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Multimodal HPLC screening of polysaccharide-based chiral stationary phasesHigh-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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Regulatory Update: The IPEC Novel Excipient Safety Evaluation ProcedureThe authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
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Aligning the three business "rights"The acquisition and integration of postdevelopment phase staff could be likened to a relay race where making the hand-over of the baton correctly is critical.
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Manufacture of Asymmetric Hydrogenation CatalystsSingle-enantiomer drugs represent an increasingly large share of new chemical entities, leading to approaches in asymmetric synthesis.
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Mefenamic acid: new polymorph or crystal defect?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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The Role of Computational Fluid Dynamics in the Pharmaceutical IndustryComputational fluid dynamics can be a valuable tool for analyzing the efficiencies and performances of process equipment, which can lead to potential cost savings.
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Outsourcing aseptic fill and finishFinding 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 fall and rise of biopharmaThe ¤9.5 billion therapeutic antibody market comprises over a dozen antibodies that have been generated using recombinant genetic methods developed over the last 20 years.
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The New Biopharmaceutical Blueprint: Service-Oriented Architecture in ManufacturingMore than ever, drug makers need to be fleet and flexible-and they need their software to be the same.
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Manufacture of Asymmetric Hydrogenation CatalystsSingle-enantiomer drugs represent an increasingly large share of new chemical entities, leading to approaches in asymmetric synthesis.
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Aspects of process development for virus vector production to improve quality and quantityThe use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..
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Understanding powder behaviour by measurig bulk, flow and shear propertiesThe trend towards developing pharmaceutical products and their manufacturing processes in tandem supports optimized production. Such developments rely on gathering process-relevant information at an early stage and being able to draw on past and current processing experience. Here, we discuss how powder rheometers can make a real difference in building a database of powder properties and removing subjectivity.
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Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
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Validation of a Clean-in-Place System on a Capsule Filling MachineThe aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.
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Determining LIMS Functionality, Cost, and ROI: System Architecture Strengths and LimitationsBefore any information technology solution can be installed, a company must decide whether applications are going to reside on individual computers at each employee's workstation, on servers within or outside of an organization, or on a vendor's website.
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Developing a modified Pulsincap systemChronotherapeutic drug delivery systems (CRDDS) have been recognized as potentially beneficial to the chronotherapy (timeoptimized therapy) of widespread chronic diseases that display time-dependent symptoms.
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Creating an Integrated Portal for Biological and Chemical InformationInformatics solutions can help change data into useful and accessible information.
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Multimodal HPLC screening of polysaccharide-based chiral stationary phasesHigh-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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Spherical Crystallization of Mefenamic AcidTablets prepared from mefanamic acid spherical crystals were shown to exhibit better physical properties than those made from mefenamic powder.
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Mitigating the Risk from Excipient VariabilityThis article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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Using Tolerance Intervals to Assess Conformance to RequirementsThe authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
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Dry powder inhalers: challenges and goals for next generation therapiesThere have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.
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Fighting Protein misfolding diseasesCells function as highly accurate quality control (QC) machines to ensure that only correctly folded proteins are released into the physiological milieu to perform their designated functions. The efficient removal of damaged or incorrectly folded/misfolded proteins at the correct time keeps a cell viable and functioning.
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Statistical Tools to Aid in the Assessment of Critical Process ParametersThere are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).
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Nanotechnology and the Quest for the Ultimate Drug-Delivery SystemThe author suggests a route for nanotechnology's future in the pharmaceutical industry.
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Oman pharma wins European approvalWhile the Gulf region has already become well-known for its globally accepted infrastructure, and large projects in tourism and other service areas, major investments in healthcare or pharmaceuticals have failed to develop as well.
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Topical delivery of oily actives using solid lipid particlesLipid-based drug delivery systems - such as liposomes, micro-and nanoemulsions, self-emulsified drug delivery systems, and solid lipid micro-and nanoparticles - are becoming more popular because lipid materials are easily characterized, contain a high range of well-defined/tolerated surfactant molecules and can be developed for several administration routes.
