Global uncertainty continues to increase, placing supply chains under pressure from logistics disruptions to shifting geopolitical and market conditions. Our global mammalian drug substance network helps simplify and protect your supply while maintaining flexibility as programs scale up or expand geographically.
With six cGMP manufacturing sites across three continents, we offer small-, mid-, and large-scale capacity, including single‑use systems up to 2,000 L and stainless‑steel bioreactors ranging from 6,000 L to 25,000 L.
Together we can optimize your clinical and commercial manufacturing strategy to meet evolving needs with confidence.
We support drug substance manufacturing across the full product lifecycle, with a strong focus on quality, consistency, scalability, and regulatory compliance:
- Clinical manufacturing
- Engineering runs
- Process Performance Qualification (PPQ)
- Commercial manufacturing
- Supply continuity management
By maintaining timelines and enabling reliable scale-up, we provide a clear and adaptable path from development to commercialization—supported by infrastructure and expertise that evolve alongside your program.
Launch readiness is among the most critical and highly scrutinized phases of any development program. Our regulatory affairs experts align closely with how your product is manufactured, validated, and supplied to enable successful commercialization.
We support launch readiness through:
- Phase‑appropriate CMC regulatory guidance, from late clinical development through commercial launch.
- Preparation and review of CMC sections for Biological License Applications (BLA), Marketing Authorization Application (MAA), and other global regulatory submissions.
- Anticipation and management of health authority questions, including participation in agency interactions when needed.
Over 35 years of mammalian manufacturing experience with a global network of seven cGMP sites. Our proven track record includes 300+ successful tech transfers, 80+ site inspections, and a 100% success rate for CMC sections of IND/BLA filings. This allows for predictable outcomes and mitigates regulatory and operational risks.
CMC failures are often the leading cause of clinical holds and launch delays or license approval rejections. None of our customer programs have been on hold due to CMC related issues to date. Our experienced SMEs proactively help address risks through early gap assessments, harmonized tech transfer processes, and end-to-end thinking. Our approach upholds compliance, accelerates timelines, and help protect your program from costly setbacks.
Our global network provides lab, pilot and commercial bioreactor scales from 1 kL to 25 kL, covering everything from preclinical non-GMP, clinical and commercial GMP manufacturing. This flexibility allows customers to secure capacity without compromising timelines or quality, even as demand fluctuates.
We initiate multiple BLA/MAA programs annually, leveraging standardized documentation frameworks, proven validation protocols, and quality-by-design principles. With 50+ commercial launches and zero CMC-related program holds, our regulatory expertise ensures smooth dossier preparation and audit readiness.
Yes. We offer process intensification strategies, advanced analytics, and predictive modeling to optimize upstream processes. Combined with our integrated DS/DP services and global SME network, these capabilities enable faster decisions, fewer surprises, and a clear path from development to market.
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