Certificate of Origin and Animal-Free / TSE-BSE Statement

Published on 22 April 2026

InVitria's signed attestation of US-based manufacturing, animal-component-free production to the tertiary level, and TSE/BSE risk assurance for all manufactured products.

What This Document Covers

This statement consolidates three related regulatory attestations into a single document signed by InVitria’s Director of Quality:

1. Certificate of Origin — formally identifying the country and city where InVitria’s products are manufactured
2. Animal-Free Component Statement — attesting that raw materials, production hosts, processing equipment, and product-contact packaging contain no animal components
3. TSE/BSE Statement — attesting that products are animal-component-free to the tertiary level, meaning Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) are not a concern

Consolidating these into one document reflects how they are commonly referenced together in supplier qualification and regulatory submissions — the three concerns are interrelated, and a single signed statement efficiently addresses all three.

What This Document Attests

Why the Three Attestations Are Consolidated

Certificate of Origin is required for international shipping, customs documentation, and many supplier qualification packages. For regulated biologics customers, it also establishes the manufacturing jurisdiction — which affects regulatory inspections, supply chain security, and geopolitical risk assessment. InVitria’s US-based manufacturing in Kansas is increasingly a supply chain differentiator as biopharmaceutical customers evaluate the resilience of their raw material supply against international disruption.

Animal-Free Component Statement is required for cell therapy, gene therapy, and vaccine manufacturing programs that must demonstrate the elimination of animal-derived materials. Regulatory authorities, including the FDA, EMA, and PMDA, have issued guidance encouraging the elimination of animal-origin components from manufacturing processes and final product formulations. Customers developing cell-based therapies specifically require animal-free raw materials to support their IND and BLA filings.

TSE/BSE Statement addresses a specific safety concern — the risk that manufacturing inputs derived from bovine sources could carry prion-based infectious agents responsible for BSE (“mad cow disease”) and related TSEs. This is a standard supplier qualification requirement for any manufacturer whose products may incorporate biological materials, and is scrutinized during ICH Q5A viral safety evaluation for biotechnology products.

The three attestations answer related questions: where is the product made, what went into making it, and is there any prion-associated risk. A single consolidated statement is efficient for both InVitria’s Quality operations and the customer teams using the document for supplier qualification.

How Customers Use This Document

This document is commonly referenced in:

• Supplier qualification packages for pharmaceutical and biopharmaceutical customers, particularly in cell therapy, gene therapy, and vaccine programs
• Animal-free raw material sourcing audits required by customer Quality and Regulatory teams
• ICH Q5A viral safety evaluation supporting documentation
• IND, BLA, and marketing authorization submissions as part of the raw material supplier dossier
• Customs and international shipping documentation where a country-of-origin attestation is required
• Quality Agreements that specify animal-free or defined-origin raw material requirements

Related Regulatory Documentation

• ISO 9001:2015 Certificate of Registration — externally audited quality management system certification from Orion Registrar, Inc.
• cGMP Statement — attesting to manufacturing practices aligned with 21 CFR Parts 210/211 and ISO 9001:2015
• Certificate of Analysis (CoA) — product-specific, lot-specific release documentation, available on request
• Safety Data Sheet (SDS) — product-specific safety and handling information, available on request
• Guidelines for Use — product-specific reconstitution, storage, and handling protocols

For IND-supporting packages, Regulatory Support Files, or custom Quality Agreement documentation, contact InVitria directly.

Download the Certificate