Peptide CRO Manufacturing Facilities
Biopeptek's GMP facilities are designed for large-scale manufacturing of Active Pharmaceutical Ingredients (API) for clinical research. Our stringent adherence to regulations, quality systems and standards ensures consistence performance. Highlights of our facility include:
- Scale up to g and kg production
- 100K clean rooms
- Large-scale peptide purification systems
- Bulk tray lyophilizer for controlled peptide drying
- Validated systems for water and air handling
- Stability testing
Peptide CRO Quality
Biopeptek offers total Quality Management: ISO9001 and cGMP. Our analytical laboratories are fully-equipped to perform necessary analytical method development and validation as well as all stability testing. At Biopeptek, every employee understands the importance of GMP compliance. Our scientists are trained to strictly follow standard operating procedures. Our equipment and instruments are qualified under IQ/OQ/PQ and calibrated routinely to ensure consistent performance.
Biopeptek provides support for regulatory filing (CTD format), in addition to complete documentation, for your IND and NDA, as well as other regulatory submissions.
To learn more about our Peptide CRO GMP capability, please contact Biopeptek at info@Biopeptek.com