CelluPro wins EXCiPACT GMP certification

CelluPro said on September 7 that it had received EXCiPACT GMP certification for pharmaceutical auxiliary materials used in its GMP-grade cell culture media manufacturing in Yantai, China. The company said the certification makes it the first Chinese cell culture media supplier to obtain EXCiPACT certification. EXCiPACT describes itself as an independent third-party certification scheme for pharmaceutical excipients and pharmaceutical auxiliary materials. The certification matters because cell culture media sit upstream in biopharmaceutical manufacturing. Manufacturing Chemist said the pharmaceutical auxiliary materials framework applies to inputs such as cell culture media that are used during the manufacture of medicines rather than incorporated into the finished product. CelluPro said the certification covers quality management, manufacturing operations and supply-chain controls tied to GMP-grade media production. (prnewswire.com) ### What exactly did CelluPro get certified for? CelluPro said the EXCiPACT GMP certification applies to pharmaceutical auxiliary materials, or PAMs, used in GMP-grade cell culture media manufacturing. The company describes itself as a supplier of serum-free cell culture media and bioprocess solutions. Morningstar’s repost of the company statement said the certification was awarded for CelluPro’s manufacturing of GMP-grade cell culture media. (manufacturingchemist.com) EXCiPACT says suppliers contract with an approved third-party certification body, agree the audit scope and standard, and receive a certificate and audit report if the audit shows compliance. The nonprofit says pharmaceutical companies use the scheme during supplier qualification and to access audit reports and certificates. ### Why does EXCiPACT matter to biopharma buyers? EXCiPACT says regulators require excipient users to qualify suppliers through GMP or GDP audits, and that third-party auditing is acceptable if conducted through a credible certification body. (morningstar.com) The scheme says it is meant to provide independent assurance on GMP, quality management and supply practices. Manufacturing Chemist said one purpose is to reduce the burden of repeated supplier audits for manufacturers. For buyers of cell culture media, that can matter because the materials are part of regulated production workflows. (excipact.org) Manufacturing Chemist said the PAM framework was developed for materials including cell culture media, giving biopharmaceutical manufacturers an independently verified assessment of suppliers in that category. ### How unusual is CelluPro’s claim? CelluPro said it is the first Chinese cell culture media supplier to receive EXCiPACT certification. (excipact.org) That claim was repeated in the company release carried by PR Newswire, Morningstar and Yahoo Finance. EXCiPACT says its certificate holders are based in more than 20 countries, though the certificate-holder page available through search results did not provide a directly readable public list entry for CelluPro in the material reviewed here. (manufacturingchemist.com) The broader market already includes other EXCiPACT certifications for biopharma inputs. Manufacturing Chemist reported that Q-VANT Biosciences also received EXCiPACT GMP certification for vaccine-adjuvant materials in Chile, underscoring that the scheme is being used for regulated upstream inputs beyond traditional excipients. ### What does this change for supply chains and facilities? CelluPro said the certification strengthens its ability to supply globally compliant cell culture media for biopharmaceutical manufacturing. (prnewswire.com) The company also said its quality system is backed by ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 22301 certifications. Those credentials, together with EXCiPACT, are aimed at customers that need documented controls, traceability and continuity in regulated production chains. (manufacturingchemist.com) For industrial property owners, that means the demand signal is less about generic warehouse space than about facilities that can support compliance-sensitive manufacturing and distribution. That is an inference from the certification scope and customer base, not a statement from CelluPro. Companies serving regulated biomanufacturing typically need cleaner operations, documented processes and dependable export-ready supply chains. (cellupro.com) ### What comes next after the certification? EXCiPACT says certificate holders share audit reports and certificates with customers as part of supplier qualification. CelluPro said the certification will support its global biopharmaceutical partners, suggesting the next practical step is use in customer onboarding, audit substitution and export-facing supply agreements. EXCiPACT’s site also points users to its certificate-holder system for current certified suppliers. (excipact.org) (cellupro.com)