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High-Potency & Cytotoxic OSD Maunfacturing

Eirgen supports global innovators with high-potency and cytotoxic OSD manufacturing designed around safety, control, and regulatory confidence. Our purpose-built containment suites and integrated development-to-commercial model help partners progress potent molecules efficiently through clinical milestones and into global markets. 

With over two decades of experience in high-potency OSD, we operate as an extension of your team -  bringing scientific expertise, operational reliability, and a strong compliance history to every programme.

Pharmaceutical Development Stages

A structured development pathway supporting potent and cytotoxic OSD

programmes from early feasibility through global commercial supply. 

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Discovery & Feasibility​

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  • API Assessment & containment requirements 

  • Early QbD considerations 

  • Feasibility for high-potency handling

Process Development & Optimization​

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  • Development of scalable processes allowing transition from R&D to production scale

  • High-containment engineering alignment 

  • Tech transfer preparation

Pre-Formulation & Formulation Development​

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  • Physicochemical evaluation 

  • Formulation design & material compatibility 

  • Analytical method development

Clinical Trial Material Supply (CTM)

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  • GMP clinical batch manufacture 

  • Full documentation & traceability 

  • Potent compounds handling controls 

Scale-Up & Validation​​

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  • Commercial scale-up

  • Process validation

  • Analytical validation â€‹

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Regulatory Support & Submission​​

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  • CMC package development 

  • Support for EMA/ FDA/ PMDA submissions

  • Ongoing lifecycle documentation​

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Trusted to Deliver, Built to Excel

Our Promise To You

Speed-To-Market - Fast project initiation, short decision cycles, and streamlined tech transfers.

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Flexible Formulation Development - Adaptable approach to meet evolving clinical and commercial needs.

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Rapid Clinical Supply - Quick GMP batch  production to support early-phase trials.

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Agile Scaling - Seamless transition from clinical to commercial scale without production delays. 

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Fast Regulatory Navigation -  Accelerated support to keep your approval timelines on track.

Start your High-Potency Programme

Connect with our development and manufacturing teams to advance your

molecule from concept to clinic and through to commercial supply.

Tour Our 40,000ft² Campus 

Featuring ISO Class 8 cleanrooms, segregated processing, analytical labs, and a 3,500m² expansion designed for increased high-containment capacity.

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