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Key Issues in the Process Development of Purification Procedures for Viral Vector and Plasmid Biopharmaceuticals

by Sibylle Herzer, PhD, Hong Zhang, and Peter Moore
Volume 4, Issue 2 (March/April 2005)

With the advent of the first gene therapy product to market, the industry faces the challenge of mass-producing high-purity viral particles and plasmids. The concept of manufacturing therapeutic genes rather than therapeutic proteins as marketable products is still in its infancy. Although manufacturers of biopharmaceuticals have decades of experience in the purification of proteins, virus and plasmid products pose unique challenges that cannot be addressed without some modifications to traditional, protein-based approaches...

Citation:
Herzer S, Zhang H, Moore P. Key Issues in the Process Development of Purification Procedures for Viral Vector and Plasmid Biopharmaceuticals.
BioProcess J, 2005; 4(2): 67-72.

 
Innovation Through Biomanufacturing Platform Development

by Marco Boorsma, PhD and José Coco-Martin, PhD
Volume 4, Issue 2 (March/April 2005)

Total market share of biopharmaceuticals is estimated to increase from $33 billion now to more than $45 billion in 2007. These numbers are accounted for by the 64 products approved by European and US regulators and some of the 500 products currently under clinical evaluation. More than 2,000 products are in discovery and preclinical development. Monoclonal antibodies (MAbs) and recombinant glycoproteins constitute a major part of these new biotech leads. The estimated demands for MAbs alone are more than 6,000 kg per year in 2006. Currently, 16 MAbs are licensed by the U.S. Food and Drug Administration (FDA) for pharmaceutical use and more than 130 are in clinical trials. This fast-growing class of biotherapeutics is expected to reach worldwide sales of more than $15 billion per year in 2008. In the coming years, mammalian cell culture technology will remain the production system of choice for MAbs and other recombinant glycoproteins. Therefore, efficient, cost-effective production systems need to be in place to meet the demands...

Citation:
Boorsma M, Coco-Martin JM. Innovation Through Biomanufacturing Platform Development.
BioProcess J, 2005; 4(2): 75-78.

 
Short Monolithic Columns — An Enabling Technology for the Purification of Proteins, DNA, and Viruses

by Matjaž Peterka, PhD, Darryl Glover, Petrar Kramberger, Marko Banjac, Aleš Podgornik, PhD, Miloš Barut, PhD, and Aleš Štrancar, PhD
Volume 4, Issue 2 (March/April 2005)

The last 30 years have seen rapid and dramatic developments in recombinant DNA technology and the related biological sciences. In 1972, Paul Berg's group used restriction enzymes to cut DNA in half and then used ligases to stick the pieces of the DNA back together. By doing this, they produced the first recombinant DNA. Within a year, the first genetically engineered bacterium existed. A little more than ten years later, recombinant human insulin was approved for diabetic patients and became the first recombinant healthcare product. Before the end of the 1980s, the first gene therapy trial had occurred. Today, a large number of recombinant proteins are used as marketed drugs and even more are in clinical trials targeting a wide range of diseases...

Citation:
Peterka M, Glover D, Kramberger P, Banjac M, Podgornik A, Barut M, Štrancar A. Short Monolithic Columns — An Enabling Technology for the Purification of Proteins, DNA, and Viruses.
BioProcess J, 2005; 4(2): 79-84.

 
FDA Spyware in Your Processing? Implications of Remote Monitoring in a Process Analytical Technology Environment

by Sandy Weinberg, PhD
Volume 4, Issue 1 (January/February 2005)

New regulatory initiatives often produce paranoid responses. These over-reactions are often a result of initial rumors fueled by less-than scrupulous consultants or by misinterpreted statements reported out of context from unscripted regulators. The “remote monitoring capability” incorporated into the emerging Process Analytical Technology (www.fda.gov/cder/OPS/PAT.htm) initiative is a prime example. Put the fear back in the closet: remote monitoring will not lead to unannounced or secret FDA electronic visits, unscheduled remote audits, or regulatory spying on industry processing activities...

Citation:
Weinberg S. FDA Spyware in Your Processing? Implications of Remote Monitoring in a Process Analytical Technology Environment.
BioProcess J, 2005; 4(1): 20-21.

 
Canadian Biomanufacturing Launches Strategy to Take Advantage of $15 Billion Biopharmaceutical Pipeline: $450 Million Investment Recommended Over Seven Years

by Ken Lawless
Volume 4, Issue 1 (January/February 2005)

Canada’s lead in biotechnology, and biotech’s rising influence, is providing a “second chance” at establishing a leading role in the global pharmaceutical industry. Half of all the new drugs approved by FDA are biologics. Why does that equate to a “second chance”? Well, with the skills, knowledge and physical manufacturing processes so completely different from the chemical synthesis of drug manufacture, the global pharma industry is “re-tooling” both its people and its facilities. Canada has the opportunity to leverage its leading biotech position to propel the biopharmaceutical industry forward in the changing landscape...

Citation:
Lawless K. Canadian Biomanufacturing Launches Strategy to Take Advantage of $15 Billion Biopharmaceutical Pipeline: $450 Million Investment Recommended Over Seven Years.
BioProcess J, 2005; 4(1): 22-23.

 
Improved Purification of p55 Protein from Secreted Virus-Like Particles from Baculovirus-Infected Insect Cells by Using an Alternative Selective Precipitation Method

by Manon Cox and Rick Chubet
Volume 4, Issue 1 (January/February 2005)

The Baculovirus Expression Vector System (BEVS) is widely used for the production of a broad variety of heterologous proteins that are often secreted into the culture medium as soluble, biologically active, properly glycosylated, and correctly folded. Downstream purification of a secreted protein is considerably easier due to the absence of many contaminating cellular proteins and nucleic acids in the culture supernatant. The BEVS system has also successfully been used for the production of virus-like particles (VLPs) for a broad variety of proteins derived from many different viruses...

Citation:
Cox M, Chubet R. Improved Purification of p55 Protein from Secreted Virus-Like Particles from Baculovirus-Infected Insect Cells by Using an Alternative Selective Precipitation Method.
BioProcess J, 2005; 4(1): 27-29.

 
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