Keyword Search

By downloading an article in PDF format, you are agreeing to follow our Article Policy.


Use the KEYWORD search located in the top left column to look for keywords, authors, and titles. If you still can't find what you're looking for, please This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

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.

 
Risk Assessment of Residual Genomic DNA in Therapeutic Proteins Using Gene Copy Number Application

by Rahul Fadnis, PhD, Reena Nr, and Rajeev Soni, PhD
Volume 13, Issue 1 (Spring 2014)

Therapeutic proteins manufactured in cellular systems contain residual DNA derived from host cell substrates used in production. Risk assessment of the residual host cell DNA is necessary, as some of these DNA sequences may be potentially infectious or oncogenic. Oncogenic potential lies in transmission of the activated oncogenes to subjects receiving the product, thereby inducing oncogenic events. Therefore, it becomes essential for drug manufacturers to show clearance of genomic DNA (oncogenic sequences as well) throughout production processes and to confirm low levels of residual DNA in the final drug substance. This study attempted to estimate the oncogenes in the total residual DNA using a highly sensitive, specific, and robust method—quantitative polymerase chain reaction (qPCR). Routinely, total residual DNA is estimated using either the 18S ribosomal (r)DNA gene or Alu equivalent multicopy gene sequence as qPCR targets. We have determined the copy numbers of these qPCR targets along with the oncogene (Ras gene) and housekeeping genes (ACTB and GAPDH) and established a ratio of their presence in protein samples. Another objective of the study was to estimate the level of oncogenes from several in-process step samples in the manufacturing and purification process and check the clearance of total residual DNA including oncogenes. Upon quantification, the proportions of oncogenes present were one tenth of the quantified residual DNA levels (Ras gene:18S RNA) in the purification stage samples, providing information that the therapeutic protein product was safe from the presence of oncogenes in residual DNA by a factor of ten...

Citation:
Fadnis R, Nr R, Soni R. Risk Assessment of Residual Genomic DNA in Therapeutic Proteins Using Gene Copy Number Application. BioProcess J, 2014; 13(1): 32-40. http://dx.doi.org/10.12665/J131.Fadnis.

Posted online April 23, 2014.

 
<< Start < Prev 11 12 13 14 15 16 17 18 19 20 Next > End >>

Endorsed Events
Please update your Flash Player to view content.
Please update your Flash Player to view content.