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Getting a clear view of business performance can be cumbersome, time-consuming and even nigh-on impossible.

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High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.

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Incorporating quality and economy into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. Experience in the chromatographic purification of biopharmaceuticals enables the use of downstream processing heuristics to produce target molecules in cost-effective processes suitable for regulatory scrutiny.

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The author analyzes the study design, participation, and data pooling from a recent benchmarking study on pharmaceutical manufacturing and raises concerns about the process used and data collected in evaluating the performance of contract manufacturers.

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When a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.

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One of the major concerns with introducing PAT, however, is that the bias towards process engineering may not ultimately lead to complete control of product quality.

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Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline. Addressing this potential roadblock to clinical success is becoming increasingly important as NCEs continue to become larger and more lipophilic and, as a result, less soluble.

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Companies that leverage new collaborative technologies in the manufacture, packaging, and distribution of clinical trial materials will be best positioned to reduce their time to market.

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It is becoming evident that quality risk management within regulated, life sciences environments is a valuable component of an effective quality management system (QMS). A QMS provides a proactive and systematic means to identify, analyse, evaluate and control potential process and product quality issues during development, manufacturing, distribution and marketing throughout the entire product life cycle.

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The financial return to industry on its investment in academia through licensing and funding of basic research can be similar to that in its own research programmes. A report from the Royal Pharmaceutical Society, UK Drug Delivery Research: The Way Forward in the New Millennium, emphasized the importance of drug delivery research in improving patient outcomes and the opportunities for industry and academia to further explore this area, particularly for newly discovered macromolecular drugs. Unsurprisingly, therefore, industry has become increasingly interested in investing in research performed in academic settings as a complement to its own research. Government is currently exhorting universities to transform their traditional role to institutions that can drive economic development and innovation.

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Following a step-by-step approach to software development involves planning, analysis, construction, and implementation.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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Determining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.

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Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

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There have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.

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Mefenamic acid has variable bioavailability and tabletting issues because of its hydrophobic nature and poor material characteristics. Recrystallization of mefenamic acid was performed from three different solvent–solvent mixtures under differing conditions. The crystals obtained were screened for the existence of new crystal properties or polymorphic forms, then characterized further.

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Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.

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Virus safety of biotech- and plasma-derived therapeutics is ensured through complementary manufacturing and quality control measures that include the control and monitoring of raw materials, the validation and implementation of effective virus clearance technology and the monitoring of final filled product for the presence of virus. Virus filtration, which is considered a robust and effective virus clearance technology, is a common unit operation in the manufacture of biologicals. In this article, we review the points that must be considered when selecting a virus-retentive filter. The areas covered include regulatory considerations; selecting, optimizing and validating a virus filtration step; and process scale implementation - areas that are critical to users of virus filters.

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This article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).

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In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

Latest:

High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.

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In view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.

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Fluidized hot melt granulation (FHMG) is an emerging technique combining the advantages of both dry and wet granulation methods, and represents an innovative continuous granulation process capable of mixing and agglomerating excipients and active pharmaceutical ingredients (APIs) to produce uniform blends of particles suitable for use in the manufacture of pharmaceutically elegant solid dosage forms.

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Finding a CMO partner will take time and an incorrect choice that leads to changing the CMO is financially very painful.

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The increasing demand for speed-to-market requires that modern pharmaceutical laboratories work faster, more accurately and efficiently than before. Unavoidably, this leads to a number of bottlenecks that threaten the overall laboratory operation and efficiency.

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How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.