Careful consideration of lot size is crucial for multiyear success of a cell therapy business. RoosterBio’s product design and acceleration business works with the company’s customers to help make plans that are appropriate for their stages of product and clinical development. We use the following major considerations in creating a sound multiyear strategy with intermediate milestones:
This special report explains how cell therapy contract services can help biotechnology startups ensure multiyear success. Just fill out the form below to read it now.
Corresponding author
Taby Ahsan,
PhD, is vice president of analytical, product, and process development, and
Jon A. Rowley,
PhD, is founder and chief product officer at RoosterBio, 5295 Westview Drive, Suite 275, Frederick, MD 21703; 301-200-5366.
Monoclonal antibody (MAb) expression systems typically use signal peptides to ensure secretion of antibodies into cell culture media. Although that reduces the complexity of purification and prevents the need for cell disruption, it does require using expensive and time-consuming techniques to separate cells from antibody-containing cell culture fluids. In this study, we describe our tests of the novel Sartoclear Dynamics Lab V system (Sartorius S Lab Instruments GmbH and Co. KG) for rapid clarification of cell culture media without requiring centrifugation or additional costly equipment. The filtration system was tested and compared with the method currently used to separate cells from antibody-containing cell culture fluids. That standard clarification method includes an initial centrifugation step followed by filtration of the cleared supernatant through a 0.45-μm filter on a vacuum-driven bottletop filter.
Further Reading
Kempken R, Preissmann A, Berthold W. Clarification of Animal Cell Cultures on a ...
+1Structural integrity of protein-based therapeutics is one of the major challenges in the biopharmaceutical industry. Multiple factors such as product stability, efficacy, and shelf life could be affected following minor changes in manufacturing process. Multiple biophysical methods employing spectroscopic and calorimetric tools can be used to analyse Higher Order Structure (HOS). Moreover, with an increasing demand for generating as much structural information as possible for regulatory submissions, a requirement for these analyses in a GMP environment is also important.
This report focuses on current biophysical analyses that provide a better understanding of a biologic drug and new analytical approaches that are key to a successful program addressing critical quality attributes to support regulatory submissions.
Just fill out the form below to download this Special Report now.
References
1
Kaplon H, Reichert JM. Antibodies to Watch in 2019.
MAbs
11(2) 2019: 219–238; doi: 10.1080/19420862. 2018.155646...
