After coexisting as close cousins in the world of life sciences, the bioprocessing and cell therapy industries now find themselves as possible allies in the pursuit of solutions to small–batch-size production technology. As cell culture titers continue to increase and biotherapies become more “personalized,†pressure is increasing on the bioprocessing industry to find more cost-effective and flexible technologies for producing smaller batch sizes than before. At the same time, the cell therapy industry (renowned for its small–batch-size production)…
Thursday, March 1, 2012 Daily Archives
IBC’s 22nd International Intensive Symposium Biological Assay Development, Validation, and Maintenance
Plan now to attend this highly technical conference for just the right mixture of practical tools, regulatory trend overviews, emerging technologies, and product case studies. Bioassay scientists are intensifying their use of new technologies. Quality by design validations are becoming common, with statistical tools implemented during development, and cells are being developed for single-use applications. This is the must-attend event for bioassay professionals who want to keep up with these changes — where scientists gather to discuss how to overcome…
Global Marketplace
Biobanking Resource Product: CryoFeed microsite Applications: Cell and tissue banking Features: Wheaton offers a curated collection of information about preserving cryogenic biospecimens online. The company responded to an influx of questions about sample containment by creating the CryoFeed website. It provides biobanking-related news and technical tips as well as a place where users can discuss related issues. As samples are collected and cryogenically stored at hospitals, universities, research institutions, and pharmaceutical companies, Wheaton says interest in biobanking and long-term storage…
Measuring kLa for Better Bioreactor Performance
Knowledge of kLa (the volumetric mass-transfer coefficient that describes the efficiency with which oxygen can be delivered to a bioreactor for a given set of operating conditions) is not new. Here I provide information for those who are unfamiliar with the measurement method and/or issues that must be considered when making these measurements. Advances in this area now make it advisable to run kLa measurements routinely in many bioprocesses. The Importance of Measuring kLa Before examining the process theory and…
Fed-Batch Cell Culture Process Optimization
Most biopharmaceutical production platforms are based on fed-batch cell culture protocols, which can support high volumetric productivity while maintaining low operational complexity (1). The industry is interested in developing or refining high-titer cell culture processes to meet increasing market demands and reduce manufacturing costs (2). Although advancements in cell engineering have enabled development of high-performing recombinant cell lines (3,4,5,6), improvements in cell culture media and process parameter settings are required to realize the maximum production potentials of those cells (7,–8).…
Top 10 Regenerative Medicine Stories of 2011
Geron Ends Stem Cell Programs in November: Big hope for a spinal cord injury trial, big loss for a field — the most discussed news of the year. Despite the company’s official comment citing a “purely business decision,†many professionals think that a “lack of impressive preliminary results†also played a role. The company is now seeking a partner to take over that trial. The effect on the cell therapy industry remains to be seen — but for…
Quality Control During Manufacture of a Stem Cell Therapeutic
Development and manufacturing of a therapeutic stem cell product requires extensive quality control (QC) to ensure the identity, quality, and safety of the cells. Here, we describe our QC pipeline to optimize the manufacturing of our MultiStem adherent stem cell product, which is in clinical trial testing for stroke, acute myocardial infarction, inflammatory bowel disease, graft versus host disease, and solid organ transplantation. Screening for growth, marker expression, immunosuppression, and multipotent differentiation — in combination with “-omics†screening for gene…
Revisiting Protein A Chromatography
Due to the molecular complexity of monoclonal antibodies (MAbs) and potential impurities in cell culture media before purification (host-cell proteins, DNA, media components) (1), subsequent downstream operations must consistently and reproducibly purify products to ensure safety and efficacy. The latest member of GE Healthcare’s MabSelect family is called MabSelect SuRe LX (2). As Table 1 shows, it has been developed using the same highly cross-linked agarose base matrix and protein A ligand as for other MAb affinity resins (Table 1).…
“Hard Cellâ€: Potency Testing for Cellular Therapy Products
Potency testing is defined in 21 CFR Part 600.3(s) as “the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result†(1). Potency measurement is especially important for complex products such as cellular therapies (CTs). It is considered an essential aspect of the quality-control system for a CT drug substance and drug product. It is…
An Industry Perspective on Quality By Design
The US FDA’s quality by design (QbD) initiative and associated ICH Q8, Q9, and Q10 guidance documents are increasingly embraced by the biopharmaceutical manufacturing industry for ensuring consistent product quality and lower costs of development and manufacturing. One critical problem the industry faces involves understanding how to implement QbD and determine the benefit of such projects — which require the work of many groups across quality, manufacturing sciences, and engineering departments. Here we present the results from a survey of…