FDF / DRUG PRODUCTS SERVICES in Europe
Lyos and liquids - Two Annex I compliant BSL-2 cleanroom suites, dedicated containment suite, Up to 50L bulk volume, Lyophilisation (x2) with gas overlay Up to 3,000 vials per batch....
About the plant
• 6,300 sq. ft sterile GMP manufacturing facility
• Two Annex I compliant BSL-2 cleanroom suites
• Dedicated containment suite
• Up to 50L bulk volume
• Lyophilisation (x2) with gas overlay
• Up to 3,000 vials per batch
• Temperature-controlled quarantine and storage of drug product GMP material management
• Grade A filling environment
• Restricted Access Barrier (RABs) technology
• Two cleanroom suites each with lyophilizer
• Dedicated cleanroom suites for Containment and Conventional drug handling
• Semi-automated filling by peristaltic pump
• Cleanroom camera monitoring
• Temperature controlled cleanrooms
• Adjacent inspection and labelling rooms
Lyophilization
• Tofflon Lyo 5 model with total 5.4m2 shelf space
• Aseptically qualified for 2,3,5,10, 20 and 50ml vials
• Bulk lyophilisation in Lyoguard trays
• Lyophilisation cycle development / optimisation on GMP scale
• Maximum batch size currently up to 3,000 vials
• SafeBridge Category 3 and solvent containment
Certifications
- FDA (cGMP)
- MHRA (UK GMP)
Activity
- Injectables, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): N/A
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), MHRA (UK)
Batch Size / Reactor
- Small, Medium
Services
- Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, CMC regulatory support
