invitria.com

InVitria manufactures recombinant, animal-origin-free proteins at an ISO 9001:2015 certified facility in Kansas, USA, with metric-ton production capacity and distribution to more than 40 countries. Its products are used in FDA- and EMA-approved biologics. If you are qualifying an upstream raw-material supplier for cell culture, biomanufacturing, or final formulation, these are the credentials to weigh — and the sections below show what each one does and does not tell you.

Manufacturing and Quality Credentials

The ISO 9001:2015 certification applies to the Kansas facility where these proteins are produced. ISO 9001 covers quality management systems, not product-specific GMP certification — so if your process requires GMP-grade raw materials, confirm the specific grade and documentation for the exact product rather than assuming it from the facility certification alone.

Supply Chain Scale and Reliability

InVitria presents four supply-side signals:

• Metric-ton capacity — production volume at the ton scale, which matters if you are scaling from bench to commercial batches.
• Global distribution across 40+ countries — relevant for multi-site manufacturing and international regulatory filings.
• 1,000+ active customers — a broad installed base, which you can use as a reference point when checking commercial traction.
• 300+ customer clinical programs — indicates the materials are used in programs progressing through clinical stages, not only research use.

For a supplier qualification file, these numbers support a scalability argument but do not replace your own checks: request a certificate of analysis, a quality/technical agreement, and lead-time or capacity commitments for your forecast volumes.

Regulatory and Application Track Record

The site states InVitria's recombinant proteins are used in over 30 on-market products, including the first FDA-approved vaccine containing recombinant human albumin (rHSA), and that they appear in FDA- and EMA-approved biologics. This is the strongest single credential for a biomanufacturing buyer, because it shows the materials have been accepted in approved drug applications.

Two caveats when using this in your own qualification:

1. Approval of a product containing these materials does not automatically qualify them for your process — you still run your own comparability and performance testing.
2. Confirm which specific product (for example, recombinant albumin versus transferrin) is referenced in each approved application, since the portfolio spans multiple protein types.

Product Scope Relevant to Supply Planning

InVitria's catalog covers:

• Recombinant proteins — albumin, transferrin, lysozyme, interleukins
• Cell culture components — insulin-transferrin supplements
• Blood-free complete media

Applications listed include gene therapy, cell therapy, vaccine production, T-cell immunotherapy, final formulation, medical device, and antibody production. If your workflow falls in one of these areas, the application pages and downloadable catalog are the fastest way to check formats and specifications before requesting samples.

How to Verify These Credentials for Your Own Qualification

1. Download the product catalog from the site to review specifications, formats, and applications across your workflow.
2. Search the knowledge base by cell line or application to find supporting data for your specific process.
3. Request quality documentation — ISO 9001:2015 certificate, certificate of analysis, and origin statements — for the exact catalog numbers you intend to use.
4. Confirm supply terms — lead times, minimum order quantities, and capacity allocation against your forecast, since metric-ton capacity is a facility-level figure, not a per-product commitment.
5. Run your own evaluation — performance and comparability testing in your cell line or formulation, since third-party regulatory use is supporting evidence, not a substitute.

Bottom Line

InVitria's credentials — ISO 9001:2015 certified US manufacturing, metric-ton capacity, 40+ country distribution, 1,000+ active customers, 300+ clinical programs, and use in FDA/EMA-approved biologics — are sufficient to justify moving to sample evaluation and documentation review for most cell culture and biomanufacturing raw-material needs. They are not sufficient on their own to skip your internal qualification, particularly if you need GMP-grade material or product-specific regulatory support.

InVitria is a manufacturer of recombinant, animal-origin-free proteins used in cell culture, biomanufacturing, and final formulation. The company produces its proteins with a proprietary ExpressTec® rice grain–based expression platform, which avoids animal- or human-derived components. Its products are used in FDA- and EMA-approved biologics, including the first FDA-approved vaccine containing recombinant human albumin (rHSA), and are made at an ISO 9001:2015 certified facility in Kansas, USA.

