The challenges of technology transfer in API

All drug development challenges start with the synthesis of the active pharmaceutical ingredient (API), making its production critical to any development program. Timelines for drug development programs are often based on cash balance and the need to meet the next milestone that will bring in another wave of investment. Late API delivery can result in missing important milestones, such as filing an investigational new drug application, which could have significant financial consequences.

There are many steps that must be followed to ensure the successful development of an API that meets with compliance and regulations. Having a scientifically optimized API strategy will not only improve success rates and timelines, but can also add value to your process and product. However, the development of an effective, streamlined process can be challenging to create.

When it comes to optimizing your API strategy, technology transfer can mean different things to different people. It can either point to the transfer of the process (together with its documentation) between product development to manufacture, or it can mean the shift between manufacturing sites – either within or between different companies. Technology transfer is in this form an integral part of API strategy, and is therefore an essential ingredient for a robust drug development program.

Flow of supply, be it for toxicological studies or clinical trials, requires effective technology shift mechanisms, as does ensuring there are no adverse variations in safety, quality, of efficacy of the product, and that the method is compliant with all needed legal and regulatory obligations. Because of this, tech transfer should be drafted carefully and cleverly – failure to do so often influences the overall timeline and running costs of development programs (if your API strategy is outsourced, it is your responsibility to guarantee the Contract Research Organization (CRO) you are operating with creates a high-quality data package, as you would do if it was under development in-house).

Technology transfer begins when the API is transferred from medicinal chemistry laboratories into the development and synthesis phase. Initially, the information presented by the laboratory team should be reviewed in way of a first step. This helps the development team to ascertain a clear knowledge of the chemistry, including its capabilities, methods, and analytics. Some considerations 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 expansion.

The outbound process starts with defining the desired end result or the point at which the method can be regarded 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 improve your API program, they adopt a collaborative approach to working with you to ensure the process that is developed meets the specifications of your program.

A detailed strategy document should be produced that includes all the shortfalls identified, how to overcome the shortfalls and a variety 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 knowledge, skills, expertise and technology.

The progress of any technology transfer depends on method understanding at the receiving site. This is best accomplished by the development and receiving teams working together in a collaborative approach towards an acknowledged end goal.

Process robustness is crucial for right-first-time transfers that reduce the impact on the supply chain. There are many advantages to your API strategy and drug development schedule for accomplishing an on-time and on-budget technology transfer, including reduced operational and compliance risk, higher product development to begin success rates and faster overall opportunity to market, therefore ending in the increased worth of the company.