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.
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