Fill and Finish
The approval for Fill and Finish of clinical grade material
allows GLYCOTOPE BIOTECHNOLOGY to provide its
customers with a complete service “from the gene to the drug” at highest technological level.
Production of Clinical Samples
Through its highly flexible setup, the Glycotope Biotechnology Fill and Finish facility can be easily adapted to the customer’s dosage, formulation & filling needs.
Sterile filling of aseptic solutions in various glass vials with qualified personnel, facilities and equipment. Media fills are performed for new primary packaging systems.
Final filling is performed in a clean room with level „A in B“ standard.
After filling, we provide complete quality control through our protein analysis department.
- Proteins as formulated pharmaceutical drugs
- Semi-automated aseptic filling of up to 500 vials/batch
- Labeling, packaging, and shipping of clinical samples
- Compliance with FDA and EMEA standards
