Issue #1 2014 – Digital edition
In Issue #1 2014: Raman Spectroscopy in-depth focus, Ingredients, LIMS, Kinase, Near Infrared in-depth focus, RNA, Microbiology...
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In Issue #1 2014: Raman Spectroscopy in-depth focus, Ingredients, LIMS, Kinase, Near Infrared in-depth focus, RNA, Microbiology...
In this Raman Spectroscopy In-Depth Focus 2014: Raman spectroscopy in the study of pharmaceuticals: the problems and solutions to sub-sampling and data analysis; Conformational state analysis of proteins by Raman spectroscopy: univariate and multivariate methods; Raman Roundtable...
In this Near Infrared Spectroscopy In-Depth Focus: Applicability and new developments; Near infrared spectroscopy: in-line biopharmaceutical Chinese Hamster Ovary cell culture monitoring...
Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most commonly encountered impurities and degradants, it is recognised that lower thresholds may be appropriate if the impurity is unusually toxic…
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…
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…
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…
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…
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…
In Issue #6 2013: PAT in-depth focus, Lab Automation, Proteomics, Next Gen Sequencing, Screening in-depth focus, Microbiology...
In this Screening In-Depth Focus: Technological and sociological advances in HTS: evolution and revolution?; Flow cytometry as a drug screening platform; Show Preview: High-Content Analysis 2014
In this Process Analytical Technology (PAT) In-Depth Focus: Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study, PAT for pharmaceutical spray drying, PAT Roundtable, Show Preview: IFPAC® 2014...
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…
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…
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…