The Lentiviral Vector Reference Working Group (LVRWG) was created at the conclusion of a meeting organized by The Williamsburg BioProcessing Foundation in June 2002, in conjunction with the American Society of Gene Therapy (ASGT) annual conference. The meeting participants were gathered to evaluate the need for developing reference material to ensure comparability of lentiviral and retroviral vectors, in a similar spirit to the Adenovirus Reference Material program that had just been completed. The concensus at the conclusion of this meeting was that the diversity in the lentiviral vector field, which includes vectors derived from different parental viruses and with various designs, does not allow for identification of a single reference material that would benefit more than a single or very few investigators…
Tag: <span>standards</span>
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…
The United States Pharmacopeia (USP) is a 184-year-old organization that has been in the forefront of technology since its inception. From publishing a manual about how to prepare therapeutic potions, USP has evolved into a compendium of standards and information on manufactured pharmaceutical products, with more than 4,000 monographs covering drug substances and biologics, and their dosage forms, excipients, and nutritional supplements. It is not surprising that the USP initiative in cell and gene therapy and tissue engineering has closely followed the emergence of these technologies…
The safety of our food supply is a major public health concern for consumers, government regulatory agencies, and the food industry. Earlier generations may recall when fresh produce was largely domestic and seasonal. Today we live in a global marketplace, where fresh fruits and vegetables may be on the vine overseas one day and on our grocer’s shelf the next. Although this has provided more yearround variety of foods for the consumer, a lack of uniformity in established agricultural standards and practices among international trading partners (e.g., sanitary issues and inspections) may ultimately lead to deleterious health effects. This is evident in the number of food-borne illness outbreaks and associated deaths. Negative economic consequences also result through lost wages and productivity, and health care costs. The impact can be far greater in developing nations. Therefore, refining domestic and international food safety policies is at the forefront of many government agencies’ efforts toward protecting the public health. Reducing the number of such incidences has become a priority for government regulatory agencies and the food industry…
Long-term growth of the biopharmaceutical industry is increasingly relying on outsourcing to overcome the current capacity constraints, especially for monoclonal antibody production. Companies are often reluctant to commit to building multimillion dollar manufacturing facilities for potential products with no guarantee of approval. Therefore to offset risks, companies will enter into contract manufacturing arrangements…
Tissue engineering is an emerging area of biotechnology that will provide replacement tissues for patients, as well as complex, functional biological systems for research and testing in the pharmaceutical industry. A new research area of tissue engineering is the investigation of how living cells interact with and respond to synthetic biomaterial surfaces. The clinical developments that underlie that research include a number of novel tissue-engineered medical products (TEMPs)…