Technology Transfer
Technology transfer is a delicate operation, carrying business, regulatory, product quality and technical risks. Our vast global experience in technology transfer and ISPE guidelines enables us to overcome any technical challenges that may emerge, due to the delicate nature of biopharmaceutical processing and the complexities of technology transfer.
Since each technology transfer case is potentially different and requires a distinct approach, we provide tailored solutions for each, potentially more or less complex, manufacturing processes.
Our technology transfer services include:
- Product documentation review
- Patent status review
- Technology verification considering yield, quality, preclinical and clinical data
- Contract (technical) preparation
- Technology transfer team setup and training
- TT timetable and activities review and revision
- TT performance (demonstration batch)
- New facility set-up or plant reorganisation
- Production of three approved commercial batches
- Test methods development
- Documentation preparation