In October 8, 2008, the Nobel Prize for Chemistry was awarded to Osamu Shimomura, Martin Chalfie, and Roger Tsien ostensibly for the discovery, cloning, and applications of green-fluorescent protein (GFP). This protein is associated with bioluminescence in coelenterates, including jellyfish and sea pansies. This award is as much a celebration of basic research as it is an acknowledgement of the achievements of three accomplished researchers…
Tag: <span>technology transfer</span>
One of the major concerns facing relatively young biotechnology companies once a lead product has been identified is the issue of manufacturing. Usually this involves the upscaling of a lab-scale process while at the same time, complying with good manufacturing practice (GMP) to ensure a reproducibly-produced and consistent product. It also involves the establishment of specific and robust assays in process controls and release criteria. This issue has become more acute in the EU since 2004 due to the EU Clinical Trials Directive requiring GMP-certified production of investigational medical products even for phase I trials. Startup biotech companies are often limited in their finances and resources, as well as being bound by tight milestones. Quite often the expertise in upscaling and GMP-compliant production as well as the facilities and equipment required are not available in-house…
In today’s aggressive biopharmaceutical market, many drug discovery organizations, including both big pharmaceutical companies and small technology start-up companies, are outsourcing the development and manufacturing of their biopharmaceuticals to specialized contract manufacturing organizations (CMOs). Outsourced biopharmaceuticals range from those in early phase production to products that are well advanced down the development pipeline. As a result, there has been an expansion of CMOs that specialize in all aspects of biopharmaceutical manufacture, from process invention and development, through small-scale GMP production, to process validation and large-scale manufacture. The CMOs provide R&D services, quality function, and state-of-the-art good manufacturing practice (GMP) facilities needed for the production of biopharmaceutics. Using CMOs for biopharmaceutical process development and manufacture provides major cost savings by dispensing with the need to invest in experienced personnel and expensive manufacturing facilities…
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…