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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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Expert Pharmaceutical Services from ElementElement offers comprehensive solutions for the entire product lifecycle.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Picodroplets for Biologics Discovery and Scale-up: A Novel Automation ApproachWebinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST
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Survey of QPs on Remote CertificationDespite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Clean Room Solutions for the Pharma IndustryAt Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology and the latest trends in the industry.
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Reliability Throughout the Pharmaceutical Supply ChainWithin several sites available for pharmaceutical contract manufacturing, WeylChem has access to many technologies, e.g. low temperature, halogenations, or complex metalloorganic chemistry. This allows us to offer our customers a reliable, transparent supply chain.
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US Pharmacopeia Sets Five-Year GoalsThe US Pharmacopeia recently convened a meeting of stakeholders to set goals for its 2010–2015 cycle.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
