DEVELOPMENT

cGMP Manufacturing

Our FDA-inspected and approved cGMP facilities are designed for large-scale manufacturing of pharmaceutical drug substances for clinical research to full-scale commercial manufacturing. Manufacturing under cGMP is performed under strict adherence to FDA regulations 21 CFR 210 and 211.

Standart Operating Procedures (SOPs) are strictly adhered to and meticulously documented during the manufacturing process by our trained staff of highly qualified specialists. We provide complete documentation and regulatory support for your IND and NDA submissions.

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Our commitment to quality is reflected in the manufacturing process. Starting materials of the highest quality are purchased from qualified vendors and carefully evaluated by our Quality Assurance Department prior to use. In our Quality Control Department, the final product is subjected to rigorous analytical tests using validated methods. As a result, our customers are assured of consistent, reliable and timely supplies of ultra-pure pharmaceutical-grade peptides.

 

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Our cGMP manufacturing capabilities include:

– Bulk scale Solid and Solution phase synthesis
– Proportionately scaled HPLC Purification
– 30 ℓ, 50 ℓ, 200 ℓ tray Lyophilization
– Cleanrooms from Class 100,000 to Class 10,000
– QA / QC and Regulatory Support
– Expertise in all Production and Purification Techniques
– Dedication to Quality and cGMP Compliance