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…
BioProcessing Journal Posts
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…
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…
R&D output continues to climb with advances in laboratory automation and data analytics but, when measured in terms of the number of drug approvals versus expenditures, the productivity of R&D has been in decline. This paradox confounds many organizations as they struggle to improve. A common strategy has been to invest in informatics. These investments are meant to increase the effectiveness and speed of the decision-making process in which validated findings are compared against predicted outcomes — to close the loop between design and experimentation. But the loop has not been closed in a broad and coherent way, and increased productivity has not been achieved. Instead, the information management landscape in life sciences R&D has remained fragmented, with barriers between disciplines and geographies that prevent broad-based productivity gains…
The manufacture of biological materials by fermentation is based intrinsically on established and well understood processes developed over a number of years. The fundamental basics of supplying a characterised cell line with sufficient nutrients over a period of time, with the intention of harvesting a selected protein for further processing, are similar throughout the industry. However, as a result of economic pressures and the need to control costs of an already expensive, high quality, and high compliance material, all manufacturing companies endeavour to maintain the highest level of productivity…
It has been reported that the biotechnology-derived medicines area of the pharmaceutical industry led to 133 marketed entities with sales of $22 billion by the year 2001. By 2002, the therapeutic protein market had reached $32 billion, with biologics representing more than 50 percent of all drugs approved by FDA — up from a modest 16 percent in 1995. The biopharmaceutical market is predicted to grow to $50 billion by 2008. Currently, approximately 40 percent of biopharmaceutical products are in Phase I and Phase II clinical trials. It is anticipated that from 2003 to 2008 there will be a more than 45-fold increase in demand for access to product development facilities capable of supplying clinical material…