Technology Transfer
When it comes to technology transfer, there is no such thing as “too much” or “too detailed” information. Technology transfer of a pharmaceutical manufacturing process can be very challenging, and any inefficiency in technology transfer results in serious loss of time and resources. Our disciplined technology transfer approach provides a seamless transition throughout the lifecycle of the project whether it is bringing your methods and processes in-house or developing them for you. We achieve this through maintaining clear and open communication between sending and receiving sites. Our goal is to identify key areas of knowledge as well as areas for improvement.
Analytical Method
- Ensuring that analytical assays are transferred ahead of the process
- Raw materials specifications
- Product specifications
- Test-method development reports
- Intermediate and raw product stability
Process / Product
- Understanding of prior knowledge from similar products
- Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and other important parameters are identified
- Formulation and filling specifications
- Primary and secondary packaging specifications
- Executed batch records and standard operating procedures (SOPs)
- Successful manufacture of demonstration batches
- Understand validation requirements/strategy
- Cleaning procedures and validation methods