We are continuing to improve our capabilities to serve our clients in the pharmaceutical community. We have several recent developments we are pleased to report on.
New Experimental Capability
KAS recently took delivery of a Bruker AvanceNEO three channel spectrometer. The NEO is Bruker’s most recent product offering and provides a wide range of new features including multi – channel transmit and receive capability, a range of options for system operation and data analysis, and compatibility with Topspin 4, Bruker’s newest NMR software. For KAS clients, this means access to state-of-the-art experimental capability and improved reliability and redundancy as we continue to operate our existing Avance spectrometer.
Implementation of Good Manufacturing Practices
KAS has completed the implementation of Good Manufacturing Practices (GMP) on the NEO system. Bruker has recently installed a new version of Topspin 4 which is designed to support compliance with 21 CFR Part 11, This software provides complete capability for the implementation of data integrity (DI) practices including audit trails, data set locking, electronic signatures, and other features. For KAS clients, this means the opportunity to perform analyses requiring GMP compliance including lot release and post-marketing surveillance.
Protocols for Analysis of Highly Potent Compounds
KAS has developed and validated a protocol for safely analyzing highly potent compounds including Band 4 and Band 5 materials. The protocol is based on a triply redundant sample containment system originally developed for the analysis of radioactive materials and includes a ventilation system that captures any material that might escape the sample containment system. For KAS clients, this means the capability to use the power of solid state NMR to characterize compounds that are impossible to analyze in-house.
We look forward to better serving your needs for solid state NMR analysis.
John P. Heinrich, Ph.D.
Managing Partner
