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Sterile Development & Manufacturing

Where beyond begins

From beginning to breakthrough, possibility to progress, it’s where inspiration becomes innovation.

Inspired by tomorrow.

Let's talk future™

Scientific

Drawing on scientific expertise, intelligence, and technology, we provide fully integrated formulation, analytical development, and scalable manufacturing.

Proven

At our core are experts, people with an absolute commitment to quality, guiding your molecule from trial to treatment.

Leading

We bring the right minds, the right science, and the right environments to unlock the full potential of your formulation from possibility to progress.

World-class CDMO solutions defined by quality

With over 25 years of expertise, we support clients with sterile drug development and manufacturing and industry-leading lyophilization, throughout their product's lifecycle, from early-stage development to market launch.

Development & manufacturing

Our expertise in sterile fill-finish and lyophilization operates in cutting-edge, Annex 1–compliant facilities that uphold the highest standards of quality and control. Our comprehensive end-to-end services and streamlined supply chain ensure every stage of your sterile drug product journey is efficient, secure, and fully connected.

Complex to compliant

With deep expertise in sterile fill-finish and world-leading experience in lyophilization, we deliver sterile manufacturing for complex formulations.

From nanoparticles and mRNA to monoclonal antibodies, proteins, oligonucleotides, and other biologics, we ensure robust, reliable performance for even the most demanding drug products.

Regulatory excellence

We are the first CDMO to successfully complete an International Coalition of Medicines Regulatory Authorities (ICMRA) inspection, demonstrating our commitment to global regulatory alignment, quality, excellence, and operational transparency.

  • 9 FDA-approved sterile lines globally
  • 66 successful regulatory inspections
  • 60+ commercial product approvals

Precision. No compromise.

Sterile Development & Manufacturing

Evolution from tech-transfer to treatment, where intelligence, technology, and scalability meet quality, safety, and speed to market