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cGMP Statement

cGMP Statement

Published on 22 April 2026

InVitria's formal attestation that manufacturing operations are designed and operated in consideration of current Good Manufacturing Practice guidelines published in 21 CFR Parts 210 and 211 and ISO 9001:2015

Ron Beckman, VP of Quality, InVitria

What This Statement Documents

InVitria’s cGMP Statement is a signed attestation from the company’s VP of Quality confirming that manufacturing operations, documentation practices, batch production records, equipment qualification, and process and cleaning validation are designed and operated with consideration to current Good Manufacturing Practice (cGMP) guidelines. The statement references 21 CFR Parts 210 and 211 — the FDA’s primary regulatory framework for drug manufacturing — and ISO 9001:2015 quality management system standards.

The statement also confirms that InVitria products have been used in cell-based vaccines in clinical studies and in products approved by the FDA and EMA, including as cell culture media components and formulation excipients.

What This Statement Covers

Area	Practice
Regulatory Framework	21 CFR Parts 210 and 211 (FDA cGMP for finished pharmaceuticals)
Quality Standard	ISO 9001:2015
Documentation	Manufacturing documentation and batch production records maintained in accordance with cGMP guidelines
Equipment	Used in certain manufacturing processes is qualified according to cGMP guidelines
Validation	Process validation and cleaning validation implemented for certain products
Product Classification	Ancillary materials used in the manufacture of biologics
Regulatory History	Used in cell-based vaccines in clinical studies and in products approved by FDA and EMA
Signed By	VP of Quality, InVitria

Understanding “Ancillary Materials”

As stated in the cGMP Statement, InVitria products are classified as ancillary materials used in the manufacture of biologics. This classification has specific meaning in a regulatory context:

Ancillary materials are components used in the manufacturing process of a biologic drug product but are not intended to be present in the final therapeutic. They are not themselves directly regulated as finished drug products by the FDA or other regulatory authorities. However, ancillary materials used in biopharmaceutical manufacturing must still meet rigorous quality expectations defined by the drug product’s manufacturer, and are typically evaluated against frameworks such as USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products.

InVitria manufactures to a quality level consistent with ancillary material expectations for clinical and commercial biologic manufacturing, with a documented QMS, cGMP-aligned practices, and ISO 9001:2015 certification.

How Customers Use This Statement

This statement is commonly referenced in:

Supplier qualification packages for pharmaceutical and biopharmaceutical customers
Raw material justification for cell therapy, gene therapy, vaccine, and biologic manufacturing
IND, BLA, and marketing authorization submissions as supporting documentation for ancillary material suppliers
Quality Agreements between InVitria and its customers, as supporting reference for the agreed quality framework
Regulatory inspection responses where the supplier’s quality infrastructure is in scope

Proof of Practice: FDA- and EMA-Approved Products

InVitria’s cGMP-aligned manufacturing has been demonstrated in practice. InVitria products are components of FDA- and EMA-approved finished biologics, including:

Merck’s ERVEBO® Ebola vaccine — Exbumin is a formulation component in ERVEBO, the first licensed injectable human vaccine to incorporate recombinant albumin as an excipient. ERVEBO is approved by the FDA, EMA, and PMDA.
Additional cell-based vaccines in clinical studies and approved products where InVitria proteins are used as cell culture media components.

This track record is the strongest external validation of InVitria’s quality system — a cGMP statement is a commitment, but incorporation into approved regulatory filings is proof.