Small-Batch Fill & Finish: Tailored for Phase I & II Clinical Trials and toxicological studies
Small-batch fill and finish services tailored specifically for Phase I and Phase II clinical trials is our specialty. We support clinical development by providing high-precision processes in Accordance with current GMP PH. EUR Annex 1 regulations.
Our specialized capabilities include:
- Micro-Volume Filling: Expert handling and precision filling of small quantities ranging from 0.3 mL to 1 mL in glass vials.
- Validated Processes: Full process reliability backed by a robust Aseptic Process Simulation (APS) that covers your specific volume and configuration needs.
- Flexible Clinical Capacity: Scaled efficiently to fill and finish up to 2,000 vials per week, minimizing product waste while meeting tight clinical timelines.
- The Annex 1 Advantage: Every batch is processed within our state-of-the-art cleanrooms, providing the full protection of Ph. Eur. Annex 1 compliance from day one.
Partner with us to transition your molecule from the lab to clinical trials with uncompromising safety, regulatory alignment, and agility.
We already succesfully provided the adjuvant for the ongoing clinical trial I of PANHPVAX (EudraCT Number: 2021-002584-22) in cooperation with the HZI from Brunswick. In addition to that we participated in TherVac B.
Product data sheet: Pharmaceuticals/ GMP
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