ISO 9001:2015 Certificate of Registration

Published on 22 April 2026

InVitria's current ISO 9001:2015 certification, issued by Orion Registrar, Inc., for the manufacture of purified and partially purified products of recombinant proteins extracted from transgenic plants.

What This Certificate Documents

InVitria holds ISO 9001:2015 certification from Orion Registrar, Inc., an ANAB- and IAF-accredited certification body. The certification covers the full scope of InVitria’s manufacturing operations at its facility in Junction City, Kansas, and applies to all recombinant proteins produced on the ExpressTec rice-grain expression platform — including Exbumin, Optibumin 20, Optibumin 25, Cellastim S, Optiferrin, Lacromin, Lysobac, OptiVERO, OptiLeukin 2, OptiKine LIF and the ITS supplement family.

InVitria has maintained continuous ISO 9001 certification since November 26, 2012 — more than 14 years of uninterrupted registration, subject to annual surveillance assessments by the certifying body.

What ISO 9001:2015 Certification Means

ISO 9001:2015 is the internationally recognized standard for quality management systems. Certification verifies that an organization’s processes, documentation, traceability, customer focus, continuous improvement, and corrective action systems meet rigorous quality management requirements — as audited independently by an accredited third-party certification body.

For biopharmaceutical and life science customers, ISO 9001:2015 certification is a foundational supplier qualification criterion. It demonstrates that:

• Quality management is systematic and documented, not ad hoc
• Manufacturing processes are controlled, validated, and continuously improved
• Corrective and preventive action (CAPA) procedures are in place and audited
• Customer feedback and nonconformance are tracked and addressed
• The certification is independently verified by an accredited body and reassessed annually

How Customers Use This Certificate

This certificate is commonly referenced in:

• Supplier qualification packages for pharmaceutical and biopharmaceutical customers
• Quality Agreements between InVitria and its customers, as supporting documentation for the agreed quality framework
• IND, BLA, and marketing authorization submissions, as part of the supporting documentation for raw material suppliers
• Customer quality audits, as evidence of an externally verified quality management system
• Regulatory inspections, as documentation of the supplier’s quality infrastructure

Related Regulatory Documentation

InVitria maintains a complete suite of quality and regulatory documentation to support supplier qualification, regulatory submissions, and quality audits. In addition to this ISO 9001:2015 certificate, the following are available:

• cGMP Statement — attesting to manufacturing practices aligned with 21 CFR Parts 210/211 and ISO 9001:2015
• Certificate of Origin and Animal-Free / TSE-BSE Statement — attesting to US-based manufacturing, animal-component-free production, and TSE/BSE risk assurance
• 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