Recommendations to Maximize Resources & Personnel Required to Open a CDMO Production Suite Intended for GMP Usage

The CDMO industry is rapidly evolving, with each company operating under its own unique model, yet all striving to achieve the same goal: producing products that follow regulatory standards quickly and repeatedly. Although every company must abide by the regulations put forward by the FDA (CFR 210 and 211) and the EU (Annex 1), no clear and predetermined methodology is publicly available for all to use. As a result, each company must create their own pathway using internal knowledge which can often conflict and cause confusion. Additionally, due to the uncertainty of this process and industry, large amounts of time, resources, and budget may be wasted impacting long-term sustainability of the business. This project seeks to address that gap by analyzing literature from others in the field, reviewing industry data, and incorporating firsthand experience from Amplify-Bio to create a standardized and adaptable recommendation for onboarding a compliant manufacturing suite and related production process. The program aims to consolidate best practices across suite construction, document development, equipment validation, personnel training, and contamination control into a single framework. By bringing these elements together, the overall time, cost, and risk associated with suite establishment can be dramatically reduced, allowing CDMOs to meet regulatory demands more efficiently and bring critical therapies to patients faster.