The challenges of technology transfer in API
When it comes to optimizing your API strategy, technology transfer can mean different things to different people. It can either refer to the transfer of the process (together with its documentation) between product development to manufacture, or it can mean the transfer between manufacturing sites – either internally or between different companies. Technology transfer is in this way an integral part of API strategy, and is therefore a vital ingredient for a healthy drug development program.
Continuity of supply, be it for toxicological studies or clinical trials, requires effective technology transfer mechanisms, as does ensuring there are no adverse changes in safety, quality, of efficacy of the product, and that the process is compliant with all required legal and regulatory requirements. Because of this, tech transfer should be planned carefully and cleverly – failure to do so often affects the overall timeline and running costs of development programs (if your API strategy is outsourced, it is your responsibility to ensure the Contract Research Organization (CRO) you are working with builds a high-quality data package, as you would do if it was under development in-house).
Technology transfer begins when the API is passed from medicinal chemistry laboratories into the development and synthesis phase. Initially, the information provided by the laboratory team should be reviewed in way of a first step. This helps the development team to ascertain a clear understanding of the chemistry, including its capabilities, methods, and analytics. There are considerations that need to be made at this point, as the chemistry may not be robust enough to undergo a scale-up in terms of synthesis or development.
The outbound process begins with defining the desired end result or the point at which the process can be considered successful and complete. A map of processes needed to achieve this follows, technology transfer only being defined as complete once the process is operating in a reliable manner within the established specifications. If you are using a third party to develop your API program, they adopt a collaborative approach to working with you to ensure the process that is developed meets the requirements of your program.
A detailed strategy document should be developed that includes all the shortfalls identified, how to overcome the shortfalls and a description of the overall transfer strategy with measures for success. One of the most frequent stumbling blocks of technology transfer is the transfer of knowledge. It is important that the team at the receiving end is fitted with the necessary information, skills, expertise and technology.
The success of any technology transfer depends upon process understanding at the receiving site. This is best achieved by the development and receiving teams working together in a collaborative approach towards an agreed end goal.
Process robustness is crucial for right-first-time transfers that minimize the impact on the supply chain. There are many benefits to your API strategy and drug development program for achieving an on-time and on-budget technology transfer, including reduced operational and compliance risk, higher product development to launch success rates and faster overall time to market, therefore resulting in the increased value of the company.