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Rapid and Effective Monitoring of Baculovirus Concentrations in Bioprocess Fluid Using the ViroCyt® Virus Counter®

by April Birch, Heather Allen, Kerrie Kennefick, Anita Gugel, and Christopher W. Kemp, PhD
Volume 13, Issue 2 (Summer 2014)

The licensing of recombinant vaccines produced using the baculovirus expression vector system (BEVS) has cleared the way for the production of a variety of biopharmaceuticals produced using this technology. Obtaining accurate estimates of both total and infectious baculovirus titer in upstream and downstream bioprocess fluids is one of many process controls that will need to be addressed during the development phase of a product’s lifecycle. Traditional plaque-titer methods require 5–7 days of incubation in order to reveal plaques that may be enumerated, and is further complicated by plaques created by multiple viruses that may be scored as a single plaque, thereby lowering the titer estimate. Titer assays based on polymerase chain reaction (PCR) have been developed, but they measure the presence of baculovirus genes, not virus particles. This often results in titers one or two logs higher than the actual titer. Immunoassays correlate with host cell infection and virus replication, but they too can be time-consuming and difficult to interpret. Our goal was to identify a method that would provide estimates of both total and infectious virus particles in as close to real-time as possible. We have evaluated the ViroCyt Virus Counter over the course of three years and have found it to provide accurate and reproducible estimates of both titer types in as little as 30 minutes. We have created an algorithm that converts total virus particle counts into estimates of infectious titer and tested these values in virus amplifications. The Virus Counter method of titer determination has also been used to track the quantity of virus particles in the culture supernatant of stirred-tank bioreactors infected with standard baculovirus stocks and with baculovirus-infected insect cells (BIIC)...

Citation:
Birch A, Allen H, Kennefick K, Gugel A, Kemp CW. Rapid and effective monitoring of baculovirus concentrations in bioprocess fluid using the ViroCyt Virus Counter. BioProcess J, 2014; 13(2): 32–9. http://dx.doi.org/10.12665/J132.Kemp.

Posted online July 10, 2014.

 

 
The Race to Market: Regulation of Cell-Based Therapies and Considerations for Process Development

by Robert Shaw, Brian Hampson, and Candice Betz
Volume 13, Issue 2 (Summer 2014)

The cell therapy industry is positioned to make major changes in healthcare and disease treatment. The Alliance for Regenerative Medicine (ARM) recently reported on the robust state of the industry and identified that revenue from cell therapy products grew from $460 million in 2010 to $1.3 billion in 2013. There are currently more than 40 commercially available cell therapy products with indications ranging from cardiovascular to cancer and non-healing wounds. The pipeline for these therapies is also expanding. ARM reports nearly 270 trials underway (Phase 1 through Phase 3). Another 58 projects are in the research stage and 245 in pre-clinical. Adding to this total, there are 77 industry-sponsored cell-based immunotherapy trials. Cell therapy represents a very different approach to treatment when compared to small molecules or many biologics. As such, regulatory authorities are evolving and adapting their approach to help ensure patient safety and efficacy of these innovative and complex therapeutics. A recent decision by regulatory authorities in Japan allows for an accelerated pathway for approval. This presents a tremendous opportunity for the industry, but at the same time, exerts tremendous pressure on developers to rapidly and efficiently characterize their products and processes in order to take advantage of such accelerated pathways. This article provides an overview of current regulations for cell-based therapies in the United States (US), European Union (EU), and Japan, and considerations for working successfully within these frameworks. It also describes a structured approach to process development that can help achieve accelerated timelines...

Citation:
Shaw R, Hampson B, Betz C. The race to market: regulation of cell-based therapies and considerations for process development. BioProcess J, 2014; 13(2): 26–31. http://dx.doi.org/10.12665/J132.Shaw.

Posted online July 10, 2014.

 

 
Using Quality by Design (QbD) to Build Effective Product and Process Control Strategies Based on a Well-Structured Design Space

by Mark F. Witcher, PhD
Volume 13, Issue 2 (Summer 2014)

This article proposes a “design space” structure for using Quality by Design (QbD) to develop processes and control strategies for developing and manufacturing biopharmaceuticals...

Citation:
Witcher MF. Using Quality by Design (QbD) to Build Effective Product and Process Control Strategies Based on a Well-Structured Design Space. BioProcess J, 2014; 13(2): 15-22. http://dx.doi.org/10.12665/J132.Witcher.

