Authors
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Regulatory Affairs’ Role in Product DevelopmentThis excerpted chapter of a longer book reviews the history of the Food, Drug, and Cosmetics act, including milestones, subsequent laws, and predictions for future laws and regulations; explores the role of Regulatory Affairs in product development; and addresses the importance of a quality management system and organization in bringing products to market.
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Ecolab Continues Mission to Protect What's Vital With Deep Investment in Life SciencesEcolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development and manufacturing.
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Trends in Single-Use BiomanufacturingSingle-use technologies have gained broad acceptance in biomanufacturing within the past few years, supporting flexible and cost-effective clinical production.
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Outsourced Manufacturing OperationsManufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.
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What's on the Box?Counterfeiting continues to be a huge challenge affecting both branded and generic products, which, although a worldwide issue, is especially prominent in developing countries.
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Challenges In The Changing Outsourcing LandscapeOriol Prat, Marketing Manager, and Marga Viñes Senior Product Manager, from Grifols give us a quick rundown of how business is changing and what challenges the company faces.
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Past, Present and Future of Softgel TechnologiesSoftgels are now being recognised as one of the preferred dosage forms for the treatment of pain, eye conditions, cough and cold, as well as allergy.
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Insourcing vs Outsourcing: Choosing the Right StrategyThe article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
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The Use Of UHPLC In Post-Drug DevelopmentUHPLC offers increased performance compared with HPLC, including shorter analysis times and increased sensitivity.
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Perspectives in MicroRNA TherapeuticsThe authors provide further insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making is compared with a QbD approach.
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Checklist for Computer Software ValidationNon-compliance issues show that users find dealing with computer systems challenging.
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Single-Use: Game-Changing Technology for the Biopharmaceutical IndustryThe success of new biopharmaceutical drugs also relies on innovative solutions such as single-use technologies that suppliers have to offer to the pharmaceutical industry.
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Improving R&D with API microdosingDirect dosing APIs during R&D studies can reduce the overall testing time of a drug candidate by allowing for a greater throughput of compounds through the R&D department.
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Maturing Aseptic Technologies Create More Flexible FacilitiesInnovative therapeutic approaches beyond mAbs will require new methods for future facility construction.
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EU Market ChallengesAlthough the European market is approximately 50% smaller than the US in terms of landmass, the population of Europe is approximately 50% larger and this presents a huge market opportunity.
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Offering a Pharma View of Social MediaWhy social media presents unique challenges and opportunities for pharmaceutical companies.
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Technology and QbD Drive Pharma DevelopmentQuality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.
