Engineering Commons^™

Improvement Of Cho Specific Productivity Using Amino Acid Derivatives, Aline Zimmer, Caroline Hecklau, Sascha Pering, Alisa Schnellbaecher, Thomas Eichhorn

Cell Culture Engineering XV

Industrial fed-batch cultivation of mammalian cells is used for the production of therapeutic proteins such as monoclonal antibodies. Besides medium ensuring initial growth, feeding is necessary to improve growth, viability and antibody production. Amino acids are key elements for the cellular metabolism but also for the quality of the recombinant protein produced. Several studies have already demonstrated the link between amino acid availability and sequence variants [1-3] or specific modifications like trisulfide bonds [4]. To avoid such modifications, the chemical modification of amino acids is an interesting alternative to modulate their overall solubility [5], …

Development Of A Chemically Defined Media And A Chemically Defined Feeding Strategy For Extended Growth And Enhanced Productivity In Cho-K1 And Cho Dg44 Cultures, Sagar Kokal, Kyle Liu, John Menton

Cell Culture Engineering XV

The biopharmaceutical industry utilizes Chinese Hamster Ovary (CHO) cells for the production of recombinant proteins. Due to regulatory restrictions, there has been much focus on using serum-free culture processes including chemically defined (CD) media and feed system. A great deal of time and cost has been invested by biopharmaceutical companies for the development of an optimal CD media. Currently, the fed-batch process is the most dominant method for the large cultivation of CHO cells. In response to these industry requirements, Kerry has developed a complete system including a CD media called Sheff-CHO CD complete and a CD feed system named …

Evaluation Of Performance Enhancing Effects Of Supplementation With Complex Feed System And Supplements With Sheff-Cho Cd Complete Media In Cho-K1 And Cho Dg44 Cultures, John Menton, Kyle Liu, Sagar Kokal

Cell Culture Engineering XV

Biopharmaceutical companies routinely utilize feed systems for maximizing the yield of recombinant proteins in Chinese Hamster Ovary (CHO) cells. Synergies between plant-derived hydrolysates, yeast extracts and recombinant proteins have previously been demonstrated to enhance productivity in CHO fed-batch cultures. Based on this knowledge, Kerry has developed CHO specific ACF (animal component free) feed systems and supplements for improving the overall culture health and enhancing recombinant protein yields. The availability of protein-free (PF) versions of the feeds and supplements provides an option for production platforms with PF requirements. Kerry has developed Sheff-CHO CD complete a CD media designed to work synergistically …

Strategies For Optimizing A Cell Culture Platform To Achieve High Recombinant Protein Titer Without Impacting Product Quality, Natarajan Vijayasankaran, Robin Gruver, Steven Meier

Cell Culture Engineering XV

Recent advances in cell line development and in the design of culture media have significantly increased both the volumetric and specific productivity of fed batch processes, which is our standard platform technology for synthesis of therapeutic proteins. Cell culture processes are generally simplified when needed as a robust platform technology to meet the imperatives of speedy timelines for early process development and ease of manufacturing. However, both culture media and feeding strategies need to be customized for specific cell lines when there is a need to achieve higher titer due to higher product demand. This presentation will focus on the …

Improving The Metabolic Efficiency Of Mammalian Cells And Its Impact On Glycoproteins Quality, Eric Karengera, Gregory De Crescenzo, Yves Durocher, Olivier Henry

Cell Culture Engineering XV

Glycosylation is a critical quality attribute for recombinant therapeutic proteins, which can be impacted by a number of process conditions, including waste metabolite accumulation. While fed-batch strategies that consist in substituting or controlling the main substrates at low concentrations have proven generally effective at improving protein titer, they can also adversely affect product glycosylation. Metabolic engineering strategies aiming at reducing by-product formation may thus be beneficial for ensuring product quality consistency. In this work, we have specifically investigated the impact of PYC2 overexpression on the quality of a recombinant glycoprotein of therapeutic interest, the interferon α2b (IFNα2b) that has one …

What Are The Facility Design Requirements To Fit Biologics Pipeline Demands?, Thomas Sauer

Integrated Continuous Biomanufacturing II

Decisions to install new facilities are typically driven by pipeline or capacity demands. While extensions to existing capacity typically restrict the level of freedom to design, this is different for pipeline products. Due to numerous unknowns in the development of drug candidates in a pipeline, maintaining a large degree of flexibility in future facility design is the most widely accepted de-risking concept. Looking more closely into the development of a biologics pipeline, certain elements help to control and limit the design space while others just effectuate the opposite.

Without question the key guiding principle for these future products is to …