Posted online July 10, 2014.

 

 
Identification of Worst-Case Model Viruses for Selected Viral Clearance Steps

by Raymond Nims, PhD and Mark Plavsic, PhD, DVM
Volume 13, Issue 2 (Summer 2014)

Viral clearance validation studies evaluate the efficacy of upstream or downstream process steps for clearing (inactivating or removing) potential viral contaminants from biologics process streams. Inactivation steps are designed to render viruses non-infectious, while removal steps achieve actual physical removal of viruses from the process stream. During validation, the efficacy of viral clearance steps is challenged through evaluation of inactivation and removal capacity, both for viruses known to be capable of infecting the manufacturing process (relevant viruses) as well as for worst-case model viruses (i.e., those believed to be most resistant to removal or inactivation). Worst-case viruses are used to challenge the process steps in order to assure that unknown or novel viruses that may be present in the process stream will be adequately cleared. Historically, the parvoviruses have been used as worst-case models for viral clearance studies due to their small size and lack of a lipid envelope. These characteristics are known to challenge removal by viral filtration and inactivation by a variety of physical and chemical means. In the present paper, we examine the literature on removal of viruses by filtration, and inactivation of viruses by heat, ultraviolet light, and gamma radiation. We conclude that for viral filtration, as well as ultraviolet and gamma irradiation, the use of a parvovirus as a worst-case model virus may not adequately assure that all types of viruses will be cleared using these steps...

Citation:
Nims R, Plavsic M. Identification of Worst-Case Model Viruses for Selected Viral Clearance Steps. BioProcess J, 2014; 13(2): 6-13. http://dx.doi.org/10.12665/J132.Nims.

Posted online July 10, 2014.

 

 
Continuous Bioprocessing and Perfusion: Wider Adoption Coming as Bioprocessing Matures

by Eric S. Langer and Ronald A. Rader
Volume 13, Issue 1 (Spring 2014)

Batch processing has long been the predominant bioprocessing paradigm, both up- and downstream. Bioprocessing fluids are processed incrementally, piped as a bolus or transferred via vessels from one process and piece of equipment to the next. This continues to work well, including a number of technological advances resulting in improvements that continue to make bioprocessing more efficient. Upstream and overall process yields are essentially doubling about every five years, with this largely driven by improved cell lines, expression systems and genetic engineering, culture media, and equipment. Among the technologies now gaining increasing adoption and market share for biopharmaceutical manufacture is continuous (bio) processing, with perfusion currently the leading technology, in terms of adoption. The use of incremental, one-step-at-a-time, classic batch processing in biopharmaceutical manufacture is different than most other major products manufacturing and high-tech industries, where processing is generally more continuous. In this context, the move toward more continuous processing in manufacturing is a common characteristic of industries starting to reach maturity. Continuous processing is exemplified by assembly lines, and petroleum refining with processing involving a rather continuous flow of the material being manufactured from one unit operation to the next. Continuous processing generally follows and eventually replaces incremental manufacturing...

Citation:
Langer ES, Rader RA. Continuous Bioprocessing and Perfusion: Wider Adoption Coming as Bioprocessing Matures. BioProcess J, 2014; 13(1): 43-49. http://dx.doi.org/10.12665/J131.Langer.

Posted online April 23, 2014.

 
Biobanking Operations: Contingency Planning and Disaster Recovery of Research Samples

by Russ Hager
Volume 13, Issue 1 (Spring 2014)

Biobanking is a critical component to realizing the promises of translational research and personalized medicine. The proper collection, processing, storage, and tracking of human biological samples allows researchers to better link molecular and clinical information, which in theory, allows for the development of more targeted therapies for patients. Realizing the scientific potential of well-annotated, properly preserved sample collections has led to the proliferation of large-scale biobanks by biopharmaceutical companies, academic organizations, governments, and non-profit research organizations. To this point, conservative industry projections estimate that in the United States, there are at least 300 million tissue samples in biobanks with an estimated accrual rate of 20 million samples annually...

Citation:
Hager R. Biobanking Operations: Contingency Planning and Disaster Recovery of Research Samples. BioProcess J, 2014; 13(1): 56-58. http://dx.doi.org/10.12665/J131.Hager.

Posted online April 23, 2014.

 
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