What InVitria makes

InVitria's catalog is built around recombinant proteins and the cell culture products formulated from them. All are described as chemically defined and free of animal or human components.

The catalog is available as a downloadable PDF covering product specifications, formats, and applications.

How the products are made

The differentiator is the expression system. Instead of plasma sourcing or mammalian cell expression, InVitria uses ExpressTec®, a rice grain–based recombinant platform. The stated consequences are:

• No animal or human components in the production chain, which removes a common source of batch variability.
• Consistency and scalability — the company cites metric-ton capacity and global distribution.
• Reduced contamination risk compared with serum- or blood-derived inputs.
• Lower carbon footprint relative to animal-derived sourcing, per the company's sustainability positioning.

For process developers, the practical appeal is replacing serum or plasma-derived albumin and transferrin with a chemically defined recombinant equivalent, which simplifies regulatory documentation around adventitious agents.

Who uses it

InVitria lists seven application areas:

• Gene therapy
• Cell therapy
• Vaccine production
• T-cell immunotherapy
• Antibody production
• Final formulation
• Medical devices

The company reports 1,000+ active customers, 300+ customer clinical programs, and distribution in 40+ countries.

When InVitria is a fit

InVitria is worth evaluating if your process needs a blood-free or animal-origin-free albumin, transferrin, or supplement, particularly if you are preparing for clinical or commercial stages where raw-material traceability and batch consistency matter. If your workflow already specifies a serum-derived component and no regulatory or yield pressure exists to change it, switching carries requalification cost. The company provides a knowledge base searchable by cell line or application, which is the fastest way to check whether a specific product is documented for your system.

Animal-origin-free recombinant proteins are used in cell culture and biomanufacturing to remove the variability and contamination risk that come with serum and other animal- or human-derived components, while keeping the process chemically defined and scalable. InVitria produces this class of proteins — recombinant albumin, transferrin, lysozyme, and interleukins — using a proprietary rice grain–based expression platform called ExpressTec®, at an ISO 9001:2015 certified facility in Kansas, USA. This approach is most relevant if you are developing a biologic, cell therapy, gene therapy, or vaccine process where lot-to-lot consistency, regulatory acceptance, and supply reliability matter.

The core problem with animal-derived components

Traditional cell culture often relies on fetal bovine serum (FBS) or human-derived proteins such as plasma-derived albumin. These materials introduce several well-known issues:

• Batch variability. Serum composition shifts between lots and suppliers, which can change growth rates, productivity, and product quality.
• Contamination risk. Animal- and human-derived raw materials carry the potential for adventitious agents, including viruses and prions.
• Undefined composition. Serum is not chemically defined, which makes process characterization and regulatory filing harder.
• Supply fragility. Serum availability and pricing fluctuate with the animal supply chain.

Recombinant, animal-origin-free proteins address these points directly: they are produced in a non-mammalian expression system, so no animal or human components enter the manufacturing chain.

What "animal-origin-free" and "chemically defined" actually mean here

These two terms are related but not identical, and both matter for process design:

InVitria's proteins are described as recombinant, chemically defined, and animal-origin-free, produced in a scalable, non-mammalian recombinant expression system.

Benefits across the biomanufacturing workflow

1. Eliminating serum variability

Because the proteins are chemically defined and produced recombinantly, they avoid the lot-to-lot drift that comes with serum. This supports more consistent cell growth and product quality — a key requirement when you move from research scale to clinical and commercial production.

2. Reducing contamination risk

Removing animal- and human-derived components from the process reduces the risk of introducing adventitious agents. This is especially important for cell therapy, gene therapy, and vaccine workflows, where the final product may be administered to patients.

3. Supporting scalable, blood-free processes

InVitria's portfolio is positioned around "chemically defined blood-free products," enabling development and production of therapeutics without any blood-derived components. The company cites metric-ton capacity and global distribution, which speaks to supply chain reliability at scale.

4. Regulatory precedent

InVitria states its recombinant proteins are used in FDA- and EMA-approved biologics, and that its recombinant human albumin (rHSA) is used in the first FDA-approved vaccine containing rHSA. For teams preparing regulatory submissions, existing use in approved products can support the case for adopting animal-origin-free components.

