Facilities & Equipment Systems
- Buildings with Environmentally controlled MFG core(Class 100,000 purification suites/ class 10,000 packaging room)
- Validated systems for water and air handling
- Waste handling systems and emergency power
- Process equipment validated under IQ/OQ/PQ
Production Control Systems
- Environmental monitoring of the clean room
- Microbiological monitoring of the facility and water systems
- In-house endotoxin and bioburden testing capability
- Specific task training
- In Process control Testing , Verification of critical steps
( i.e., Ninhydrin, pH, AAA, HPLC)
Water Purification and Monitoring System
Capability of purifying city water to USP grade water through ion exchange, carbon treatment, UV polishing, reverse osmosis and 0.2 micron filtration. USP grade water pumped directly to peptide purification suites and continuously monitored.
Solvent Storage
Self-contained and flame resistant solvent storage area with pumping module.
294L Tray Lyophilizer is Equipped with a CIP System
The validated Clean In Place (CIP) system for our 294L lyophilizer prevents cross contamination between batches.
Quality Systems
- QA release of Master BPR specifically for each lot
- QC testing of Raw Materials / QA final release
- QC compilation of results during final testing of drug substance compared to specifications (incl. C of A)
- Creation of a document set including BPR, SOP’s, list of materials/equipment, list of assays and specifications, monitoring of intermediates and final product quality
- Document and Drug Substance Physical Control
- Recalls and Complaints, Training, Stability Protocol execution
Conclusion
– Made over 3,000 sequences many of which have progressed to over 200 APIs made in last 3 years alone.
– Extensive experience from mg to multi-kg scale
– Conjugation & PEGylation experience
– Creating long-term business relations
– Growth potential