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Issue 1 2014

Issue #1 2014 – Digital edition

11 April 2014 | By European Pharmaceutical Review

In Issue #1 2014: Raman Spectroscopy in-depth focus, Ingredients, LIMS, Kinase, Near Infrared in-depth focus, RNA, Microbiology...

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Raman Spectroscopy In-Depth Focus 2014

10 April 2014 | By European Pharmaceutical Review

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...

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Near Infrared Spectroscopy In-Depth Focus 2014

9 April 2014 | By European Pharmaceutical Review

In this Near Infrared Spectroscopy In-Depth Focus: Applicability and new developments; Near infrared spectroscopy: in-line biopharmaceutical Chinese Hamster Ovary cell culture monitoring...

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ICH M7 Mutagenic impurities: A critical evaluation

19 February 2014 | By David Elder (JPAG member and consultant)

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…

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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…

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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…

product

Product Hub: AMRI’s SMARTSOURCING™ approach and the use of Raman technology

19 February 2014 | By Dr Xufeng Sun, Senior Research Scientist II, AMRI

Dr Xufeng Sun, Senior Research Scientist II at AMRI, discusses their SMARTSOURCING™ approach, looking particularly at the use of Raman technology...

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Can mTOR kinase inhibitors beat rapalogues in fighting against cancer?

19 February 2014 | By Shi-Yong Sun (Emory University School of Medicine and Winship Cancer Institute)

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…

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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…

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Fungal contamination of pharmaceutical products: a growing menace

19 February 2014 | By Tim Sandle

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…

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Issue 1 2014