Where these products are applied

InVitria lists the following application areas for its portfolio:

• Gene therapy
• Cell therapy
• Vaccine production
• T-cell immunotherapy
• Final formulation
• Medical device
• Antibody production

The product types span recombinant albumin, recombinant transferrin, recombinant lysozyme, recombinant interleukins, cell culture components, insulin-transferrin supplements, and blood-free complete media.

When this approach is the right fit

Animal-origin-free recombinant proteins are worth prioritizing when:

• You need regulatory-friendly, chemically defined raw materials for a clinical or commercial process.
• Serum variability is causing inconsistent results in your cultures.
• You are building a blood-free or animal-component-free manufacturing chain.
• You need scalable supply with documented quality systems (InVitria's facility is ISO 9001:2015 certified).

They may be less of a priority for early-stage, non-regulated research where cost sensitivity outweighs consistency and traceability requirements — though even there, reproducibility benefits can justify the switch.

How to evaluate a supplier

If you are comparing animal-origin-free recombinant protein suppliers, check:

1. Expression system — non-mammalian and animal-origin-free, as with InVitria's rice-based ExpressTec® platform.
2. Quality certification — e.g., ISO 9001:2015.
3. Regulatory track record — use in FDA- or EMA-approved products.
4. Scale and supply — stated capacity and distribution reach.
5. Documentation — product specifications, formats, and application data; InVitria offers a downloadable catalog covering these.

InVitria reports over 1,000 active customers, 300+ customer clinical programs, and distribution in 40+ countries, which gives a sense of its installed base and reach.

InVitria uses its proprietary ExpressTec® platform — a rice grain–based recombinant expression system — to produce highly pure, consistent proteins without animal- or human-derived components. The proteins are manufactured at an ISO9001:2015 certified facility in Kansas, USA, and the platform is designed for scalable supply, with metric ton capacity and global distribution. This matters if you're sourcing recombinant proteins for cell culture, biomanufacturing, or final formulation and want to avoid serum variability and reduce contamination risk.

What ExpressTec® is

ExpressTec® is InVitria's proprietary expression platform built on rice grain. Instead of using mammalian or other animal-derived expression systems, InVitria expresses recombinant proteins in this non-mammalian system. The result is a suite of recombinant protein products that are completely free of animal or human components.

The platform underpins InVitria's positioning around three attributes it states directly: Recombinant, Scalable, Sustainable.

How the production approach works

Based on InVitria's description, the process follows this logic:

1. Expression in rice grain — the target protein is produced via the ExpressTec® rice grain–based expression platform.
2. No animal or human inputs — because the system is non-mammalian and animal-origin-free, the resulting proteins avoid animal- or human-derived components.
3. Manufacturing at a certified facility — production takes place at an ISO9001:2015 certified facility in Kansas, USA.
4. Scalable output — the platform supports metric ton capacity and global distribution.

The stated outcome is proteins that are highly pure and consistent, which InVitria frames as a way to eliminate serum variability, reduce contamination risk, and improve process consistency.

What this means in practice

If your workflow depends on recombinant proteins, the practical implications InVitria highlights are:

• Animal-origin-free, chemically defined proteins — relevant when you need to avoid blood-derived or animal-derived components.
• Consistent, scalable supply — supported by metric ton capacity and global distribution.
• Reduced contamination risk — a direct consequence of removing animal/human-derived components.
• Proven in regulated products — InVitria states its proteins are used in FDA- and EMA-approved biologics, and that its recombinant proteins are used in over 30 on-market products, including the first FDA-approved vaccine containing rHSA.

Product types produced on the platform

InVitria's catalog of recombinant, animal-origin-free products includes:

These are applied across gene therapy, cell therapy, vaccine production, T-cell immunotherapy, final formulation, medical device, and antibody production.

