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Spent Media Analysis with an Integrated CE-MS Analyzer of Chinese Hamster Ovary Cells Grown in an Ammonia-Stressed Parallel Microbioreactor Platform

by Kathryn Elliott, Ji Young L. Anderson, Colin M. Gavin, Kenion H. Blakeman, Sarah W. Harcum, and Glenn A. Harris
Volume 19, Open Access (Jan 2020)

When working on biotherapeutic process development, the analysis of spent cell culture media is often a daily practice during the optimization of bioreactor conditions and media composition. The introduction of parallel microbioreactor systems has decreased the complexity and costs of process development by allowing for concurrent studies of multiple bioreactor and media variables. However, the bioreactors’ small volumes (typically less than 250 mL) limit the volume of media one can extract for daily sampling. We describe a means to analyze spent media with an integrated microchip capillary electrophoresis mass spectrometer (CE-MS) analyzer with minimal sample volume requirements and rapid analysis time. The platform was evaluated with a parallel microbioreactor system (ambr® 250) culturing a Chinese hamster ovary (CHO) cell line stressed by varying levels of ammonia (NH3).

The spent media analysis identified net increases in the levels of the amino acids (AA) Ala, Arg, Asp, Glu, Gly, His, Ile, Leu, Lys, Phe, Thr, Trp, Tyr, and Val in all bioreactors, with Gly levels showing increases in excess of 8-fold initial levels in all bioreactors. Other media components either steadily decreased in concentration or were completely depleted by the end of culture. For example, Asn was depleted in all of the unstressed and 10 mM NH3-stressed bioreactors, but was approximately twice as high as the initial levels in the 30 mM NH3-stressed bioreactors at the end of the culture periods. Also, the 30 mM NH3-stressed condition may have caused either complete degradation or rapid consumption of choline, since it was no longer present starting at the t = 36 h sampling. Overall, the monitored media components were observed to have independent trajectories based on feeding and consumption by the cells, and depending on the stressed condition. The capability to have more frequent spent media analyses would allow for real-time observation of these process changes and associated control strategies.

Elliott K, Anderson JYL, Gavin CM, Blakeman KH, Harcum SW, Harris GA. Spent media analysis with an integrated CE-MS analyzer of Chinese hamster ovary cells grown in an ammonia-stressed parallel microbioreactor platform. BioProcess J, 2020; 19.

Posted online Feb 29, 2020.

Scale-Down Models to Support Process Characterization

by Barney Zoro and Kevin McHugh
Volume 19, Open Access (Jan 2020)

Process characterization using qualified scale-down models (SDM) offers time and resource-saving advantages to companies developing biotherapeutics. Current approaches with glass benchtop bioreactors as SDMs have demonstrated the ability to predict process performance and product quality, but are throughput- limited by infrastructure that requires significant operational input, as well as large volumes of media and reagents. In this article, the Sartorius Stedim Biotech ambr®250 high-throughput, single-use mini bioreactor system will be discussed for its suitability as an SDM for process characterization.

Zoro B, McHugh K. Scale-down models to support process characterization. BioProcess J, 2020; 19.

Posted online Jan 25, 2020.

Estimating the Uncertainty of Structured Pharmaceutical Development and Manufacturing Process Execution Risks Using a Prospective Causal Risk Model (PCRM)

by Mark F. Witcher
Volume 18, Open Access (Sep 2019)

While many risk analysis methods describe how execution or performance risks originate and propagate through pharmaceutical and biopharmaceutical manufacturing processes and systems, few provide methods for efficiently estimating the uncertainty of an execution risk’s occurrence. This article describes prospective causal risk modeling (PCRM) for estimating the risk’s uncertainty of failures associated with executing processes, particularly when little process performance information or data is available. Building upon a basic unit of risk, the process-based system risk structure (SRS) approach is combined with PCRM to provide a method of carrying out quality risk management (QRM) exercises that properly assess both the severity and uncertainty of process execution risks. After the risks are structured using an SRS, PCRM provides a straightforward and effective method for using subjective human judgement and thought experiments to evaluate the risk process’s causal mechanisms for analyzing, evaluating, and controlling the uncertainty, including its likelihood of occurrence, of significant risks associated with developing and manufacturing pharmaceuticals. Using an SRS/PCRM-based QRM exercise, a wide variety of process execution risks can be efficiently evaluated and accepted or rejected so that important risks requiring mitigation can be identified for additional evaluation, control, and eventual acceptance.

Witcher M. Estimating the uncertainty of structured pharmaceutical development and manufacturing process execution risks using a prospective causal risk model (pcrm). BioProcess J, 2019; 18.

Posted online Sep 18, 2019.

Fetal Bovine Serum – Country of Origin, Geographic Relevance, and Labeling

by Percy W. Hawkes, Ole Bødtker Nielsen, and Marc Wintgens
Volume 18, Open Access (Aug 2019)

With an ever-increasing number of countries involved in the collection, processing and marketing of serum, it is necessary to understand the relevance and rules relating to geographic region of origin. This article reviews and discusses the safety and quality of FBS, rules of origin, consumer market-motivated misinformation, and how mislabeled serum can be detected. The article concludes that high-quality serum needed for scientific research and biopharmaceutical products can originate from any country, as long as it is collected, imported, and processed following all the applicable regulatory and industry requirements...

Hawkes P, Nielsen OB, Wintgens M. Fetal bovine serum – country of origin, geographic relevance, and labeling. BioProcess J, 2019; 18.

Posted online Aug 28, 2019.

Fetal Bovine Serum – Geographical Origin and International Trade

by Jennifer A. Murray and Rosemary J. Versteegen
Volume 18, Open Access (Aug 2019)

It is a common belief that fetal bovine serum (FBS) collected from certain geographical regions, such as New Zealand, is of superior quality to material collected from South America. Whilst it is true that origin does have an impact on the price of serum, it does not affect the quality or biological performance of the product. FBS collected under similar conditions from any geographical region will demonstrate comparable ability to support cell growth. For FBS, the term “quality” is frequently confused with “health status.” It is the health status of the geographical region from which the serum is collected that will dictate its potential use, the availability of material for import, and eventually, the price. It should be noted that health status should be considered a result of more than just the geographical source of the material, but also the regulatory infrastructure and how well regulations are enforced by the countries within that region...

Murray JA, Versteegen RJ. Fetal bovine serum – geographical origin and international trade. BioProcess J, 2019; 18.

Posted online Aug 28, 2019.

Testing for Geographic Origin of Fetal Bovine Serum

by Rosemary Versteegen, PhD, Olya Shatova, PhD, Sam Lind, PhD, and Kate Linterman
Volume 18, Open Access (May 2019)

Since its inception in 2006, the International Serum Industry Association (ISIA) has been focused on providing a more informative characterization standard for animal sera. A fundamental aspect of this effort has been the development of a program focused on product traceability from abattoir to end-user. This goal has been achieved in part by implementing the ISIA-sponsored audit program. Serum vendors determined to be compliant with all audit requirements are awarded ISIA Traceability Certifications. In conjunction with Oritain Global Ltd, ISIA has developed and implemented a method for establishing geographical origin of serum products. The method and its capability of determining geographical origin are described in this paper...

Versteegen R, Shatova O, Lind S, Linterman K. Testing for geographic origin of fetal bovine serum. BioProcess J, 2019; 18.

Posted online May 15, 2019.

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