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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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A Literature Review of Pharmaceutical Process ValidationThe renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the development of pharmaceutical process validation, and demonstrate how industry opinion regarding the concept has shifted from that of a regulatory burden to something driving total quality management and cost benefits.
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Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based ApproachThe authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.
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Quantitative open-access HPLC analysis: a new calibration approachA novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.
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Speeding Sample Preparation and API Extraction from Solid Oral Dosage FormulationsLaboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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The challenges of outsourcing early developmentOutsourcing early drug development can be viewed from a tactical or strategic perspective. These perspectives are often driven by the size of the company and provide different advantages.
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Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
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Driving Consistency in Validation ManagementWith data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.
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Quantitative open-access HPLC analysis: a new calibration approachA novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.
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A Novel Method for the Study of Water Absorption Rates by Swellable MatricesFollowing the water absorption kinetics of hydrophilic matrices helps determine swelling behavior without disturbing the gel layer and aids in the quantitation of the water absorption pattern.
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A Detail View of Single-Use Equipment OpportunitiesThe authors propose increased use of single-use technologies in biopharmaceutical manufacturing to achieve operational excellence without compromising product quality.
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The Dilemma with Orphan DrugsOrphan drugs for rare diseases are a major area of investment for pharmaceutical companies, but are they becoming too expensive for Europe to afford them?
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The benefits of outsourcing highly potent API manufactureThe main advantage of outsourcing highly potent API (HPAPI) manufacture is that it eliminates the need to invest in expensive containment infrastructure, which can also be complex to engineer, install and maintain.
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Pharma-Biotech Partnerships: Lessons for Personalized MedicineBig Pharma entered biotech too late. That same mistake can be avoided in personalized medicine.
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'Thinking Inside The Box' To Encourage InnovationBy introducing a Patent Box scheme that offers reduced taxes to innovative companies, the UK government hopes to encourage investment in the country.
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Speeding Up Formulation DevelopmentQbD principles and strategic thinking can reduce the time required to optimize formulation.
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Establishing a Minimum Incubation Time for Biological IndicatorsThe industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
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Packaging: The Experts' ViewLeading European experts from the pharmaceutical packaging industry explain how they are coping with industry trends.
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Thinking of theranostics?Are manufacturers ready to deal with the economic and logistical challenges that accompany tailored therapeutics?
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Formulation of Lactose for Inhaled Delivery SystemsDry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.
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Belgium: Will its enviable geographic position continue to ensure success in pharma?Belgium is one of the largest centres for pharmaceutical distribution and has the second highest number of pharma exports per capita worldwide.
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A new tool to battle counterfeitsJeff Robertson talks about a unique form of micro-tag technology that can be applied to solid dose pharmaceuticals.
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Successful packaging of aseptically prefilled productsWhy correctly calibrating a drug with its packaging is the key to success.
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Evaluating Functional Equivalency as a Lyophilization Cycle Transfer ToolThe authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
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Quality by Design for Generic DrugsThe authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
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Quality by Design for Generic DrugsThe authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
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Selecting Lactose for a Capsule-Based Dry Powder InhalerDry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.
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Quality by Design for Generic DrugsThe authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
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Human error costs industry billionsOne of the greatest risks to the success of a business is human error caused by employees' misunderstanding of key aspects of their job roles, and this risk is commonly overlooked or underestimated.
