Tech Transfer For Oral Pharmaceutical Products

By Koshy George, Dylan Amig, and Sundeep Sethia, Pharmaceutics International

If any of these scenarios apply to you, you likely need a tech transfer of your oral pharmaceutical:

• You are in development and need spray drying technology that you are not experienced with or cannot access.
• You are ready to scale-up your soft gels process to commercial manufacturing but don’t have the capacity.
• You have an old, discontinued tablet product that you want to repurpose and bring back to the market, but need to update its compliance with S. Food and Drug Administration (FDA) regulations.¹

For these reasons and many more, tech transfer — the transition of the product/process/analytical method between development and/or manufacturing sites — to a contract development manufacturing organization (CDMO) is increasingly common.² CDMOs have proven they can significantly reduce costs and development time for pharmaceutical companies.³

This handover can be a daunting prospect for oral products with complex and highly sensitive formulations and manufacturing processes. But with the right CDMO, a proper tech transfer offers an opportunity to re-examine quality, process procedures, and supply chain issues, including provider partnerships.

This article will cover the high-level initial thinking that should launch building a tech transfer plan, what qualities to look for in a CDMO partner manufacturing oral pharmaceuticals, and the basic phases of a tech transfer.