The Hidden Risks of Blood-Derived Raw Materials in Biologics Manufacturing

Published on 19 April 2025

How blood-derived raw materials introduce hidden risks, regulatory hurdles, and delays—and why recombinant alternatives offer a safer path forward.

Reading time: 4 minutes

Share this article:

Here’s a breakdown of the five biggest risk areas—and why animal-origin-free (AOF), recombinant materials offer a better path forward.

1. Contamination Risks: Viral, Prion, and Endotoxin Threats

Blood-derived materials carry inherent risks of harboring adventitious agents, including:

• Viral contamination (e.g., BVDV, HoBi-like pestiviruses, Vesivirus 2117)
• Prion transmission (TSE agents like BSE/vCJD)
• Endotoxins and microbial toxins (from Gram-negative bacteria)

Real-World Example:
In 2009, a viral contaminant in raw material forced Genzyme to shut down its Allston plant, resulting in months-long drug shortages for critical enzyme therapies.

Recombinant Advantage:
AOF materials are made in closed, controlled systems without human or animal donors—virtually eliminating adventitious agent risks. They are low in endotoxins by design and sterile by production.

2. Variability: Lot-to-Lot Inconsistency

Every batch of FBS, serum, or plasma protein differs due to:

• Donor biology
• Harvesting methods
• Geographic and seasonal variables

This can cause:

• Unpredictable cell culture performance
• Fluctuating yields
• Increased process troubleshooting

“The composition of FBS is not fully characterized… batch-to-batch variation leads to unintended effects.” – NC3Rs report

Recombinant Advantage:
Recombinant proteins are chemically defined and consistent from lot to lot—reducing time spent screening lots and improving reproducibility across manufacturing.

3. Regulatory & Documentation Burdens

Using blood- or animal-derived raw materials triggers heavy compliance requirements, including:

• TSE documentation (e.g., CEPs, country-of-origin)
• Donor traceability and screening logs
• Viral safety validation studies
• Supplier audits and change controls

These documents can:

• Delay IND/BLA filings
• Create regulatory scrutiny during inspections
• Slow down global approval timelines

Recombinant Advantage:
Animal-origin-free inputs bypass most of this burden, streamlining compliance, inspections, and regulatory submissions.

 

4. Supply Chain Instability

Blood-derived raw materials are vulnerable to:

• Shortages (due to donor limits, droughts, disease outbreaks)
• Price volatility (FBS prices increased 300%+ in some regions)
• Import/export restrictions (biohazard classification, disease embargoes)

They also require:

• Cold chain logistics
• Permits and border clearance
• Long lead times and lot reservation systems

Recombinant Advantage:
Recombinant materials can be scaled on demand, have more predictable pricing, and face no disease-related trade restrictions.

 

5. Patient Safety Risks

Using animal- or blood-derived materials can result in:

• Immune reactions from trace proteins (e.g., bovine albumin, Neu5Gc)
• Alloimmunization from human-derived supplements
• Adverse events if contaminants slip through
• Delays to market from regulatory questions or supply issues

Case in point:
Patients with Gaucher disease faced treatment delays when raw material contamination forced a manufacturer to halt production.

Recombinant Advantage:
AOF materials are free of xenoantigens and immunogenic impurities, reducing the risk of immune response and supporting faster, safer product development.

The Case for Animal-Origin-Free, Recombinant Raw Materials

Switching to recombinant and chemically defined inputs mitigates nearly all the issues listed above.

Benefits of Recombinant Materials:

• No viral, prion, or endotoxin carryover
• Consistent batch quality
• Reduced regulatory documentation
• More stable and scalable supply chains
• Improved patient outcomes and safety

In a landscape where consistency, compliance, and patient safety matter more than ever, recombinant materials future-proof your process.

 

Want to Reduce Risk and Streamline Your Workflow?

At InVitria, we manufacture high-purity, animal-origin-free proteins designed for biologics, vaccines, and cell therapies. Our recombinant solutions help you:

• Eliminate viral and prion risk
• Simplify documentation and compliance
• Improve consistency and yield
• Reduce delays and accelerate time to market

If you’re interested in discovering how InVitria’s animal-origin-free, chemically defined, recombinant products can reduce risk, simplify compliance, and accelerate your path to market, our team is ready 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

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