The Application of NMR for Drug Development and Manufacturing in a Good Manufacturing Practice Setting
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At Almac, GMP regulations set by the Pharmaceutical regulatory bodies such as the FDA (Food and Drug Administration) and the MHRA (Medicine and Healthcare products Regulatory Authority) ensure that manufacturing processes and facilities are properly designed, monitored and controlled. The GMP environment guarantees the identity, strength, quality and purity of drug products. In this webinar, technical leader at Almac, Kerry Hughes, will discuss the application of NMR in the GMP setting to ensure continued high-quality performance of drug discovery, drug development and manufacturing workflows. The organization has two Bruker instruments for the whole spectrum of GMP activities, from the early phase of development through to the final commercial product, which could be anything from raw materials through to active pharmaceutical ingredients that are ready for release.
The webinar provides an overview of GMP and the convenience of applying NMR to the molecules the company is developing and using. NMR requires few set-up stages and the instruments are also open access, walk-up devices. Specific examples will be given of how NMR is applied to meet GMP regulations.
- The versatility, convenience and accessibility of NMR in a GMP setting
- NMR in a GMP environment requires qualification and controls to ensure continued high-quality performance.
- Applications include supplier qualification, method validation, the quantification of residual solvents and full structural elucidation of small molecules and peptides
- Bruker’s 400 AVANCE with QNP probe and 500 AVANCE NEO with prodigy cooled CryoProbe
Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.