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Articles

Pills
Pills

Excipient selection in biologics and vaccines formulation development

19 February 2014 | By M. Babu Medi and Ramesh Chintala, Vaccine Drug Product Development, Merck & Co, Inc and Akhilesh Bhambhani, Novel Adjuvants, Formulation and Delivery Technologies, Merck & Co, Inc.

Excipients are an integral part of pharmaceutical products and play an important role in the formulation development of both small and large molecule pharmaceuticals. The type and extent of excipient use depends on several factors, including the type of active ingredient, route of administration, dosage form, target population and indication…

Cindy Novak-DeLaurell
Cindy Novak-DeLaurell

Mitigating the common pitfalls of LIMS implementation

19 February 2014 | By Cindy Novak-DeLaurell, Systems Application Consultant, Allergan

Over the past 20 years, I have participated in numerous LIMS implementation projects in a variety of roles. I have participated as a subject matter expert (SME), validation coordinator, programmer, System Administrator and technical representative, and have worked both in the laboratories and IS during these projects; gaining an insight…

Shi-Yong Sun
Shi-Yong Sun

Can mTOR kinase inhibitors beat rapalogues in fighting against cancer?

19 February 2014 | By

The mammalian target of rapamycin (mTOR) has emerged as a promising cancer therapeutic target. Some rapamycin analogues (rapalogues) as mTOR allosteric inhibitors are FDA-approved drugs for treatment of certain types of cancers. However, the modest clinical anticancer activity of rapalogues, which preferentially inhibit mTOR complex 1, in most types of…

Double Helix
Double Helix

RNA: Converting imaging-based cell biology to high-throughput biology

19 February 2014 | By Juha K. Rantala, Department of Biomedical Engineering and Knight Cancer Institute, Oregon Health and Science University

The last 10 years in biomedical research marks the period of deepening our understanding of the human genome. In the context of cancer research, The Cancer Genome Atlas (TCGA) and related international genomics efforts have now revealed the full complexity of genomic aberrations in human cancers that are postulated to…

Microbiology Fungal Contamination
Microbiology Fungal Contamination

Fungal contamination of pharmaceutical products: a growing menace

19 February 2014 | By

Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to…

Foreword: ICH Q6A - Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
Foreword: ICH Q6A - Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

15 December 2013 | By

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…

lab-automation
lab-automation

Laboratory Automation: Liquid handling devices in drug discovery – when, what, why?

15 December 2013 | By Sergio C. Chai, Asli N. Goktug and Taosheng Chen, High Throughput Screening Center, Department of Chemical Biology and Therapeutics, St. Jude Children’s Research Hospital

Liquid handlers are ubiquitous and essential tools in every aspect of the drug discovery arena. Innovations in the past few decades resulted in a sizeable array of devices. With so many choices, it is important to identify appropriate instrumentation for a particular screening strategy, which should be based on unique…

LC-MSMS IVD kits
LC-MSMS IVD kits

Pharmaceutical proteomics: a journey from discovery and characterisation of targets to development of high-throughput assays

15 December 2013 | By Joerg Reinders, Institute of Functional Genomics, University of Regensburg

Proteomics has evolved during the last few years from a time-intensive, cost-intensive and hard-to-reproduce technique in basic research to a versatile and reliable tool in various areas of pharmaceutical research. The exploding progress in mass-spectrometry-compatible protein and peptide-separation methods led to the development of new approaches particularly suited for monitoring…

Roche acquires in vitro diagnostics company GeneWEAVE
Roche acquires in vitro diagnostics company GeneWEAVE

Next generation sequencing: Application of next generation sequencing to preclinical cancer model profiling

15 December 2013 | By

Preclinical cancer models allow us to gain insight into therapeutic potential and mechanism of anti-cancer agents early in the drug discovery process. Whilst traditional array-based approaches have made a significant contribution to the characterisation of these models, the advent of next generation sequencing has revolutionised genomic research and is anticipated…

Microbiology pipette test tube
Microbiology pipette test tube

Microbiology: Mould contamination in pharmaceutical drug products and medical devices

15 December 2013 | By

Invasive fungal infections associated with high mortality rates are common in hospital settings, especially in intensive care units where patients may be immune-compromised, subject to invasive procedures and treated aggressively with antibiotics. The most common nosocomial fungal infections in descending order are due to the genera Candida, Aspergillus, Rhizopus, Fusarium…

tablets
tablets

Process systems engineering (PSE) in the pharmaceutical industry: past and future

15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc

Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…

DNA Strand
DNA Strand

Next generation sequencing: Using RNAseq to identify anti-cancer targets in the tumour vasculature

15 December 2013 | By Klarke M. Sample and Roy Bicknell, University of Birmingham

It is possible to attack the vasculature within solid tumours and achieve an anti-cancer effect. In the last decade, a number of studies have utilised cDNA libraries, SAGE analysis and microarrays to identify potential drug targets in the tumour endothelium. Modern sequencing technologies are likely to be a far more…