GMP Manufacturing
- Milligram to multi-kilogram GMP manufacturing
- Regulatory compliance to international GMP standards
- Analytical method validation, raw material testing and release, in-process-controls 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
GlycoSyn's GMP manufacturing capability draws together its highly experienced chemists and engineers, quality assurance, analytical and support personnel into cohesive project teams. In state-of-the-art facilities, the teams led by dedicated project managers carry out expert manufacture of GMP carbohydrates, dendrimers and small molecules.
GlycoSyn is safe and flexible, able to manufacture from milligrams to kilograms to support clients’ pre-clinical and clinical requirements.
Quality standards
GlycoSyn’s operations meet the highest international standards for manufacturing small molecules for use in human clinical trials. A programme of continuous improvement and constant review ensures our quality assurance unit maintains rigorous control in a fast changing global regulatory environment.
- We are licenced to manufacture medicines by Medsafe (New Zealand’s Medicines Regulator) on behalf of the NZ Ministry of Health.
- A large proportion of our work involves producing active pharmaceutical ingredients (APIs) for IND (investigational new drug)-enabling studies in the US.
- Our GMP operations are audited annually by Medsafe - and additionally for each API - against the requirements of the New Zealand Code of Good Manufacturing Practice for the Manufacture and Distribution of Therapeutic Goods Part 1 - Manufacture of Pharmaceutical Products. On 1 September 2009 this code was updated to incorporate the PIC/S (Pharmaceutical Inspection Cooperation Scheme) guidance documents:
- As a manufacturer of active pharmaceutical ingredients for use in clinical trials we are required to comply with the applicable parts of PE 009-8 (Part II) PIC/S GMP Guide (Part II: Basic requirements for active pharmaceutical ingredients)
- PE 009-8 (Part II) is equivalent to ICH Q7 (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
