Latest issue

Towards Global stability protocols:a decade of lost opportunities

Latest issue / 18 April 2013 / European Pharmaceutical Review

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 globally acceptable stability requirements, but unfortunately, that early optimism rapidly dissipated. Less than two years later, the ASEAN (Association of South East Asian Countries) group had broken ranks with ICH guidance and introduced their own guideline on stability requirements. In particular, they mandated the use of 30°C/75%RH for the long term storage conditions for climatic zone IV (hot and wet). (more…)

Tagged with: Association of South East Asian Countries (ASEAN), European Pharmaceutical Review, International Conference on Harmonisation (ICH)

Current activities of the USP Microbiology Expert Committee

Latest issue / 18 April 2013 /

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 the product’s life cycle. (more…)

Small RNA molecules of great utility as diagnostic biomarkers in lung cancer

Latest issue / 18 April 2013 / 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 to multiple conserved sites within the lin-14 mRNA 3’-UTR3 and that this base comple – mentarity was required for the repression of lin-14 protein expression by lin-4 RNA2. Immediately after their extraordinary discovery, and for almost 10 years, these small RNAs received relatively little attention from the scientific community. The tiny size of these RNA molecules probably contributed to their obscurity. (more…)

Tagged with: Centre for Integrative Biology, Chiara Cantaloni, Labaratory of RNA Biology and Biotechnology, Margherita Grasso, Mattia Barbareschi, Michela A. Denti, RNA Molecults, Santa Chiara Hospital, Unit of Surgical Pathology, University of Trento

A pragmatic approach for the adoption of QbD principles for analytical method development and validation

Latest issue / 18 April 2013 / 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 definition of a respective design space. The overall objective of QbD is to increase product understanding and to ensure a science and risk based approach in pharma – ceutical development. (more…)

Tagged with: Boehringer Ingelheim Pharma GmbH & Co KG, Heike Gottschalg, Holger Memmesheimer and Holger-Thorsten Steinführer, ICH guidelines, QbD principles, Rüdiger Gössl

Erica Hirsch, Product Manager at Thermo Fisher Scientific looks at the next generation handheld Raman spectrometer the Thermo Scientific TruScan RM

Latest issue / 18 April 2013 / Erica Hirsch, Product Manager, Thermo Fisher Scientific

Thermo Fisher Scientific has a diverse portfolio of products, from analytical instruments and laboratory equipment to software, services, consumables and reagents. The company’s scientific and research products primarily serve pharmaceutical and biotechnology companies, as well as academia, research institutes, government agencies, OEMs, quality control and R&D laboratories. Created in 2006 by the merger of Thermo Electron and Fisher Scientific, Thermo Fisher Scientific has over 100 years of experience and insight in their products and services. (more…)

Tagged with: Erica Hirsch, Product Manager, Raman spectrometer, Thermo Fisher Scientific, Thermo Scientific TruScan RM

The role of proteomics in the development of personalised cancer medicine

Latest issue / 18 April 2013 / Pedro R. Cutillas, MRC Clinical Sciences Centre, Imperial College London

Not all cancer patients, even those with the same tumour type, respond to therapy equally well. An understanding of this heterogeneity at the molecular level is crucial for further advances in the development of cancer therapies. Discerning the mechanisms of cancer heterogeneity will lead to a better selection of the most appropriate therapy for each patient and to an improvement in therapeutic outcomes. The success of such personalised cancer therapies requires biomarkers that can be used to stratify patients based on the likelihood that they may respond a particular drug or therapy1. This article discusses the rationale of using proteomics approaches to characterise such biomarkers. (more…)

Tagged with: Imperial College London, MRC Clinical Sciences Centre, Pedro R. Cutillas, Proteomics

