Utilizing Analytical Services for Success in Innovation

Many bio/pharmaceutical companies don't have the knowledge, experience, instruments, or personnel to perform such testing; therefore, many analytical processes are outsourced to contract research, contract development, or contract manufacturing organizations (CROs, CDMOs, CMOs). Pharmaceutical...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2019-03, p.S8-S11
Main Author: Haigney, Susan
Format: Article
Language:English
Subjects:
Access control
Antibodies
Best practice
Biological products
Compliance
Data integrity
Laboratories
Mass spectrometry
Methods
NMR
Nuclear magnetic resonance
Outsourcing
Pharmaceutical industry
Pharmaceutical sciences
Problem solving
Product development
Quality
Scientific imaging
Success
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Summary:Many bio/pharmaceutical companies don't have the knowledge, experience, instruments, or personnel to perform such testing; therefore, many analytical processes are outsourced to contract research, contract development, or contract manufacturing organizations (CROs, CDMOs, CMOs). Pharmaceutical Technology Europe spoke with Kimberly McClintock, executive vice-president at Metrics Contract Services, which offers method development and validation for small-molecule drug substances and drug product stability and release testing including on-site microbial testing; and Patrick A. Tishmack, PhD, analytical services general manager at AMRI West Lafayette, which offers both small- and large-molecule analysis, about the benefits of outsourcing analytical processes and testing. NMR spectroscopy of large molecules is still a very specialized technique that requires a highly skilled scientist with specialized training to collect good quality data and to properly interpret the complex NMR spectra. [...]relatively few CROs have this capability. Patrick A. Tishmack, AMRI BEST PRACTICES FOR IMMUNOGENICITY TESTING OF BIOLOGICS Pharmaceutical Technology Europe spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development, validation, and sample analysis services, about best practices to ensure that biologics are safe and effective.
ISSN:1753-7967