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Virotherapy Process Optimization

by Michael Artinger, PhD
Volume 14, Issue 1 (Spring 2015)

An emerging application of viruses involves engineering them to treat diseases using a number of approaches. Broadly defined under the “virotherapy” umbrella, these include viral vectors used for gene therapy, oncolytic viruses, and viral immunotherapy. Although a majority of these products are in various stages of clinical development, the diversity of the therapeutic targets and wealth of future opportunities is encouraging. A significant challenge, as it is for any virus-based technology, is gaining a clear picture of the quality of a sample at any given point—from early research and development through manufacturing and product release. Of prime concern is the quantification of viruses, which in the past, has relied on slow, labor-intensive, subjective methods such as plaque titer assays and electron microscopic imaging. However, the diversity of new viral technologies now being used as the basis for innovative drugs and vaccines requires advanced, sophisticated analytical systems. In this white paper, we discuss how the real-time enumeration of viruses made possible by the ViroCyt® Virus Counter® 3100 can significantly enhance the pace of virotherapy product development...

Citation:
Artinger M. Virotherapy process optimization. BioProcess J, 2015; 14(1): 26–9. http://dx.doi.org/10.12665/J141.Artinger.

Posted online May 1, 2015.

 
Successful High Density Escherichia coli Fermentation Using the Eppendorf BioFlo® 320 Advanced Bioprocess Control System

by Bin Li, PhD and Ma Sha, PhD
Volume 14, Issue 1 (Spring 2015)

The gram-negative bacterium, Escherichia coli, has a long history in the world of laboratory and industrial processes due to its ease of manipulation and well-understood genome. It is widely cultured under aerobic conditions. High cell density cultivation of E. coli is a powerful technique for the production of recombinant proteins. Indeed, 30% of the FDA-approved biopharmaceuticals on the market are produced in E. coli. An Escherichia coli fermentation run conducted using the Eppendorf BioFlo® 320 bioprocess control station achieved high cell density at 12 hours, as determined by a maximum optical density (OD600) measurement of 215.2. The weights of dry and wet cells were also measured...

Citation:
Li B, Sha M. Successful high density Escherichia coli fermentation using the Eppendorf BioFlo® 320 advanced bioprocess control system. BioProcess J, 2015; 14(1): 20–4. http://dx.doi.org/10.12665/J141.LiSha.

Posted online May 1, 2015.

 
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.

Citation:
Lusczakoski K. Continued process verification: monitoring and maintaining a state of control. BioProcess J, 2015; 14(1): 36–42. http://dx.doi.org/10.12665/J141.Lusczakoski.

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.

Citation:
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. http://dx.doi.org/10.12665/J141.Witcher.

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...

Citation:
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. http://dx.doi.org/10.12665/J141.Hahn.

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...

Citation:
Ward T. Streamline your cell line screening: with the automated, microscale, stirred tank, single-use bioreactor. BioProcess J, 2015; 13(4): 60–1. http://dx.doi.org/10.12665/J134.Ward.

Posted online January 20, 2015.

 
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