The central role of excipients in drug formulation

Latest issue / 18 April 2013 / Pascal Furrer, Pharmacist

Active substances are rarely administered alone. For example, levothyroxine, a synthetic form of the thyroid hormone, indicated in the treatment of hypothyroidism, is administered at a very low dosage, ranging from 15 μg to 200 μg. These very small amounts of powder mean that it is not possible to manufacture tablets containing only this drug. Hence, the formulation of levothyroxine tablets requires the combination of the hormone with one or more nonmedical agents known as pharmaceutical inactive ingredients or excipients that serve varied and specific pharmaceutical functions1. (more…)

Tagged with: Excipients, Pharmacist

Under the MICROSCOPE with Volker J. Frost, Chief Profit Center Spectroscopy, Metrohm AG

Latest issue / 18 April 2013 /

Metrohm, a leading manufacturer of instruments for chemical analysis and FOSS, a leading supplier of dedicated analytical solutions to optimise quality and control, have entered into a strategic alliance strengthening the two companies’ leading positions in their respective key markets. In this strategic alliance, Metrohm will become the sole global distributor of FOSS NIR instruments for the chemical, petrochemical, pharmaceutical and environmental sectors. FOSS will continue its strong R&D program within NIR technology and manufacturing for both companies. Under the deal, FOSS NIRSystems, Inc., based in Laurel, Maryland, USA, will become a division of Metrohm USA to be named Metrohm NIRSystems. The global NIR instrument business for the abovementioned sectors will continue to be run by the Metrohm NIRSystems division of Metrohm. (more…)

Tagged with: Chief Profit Center Spectroscopy, European Pharmaceutical Review, FOSS NIR Instruments, Metrohm AG, Volker J. Frost

Mass Spectrometry: In-depth focus 2013

Latest issue / 17 April 2013 / Uwe Christians, Jelena Klawitter, Jost Klawitter, George McLeod, Min Yang

This free to view Mass Spectrometry in-depth focus is supported by AB Sciex, Bruker and Shimadzu:

• Corticosteroids and mass spectrometry; latest applications using LC/MS³
  (András Szeitz Faculty of Pharmaceutical Sciences, University of British Columbia)
  The adrenals were identified in man more than 400 years ago, but in the following few hundred years, not much progress was made to learn about their role1. This delay was certainly made up for by the remarkably quick development of the corticosteroids (CSs), the hormones of the adrenals, beginning with their isolation from the adrenal glands in the late 1920s to their widespread use as therapeutic agents in the present day. CSs can be analysed by several methodologies, and this brief review is focused on the mass spectrometry techniques for the determination of CSs in a variety of matrices.
• Multi-analyte LC-MS/MS assays for the quantification of endogenous compounds during the development of drugs and companion diagnostics – the beauty and the beast
  (Uwe Christians, Jelena Klawitter and Jost Klawitter, iC42 Integrated Solutions for Systems Biology in Clinical Research and Development, Department of Anesthesiology, University of Colorado Denver)
  Personalised medicine is an intriguing concept and constitutes a paradigm shift in medicine. Abandoning the blockbuster drug concept will not only require the development of safer and more efficacious drugs that are focused on the individual patient’s genotype and/or phenotype, it also requires the development of new context-specific diagnostic tools that provide biological or clinical information that allows for better decision-making about the development and use of a drug, so-called context dependent biomarkers and companion diagnostics. Once approved together with a drug, companion diagnostics are used to predict if an individual patient will benefit from this drug or not.
• Q&A
  George McLeod, Market Manager, Pharmaceutical and Structural Chemistry, Bruker Daltonic sits down with Min Yang, UCL School of Pharmacy to answer his questions on mass spectrometry.
• Show preview – European Lab Automation (ELA) 2013 Conference and Tradeshow
  Select Bio is delighted to announce that the European Lab Automation (ELA) 2013 Conference and Tradeshow will open its doors from 6 June 2013. A two day, five track congress, the event offers over 75 scientific presentations on automation and its application within life science, alongside more than 100 equipment vendors and supporting companies, and an over 1,000 expected visitors. ELA provides life science researchers and professionals with an unparalleled opportunity to encourage technological discussions and scientific collaboration.
• Show preview – ASMS Conference on Mass Spectrometry and Allied Topics
  The 61st ASMS Conference on Mass Spectrometry and Allied Topics will take place from 9 – 13 June at the Minneapolis Convention Center, Minnesota, USA. The American Society for Mass Spectrometry sponsors the conference, which will be attended by more than 6,500 scientists. Approximately 3,000 papers will be presented as posters and talks. (more…)

