Saturday, June 23, 2018 Daily Archives

Oxygen Mass Transfer Correlation for a Rocking-Motion Bioreactor System

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Disposable bioreactor systems are technologies commonly used in bioprocessing. They provide cost-effective contamination control and allow more flexible facility layouts than do stainless steel alternatives. One of the most popular types of single-use bioreactors uses a rocking platform in place of a traditional shaft and agitator assembly to aerate and mix cell culture material within a presterilized, single-use plastic bag (1). The system studied here is the ReadyToProcess WAVE 25 bioreactor (GE Healthcare Life Sciences). In contrast to conventional stirred…

June 23, 2018

Demonstrating Scalable T-Cell Expansion in Stirred-Tank Bioreactors

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Emerging cell therapies have excited the pharmaceutical industry because they indicate potential new pathways to treat some of the most life-threatening diseases. T-cell therapies currently are the flagship technology in cell therapy with recent US FDA approvals of Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) treatments. Those therapies and others still in development use peripheral blood isolated lymphocytes (PBLs) modified with chimeric antigen receptors (CARs) or modified T-cell receptors (TCRs) to trigger the innate cytotoxic response of these immune…

June 23, 2018

Single-Use Bioreactors: Performance and Usability Considerations Part 1: Performance for Process Control

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There is ever increasing pressure for the biopharmaceutical industry to drive toward higher efficiency and lower costs. Compared to the past, target markets for many drugs typically are becoming smaller, and so-called blockbuster drugs are becoming more the exception than the rule. Regulatory agencies have continued to increase the pressure on drug makers to meet increasing quality standards and accept higher levels of responsibility. Furthermore, customer pricing, healthcare markets, and recent biopharmaceutical pricing scandals all add incentives toward more efficient…

June 23, 2018

PDB-Dimer Payloads for Antibody Drug Conjugates: A Robust Approach to cGMP Production

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From the 1960s when monomeric pyrrolobenzodiazepines (PBDs) such as anthramycin were isolated and characterized, to the dramatic increase of potency induced by dimerization in the 2000s, PBD dimers have evolved as one of the leading classes of antibody drug conjugate (ADC) payloads. Currently, 17 ADCs are in clinical trials involving PBD-dimers — second only to auristatins (23 ADCs), and more than those with maytansines (16 ADCs). Four different PBD-dimer ADC payloads are in clinical trials: Talirine (SGD-1910) from Seattle Genetics;…

June 23, 2018