Aseptic Fill & Finish Services for Small Batches in Clinical Phases

In the area of clinical phases, we offer contract filling of small batches under LF and also safety workbenches, either manually or with highly flexible semi-automatic filling and closing equipment from groninger and Berner (safety) workbenches. These processes, mainly for filling vials in phases 1 and 2, offer our customers the greatest possible flexibility and an enormous time advantage. With the specification of the exact product parameters and quantity as well as the change to an optimal primary packaging material in phase 2, we support our customers with sterile filling (GMP and non-GMP) – including engineering batches, stability tests, batches as well as verification of container closure integrity. For phase 3, we offer aseptic filling for glass or polymer vials, syringes or cartridges. The filling processes developed and applied during the clinical phases  as well as freeze-drying parameters can then also be scaled up to our commercial groninger production lines by means of simple, cost-effective and rapid technology transfer.

Our capabilities at the Pharmacampus include aseptic processing for “Small & Large Molecules”, but also the processing of “mRNA”, “Cell & Gene” products such as viral vectors (AAV) under S2 conditions or toxic products up to OEB 5. We offer our customers the possibility to fill products, cool them, and store them at temperatures as low as -80 degrees Celsius.

Project enquiries to Thorsten Häfner
Phone: +49 172 3213362

Our End-To-End CDMO Services for Clinical Phases

  • Process development freeze drying on laboratory scale
  • Semi-automatic aseptic filling for syringes, vials or cartridges (non-GMP or GMP) for e.g. changes or adaptation of primary packaging materials, container closure integrity tests or technical transfer batches / engineering batches
  • Semi-automatic aseptic filling for syringes, vials or cartridges (GMP) for e.g. sterility testing, validation batches of commercial products for small and very small batch sizes
  • Processing capabilities for toxic products (up to OEB5) and active agents such as viral vectors (up to S2)
  • Analytical services for product releases including in-house qualified person
  • Terminal sterilization
  • Manual optical inspection, CCI, labeling and secondary packaging
  • Cold storage as low as – 80 degrees Celsius
  • GMP storage and GDP transport