Where to verify specifics

For product specifications, formats, and application details, InVitria provides a downloadable catalog covering recombinant proteins, cell culture supplements, and blood-free cell culture media. Because formats and specifications vary by product, check the catalog or the relevant product page before selecting a protein for your workflow.

Start with the application, then narrow to the product type, then pull the technical detail. InVitria organizes its site around three entry points that map to how most people actually search: Product Applications (gene therapy, cell therapy, vaccine production, T-cell immunotherapy, final formulation, medical device, antibody production), Product Types (recombinant albumin, transferrin, lysozyme, interleukins, cell culture components, insulin-transferrin supplements, blood-free complete media), and a Knowledge Base you can search by cell line or application of interest. If you already know your application, the application pages are the fastest route. If you know your molecule or supplement need but not the workflow, go through Product Types. If you are troubleshooting or matching a specific cell line, the Knowledge Base is the intended tool.

Route 1: Start from your application

InVitria's Product Applications section is organized by the downstream use case rather than by catalog number. The listed applications are:

• Gene Therapy
• Cell Therapy
• Vaccine Production
• T-Cell Immunotherapy
• Final Formulation
• Medical Device
• Antibody Production

Each application page is described as showing how the products set standards in biologics manufacturing for that specific workflow. This is the right entry point when your question is "what do I use for X process" rather than "what formats does product Y come in."

Route 2: Start from the product type

If your constraint is the component itself — for example, you need a recombinant albumin or a transferrin supplement — the Product Types section lists the portfolio directly:

All of these are described as completely free of animal or human components, produced in a scalable, non-mammalian recombinant expression system at an ISO9001:2015 certified facility in Kansas, USA. That single sentence answers the most common screening question — origin and certification — before you open a spec sheet.

Route 3: Search the Knowledge Base by cell line

The Knowledge Base is the only entry point explicitly built for cell-line-level queries. The site instructs you to "select the cell line or an application of interest" to find more. Use this route when:

• You have a specific cell line and need to know which supplement or media fits.
• You are comparing your current serum-containing process against a blood-free alternative.
• You need background on why a recombinant component replaces a serum-derived one.

Getting the specifications: download the catalog

The Product Catalog page is the place to get concrete detail rather than marketing-level claims. It covers three groups — Recombinant Proteins, Cell Culture Supplements, and Blood-Free Cell Culture Media — and the site provides a Download PDF action. The stated purpose is to "review product specifications, formats, and applications across your workflow." If you need formats or specs to make a sourcing decision, this is the document to pull rather than reading individual pages.

What the site claims, so you can weigh it

These points are worth knowing before you commit to a route, because they tell you what evidence exists behind the catalog:

• Proven in approved biologics. InVitria states its recombinant, animal-origin-free proteins are used in over 30 on-market products, including the first FDA-approved vaccine containing rHSA, and that its products are used in FDA- and EMA-approved biologics.
• Scale. The site cites metric ton capacity, global distribution, and Made in the USA manufacturing.
• Adoption signals. 1,000+ active customers, 300+ customer clinical programs, and distribution in 40+ countries.
• The platform. Proteins are made using the proprietary ExpressTec® rice grain–based expression platform, which is the mechanism behind the animal-origin-free and chemically defined claims.

If your selection criteria include regulatory precedent or supply-chain scale, those claims are the ones to verify against the catalog and spec sheets rather than the homepage.

A practical sequence

1. Identify whether your question is application-driven or component-driven.
2. Application-driven: open the matching Product Applications page.
3. Component-driven: open the matching Product Types page.
4. Cell-line-specific or troubleshooting: search the Knowledge Base.
5. Before requesting or specifying anything, download the catalog PDF to confirm specifications and available formats.

Common sticking points

• The catalog is a PDF, not a filterable database. You will not get a live product selector; you get a document to review offline.
• Pricing is not published on the pages described here. No pricing links or payment platforms appear in the site data, so treat cost as a direct inquiry rather than something you can look up.
• "Animal-origin-free" and "chemically defined" are distinct claims. The site uses both; check which applies to the specific product you need, since supplements and complete media may differ from the recombinant proteins on this point.