The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate research in vaccine development. The VRC is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases. It was established by former president Bill Clinton as part of an initiative to help develop an AIDS vaccine and is part of the NIAID organization. Since the inception of the VRC, its mission has expanded to include the development of vaccines against bioterrorism and emerging infectious diseases…
BioProcessing Journal Posts
The approval of a new biological drug for therapeutic use requires supporting data from a variety of studies, including those that demonstrate the suitability of the manufacturing process. The regulatory guidance advocates that one of these studies address the issue of cell substrate stability by testing for consistent production of the product of interest by a characterised cell bank, generally the working cell bank (WCB). The study should evaluate stability during cultivation for production by examining a minimum of two time points — at a minimal number of population doublings and at or beyond the limit of in vitro cell age for production. The guidelines state that, “Evaluation of the cell substrate with respect to the consistent production of the intended product of interest should be the primary subject of concern”…
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…
Short Monolithic Columns — An Enabling Technology for the Purification of Proteins, DNA, and Viruses
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…
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…
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…
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…
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…
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…