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The case for outsourcing water for injection
Essential for any medicine that must be sterile and safe for injection, ROIS’ Miguel Ángel Ortega Sánchez presents the case for outsourcing WFI production to a trusted partner.
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Articles
PAT for packaging: review of applications for expeditious, nondestructive quality testing
15 April 2014 | By Jose Montenegro-Alvarado, Bradley Diehl, Jean-Maxime Guay, Steve Hammond, Hiwot Isaac, Ben Lyons, Conor McSweeney, Seamus O’Neill, Jean-Sébastien Simard and Joep Timmermans, Pfizer Inc.
This article reviews some emerging applications of Process Analytical Technologies (PAT) for packaging quality testing. Specifically, four commercially-available packaging applications are explored in further detail: Raman spectroscopy for rapid material identification testing of polymeric packaging materials; vision-based elastic deformation for non-destructive blister integrity testing; X-ray monitoring for inline blister fill…
Excipients in medicines for children: scientific and regulatory paradigms
15 April 2014 | By Ali Al-khattawi, Postdoctoral Research Associate, Aston University / Afzal R. Mohammed, Senior Lecturer in Pharmaceutics, Aston University
There is an ongoing debate over the use of pharmaceutical excipients in medicines for children, triggered by the increased number of formulations suitable for this target patient population. Pharmaceutical excipients can be regarded as essential / necessary enablers in formulation development. These are materials other than the ‘active pharmaceutical ingredient’…
Issue #1 2014 – Digital edition
In Issue #1 2014: Raman Spectroscopy in-depth focus, Ingredients, LIMS, Kinase, Near Infrared in-depth focus, RNA, Microbiology...
Raman Spectroscopy In-Depth Focus 2014
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...
Near Infrared Spectroscopy In-Depth Focus 2014
In this Near Infrared Spectroscopy In-Depth Focus: Applicability and new developments; Near infrared spectroscopy: in-line biopharmaceutical Chinese Hamster Ovary cell culture monitoring...
ICH M7 Mutagenic impurities: A critical evaluation
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…
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…
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…
Can mTOR kinase inhibitors beat rapalogues in fighting against cancer?
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…
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…
Fungal contamination of pharmaceutical products: a growing menace
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…
Issue #6 2013 – Digital edition
In Issue #6 2013: PAT in-depth focus, Lab Automation, Proteomics, Next Gen Sequencing, Screening in-depth focus, Microbiology...
Screening In-Depth Focus 2013
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
Process Analytical Technology (PAT): In-Depth Focus 2013
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...
ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
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…
