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Breaking barriers: EnzeneX™ to EnzeneX™ 2.0Shilpa Gadgil, PhD (VP, Head of Process and Analytical Development, Head of CDMO Development) discusses Enzene's new technologies and the New Jersey site capabilities.
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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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ECHA’s Microplastics Use Restriction—Impact on PharmaceuticalsTo restrict the use of intentionally added microplastics, the European Chemicals Agency has proposed a restriction dossier that describes various measures aimed at minimizing the use of microplastics in various industrial segments, including pharmaceuticals. In this paper, the authors discuss these restrictions.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
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Expediting IND SubmissionAn integrated CMC provider can help smaller companies to streamline development timelines and reduce project management complexity when compared with multi-provider models.
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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
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Excipient World Conference and Expo: May 4–6, 2026The IPEC-Americas event focuses exclusively on excipients and brings buyers and suppliers together.
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In a Digital Gold Rush, Data Integrity is PricelessData integrity is crucial in unlocking novel data-based insights.
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Mechanistic Modeling of Renal Clearance: Optimizing Dosing Strategies for Elderly PatientsThis paper provides an in-depth overview of the anatomical structure and functional dynamics of renal filtration, secretion, and reabsorption processes that govern drug clearance.
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Regulatory Challenges Are Hindering The Use Of Novel ExcipientsEurope needs a more standardised and consistent approach for supplying excipient information to the regulators.
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Validating Pharma 4.0 for Smart ManufacturingThe drug manufacturing ecosystem Pharma 4.0, a term coined in 2017 by the International Society for Pharmaceutical Engineers, promises a revolution across drug discovery, manufacturing, and supply chain logistics, ensuring drugs are delivered precisely when needed, and improving overall patient care.
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Entering New Domains for 3D Printing of Drug Products3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
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Ensuring Quality in Contracted SupportThis article looks at the relationship between a CDMO quality organization and the client.
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The Quest for Quality: Challenges and Strategies in Raw Material Selection for BiopharmaceuticalsBiopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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Fabrication Modulation of Zein-based Fibers for Oral Delivery of HydrochlorothiazideThis study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.
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Mitigating Human Error and Supporting Compliance with Smart TechnologyTechnological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.
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Manufacturing OSD Forms: Key Trends Shaping the IndustryThe latest manufacturing technologies are essential for helping pharmaceutical formulators meet up-and-coming trends in OSD treatments.
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Emerging Trends in the Pharma Industry: Drug Development, Sustainability, and DigitalizationWebinar Date/Time: Tuesday, June 27th, 2023 at 8am EDT | 1pm BST | 2pm CEST | 5am PDT Wednesday, June 28th, 2023 at 8am EDT | 1pm BST | 2pm CEST | 5am PDT Thursday, June 29th, 2023 at 8am EDT | 1pm BST | 2pm CEST | 5am PDT
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GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 PandemicAn annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
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Determining Efficacy and Proper Methodology in Cleanroom CleaningIt is vital to consider optimal cleaning and disinfection practices when operating a cleanroom.
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Peptide analytical method development (Oct 2023)Analytical Method Development for Synthetic Peptide Purity and Impurities Content by UHPLC - Illustrated Case Study
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Drug Substance Starting Material SelectionThe authors review the current regulatory framework for the selection of drug substance starting materials.
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