Monoclonal Antibodies (mAbs)
A monoclonal antibody is a laboratory-produced immune system protein that binds specifically to a single, well-defined target on a cell. It originates from a single cell line and is therefore completely uniform in structure and function. Monoclonal antibodies can block disease signals, modulate immune responses, or deliver therapeutic agents directly to specific cells. They are primarily used in cancer, autoimmune, and inflammatory therapies, as well as in diagnostics.
At PSM, we have focused, among other things, on monoclonal antibodies (mAbs) and offer GMP-compliant, comprehensive process solutions. This includes all processes from freezing, controlled thawing, to formulation, filling, and visual inspection. For monoclonal antibodies for rare diseases, and therefore smaller batches, we use a dedicated Groninger filling line, which significantly reduces product loss during the process compared to conventional filling lines.
PSM equipment and processes are implemented for handling mAbs:
- Storage of APIs at −80 °C
- Controlled thawing process using HOF thawing units
- Single-use compounding with batch sizes of up to 100 L
- Sterile filtration with single-use filters and product tubing, including PUPSIT
- Use of all common pre-sterilized packaging, such as PFS syringes, vials, or cartridges
- Sterile filling using state-of-the-art Groninger technology, with a focus on the highest quality standards and minimal product loss:
- Equipment priming at the start of each batch
- 100 % weight inspection with top-up for underfills
- Various pumping systems, stopper placement via vacuum or insertion tube, and optional gassing
- Fully automated and controlled movements with no human intervention in core processes
- Minimal product loss throughout the entire processing chain
- Optical inspection, CCIT, and packaging
- Cold storage and GDP-compliant transport at 2–8 °C
With the Robocell filling system from Groninger and SKAN, we can fill batch sizes of up to 100 liters. We offer maximum flexibility in processing ready-to-use syringes up to 10 ml, vials up to 50 ml, and cartridges up to 10 ml in glass or polymer, while ensuring minimal product losses with 100 % check weight control.
With the Groninger Flexfill filling system, we can fill batch sizes of up to 600 liters. We offer maximum flexibility in processing ready-to-use syringes up to 50 ml, vials up to 100 ml, and cartridges up to 10 ml in glass or polymer. This line is equipped with peristalitc and rotary piston pumps and various gassing and vacuum options.
