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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.
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Siemens Finalizes $5.1B Dotmatics AcquisitionSiemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.
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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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Controlled Release Redefined: The Strategic Use of Excipients in FormulationsWebinar Date/Time: Wed, Jun 12, 2024 11:00 AM EDT
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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Getting Lab Data Closer to the Decision Point Keeps Product Release on TrackUsing one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster.
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Clinical And Cost Considerations Of Developing A BiosimilarBoth biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
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Contamination Control for Cell and Gene Therapies Needs New AnalyticsAnalytical methods need a boost to ensure quality control for cell and gene therapies.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
