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Nanotechnology: A lifeline for drying pharma pipelines?Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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5 Critical Keys to Avoid Derailment of Drug Development: Delaying the Application of a First-Rate Quality System is Risky BusinessAny responsible business or industry takes quality seriously. It’s crucial to customer safety and satisfaction, and its prioritization in the development of healthcare products and services – especially pharmaceuticals – is obviously even more so. Nonetheless, it can be easy in development for smaller teams and companies to overlook some components of Quality, despite governmental requirements around complex quality initiatives. Those concerns are well-founded.
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An Intelligent Drug Development ParadigmAn intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
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Using ddPCR to Asses CAR-T Cell QualityStandardization is needed in CAR-T cell therapy development due to its inherent complexity.
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Assessing Data Integrity Risks in an R&D EnvironmentA data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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How to Get the Most Out of Your Oral Solid Dosage FormsFocus on the contribution of modified release technologies
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Inside IPEC-EUROPE: Pharmaceutical Excipients—The View from the EUA changing regulatory environment is on the horizon for excipient suppliers and users.
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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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Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
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Meeting Secondary Packaging Challenges of Innovative Delivery Systems for BiologicsRapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.
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How to Pave an Expressway to Phase I – Strategies That Accelerate Your Early-Phase ProgramsSpeed is a critical factor in early-stage development. Solid state studies within an integrated CMC platform can support formulation development, accelerate timelines to Phase I clinical studies and increase the likelihood of successful clinical trial results.
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Executive Summary: Commercial Tech Transfers in OSD ManufacturingCollaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.
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Shining a Light on Lipid Nanoparticle CharacterizationUsing an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.
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Challenges of Expanding CAR-T Cell Therapy into Solid TumorsThe development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.
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Evaluating CMO/CDMO End-to-End Expertise: The Importance of Standardizing Cold ChainConversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.
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Recent Pharma Trends, EU Annex 1, and More with SyntegonAt a recent INTERPHEX conference, Laura Moody (Director of Product Management, Pharma North America, Syntegon) shared some insights into current trends in the pharmaceutical industry, including the EU Annex 1.
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Will Remote Pharma GMP Auditing Endure Post-Pandemic?A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients.
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The Importance of Holistic Sterile Drug Product DevelopmentWebinar Date/Time: Mon, Oct 23, 2023 11:00 AM EDT
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Understanding Nitrosamine Impurities in the Pharmaceutical IndustryDetection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.
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Compliance Gap: Why Labeling and Instructions for Use Documents Need to Be a Single ProcessRather than relying on a myriad of different systems, the author proposes that a cloud-based solution can control and coordinate everything, allowing manufacturers to deftly respond when changes in labeling requirements arise.
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Legal and Regulatory Perspectives on 3D Printing: Drug Compounding ApplicationsThis paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.
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Using Gas Headspace Analysis to Assess Glass and Nontraditional Vial-Closure IntegrityIncreased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.
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Restructuring Method Transfer Through Global SitesMethod-transfer kits help simplify analytical method transfer for global site certifications.
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ePedigree: Using the Gift of Time WiselyThe year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.
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Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) GuidelinesThis article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Challenges of Expanding CAR-T Cell Therapy into Solid TumorsThe development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.
