Sterin Labs actively scouts for contract manufacturers (CMOs) that align with the specific nature of the products developed at our facilities. Collaborating with a CMO that possesses the necessary expertise to oversee the tech transfer process is essential for fostering a smooth and effective partnership.
Sterin Labs undertakes a comprehensive regulatory assessment to determine the suitability of potential contract manufacturers in accordance with the requirements of the targeted market. In the selection process, we prioritize organizations with a proven history in cGMP manufacturing and a solid track record of successful regulatory audits and inspections.
Sterin Labs will evaluate the discrepancies between the development and manufacturing sites and examine the process characterization studies to ensure they align with the product requirements.
Sterin Labs will meticulously prepare and transfer all essential documentation, including the tech transfer protocol, cleaning method validation, test method validation, specifications, and other pertinent materials to the contract manufacturing site.
To ensure a seamless execution process, a Sterin Labs scientist will travel to the manufacturing site for an in-person transfer. This hands-on approach is crucial for facilitating effective product execution at the contract manufacturing location and enhancing overall collaboration.
