FDF / DRUG PRODUCTS SERVICES in Europe
Lyo CDMO
About the plant
COMSER is a lyophilization and liquid injectable CDMO providing solutions to the biopharmaceutical and biotechnology industries. Located in Terrassa (Barcelona - SPAIN), our contract services range from product formulation, lyophilization process development & optimization and scale-up/tech-transfer.
We are experts in the development of lyo process for any type of molecule (large or small molecules) as well as up to OEB5 High Potent APIs.
We are also in the process of building a GMP plant to manufacture small scale batches for preclinical and clinical phases I-II, which is expected to be fully operational at the end of 2027. Because of our manufacturing capabilities, we are very focused in supporting biotech companies with poorly stable injectable formulations requiring lyophilization to reach clinical phase, acting as a technical partner throughout development.
Our batch size manufacturing capabilities depending on the vial format are:
4732 vials (2R/3R/4R)
2420 vials (6R/8R)
2016 (10R/15R)
1276 (20R/25R/30R)
760 (50R)
504 (100R)
Compliance
- ISO
- EMA (EU GMP)
- 9001
Activity
- Injectables, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Human, Veterinary
- 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1, 2
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
- Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), NMPA (China), MFDS (South Korea)
Batch Size / Reactor
- Small
Services
- Development services, Manufacturing services, Analytical / QC services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Comparability studies, Tech transfer, Pilot plant, Lyophilization, Research batches, Scale-up, Pilot batches, Clean room rental, Stability tests, Content, Physicochemical characterization, Water content (KF), Particle size (LD)
