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Serum: What, When, and Where?

by Rosemary J. Versteegen, PhD
Volume 15, Issue 1 (Spring 2016)

For over 80 years, fetal bovine serum (FBS) and other animal-derived materials have been widely used in the production of vaccines, and more recently, biotherapeutics, for both human and animal applications. Ever since FBS was initially developed as a cell culture reagent, there have been efforts made to avoid the use of this critical commodity. The International Serum Industry Association (ISIA) recognizes the requirement for robust risk assessment and management, and has several ongoing programs designed to help mitigate the risk of using animal-derived materials. This article will provide an outline of the state of the industry and of these programs...

Citation:
Versteegen RJ. Serum: what, when, and where? BioProcess J, 2016; 15(1): 18–21. https://dx.doi.org/10.12665/J151.Versteegen.

Posted online April 7, 2016.

 
Fetal Bovine Serum: Risk Management

by William Siegel
Volume 15, Issue 1 (Spring 2016)

Safety is typically viewed, perhaps unconsciously, as the result of a collection of factors, conditions, or behaviors. For example, consider “safety” in the context of personal, financial, or travel. With each, safety is defined as a set of component risks that have been managed to satisfactory levels for a particular situation. The same is true for product safety and risk, whether it be for raw materials or finished goods. The “safe” use of fetal bovine serum (FBS) is achieved by the management of controllable risks to a level that is acceptable for each particular application. For example, risk reduction requirements for research applications are not as stringent as for diagnostic, therapeutic, or manufacturing applications. Each end-user must decide on the level of risk reduction that is appropriate for their application...

Citation:
Siegel W. Fetal bovine serum: risk management. BioProcess J, 2016; 15(1): 22–5. https://dx.doi.org/10.12665/J151.Siegel.

Posted online April 7, 2016.

 
Development and Assessment of a Novel Device for the Controlled, Dry Thawing of Cryopreserved Cell Products

by John M. Baust, PhD, William L. Corwin, PhD, Kristi K. Snyder, PhD, John G. Baust, PhD, and Robert G. Van Buskirk, PhD
Volume 15, Issue 1 (Spring 2016)

While playing an integral role in biotechnology and medicine, cryopreservation (CP) is often viewed as a “simple tool” and is overlooked as a critical and evolving component of cell and tissue bioprocessing. Despite this, cryopreservation serves as an enabling technology in numerous areas including the latest cell therapies. For example, over one third of the cells used in clinical trials are cryopreserved using the traditional methods, which in many cases yield suboptimal outcomes. Further, researchers still rely on the assessment of cell survival immediately post-thaw (within a few hours), and fail to account for the impact of cryopreservation-induced delayed-onset cell death (CIDOCD) which continues to impact survival from hours to days post-thaw. Interestingly, despite the fact that CP research remains in a growth phase that focuses on the role of the cellular molecular response to CP stress, these discoveries, and the resultant paradigm shift, have yet to filter into mainstream utilization. Given the crucial role of CP, coupled with other challenges needed to keep pace with modern biomedicine, we have embarked on a goal of developing a novel device and protocol designed to enable rapid, controlled, multi-sample, and high-throughput thawing in an effort to improve overall sample viability and function post-thaw. We have achieved this with the development of the SmartThaw™ device. Studies were conducted using human prostate cancer cell (PC-3) and human mesenchymal stem cell (hMSC) samples cryopreserved using standard, controlled-rate freezing protocols and then thawed with SmartThaw. Post-thaw survival results were equivalent or improved, as compared to traditional water bath approaches, depending on the freezing media utilized. All SmartThaw experiments were achieved in a clean, dry, sterile field with real-time monitoring of the sample thaw thermal profile. Study results suggest that SmartThaw outperforms traditional methodologies. Importantly, these investigations are providing new technologies and direction that are built on a cell/molecular foundation that helps accelerate research, technology, and procedure development initiatives in which CP serves as an enabling component. Further, improvements in standardized sample thawing devices and protocols may pave a path for increased use of cryopreserved cells in clinical applications that enable improved post-thaw viability, homing, biodistribution, and engraftment...

Citation:
Baust JM, Corwin WL, Snyder KK, Baust JG, Van Buskirk RG. Development and assessment of a novel device for the controlled, dry thawing of cryopreserved cell products. BioProcess J, 2016; 15(1): 30–41. https://dx.doi.org/10.12665/J151.Baust.

Posted online April 7, 2016.

 
Regulatory and Monetary Drivers for Real-Time Analytics

by Barry Rosenblatt, PhD
Volume 15, Issue 1 (Spring 2016)

Implementation of “real-time” analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development process...

Citation:
Rosenblatt B. Regulatory and monetary drivers for real-time analytics. BioProcess J, 2016; 15(1): 5–9. https://dx.doi.org/10.12665/J151.Rosenblatt.

Posted online April 7, 2016.

 
The Contamination Triangle: A New Model for Assessing the Risk of Biological Process Contamination and Performing Investigations

by Bill Ogden
Volume 15, Issue 1 (Spring 2016)

Microbial contamination is of great concern in pharmaceutical and biotech manufacturing. Many organizations struggle with determining the root cause of contamination when it occurs, and identifying effective safeguards to prevent future contaminations. This article will introduce a new model for understanding microbial contamination in biopharmaceutical and sterile products and processes. The “Contamination Triangle” identifies the three factors necessary for microbial ingress into a sterile (or pure) system. The use of this model will provide guidance for contamination investigations, clarify the explanation of the contributing root causes in Non-Conformances, and assist in identifying risks and risk mitigation measures as part of a Failure Modes and Effects Analysis (FMEA) or other risk assessment method...

Citation:
Ogden B. The contamination triangle: a new model for assessing the risk of biological process contamination and performing investigations. BioProcess J, 2016; 15(1): 49–53. https://dx.doi.org/https://dx.doi.org/10.12665/J151.Ogden.

Posted online April 7, 2016.

 
Antibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect
A Discussion About Improving Bioassay Reproducibility

by Ulrike Herbrand, PhD
Volume 15, Issue 1 (Spring 2016)

Antibody-dependent cellular phagocytosis (ADCP), which relies on macrophages to attack and devour tumor cells following antibody binding, is a potentially useful mechanism of action (MOA) for antibody drug developers and vaccine makers to consider in determining product efficacy. Unfortunately, it is often ignored in favor of more accessible MOAs driving biological function such as antibody-dependent cellular cytotoxicity (ADCC) because the assays are tedious to prepare, perform, and reproduce. This article will summarize a number of those challenges and discuss how novel approaches, such as a reporter-gene assay that replaces the macrophages with an engineered cell line, are more reliable in measuring this neglected MOA. We will also discuss why this could help developers better understand how their biosimilars compare to the originator product...

Citation:
Herbrand U. Antibody-dependent cellular phagocytosis: the mechanism of action that gets no respect — A discussion about improving bioassay reproducibility. BioProcess J, 2016; 15(1): 26–9. https://dx.doi.org/10.12665/J151.Herbrand.

Posted online April 7, 2016.

 
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