Rigorous quality standards and outstanding test development
GlycoSyn has a 560m2 (6000ft2) processing facility with flameproof hazardous area where we manufacture APIs by chemical synthesis at any scale for use in pre-clinical and clinical trials. We also have an onsite specialist laboratory for developing optimum API testing methods. Each project has a dedicated project manager to ensure we respond flexibly to client issues as they arise.
Meanwhile, our quality assurance unit constantly reviews and improves our quality commitments in a fast changing global regulatory environment.
What we offer:
• Milligram to multi-kilogram GMP manufacturing
• Regulatory compliance to international GMP standards
• Analytical method validation and in-process controls
• Raw material and final product testing and release
• Certificates of analysis and compliance for all GMP products
• ICH stability studies
• Chemistry, manufacturing and control documentation to support IND filing
• Technology transfer
"GMP is a cultural thing and it’s certainly in our blood. That heritage, along with our flexibility and commitment to the final goal is the perfect recipe"
Clive Edwards, Quality Manager, GlycoSyn
"Being on-site with the development and manufacturing accelerates the exchange of ideas, leading to symbiotic project delivery throughout GlycoSyn,”
Dr Russell Clayton, Analytical Team Leader, GlycoSyn
GlycoSyn is licensed to manufacture medicines by New Zealand’s medicines regulator, Medsafe, which conducts an annual audit of our facilities. As a manufacturer of APIs for use in clinical trials, our facilities are compliant with:
- ICH Q7 (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
- PIC/S GMP Part II (Pharmaceutical Inspection Cooperation Scheme)
Since much of our work involves producing APIs for IND-enabling studies in the United States, we also welcome audits by external clients.