There are different reasons why pharma and biotech companies undergo a technology transfer. For some, it provides a back-up strategy for risk management to provide an adequate market supply for the patient. For others, it may be due to a lack of appropriate resources/capacity for process optimization, secondary packaging or a change in the product life cycle management.
Furthermore, a technology transfer is also necessary for scale-up or when moving a drug product from one commercial aseptic manufacturing facility to another due to the need for a larger batch size. All technology transfers are high-risk, involving strict regulatory requirements and adherence to detail. An experienced clinical supply partner is critical in this challenging manufacturing process.
Commercial transfers can take more than a year due to regulatory changes and the potential risk of unforeseen challenges. It also takes time for regulatory bodies to ascertain that there is no impact to the specified quality attributes of the product.
Baerbel Hinneburg, Director Technology and Process Transfer
Start with a Gap and Risk analysis
Technology transfer is a complex and time-consuming undertaking, especially since multiple partners and sites are involved. Any knowledge of the existing process at the sending site and the envisioned process at the receiving side must be identified, including:
- Filing strategy
- Critical quality attributes (CQAs) to achieve the target product profile (TPP)
- Logistical procedures
- Analytical methods
- Equipment, materials, and instructions
- Organizational issues
The major elements necessary for robust, reproducible manufacturing include a combination of gap and risk analysis to assist in identifying and evaluating any knowledge gained from the development and manufacturing process of the drug. It is also necessary for assessing the risk of any identified differences between transfer sites.
Potential risks to the product quality attribute, process and regulatory consequences must then be identified and, possibly, new process parameters established. At the receiving site, process design is necessary to accommodate the known and newly-identified critical process parameters (CPPs) to meet critical quality attributes.
Process qualification to verify constant quality, the establishment of a control strategy at the receiving site, as well as the identification and controlling of sources of variability in material and processes are also necessary.
To protect timelines, cost projections, and regulatory compliance, we partner closely with our customers to develop processes that mirror those at our commercial production facilities.
Henrik Oberle, Vice President Development Service
Expertise and strong project management are critical
As with any complex and intricate action involving high-quality GMP-conforming clinical manufacturing, detailed planning and reliable execution within time and budget is required.
Numerous steps and challenges that include strict regulatory requirements and extreme attention to detail are critical for a successful transfer. And, because every transfer is associated with its own set of issues, its unique complexities should never be underestimated.
Most often, the best approach is working with a skilled partner that has considerable experience in transferring aseptic manufacturing processes, necessary systems, routine and management skills.
To assist with the transfer, the creation of a dedicated transferring team with the necessary skill sets and level of know-how in addressing multiple areas of the process is critical.