Tagged with: AB Sciex, ASMS, Bruker, Bruker Daltonik GmbH, Corticosteroids, drug development, European Lab Automation (ELA), George McLeod, Jelena Klawitter, Jost Klawitter, LC/MS, Mass spectrometry, Min Yang, Shimadzu, UCL School of Pharmacy, University of Colorado Denver, Uwe Christians

Stem Cells: In-depth focus 2013

Latest issue / 17 April 2013 / Katharina Drews, James Adjaye, Annette Meeson, George E. Plopper

This free to view Stem Cells in-depth focus is supported by BD Biosciences, CellGenix, Cellular Dynamics, Charles River and Life Technologies:

• The promise held by induced pluripotent stem cells for research and regenerative medicine
  (Katharina Drews, Molecular Embryology and Aging Group, Department of Vertebrate Genomics, Max Planck Institute for Molecular Genetics / James Adjaye, Molecular Embryology and Aging Group, Department of Vertebrate Genomics, Max Planck Institute for Molecular Genetics & Institute for Stem Cell Research and Regenerative Medicine, Heinrich Heine University)
  Human induced pluripotent stem cells (iPSCs) have had an unprecedented impact on biomedical research, disease modelling, toxicology studies and drug development. In addition to circumventing ethical and moral disputes associated with the use of blastocyst-derived embryonic stem cells (ESCs), iPSCs provide new perspectives for personalised medicine in the future. In this review, we highlight mechanisms underlying the induction of pluripotency in somatic cells and discuss potential applications in the field of regenerative medicine.
• Workshop preview – Cell based assays for screening
  Recent years have witnessed an expansion in the disciplines encompassing drug discovery outside the pharmaceutical industry. This is most notable with a significant number of universities worldwide that now host infrastructure such as compound libraries and automated screening centres. An archetypal small molecule drug discovery project will aim to identify chemical starting points that modify the functions of genes, cells or biochemical pathways. In some but not all instances, these functions may be linked to disease processes, and an opportunity will exist to further develop the chemical starting points into novel therapeutic agents. In small molecule drug discovery, the ultimate aim is to identify new therapeutics, an activity that for reasons of high risk and cost has historically been conducted within the commercial sectors.
• Cardiac stem cells
  (Annette Meeson, Institute of Genetic Medicine, Newcastle University)
  For many patients with heart failure, treatment options include optimised medical management, surgical intervention, the use of devices such as pacemakers, ventricular assist devices (VADS) or total artificial hearts (TAH) or if available, a heart transplant. These approaches are not without their limitations and not all are suitable for all cardiac patients. Pharmacological management carries with it the risk of drug-related side-effects. The use of devices such as pacemakers, TAH and VADS may come with increased risks of infection, bleeding and device failure. Heart transplantation is a highly invasive procedure carrying the added risk of transplant organ rejection and the side-effects of long term immunosuppression, and remains a limited treatment option due to the shortage of suitable donor organs.
• Stem Cells Roundtable
  (Moderator: George E. Plopper, Professor, Department of Biology, Rensselaer Polytechnic Institute)
• Show preview – ISSCR 11th Annual Meeting
  The ISSCR 11th Annual Meeting will be held on 12 – 15 June 2013 at the Boston Convention and Exhibition Center (BCEC), Boston, MA, USA, hosting stem cell professionals from around the globe. (more…)

Tagged with: Annette Meeson, BD Biosciences, Cell-Based Assays for Screening, CellGenix, Cellular Dynamics, Charles River, George E. Plopper, Heinrich Heine University, ISSCR, James Adjaye, Katharina Drews, Life Technologies, Max Planck Institute, Newcastle University, Stem Cells