Our state-of-the-art analytical laboratory ensures you have a thorough understanding of your product, so you can go into regulatory submission with full confidence.
GlycoSyn’s Analytical Services division provides in-process control, product release, and stability data.
We also offer full analytical method development and validation to meet ICH requirements for APIs in pre-clinical and clinical trials. Our new purpose-built laboratory employs state-of-the-art analytical equipment and techniques to ensure you have a thorough understanding of your product for IND regulatory submission.
What We Offer:
- Method development
- Method qualification and validation
- Stability studies to ICH guidelines
- In-process control testing
- Raw material release testing
- Reference standards
- Impurity identification
- Product release testing
“Our end-to-end service model and our “right first time” approach ensure we offer world-class testing to cost-effective deadlines. For instance, we recommend UPLC as a first choice since it increases both the productivity of method development and impurity resolution. UPLC can also reduce solvent usage, lowering our environmental footprint and keeping to New Zealand's green mantra.
Being on-site with the development and manufacturing accelerates the exchange of ideas, leading to symbiotic project delivery throughout GlycoSyn. Analysts are imbedded in the project team from inception and follow the project through to delivery of clinical material; keeping that background knowledge on-hand and providing the client with a familiar face to talk to.”
-Dr Russell Clayton, Analytical Team Leader, GlycoSyn
Analytical Services Available:
- HPLC & UPLC
- UV, CAD, RI, MS, ELS detection
- GC-FID, CS-MS
- HRMS, MSMS
- CE, size exclusion, ion exchange LC
- NMR (2 x 500 MHz)
- XRPD, DSC, TGA, microscopy
