Authors
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Implications and Opportunities of Applying QbD Principles to Analytical MeasurementThe authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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Improving Dose Content Uniformity Testing for MDIs and DPIsIt has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
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The Biosimilars Market Today And TomorrowLast year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.
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The Effect Of The Financial Crisis On OutsourcingThe economic crisis has affected outsourcing providers in several ways.
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Quality management systems for small organizations: Reducing the headacheMany small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.
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Control of Quality Records in the Pharmaceutical IndustryThe security of documents in the pharmaceutical industry has become a critical issue since the advent of electronic data transfer. Companies in Europe must comply with 21 CFR Part 11 if they sell in the US. The regulations also require that secure, computer-generated, time-stamped audit trails are used to record the date and time of operator entries and actions that create, modify or delete electronic records. In particular, the record change must not obscure previously recorded information.
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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 CDMO’s Perspective of Important Bio/Pharma Industry TrendsKeeping abreast of the latest industry trends and retaining flexibility are key to maintaining a strong market position.
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Biosimilars: Perception, cost And The Impact On Biotech InnovationIn light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.
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Quality management systems for small organizations: Reducing the headacheMany small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.
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Current Perspectives on Aseptic FormulationsThe author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.
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Reverse Engineering a Pressurized Metered Dose InhalerUnderstanding the components of a reference marketed pMDI is needed to develop a generic pMDI.
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Ensuring Tabletting Safety For High Potency APIsThe main challenge for tablet manufacturers processing highly potent APIs (HPAPIs) is to protect equipment operators from the inhalation of airborne particles and prevent skin contact with the product during the entire production process: dispensing, granulation, tablet compression, coating and packaging.
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Authenticating drugs with edible microtagsOn-dose authentication, such as edible microtags, is a relatively new market that has been quietly developing but has the capability to provide new forms of anti?counterfeiting tools.
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Ethyl Cellulose as a Matrix Former: The Influence of Particle Size on Tabletting and Drug Release BehaviourThe aim of this work was to investigate the compactibility, compressibility and drug release behaviour of different fractions of a commercially available ethyl cellulose.
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Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity TestingThe authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes. This article is part of a special issue on Bioprocessing and Sterile Manufacturing.
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Controlling the Release of Highly Dosed and Highly Soluble DrugsThe authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."
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Dissolving the InsolubleAn authoritative book helps drug developers face one of their toughest problems.
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Characterizing A Nasal Spray Formulation From Droplet To API Particle SizeThe way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.
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CMO Industry Adoption Of Single-Use TechnologySingle?use solutions, such as bags, tank replacements and aseptic connection devices (ACDs) have revolutionised our industry, providing improved sterility assurance.
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Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part II: Expert OpinionsEuropean expert opinions regarding pharmaceutical process validation were collected and studied by performing an Internet Delphi survey. In total, 36 experts from 10 countries representing the pharmaceutical fields of industry, regulation and academia participated in the survey. The overall attitude to process validation appeared to be positive; however, a number of concerns were raised. More education, better use of prioritizing tools and increased evidence of cost-effectiveness is needed to further develop and facilitate process validation.
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Industrialized Production of Human iPSC-Derived Cardiomyocytes for Use in Drug Discovery and Toxicity TestingThe authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes. This article is part of a special issue on Bioprocessing and Sterile Manufacturing.
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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 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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Checklist for Computer Software ValidationNon-compliance issues show that users find dealing with computer systems challenging.
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A new generation of transdermal deliveryTransdermal drug delivery is valued by patients and physicians for the comfort and convenience it offers — no needles, no pills and ease of use
