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
E-mail: thorsten.haefner@psm-saar.de
Phone: +49 172 3213362

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