Germany Europe
BIOLOGICS in Europe
CGT CDMO Cell Manufactruing Ppant
Certifications
- EMA (EU GMP)
- FDA (cGMP)
Activity
- Cell therapy derivatives / Secretomes, ATMP (Advanced Therapies), BIOLOGICS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification):
- DEA: N/A
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Labeling, Storage, CMC regulatory support
