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Performance Challenging Fetal Bovine Serum (FBS) and FBS Alternatives

by William Siegel
Volume 17, Open Access (May 2018)

Growth performance testing in cell culture is an effective approach to making serum suitability and purchase decisions. An independent commercial testing lab conducted two separate and sequential growth promotion studies to underscore the need for pre-purchase lot performance testing with: (1) FBS; and (2) FBS alternatives. Results from both studies are presented here to compare and contrast:
• FBS lots to each other
• FBS alternatives lots to each other
• FBS alternatives lots to FBS
FBS alternatives are included because they are often overlooked as a cost-effective substitute for FBS, providing, in many cases, equivalent performance. It is advisable to avoid preconceived notions concerning the quality or performance of a serum product without considering the culture system, culture conditions, and the subject cells, which can all have a material impact on its performance in cell culture.
Test – then decide...

Citation:
Siegel W. Performance challenging fetal bovine serum (FBS) and FBS alternatives. BioProcess J, 2018; 17. https://doi.org/10.12665/J17OA.Siegel.

Posted online May 21, 2018.

 
Integrating Development Tools into the Process Validation Lifecycle to Achieve Six Sigma Pharmaceutical Quality

by Mark F. Witcher, PhD
Volume 17, Open Access (April 2018)

Achieving very high levels of pharmaceutical product quality, particularly for the next generation of biologics, will require proactive use of a broad range of quality and process development tools throughout the therapeutic’s development and manufacturing lifecycle. These tools are most effective when integrated using an expanded form of FDA’s 2011 process validation guidelines. This article explains how process validation can be combined with quality by design (QbD), ICH Q8 design space (DS) and control strategies (CS), process analytical technology (PAT), and quality risk management (QRM) tools to provide a path to manufacturing very high-quality products. The approach establishes clear goals and then proactively builds appropriate control systems during process development to assure continuous control and verification of all manufacturing activities. Prospectively using the tools over the complete manufacturing lifecycle, from preclinical through commercial manufacturing, is particularly important to assure comparability from early product research and development all the way to commercialization. The continued evolution of these quality tools, as well as building new tools, will provide a path for the pharmaceutical industry to reach and maintain Six Sigma levels of product quality...

Citation:
Witcher MF. Integrating development tools into the process validation lifecycle to achieve six sigma pharmaceutical quality. BioProcess J, 2018; 17. https://doi.org/10.12665/J17OA.Witcher.0416

Posted online April 13, 2018.

 
Gamma Irradiation of Animal Serum: Maintaining the Cold Chain Throughout the Process

by Sue Brown, Bart Croonenborghs, PhD, Kevin Head, Mara Senescu, Raymond Nims, PhD, Mark Plavsic, PhD, DVM, and Rosemary J. Versteegen, PhD
Volume 17, Open Access (January 2018)

This paper reviews the importance of maintaining low temperature storage and handling (i.e., cold chain) for animal serum through all stages of processing, from finished product to the actual end-user. This cold chain extends from serum manufacture through the irradiation process, during shipment back to the supplier post-irradiation, as well as storage at supplier, irradiation, and end-user facilities. Anecdotal experience and theoretical considerations emphasize the point that maintenance of the cold chain is necessary for preserving the performance of serum for cell culture and other applications...

Citation:
Brown S, Croonenborghs B, Head K, Senescu M, Nims R, Plavsic M, Versteegen RJ. Gamma irradiation of animal serum: maintaining the cold chain throughout the process. BioProcess J, 2018; 17. https://doi.org/10.12665/J17OA.Brown

Posted online January 17, 2018.

 
A Method for Differentiating Fetal Bovine Serum from Newborn Calf Serum

by Michelle Cheever, Alyssa Master, PhD, and Rosemary J. Versteegen, PhD
Volume 16, Open Access (December 2017)

The continued use of animal serum as an important component in biotechnology manufacturing processes has raised questions regarding both the reliability of geographic origin and possible adulteration of product. The International Serum Industry Association (ISIA) has implemented a traceability certification program designed to demonstrate traceability from slaughterhouse or abattoir to the end-user. This is based on an audit performed by an independent, approved third-party auditor according to an approved audit plan, using a detailed audit checklist. Recent advances have led to the development of a complementary testing program to determine geographic origin of material. The methodology described in this paper differentiates fetal bovine serum from newborn calf serum on the basis of biochemical composition...

Citation:
Cheever M, Master A, Versteegen R. A method for differentiating fetal bovine serum from newborn calf serum. BioProcess J, 2017; 16. https://doi.org/10.12665/J16OA.Cheever

Posted online December 22, 2017.

 
Novel Lipid Delivery Mechanism of Cell-Ess Increases Higher Order Glycoforms and the Consistency of Glycan Patterns on Monoclonal Antibodies Produced by CHO Cells

by Adam Elhofy, PhD and Justin A. Beller, PhD
Volume 16, Open Access (October 2017)

Glycosolation drives protein quality and therapeutic benefits in protein-based therapies. Recently, there has been a push in the pharmaceutical industry to improve the consistency and quality of the glycan patterns on therapeutic proteins like monoclonal antibodies. Post-translational modification begins in the endoplasmic reticulum but is finished in the Golgi where more complex glycans are added. In this study, the addition of lipids via a novel mechanism provided by the medium supplement, Cell-Ess®, improves the consistency in glycan patterns so that they are more reproducible between product batches. The effect of media supplementation with Cell-Ess on the variation of glycan patterns was measured in two different media formulations across two separate experiments. Supplementation with Cell-Ess resulted in a statistically significant reduction in the variation of glycoforms when measured by the standard error of the mean. In addition, to improved consistency, there were increased higher glycoforms or galactosylation. There was also significantly more total galactosylation and significantly fewer lower glycoforms for antibodies produced by CHO cells supplemented with Cell-Ess. These data taken together suggest that the addition of lipids via Cell-Ess results in a more functional Golgi and an associated improvement of protein quality and consistency...

Citation:
Elhofy A, Beller JA. Novel lipid delivery mechanism of Cell-Ess increases higher order glycoforms and the consistency of glycan patterns on monoclonal antibodies produced by CHO cells. BioProcess J, 2017; 16. https://doi.org/10.12665/J16OA.Elhofy.

Posted online October 2, 2017.

 
Analyzing and Managing Biopharmaceutical Risks by Building a System Risk Structure (SRS) for Modeling the Flow of Threats Through a Network of Manufacturing Processes

by Mark F. Witcher, PhD
Volume 16, Open Access (September 2017)

Biopharmaceutical manufacturing process risks can be described as a network of processes that may include some combination of unit operations, equipment, instruments, control systems, procedures, and personnel practices. The system’s risks can be modelled by a system risk structure (SRS) that describes how threats originate and flow through the network to result in negative consequences (risks). The SRS is a quality risk management (QRM) tool a team of subject matter experts can use to prospectively identify and evaluate a wide variety of risks over the product’s entire development and manufacturing lifecycle. Based on the understanding developed from an SRS analysis, control strategies can be developed by modifying or adding new processes to mitigate the threats, thus reducing the likelihood of the risk consequence being realized. The SRS tool extends the ICH Q9 QRM approach described in a series of articles. Two examples are used to demonstrate how an SRS can be assembled and then used to prospectively identify, understand, and reduce significant risks by controlling the source and flow of threats within the systems described...

Citation:
Witcher MF. Analyzing and managing biopharmaceutical risks by building a system risk structure (SRS) for modeling the flow of threats through a network of manufacturing processes. BioProcess J, 2017; 16. https://doi.org/10.12665/J16OA.Witcher.

Posted online September 25, 2017.

 

 
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