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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.

 
Critical Path: A Mindset for Better Product Development

by Keith L. Carson
Volume 4, Issue 1 (January/February 2005)

Although biological products are being licensed at a fairly steady pace, the cost to develop each product can be incredibly high, and far too many products with very little chance of success are entering clinical trials. The cost of developing a biological product is now estimated to be as high as $1.7 billion. This is truly a staggering figure that would seem to prevent all but the strongest company from attempting such a gamble. However, this number includes the cost of all the products that didn’t make it through pre-clinical development, or which entered clinical trials and failed for any number of reasons...

Citation:
Carson KL. Critical Path: A Mindset for Better Product Development.
BioProcess J, 2005; 4(1): 31-34.

 
Safety Assessment of a Renal Bio-Replacement Therapy System: A Case Study

by Zorina Pitkin, PhD
Volume 4, Issue 1 (January/February 2005)

Acute Renal Failure (ARF) is a severe inflammatory disease state often accompanied by multiple organ failure (MOF). ARF is precipitated by many factors such as blood loss, surgery, sepsis, toxins, trauma, and is most often linked to the loss of kidney tubule function. Proximal tubule cells are specifically injured in acute renal failure. Current therapies for ARF involve conventional kidney support with hemodialysis or hemofiltration. These therapies offer replacement of normal renal functions such as waste removal, fluid, and electrolyte balance, but they cannot provide vital endocrinological and metabolic functions of a healthy kidney. Despite advances in synthetic materials and extracorporeal circuits for hemodialysis and hemofiltration, ARF is associated with a high mortality rate ranging between 55–70 percent...

Citation:
Pitkin Z. Safety Assessment of a Renal Bio-Replacement Therapy System: A Case Study.
BioProcess J, 2005; 4(1): 37-40.

 
Closed Systems in BioProcessing: Impact on Facility Design

by Jeffrey N. Odum
Volume 4, Issue 1 (January/February 2005)

One of the fundamental foundations of bioprocess system design is the use of “closed” systems for production. Closed systems and equipment are utilized to prevent contamination of the product. They are also used as a means of containment to protect not only the product, but also workers and the facility environment. The concept of a closed processing system makes common sense. What is surprising is how closed systems are defined and referenced within the body of regulatory guidance documents and how companies differ in their implementation of a “closed manufacturing” concept. What is not surprising is the impact that closed systems have on facility design...

Citation:
Odum JN. Closed Systems in BioProcessing: Impact on Facility Design.
BioProcess J, 2005; 4(1): 41-45.

 
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