Authors
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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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Advances in Radio-Frequency Transdermal Drug DeliveryA microelectronic system based on radio-frequency (RF) cell ablation addresses limitations of other transdermal drug-delivery methods. This system expands the transdermal spectrum to include the delivery of water-soluble molecules, peptides, proteins, and other macromolecules.
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Dissolution Testing For Inhaled DrugsAlthough there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.
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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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Bringing Collaboration to the Horizon Once MoreUK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.
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Pharmatech Insights – The Difference Between Compliance and QualityCompliance and quality are not the same thing. While compliance means manufacturers demonstrate they meet regulatory requirements, quality is foundational to patients’ confidence in the safety and effectiveness of their medications.
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A New Route to Pharma GDP Compliance and StandardizationA consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
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Overcoming Data Gaps in PharmacovigilanceBy leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.
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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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Managing the Complexity of Modern Sterile Product DevelopmentsManaging the intricacies of sterile product development is imperative for successful and compliant outcomes.
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Peer-Reviewed Topical Review: The Importance of Quality in Corrosion-Resistant Alloys in Biopharmaceutical ManufacturingIn this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.
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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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PDA Week 2025: April 6–11, 2025Considered "the premier annual homecoming event for the global pharma community," the 2025 theme is "Embracing Change: Catalysts for Disruption."
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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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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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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.
