Pharma-Grade Compliance Begins with Nutrient Precision
Producing pharmaceutical-grade hyaluronic acid through microbial fermentation demands absolute control over every process variable — from the nutrient profile to the final purification steps. Among these variables, the composition and consistency of the culture medium play a defining role in meeting strict quality, safety, and regulatory standards.
ProCel®, developed by Procelys by Lesaffre, is a yeast-based nutrient solution designed to meet the pharmaceutical industry’s highest expectations for documentation, audit compliance, and reproducibility. It supports manufacturers targeting injectable, ophthalmic, and other medical-grade hyaluronic acidapplications, where purity and traceability are non-negotiable.
What is NuCel® — and What Makes It Different
- Fully animal-free, allergen-free, GMO-free, compliant with food and cosmetic-grade standards.
- Certified Halal and Kosher.
- Available as a light-colored, highly soluble powder formulated for clarity and consistent nutrient delivery.
This composition ensures both process performance and regulatory peace of mind.
Why Compliance Is a Strategic Requirement in Hyaluronic Acid Production
Pharmaceutical manufacturers must navigate a complex regulatory environment that demands both product consistency and process transparency. Regulatory agencies expect full traceability of all raw materials, validated processes, and evidence of reproducibility across production batches.
While conventional yeast extracts often vary in amino acid content, trace elements, or nucleotides, ProCel® ensures controlled composition and low variability, preventing lot-to-lot differences that could affect downstream purification or final hyaluronic acid molecular weight distribution.
Procelys integrates the same pharma-grade quality systems applied to the Lesaffre Group’s biotechnology activities:
- Complete documentation package compliant with audit standards.
- CoA issued for every batch, including microbial, chemical, and physical parameters.
- Compliance with pharmaceutical, cosmetic, and food-grade regulations.
- Dual sourcing and full traceability of production sites across Europe and Asia.
This level of compliance transforms ProCel® from a nutrient input into a regulatory enabler — helping manufacturers align their hyaluronic acid fermentation process with GMP expectations.
Meeting the Technical Standards of the Pharmaceutical Segment
Pharma-grade hyaluronic acid producers typically aim for:
- Purity: 95–100 % with minimal endotoxin levels.
- High viscosity and molecular weight: usually 6–10 g/L in fermentation broth, 200–10 000 kDa final MW range.
- Scalability and reproducibility: from lab to pilot and full-scale reactors.
ProCel® meets these requirements by delivering a range of yeast-based nutrients that minimizes interference during downstream purification. In fermentation trials, ProCel® showed process stability, lower residual impurities, and reduced contamination risks compared to animal-derived peptones — a critical point for injectable-grade hyaluronic acid.
The result is a cleaner fermentation broth, simplifying separation, filtration, and alcohol precipitation steps. This enables faster purification, better control of hyaluronic acid molecular weight, and improved overall recovery rates.
Consistency That Supports Reproducibility
In pharmaceutical production, consistency is more than an operational metric — it is the foundation of product registration and regulatory validation. ProCel®’s batch-to-batch uniformity ensures that hyaluronic acid producers can rely on stable yields and reproducible viscosity profiles across production cycles.
ProCel® is analytically characterized for nitrogen content, amino nitrogen, nucleotides, ash, trace minerals, and molecular weight distribution. This controlled composition limits nutrient-induced variability in microbial metabolism, which can otherwise lead to shifts in hyaluronic acid molecular weight or viscosity.
Procelys’ application data confirm that ProCel® enables faster stabilization and lower variance in hyaluronic acid yield curves. When used under optimized conditions with Streptococcus zooepidemicus, ProCel® delivers steady performance at pilot and industrial scale.
Ensuring Low Endotoxin Risk and Regulatory Peace of Mind
For hyaluronic acid producers targeting medical devices and injectables, endotoxin control is a central compliance concern. Any contamination, even at trace levels, can compromise product safety and lead to costly batch rejections.
ProCel® is produced under controlled biotechnological conditions using non-pathogenic yeast, ensuring low endotoxin content and eliminating risks associated with animal-based materials. The nutrient complies with Halal, Kosher, and non-GMO standards, supporting manufacturers that must meet multiple regional certifications (EU, U.S., and APAC). Specific ProCel range products which are with very low level endotoxins are made available for our customers. This risk mitigation is further reinforced by full supply-chain traceability and a technical data package available for customer audits, including contaminant testing, allergen statements, and BSE/TSE-free certification
A Partner for Validation and Co-Development
Procelys doesn’t only supply nutrients — it partners with manufacturers throughout process development and validation. Dedicated application laboratories in Europe, America and Asia provide technical support for hyaluronic acid fermentation optimization, molecular weight control, and scale-up assistance.
Customers also benefit from the Lesaffre Industrial Performance Network, ensuring continuity of supply, technical troubleshooting, and regulatory support from pilot studies to full GMP production.
Pharma-Grade Hyaluronic Acid Requires Pharma-Grade Nutrients
Critical Compliance Aspect | ProCel® Contribution |
Batch-to-batch reproducibility | Controlled nutrient composition and CoA per batch |
Endotoxin management | Non-animal origin, low endotoxin content |
Regulatory documentation | Full audit-ready dossier (GMP, ISO, allergen-free, traceability) |
Process scalability | Validated from lab to industrial scale |
Purity and yield | Cleaner broth, easier purification, higher HA recovery |
Conclusion
As the pharmaceutical hyaluronic acid market continues to expand — driven by ophthalmic, orthopedic, and dermal applications growing above 8 % CAGR — manufacturers are rethinking every input in their process for compliance and reproducibility.
By aligning nutrient performance with pharma-grade regulatory expectations, ProCel® helps producers achieve not just higher yields but also the peace of mind that every batch meets the same uncompromising standards.
With ProCel®, compliance becomes a built-in feature of the fermentation process — not an afterthought.
