Regulatory health authorities seek substantial information from sponsors regarding the practices used to generate production cell lines for mAbs and other therapeutic proteins. In an interest to promote production processes…
In designing cell culture processes for the manufacture of biologics, we often place the greatest focus on product titer. Titer is determined by multiplying together two factors: the amount of…
Capture of antibodies in biopharmaceutical processes is most commonly performed using affinity chromatography on Protein A. While Protein A works well, the commercially available chromatography resin is expensive and its…
We have discussed bispecific antibodies (BsAbs) in this blog before. Teneobio, Inc., a biotechnology company in Menlo Park, CA, is developing a BsAb as a potential therapeutic for the treatment…
Cell growth and product expression are key operating parameters in the manufacture of biologics from CHO cells. Chemical additives such as sodium butyrate have been used to enhance product expression. …
Bioprocesses used to produce recombinant proteins are based on the growth and expansion of living cells in bioreactors. Using the tools of genetic engineering, scientists modify living cells, usually Chinese…
Patients today are receiving personalized treatment regimens that include a wide variety of medications ranging from standard-of-care antibiotics to advanced therapies such as monoclonal antibodies. Increasing demand for therapeutic proteins…
We co-authored this article with David Green at Angus Chemical. In the article, we outline the importance of selecting the appropriate buffers for biologic manufacturing. We define the chemical properties,…
Companies developing monoclonal antibodies face major challenges in developing and implementing a suitable manufacturing strategy and securing adequate capacity. Planning for products that are under development, and possibly years away…
Gone are the days when people communicate by posting a letter and waiting for a response. Many people these days have given up home “land lines”; most people carry cell…