, but it is made easier if methods are included in an application (e.g., a biologics license application, BLA) rather than changing a method that is already part of an approved process. Comparing different detection platforms can be a challenge if they have different readouts, and validation…

FUJIFILM Diosynth Biotechnology (FDB) is a multifunctional commercial development manufacturing organization (CDMO) that manufactures virus-based therapeutics. Its site in Texas specializes in both adherent and suspension cell culture for production of virus vectors and for development of analytical assays to support production and expression of our clients’ therapeutics. We work with a number of cell lines such as human embryonic kidney (HEK293) and human retinal cells (Johnson & Johnson/Crucell’s proprietary PER.C6 line), which can grow in suspension. However, many of…

Protein A affinity chromatography continues to be the preferred method for commercial purification of antibodies due to its very high selectivity and robust resin performance over repeated purification cycles. It is now estimated that over US$125 billion of yearly sales will be generated from monoclonal antibody (MAb) products by 2020 (1). The clear majority will be purified by large-scale protein A affinity chromatography. With the continued growth and therapeutic commercial importance of MAb production, the availability of high-quality resin material…

Gene therapy is one of the most progressing fields in life sciences. Although only eight gene therapy products have reached market approval, the pipeline is robust with ~500 candidates in different stages of clinical development. More than 1,700 clinical studies are being conducted, and the value of this industry segment is expected to grow by ~17% annually over the next 10 years. Gene therapy involves using genetic material to fight or prevent disease. The gene is delivered into a patient’s…

The past 30 years have brought significant progress in the design and manufacture of cell culture media as well as in the types of components used. With these advances, the biopharmaceutical industry improved its processes — from producing just a few milligrams of product per liter of culture to ≥10 g/L. Since the early days of microbiology, peptones have been used widely as a basic ingredient of microbial media. In the 1990s, peptones were introduced as a substitute for serum…

As the demand for new life-enhancing therapies increases globally, the pharmaceutical manufacturing community faces an unprecedented challenge to accelerate speed to market. Keeping up to date on industry trends is critical to maintaining a competitive edge. But how do you actively drive these trends and apply them to your manufacturing processes to bring your innovation strategy to life? Whether you are implementing single-use technologies to reduce costs and increase productivity or expanding your operations in emerging markets, scientific collaboration and…