How Can Cell Culture Conditions Affect Biologic Product Quality?

BioProcess Online Newsletter | March 11, 2015   How Can Cell Culture Conditions Affect Biologic Product Quality? By Trisha Gladd, editor, Pharmaceutical Online and BioProcess Online When it comes to the development of new biotherapeutics, particularly glycoproteins and other post-translationally modified proteins, it is important that such modifications do not alter the activity, pharmacokinetics, or stability of a protein nor provoke immunogenicity in the patient. By understanding what factors can change a protein, as well as the steps to detect and analyze those changes, the risk of doing so is reduced and the efficacy and safety of the drug is preserved. Sponsor Featured Content Particle Testing In Cleanroom High-Pressure Gas Lines For ISO 14644 By Bob Latimer and Bill Bars, Beckman Coulter Life Sciences This paper provides guidelines for the testing of high-pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines, and the EU GMP guidelines. Anaerobic Yeast Fermentation Using Redox Control Metabolic activity of microorganisms depends on many factors, including oxidation and reduction reactions, or the “redox potential” of the culture environment. Comparison Of Assay Methods For The Detection Of Residual Protein A In Biological Therapeutics By P. Brescia, P. Banks, J. Green, and M. Cortes-Caminero, Bio-Tek Instruments Protein A is used in affinity chromatography for therapeutic antibody purification. Protein A has been shown to leach from columns during purification of antibodies, resulting in contamination. The Potential For Implementing Quality By Design In Biomanufacturing By Nick Hutchinson, Ph.D., Bioprocess Lead, Parker domnick hunter If QbD promises a more efficient manufacturing process in which product quality and safety are a given, why is there reticence among the industry to adopt the approach? Featured Downloads From Cold To Controlled World Courier Ground Europe reveals impressive test results for new fleet of temperature-controlled vehicles. Shipping Qualification: What Is It And Why Is It Necessary? Shipping qualification is a process that demonstrates that a product will be both physically and thermally protected throughout the entire shipping process. It Might Look Like Just A Box, But It's A Lot More Than That Envirotainer R&D continuously strives to improve reliability — it is the core of all our operations. As a market leader, Envirotainer also takes on the role of driving innovation of existing products and solutions for the future. Freezing And Thawing In A Controlled-Rate Chamber The purpose of the study was to determine the rate at which the Farrar Scientific Model 4002 -80° C to +40° C Rate Chamber could freeze and thaw 2 L, 6 L, and 16 L ASI Acclimate freeze/thaw containers. Featured Products And Services Wet Ink Roll Scanner Scan W-ink uses new state-of-the-art technology that will not absorb or smudge wet or tacky ink and is designed to require no special maintenance or cleaning schedule; keeping you up and running at all times. Download Brochure Global Vision Inc. Vydac 150HC Peptide Media To address the growing demand for effective peptide purification, Grace has developed the Vydac 150HC purification media, highly effective at purifying many small to midsize peptides with greater loading capacity and improved productivity. Download Datasheet • Request Information Grace Bioprocessing Systems And Solutions Thermo Scientific provides quality sera for cell culture, classical media, serum-free and protein-free media, process liquids, and flexible and single-use bioprocess container systems. Thermo Scientific Sterile Single-Use Connector: AseptiQuik S Connector AseptiQuik S Connectors from Colder Products Company enable small format, sterile, single-use connections with 1/8-inch and 1/4-inch flow configurations. Repeatable and reliable performance with no additional hardware required. Download Datasheet • Request Information CPC Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine.