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Continued Process Verification: Monitoring and Maintaining a State of Control

by Kate Lusczakoski, PhD
Volume 14, Issue 1 (Spring 2015)

To ensure that a commercial biomanufacturing process is in a state of control, life science companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Management at pharmaceutical, biotech, and medical device companies commonly receive directives associated with data monitoring. Various challenges arise in the development and maintenance of a successful global monitoring program. Because of this, many companies develop data monitoring programs that are not scalable and sustainable. Company leaders struggle with how best to adopt, deploy, and scale monitoring systems to achieve defined quality monitoring goals. The purpose of this article is to display a maturity model to help companies navigate the major steps of implementing a global monitoring plan for continued process verification.

Lusczakoski K. Continued process verification: monitoring and maintaining a state of control. BioProcess J, 2015; 14(1): 36–42.

Posted online April 29, 2015.

Using Product Lifecycle, Process Validation, and Quality by Design (QbD) Paradigms to Efficiently Take New Biopharmaceutical Products from Pre-IND to Commercial Manufacturing

by Mark F. Witcher, PhD
Volume 14, Issue 1 (Spring 2015)

This paper describes how a biopharmaceutical product development effort can be structured to identify, understand, and plan activities and goals required to efficiently and rapidly deliver new products and therapies to patients. Although the paper focuses on manufacturing, the approach can be used for all aspects of pharmaceutical product development from establishing an intellectual property position, developing a comprehensive manufacturing plan, to creating a marketing program.

Witcher MF. Using product lifecycle, process validation, and quality by design (QbD) paradigms to efficiently take new biopharmaceutical products from pre-IND to commercial manufacturing. BioProcess J, 2015; 14(1): 30–5.

Posted online April 15, 2015.

Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology

by Timothy J. Hahn, PhD et al.
Volume 14, Issue 1 (Spring 2015)

For the ongoing 2014 Ebola virus outbreak, all viable options and technologies need to be evaluated as potential countermeasures to address this emerging biological threat. Novavax, Inc. has a rapid, practical vaccine development and manufacturing platform with the capability to deliver clinical trial material and, ultimately, commercial doses in response to novel infectious disease agents. This report describes the application of our platform technology for the successful generation, manufacture, and release of a clinical batch of Zaire ebolavirus glycoprotein nanoparticle vaccine three months from project initiation...

Hahn TJ et al. Rapid manufacture and release of a GMP batch of Zaire ebolavirus glycoprotein vaccine made using recombinant baculovirus-Sf9 insect cell culture technology. BioProcess J, 2015; 14(1): 6–14.

Posted online February 10, 2015.

Streamline Your Cell Line Screening: With the Automated, Microscale, Stirred Tank, Single-Use Bioreactor

by Tim Ward
Volume 13, Issue 4 (Winter 2014/2015)

The price per patient for protein-based and monoclonal antibody (mAb) therapies runs into thousands of dollars per patient each year. These therapies cost considerably more to manufacture than small molecules. Hence, if mammalian or insect cell lines expressing high protein titres can be selected and optimized for protein expression using microscale bioreactor models early in development, then manufacturing costs can be reduced significantly...

Ward T. Streamline your cell line screening: with the automated, microscale, stirred tank, single-use bioreactor. BioProcess J, 2015; 13(4): 60–1.

Posted online January 20, 2015.

Biopharmaceutical Manufacturing: Historical and Future Trends in Titers, Yields, and Efficiency in Commercial-Scale Bioprocessing

by Ronald A. Rader and Eric S. Langer
Volume 13, Issue 4 (Winter 2014/2015)

This article documents the progress, current state, and projected future trends in titer and yield as industrial and technological benchmarks for commercial-scale biopharmaceutical manufacture. Biopharmaceutical product commercial-scale manufacturing (bioprocessing) was benchmarked by tracking titers and yields over time, from the 1980s to the present, and further out ten years. This study compiled commercial-scale titer and yield data for a set of 39 major biopharmaceuticals, nearly all mammalian-expressed proteins, particularly, monoclonal antibody products. This included extensive searches of many potential data sources, including contacting knowledgeable bioprocessing professionals. In the 1980s and early 1990s, average titers at commercial scale started out at < 0.5 g/L. The current average reported commercial-scale titer is 2.56 g/L. We also confirmed that the manufacture of commercial products has, over the years, undergone repeated cycles of technical production upgrades, with titers and yields increasing incrementally, even for the oldest products. BioPlan estimates that ≥3 g/L is now the industry standard titer for new bioprocesses being developed, with ≤7 g/L now presumed to be the general industry top-end titer level that, while not unusual, is not often achieved. In terms of yields, we found a 70% yield to be the current industry average yield, not the often-cited 75%. Improvements in downstream purification technologies (e.g., as demonstrated by higher yields) have been fewer and adopted more slowly than upstream production...

Rader RA, Langer ES. Biopharmaceutical manufacturing: historical and future trends in titers, yields, and efficiency in commercial-scale bioprocessing. BioProcess J, 2015; 13(4): 47–54.

Posted online January 20, 2015.

In Situ Hybridization: The Importance of Ultrapure Water for RNA Technologies

by Frauke Nitzki and Elmar Herbig
Volume 13, Issue 4 (Winter 2014/2015)

In situ hybridization (ISH) for localization of DNA/RNA hybrids in cytological preparations was first described in 1969 by Gall and Pardue. This method enables mRNA transcripts to be detected in tissue sections. Unlike expression analyses based on polymerase chain reactions, the exact localization of the target transcripts can be identified within the tissue...

Nitzki F, Herbig E. In situ hybridization: the importance of ultrapure water for RNA technologies. BioProcess J, 2015; 13(4): 56–9.

Posted online January 20, 2015.

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