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Analytical techniques

 

ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities

20 August 2013 | By

The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…

Raman spectroscopy: an enabling tool for accelerating pharmaceutical discovery to development

20 August 2013 | By Chanda R. Yonzon, Atul Karande, Sai P. Chamarthy and Brent A. Donovan (Merck & Co. Inc)

Raman spectroscopy has emerged as the preeminent analytical tool for a number of applications within drug discovery and development. Advances in the instrumentation, sensor fabrication and data analysis have enabled the wider acceptance of Raman spectroscopy1,2. In discovery, Raman spectroscopy is used to elucidate structural activity relationships3 and to optimise…

GPCRs: Cell based label-free assays in GPCR drug discovery

20 August 2013 | By Niklas Larsson, Linda Sundström, Erik Ryberg and Lovisa Frostne (AstraZeneca)

G protein-coupled receptors are one of the major classes of therapeutic targets for a broad range of diseases. The most commonly used assays in GPCR drug discovery measure production of second messengers such as cAMP or IP3 that are the result of activation of individual signalling pathways. Such specific assays…

Handheld raman analyzer software improves speed and effectiveness

13 August 2013 | By

Pharmaceutical manufacturers and regulatory agencies can now enhance the performance of the Thermo Scientific TruScan RM analyzer by downloading the newest software update. In addition to improved speed, Thermo Fisher Scientific designed the software update to enable users to more effectively develop and validate robust methods for pharmaceutical manufacturing and…

Screening In-Depth Focus 2013

30 July 2013 | By

In this Screening In-Depth Focus: New approaches to cell based assays for high content screening and analysis; Reduce, reuse, recycle: how drug repositioning is finding its niche in drug discovery; Workshop Review: Biochemical assays for screening. Screening roundtable...

Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes

13 June 2013 | By Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey, University of Strathclyde

Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that offer benefits such as shorter time lines, improved consistency, higher monoclonal antibody (mAb) production, better genetic stability and increased flexibility. Each of these advantages extends a potentially large cost benefit to companies as their recombinant protein products…

Isothermal calorimetry in the pharmaceutical sciences

13 June 2013 | By Anthony E. Beezer and Simon Gaisford, UCL School of Pharmacy

Fifty years ago, isothermal microcalorimetry (IMC) was a means to determine thermodynamic data (principally values for enthalpies of formation or reaction to assist in the calculation of Gibb’s Free Energy functions and entropies). These data were used in the compilation of tables of thermodynamic values, for use in evaluating, inter…

Under the MICROSCOPE

13 June 2013 | By Katherine Bakeev, Director of Applications Support, B&W Tek

We talk to Katherine Bakeev, Director of Applications Support, B&W Tek. B&W Tek is a leading supplier of handheld Raman spectroscopy, a recognised method for compliance with the PIC/S GMP guide to provide 100 per cent assurance of the identity of pharmaceutical materials. Katherine Bakeev, Director of Applications Support at…

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