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Production of Kojic Acid by Aerobic Aspergillus Fermentation

by Sudarshan Lakhawat, Jignesh Chaudhary, and Amrendra Nath Pathak
Volume 13, Issue 3 (Fall 2014)

Kojic acid is produced industrially by the Aspergillus species using aerobic fermentation processes. Kojic acid has applications in several fields such as the pharmaceutical, food production, cosmetics and dermatology, agriculture, and chemical industries. The production of kojic acid is greatly increasing, based on the demands of these industries, and studies focused on improved processes are ongoing. This article will discuss the methods written about by various members of the scientific community.

Citation:
Lakhawat S, Chaudhary J, Pathak AN. Production of kojic acid by aerobic Aspergillus fermentation. BioProcess J, 2014; 13(3): 62–9. http://dx.doi.org/10.12665/J133.Lakhawat.

Posted online October 13, 2014.

 
Insect Cell-Based Recombinant Adeno-Associated Virus Production: Molecular Process Optimization

by Jacek Lubelski, PhD, Wim Hermens, PhD, and Harald Petry, PhD
Volume 13, Issue 3 (Fall 2014)

An increasing number of clinical trials, and the recent approval of the first gene therapy in Europe, alipogene tiparvovec (Glybera®, uniQure), holds promise for recombinant adeno-associated virus (rAAV) to become a mainstay in clinical practice. Since the molecular cloning of AAV in the 1980s, a plethora of production protocols/manufacturing systems for generating rAAV vectors have been developed. uniQure’s manufacturing platform, which has received validation through regulatory approval, is also capable of supporting industrial-scale production based on the baculovirus expression vector system (BEVS) and insect cells. In this paper, we review the molecular process optimization of the various components of uniQure’s rAAV production platform...

Citation:
Lubelski J, Hermens W, Petry H. Insect cell-based recombinant adeno-associated virus production: molecular process optimization. BioProcess J, 2014; 13(3): 6–11. http://dx.doi.org/10.12665/J133.Lubelski.

Posted online October 2, 2014.

 
Impact of Process Loading on Optimization and Scale-Up of TFF Microfiltration

by Seat Yee Lau, Priyabrata Pattnaik, PhD, Takao Ito, PhD, and Bala Raghunath, PhD
Volume 13, Issue 2 (Summer 2014)

Tangential flow filtration (TFF) microfiltration has been used as one of the choices for clarification of mammalian cell or microbial cell culture in the biopharmaceutical industry. Unlike the ultrafiltration process for protein concentration and the diafiltration application where the feed solution is relatively clean (free of colloids or larger particles after the clarification/purification process), the microfiltration process needs to handle a rather high-fouling feed stream such as cells, cell debris, colloids, etc. In a previously published article, we discussed that a TFF microfiltration step is limited by a maximum throughput or capacity obtainable under a given set of operating conditions. Some distinct microfiltration characteristics, such as critical permeate flux, permeate flux control, and maximum throughput were explained in that article...

Citation:
Lau SY, Pattnaik P, Ito T, Raghunath B. Impact of process loading on optimization and scale-up of TFF microfiltration. BioProcess J, 2014; 13(2): 46–55. http://dx.doi.org/10.12665/J132.Pattnaik.

Posted online July 10, 2014.

 

 
Optimising Vaccine Process Scale-Up of Attachment-Dependent Cells Using Micro Bioreactors and Microcarriers

by Barney Zoro, PhD
Volume 13, Issue 2 (Summer 2014)

The trend for increased vaccine production is being driven by the requirement to produce affordable prophylactic vaccines for use in emerging markets, and also for newer types of therapeutic vaccines to treat an ever-increasing array of diseases such as cancer. These drivers, coupled with the current need to produce vaccines rapidly for pandemic threats and seasonal influenza prevention, has lead to the investigation of rapid method development for optimising the scale-up of cGMP-compliant manufacturing processes...

Citation:
Zoro B. Optimising vaccine process scale-up of attachment-dependent cells using micro bioreactors and microcarriers. BioProcess J, 2014; 13(2): 41–5. http://dx.doi.org/10.12665/J132.Zoro.

Posted online July 10, 2014.

 

 
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.

 

 
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