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Pharmaceutical Companies Can Optimize Enterprise Asset Management and Achieve SuccessAn integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.
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Easy Coloring for Liquid- and Solid-Dosage Drug Forms***Live: Tuesday, November 24, 2020 at 9am EST| 2pm GMT| 3pm CET*** Coloring as an aesthetic value for a product is becoming more important for pharmaceutical and nutritional products and helps differentiate between various grades of active ingredients. This webcast introduces the world of easy coloring, answers questions about pigments, pigment blends, and how to color solid- or liquid-dosage forms in an efficient way. Register for this webcast to learn how ready-to-use coloring systems can simplify production process.*** On demand available after final airing until Nov. 24, 2021.***
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Serialization: Reducing Counterfeit Drugs and Increasing SalesAn effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.
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Emerging Applications of Vitamin E TPGS in Drug DeliveryThe author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.
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High-Growth Microbial Fermentation for the Manufacture of BiologicsChallenges in fermentation can be addressed through equipment changes, facility design, and process development.
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Accelerating Project Delivery with a Lean Alternative to DBBLean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
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BioDuro is Redefining CRDMO Partnerships With End-to-End InnovationHow BioDuro is expanding its global CRDMO footprint by improving integrated capabilities and delivering high-quality, end-to-end solutions for drug development and manufacturing
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Elaboration, Expansion, and Evolution in Outsourcing of Clinical ResearchThe rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
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Untethered Data: Unifying and Contextualizing Drug Discovery DataCapturing and curating R&D data are crucial to realizing the full value of advanced analytics.
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Designing and Delivering Therapeutic ProteinsAn updated book summarizes recent research for formulators and drug-delivery specialists.
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Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision MakingMore attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.
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Protecting Intellectual Property for COVID-19 InnovationsOpposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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The Relevance and Readiness of AI for GMP Manufacturing: An Industry PerspectiveLeverage artificial intelligence (AI) for a more streamlined GMP manufacturing process.
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Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory ContextLife sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.
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EGA Position On The EC's Proposal For A Falisifed Medicines DirectiveAlthough the European Generic medicines Association (EGA) n has welcomed the European Commission's proposal for a Directive on the falsification of medicines, it has also identified subjects that are of specific relevance to the European generic medicines industry.
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New alloys for manufacturing freeze-dryersThis article explores the challenges found in manufacturing of a pressure vessel as main component for freeze drying technology
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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Improving Packaging SecurityLegislation has prompted the pharma industry to seek technologies that can be used to secure a product throughout the supply chain.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Major Growth & Investment at Pace® Life SciencesDean Bornilla, Pace® Life Sciences, highlights his organization's future role in supporting biopharmaceutical development and manufacturing coast-to-coast.
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Pooling of Batches for Stability Data AnalysisOne of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.
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Viewpoint: Data Integrity and Its Ties with Personal IntegrityThe root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual.
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Actylis Biopharma CapabilitiesWe demonstrate the wide range of customized products and services that Actylis offers its biopharma customers.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Industrial Applications of Whole-Cell BiocatalysisRecombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
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Verifying Compendial MethodsExperts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.
