GCM Pharma
Contract development and manufacturing organization (CDMO) offering sterile fill–finish services for biologics and small molecules using automated aseptic isolator systems and continuous manufacturing. Services span feasibility and method development, tech transfer and scale-up, analytical and microbiological testing, regulatory filing support, packaging and cold-chain distribution. Facility operation and quality systems are stated to align with cGMP Annex 1.
Industries
N/A
Services
Small-scale clinical manufacturing (Phase I/II)
Dedicated cleanroom suite and aseptic isolator-based filling for early phase clinical product manufacture.
Automated aseptic fill–finish (clinical and commercial)
Flexible, fully automated filling for nested, presterilized and depyrogenated vials, syringes and cartridges for Phase III and commercial runs.
Analytical chemistry & microbiology testing
Analytical and microbiological testing services for feasibility, release and QC support.
Regulatory filing support
Assistance with regulatory submissions related to clinical manufacturing and product commercialization.
Labeling & packaging design and clinical repackaging
Label and packaging design work plus repackaging services for clinical trial materials.
Temperature-controlled storage and distribution
Cold-chain storage and temperature-controlled distribution services for clinical and commercial products.
Small-scale clinical manufacturing (Phase I/II)
Dedicated cleanroom suite and aseptic isolator-based filling for early phase clinical product manufacture.
Automated aseptic fill–finish (clinical and commercial)
Flexible, fully automated filling for nested, presterilized and depyrogenated vials, syringes and cartridges for Phase III and commercial runs.
Analytical chemistry & microbiology testing
Analytical and microbiological testing services for feasibility, release and QC support.
Regulatory filing support
Assistance with regulatory submissions related to clinical manufacturing and product commercialization.
Labeling & packaging design and clinical repackaging
Label and packaging design work plus repackaging services for clinical trial materials.
Temperature-controlled storage and distribution
Cold-chain storage and temperature-controlled distribution services for clinical and commercial products.
Expertise Areas
- Aseptic fill–finish for biologics and small molecules
- Clinical manufacturing for early-stage trials (Phase I/II)
- Automated and continuous manufacturing
- Tech transfer and process scale-up
Key Technologies
- Aseptic isolator systems
- Automated aseptic fill–finish systems
- Continuous manufacturing
- Analytical chemistry methods