• Home
  • The Hidden Costs of Blood-Derived Raw Materials: What You Don’t See Is Costing You

The Hidden Costs of Blood-Derived Raw Materials: What You Don’t See Is Costing You

Published on 19 April 2025

You’re not just paying for product—you’re paying for extra testing & paperwork

Reading time: 4 minutes

Share this article:

Biomanufacturers know that raw material quality directly impacts safety, consistency, and regulatory success. But what many teams overlook are the invisible costs—financial, operational, and regulatory—associated with blood- and animal-derived inputs.

Whether it’s human serum albumin (HSA), transferrin, insulin, or other plasma proteins, blood-derived raw materials introduce a burden that goes far beyond price-per-gram. At InVitria, we work with customers who’ve seen firsthand how viral risk, TSE documentation, and regulatory delays can quietly erode budgets and timelines.

Per-Lot Testing: A Hidden Line Item

Blood-derived materials must undergo a range of costly and time-consuming tests for every lot. These include:

  • Viral panels (HIV, HBV, HCV, HAV, etc.)
  • Adventitious virus screening for bovine or porcine agents (e.g., BVDV, PPV, PRV)
  • Mycoplasma testing
  • Endotoxin testing for injectable or cell therapy use

While InVitria’s recombinant proteins also undergo mycoplasma and endotoxin testing, our products eliminate the need for viral and prion-related screening altogether.

Estimated testing cost per lot:

The TSE Burden: Documentation Nobody Talks About

Every animal- or blood-derived input comes with a regulatory burden related to Transmissible Spongiform Encephalopathies (TSEs), such as BSE and vCJD. Compliance requires:

  • EDQM Certificates of Suitability (CEPs)
  • Country-of-origin documentation
  • QA archiving and audit trails
  • Supplier qualifications and audits
  • Per-lot traceability reviews

While these activities don’t show up on a line-item invoice, they consume real time, labor, and budget.

Estimated hidden TSE compliance costs:

💡 With InVitria: All of this is eliminated.

Beyond the Numbers: What This Really Means

When you account for all the time, cost, and complexity introduced by blood-derived raw materials, the value of a recombinant, animal-origin-free alternative becomes clear:

  • ✅ No viral or prion testing
  • ✅ No TSE documentation or audit prep
  • ✅ No global import/export headaches
  • ✅ Full GMP traceability and CoA documentation
  • ✅ Consistent, chemically defined formulation

Simplify Your Workflow with InVitria

InVitria’s recombinant proteins are engineered to help you streamline development, reduce risk, and accelerate time to clinic or market. Our materials are animal-origin-free, chemically defined, and supported by full quality documentation—making them ideal for cell therapy, gene therapy, vaccine, and biologics applications.

👉 Ready to simplify your raw material strategy?

So what’s next? If you’re interested in discovering how InVitria’s animal-origin-free, chemically defined, recombinant products can reduce risk, cut costs, and simplify your regulatory workflow, our team is here to help! Contact us today.

 

Stay at the Forefront of Innovation

At InVitria, we’re dedicated to pushing the boundaries of biomanufacturing with advanced, recombinant, and chemically defined solutions. Our team is constantly innovating to support the industry’s evolving needs. Sign up for our newsletter to get early access to product updates, expert insights, and exclusive content.

Subscribe Now

Featured Solution

InVitria's Optibumin 25 – a 100 mL sterile bag of 25% recombinant human serum albumin (rHSA) with closed-system tubing.

Optibumin 25 ® – Recombinant Human Serum Albumin in Bags

Optibumin 25 in bags supports closed-system biomanufacturing with enhanced safety, consistency, and scalability. This high-purity, recombinant, animal-free albumin solution eliminates contamination risks from animal- and human-derived materials, ideal for advanced cell therapy and vaccine workflows. Its chemically defined formulation promotes stable cell growth, viability, and process reliability.

Learn more about Optibumin 25

 

Footnotes

References

  1. European Medicines Agency. (2011). Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 Rev.3). https://www.ema.europa.eu/en/documents/scientific-guideline
  2. S. Food and Drug Administration. (2020). Guidance for industry: Pyrogen and endotoxins testing: Questions and answers. https://www.fda.gov/media/83477/download
  3. S. Food and Drug Administration. (2010). Points to consider in the characterization of cell lines used to produce biologicals. https://www.fda.gov/media/113274/download
  4. S. Food and Drug Administration. (2020). Q&A on endotoxin testing for biologics. https://www.fda.gov/vaccines-blood-biologics/general-biologics/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers
  5. ICH Harmonised Tripartite Guideline. (1999). Q6B: Specifications – Test procedures and acceptance criteria for biotechnological/biological products. https://database.ich.org/sites/default/files/Q6B_Guideline.pdf
  6. ICH Harmonised Tripartite Guideline. (1995). Q5B: Quality of biotechnological products: Analysis of the expression construct in cells used for the production of r-DNA derived protein products. https://database.ich.org/sites/default/files/Q5B_Guideline.pdf
  7. S. Pharmacopeial Convention. (2023). <85> Bacterial Endotoxins Test. In United States Pharmacopeia and National Formulary (USP 47–NF 42).
  8. Bauermann, F. V., Ridpath, J. F., Dargatz, D. A., & Rossow, K. D. (2020). Bovine viral diarrhea virus in biological products: Risks, regulations, and testing. Frontiers in Veterinary Science, 7, 530. https://doi.org/10.3389/fvets.2020.00530
  9. WHO Expert Committee on Biological Standardization. (2013). Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report Series No. 924. https://www.who.int/publications/i/item/9241209246