FDF / DRUG PRODUCTS in Europe
End-to-End Pharma CDMO
About the plant
PSM GmbH is a family-run German company that operates as a Contract Development and Manufacturing Organization (CDMO) in the pharmaceutical industry, located in Schiffweiler in the state of Saarland. With our new state-of-the-art facility, we are proud to be one of the first European CDMOs to have passed the inspection by the local authorities under the new EU GMP Annex 1.
As an end-to-end CDMO, we provide services for the entire implementation process and lifecycle of your drug, from clinical phases to commercial GMP manufacturing. Our portfolio includes method and process development, in-house analytical services, aseptic fill and finish services, visual inspection with CCIT, secondary packaging with serialization, as well as GMP storage and GDP transport.
Our facility is designed to process all common ready-to-use primary packaging containers, including pre-fillable syringes (PFS) up to 10 mL, vials up to 100 mL, and cartridges up to 10 mL, made of glass or polymer.
This flexibility enables us to offer fill and finish services for biopharmaceutical drugs, biosimilars, small molecules and diluents (e.g. WFI). Our current processes can accommodate batch sizes of up to 600 liters.
For very high-value drugs, we use the most sophisticated fill and finish technologies to minimize product loss throughout the entire processing cycle for batch sizes of up to 100 liters.
Certifications
Activity
- Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
- Controlled substance: N/A
- BSL: 1
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), TGA (Australia), NMPA (China)
Batch Size / Reactor
- Small, Medium, Large
Services
- Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, QbD (Quality by Design), Process development, Process validation, Lyophilization cycle development, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Lyophilization, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP
