Thursday, February 15, 2018 Daily Archives

eBook: Addressing Quality in Cell-Line Development — Direct Analysis of Bioreactor Harvest for Clone Selection and Process Optimization

by , , , , and

Using Direct Analysis of Bioreactor Harvest for Clone Selection and Process Optimization Therapeutic monoclonal antibodies (MAbs) mostly are manufactured using bioengineered mammalian cells cultured in a bioreactor for two to three weeks. High temperatures and an altered redox environment may compromise the quality of MAbs produced (e.g., fragmentation, truncation), as can the presence of proteases, reductases, and other chemicals released from dead cells. Thus, it would be valuable to establish analytical methods that can help cell culture groups monitor immunoglobulin…

February 15, 2018

Important Considerations in Successful Viral Clearance Studies

by

This webinar features: Esha Vyas, Field Applications Manager, Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products. Rigorous and careful validation of this process-dependent step is necessary to demonstrate that the selected virus filter meets regulatory requirements. Thoughtful design and implementation of spiking studies are imperative to successful validation, and these studies may include consideration of various robustness and process parameters. Overall, the study design should be conducted as a representative scaled-down…

February 15, 2018

eBook: Addressing High Demands for Increased Productivity in Downstream Operations

by

Protein A has made monoclonal antibodies (MAbs) highly manufacturable and easier to develop in laboratories. Its use has enabled purification platform approaches, which have been key elements in growth of the MAb market. But in general, protein A columns are too large, which means they either limit the use of prepacked technology, or create a mismatch between a protein A column and downstream operations. Protein A columns also are more prone to bioburden contamination than any other step in a…

February 15, 2018

Lonza to Establish Cell- and Gene-Therapy Centers of Excellence to Accelerate Growth

by

Lonza will establish Centers of Excellence for Cell and Gene Therapy to support and accelerate the growth of this priority area for the company. This decision advances Lonza’s strategy of being one of the world’s leading, integrated, value-added solutions providers along the healthcare continuum. To further improve its support to customers, Lonza’s Cell- and Gene-Therapy Centers of Excellence will include Lonza sites that are already serving customers and their patients with these innovative technologies. The Lonza sites in Pearland, TX…

February 15, 2018