Once a proprietary manufacturing process has been validated and approved, and no additional GMP custom peptide development is required, the production of the peptide becomes one of contract manufacturing.
Depending on the scale of the manufacturing process and the annual requirements for the peptide, the process may be transferred to a manufacturing suite dedicated specifically to the peptide API (Active Pharmaceutical Ingredient).
Contract manufacturing (of proprietary peptides) can be performed at any of our cGMP facilities worldwide. Most contract manufacturing processes are currently performed at our Swedish facility which has the largest capacity within the group and was designed specifically to accommodate this type of operation. Contract manufacturing will also be performed at our new site in Ambernath in India when it starts operations in 2009.
Peptide APIs are manufactured in compliance with ICH Q7 GMP in approved facilities which have been inspected by the FDA and other regulatory authorities either for approval of specific products or site inspections. GMP Support (including preparation of documents, responses to questions from and visits to regulatory authorities on behalf of the customer), provided throughout the contract manufacturing process, is included in the price of the peptide.