Issue #3 2013 – Digital version
Read the free digital version of the June / July edition of European Pharmaceutical Review magazine...
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Articles
Screening In-Depth Focus 2013
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...
Ingredients In-Depth Focus 2013
In this Ingredients In-Depth Focus: Revisiting a mutual recognition agreement approach for GMP inspections to secure the safety of the supply chain of APIs; Solid form diversity of commonly used tableting excipients and its impact...
New guidelines for breakmarks on tablets
13 June 2013 | By Tony Moffat, UCL School of Pharmacy and Joint Pharmaceutical Analysis Group
The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).
The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies
13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com
This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…
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…
Raw material identity verification in the pharmaceutical industry
Inspection of incoming raw materials is an essential step in the pharmaceutical industry to verify that the correct raw material which meets the quality specifications has been received. It will not only help to ensure that the final product is of best quality and minimise wasted time, material costs and…
Label-free quantitative proteomics: Why has it taken so long to become a mainstream approach?
13 June 2013 | By Thierry Le Bihan, SynthSys and Institute of Structural and Molecular Biology, University of Edinburgh
In recent years, mass spectrometry (MS) based proteomics has moved from being a qualitative tool (used to mainly identify proteins) to a more reliable analysis tool, allowing relative quantitation as well as absolute quantitation of a large number of proteins. However, the developed quantitative methods are either specific for certain…
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…
Towards global stability protocols: a decade of lost opportunities
This year marks the 10th anniversary of the introduction of the International Conference on Harmonisation (ICH) guidance on stability testing of new drug substances and products (ICH Q1A(R2)) and the ancillary guidance on storage conditions (ICH Q1F). In 2003, the pharmaceutical industry thought that it had achieved its goal of…
Current activities of the USP Microbiology Expert Committee
18 April 2013 | By Radhakrishna S. Tirumalai
For sterile as well as nonsterile pharmaceutical products, manufacturers must eliminate or minimise potential risks to patients as well as product quality. While many contributing factors may affect the quality of a medicine or its ingredients, microbial contamination control and proper sterilisation methods are critical considerations for the manufacturer throughout…
microRNA: Small RNA molecules of great utility as diagnostic biomarkers in lung cancer
18 April 2013 | By Michela A. Denti and Margherita Grasso, Laboratory of RNA Biology and Biotechnology, Centre for Integrative Biology, University of Trento, Mattia Barbareschi and Chiara Cantaloni, Unit of Surgical Pathology, Santa Chiara Hospital
In 1993, the laboratories of Victor Ambros and Gary Ruvkun, studying the larval development of the nematode Caenorhabditis elegans, found a small RNA molecule (22 nucleotides) which regulated the translation of the lin-14 gene in an unusual way1,2. They observed that the sequence of the tiny lin-4 RNA was complementary…
A pragmatic approach for the adoption of QbD principles for analytical method development and validation
18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG
The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…
The next generation handheld Raman spectrometer: the Thermo Scientific TruScan RM
Erica Hirsch, Product Manager at Thermo Fisher Scientific looks at the next generation handheld Raman spectrometer the Thermo Scientific TruScan RM...
