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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.
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Inside IPEC: Dual-Use LabelingClear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.
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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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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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ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable FacilitiesThis paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
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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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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEurDimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.
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Building Velocity into Fill/Finish Timelines: Your Guide to Quality and Regulatory Success in the CDMO SpacePartnering with a CDMO with collective insights and capabilities to support the development and manufacture of an innovative biotherapeutic program is an essential first step to providing better care to patients.
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Using Glycobiology to Study the Nuances of Immune CellsCapturing the nuances of immune cell phenotype and function can be achieved using glycosylation analysis.
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Seeking Economies of Scale for BiocatalysisNew enzymes and protein engineering have advanced biocatalysis processing toward commercial acceptance. Technology and economic roadblocks must be overcome for the process to be widely embraced by pharma.
