State of the art analytical chemistry laboratory
We promise to give you a thorough understanding of your product, so you can go into regulatory submission with full confidence.
Scientifically sound methods are at the heart of our analytical strategy.
Our experienced in-house analytical chemistry services team works together seamlessly with our process chemists and engineers to ensure that precise and consistent understanding is achieved at each step of your process.
This symbiotic relationship between chemist and analyst is critical for a thorough understanding of the impurities that may arise in a chemical process and offers an expedited path toward the development of robust active pharmaceutical ingredient (API) manufacturing processes
What we offer
Analytical method development
Phase appropriate qualification and validation of analytical methods, novel assay development
Supplier assurance
Regulatory key starting material analysis and raw materials release testing
ICH stability studies
Two-year ICH Q7 stability studies and accelerated stability studies
Best practices
Impurity identification, in-process control testing, reference standards, product release testing, quality control
Validating ICH requirements
Our services and technical capabilities cover the needs for full analytical method development and phase appropriate verification to meet ICH requirements for APIs.
We know it is vital to take into account the specific needs of each project and its respective development stage. We are flexible and can change our processes to meet your pharmaceutical needs. Our extensive experience will ensure you have transferrable methods that are scientifically sound, robust, and reproducible.
We smooth the regulatory process by preparing documentation that demonstrates a clear strategy for the control of impurities originating from the starting materials, those derived from the process, and from the degradation of the product. In addition, we perform any ICH stability studies and ongoing regulatory support necessary to get your product to the clinic as safely as possible.
Our Approach
“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 embedded 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 Chemistry Team Leader
GlycoSyn
Our equipment
- Chromatography: HPLC & UPLC, GC, CE, Size exclusion, Ion Exchange
- Detectors: UV, CAD, RI, MALS MS, ELS IR, FID, UV
- Mass Spectrometry: HRMS, MSMS
- NMR (3 x 500 MHz, 1 x 400 MHz)
- XRPD, DSC, TGA, microscopy
- Karl Fischer Titrator
- Polarimeter
- Melting Point Apparatus
- Residue on Ignition (RoI)