If good science is to translate into new medicines, then effective technology tranfer is essential. At IIR’s recent Technology Transfer for Biopharmaceuticals meeting, the focus was on the latest developments and challengesfrom scale-up and process modeling to project and people management.
The highly complex process of technology transfer has become a fundamental aspect of the current biopharmaceutical environment, according to Andy Stephenson, senior consultant at Smarttech Consulting Services, who advises many companies on tech transfer.
It is, however, hard to define technology transfer because it is highly context-specific and encompasses so many different aspects, including in-house expertise, process definitions, manufacturing techniques and procedures, analytical methodology, and information packages.
Stephenson sees tech transfer as being driven by the trend toward outsourcing as well as changes in marketing requirements and company strategy, including takeovers and M&As. Good project management, with a dedicated manager and team, is essential to successful tech transfer, he explained, but deficiencies, such as insufficient resource allocation and insufficient time allowance and preparatory work, are often seen.
In particular, experts should be made more available to transfer recipients. Senior management buy-in is also important, he added. It is not uncommon to see projects without proper upward reporting.
Sunil Chhatre, research engineer at the department of biochemical engineering, University College, London, described some of the technologies being developed there to facilitate tech transfer.
Ultra-scale-down, which is the development of a small-scale version of an industrial process, has been found to give important insights and is usefully complemented by bioprocess and decisional modeling tools. Modeling is, said Chhatre, currently underutilized in biotech, and what is currently done often tends not to accurately reflect a real manufacturing process; his own research seeks to change this by using a more dynamic approach.
Chhatre has been able to apply these new tools in collaboration with Protherics (www.protherics.com) to improve yield and cost of goods in the manufacture of its rattlesnake antivenom product. Modeling allows rapid visualization of the impact of various process changes, he explained.