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The Value of Primary Working Standards in Pharmaceutical Quality ControlIt is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.
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The Importance of Continued Investment in R&DThere has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.
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Accelerate Biomedical and Life Sciences Research and Discovery Processes with the Power of Next-Generation AlWednesday, September 8, 2021 at 8am EDT| 5am PDT| 1pm BST| 2pm CEST AI has opened up an enormous amount of possibilities for biomedical and life sciences organizations to use growing volumes of data to accelerate and improve upon critical processes that can speed time to value and improve patient outcomes. Learn how next generation AI is revolutionizing how these organizations can deliver innovation and value to patients and overcome the constraints of legacy technology, easier and faster than ever before.
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Using Tolerance Intervals to Assess Conformance to RequirementsThe authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
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Ensuring Stability Excellence for Global Consumer and OTC ProductsWebinar Date/Time: Tue, Jan 31, 2023 11:00 AM EST
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Industrial Applications of Whole-Cell BiocatalysisRecombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.
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Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Challenges in the Secondary Manufacture of Encapsulated High-Potency DrugsLiquid and semisolid encapsulation using two-piece hard capsules is an ideal drug delivery approach for highly potent compounds and poorly water-soluble drugs. The authors detail the factors to reduce risk when designing and operating a facility for secondary manufacturing of highly potent drugs.
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Latest EU Guidelines For Biosimilars DissectedThe EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.
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Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 2In this episode of the Drug Solutions Podcast, Meg Rivers discusses outsourcing strategies in biopharma with Jeff Henderson, key account manager of Vetter.
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The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical ManufacturingThe growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
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EU GMP Annex 1 - Impact on Cleaning and DisinfectionAnnex 1 was released in 2022 and has had an impact on cleaning and disinfection. Download this article for more information on how your facility can stay compliant.
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Privacy and COVID-19 Clash, Creating Unprecedented Risks for PharmaTo maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.
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Extending Shelf-Life With SorbentsExtending a drug product's shelf life while maintaining its strength, quality and purity is a challenge for pharma companies.
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Growing Opportunities in Outsourced Biopharma APIsConsistent growth in outsourced biomanufacturing points to an evolving industry increasingly reliant on external capacity and expertise.
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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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Integrated Approach Facilitates Inhalation Drug DevelopmentThe choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
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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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Improving Scalability of PLGA-based Drug Products for Parenteral AdministrationWebinar Date/Time: Wed, Oct 25, 2023 2:00 PM EDT
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Overcoming The Challenges Of Cell-Based BioProcessingDiscussing the key challenges that face cell-based bioprocess manufacturers today, how these challenges might be addressed and the innovations that could facilitate the process in the future.
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Determining Low PPB Levels of Nitrite in Polymeric ExcipientsIn this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.
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Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master PlanA thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.
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Strategies to Simplify the Evaluation of Pharmaceutical Excipients***Wednesday, April 28, 2021, 8AM PDT | 11AM EDT | 4PM BST | 5PM CEST*** This webinar brings together experts from LGC and PerkinElmer to share their perspectives on addressing challenges in excipients testing, as well as providing insights and strategies for a successful path for the control of impurities in excipients to achieve 21 CFR Part 11 compliance.*** On demand available after final airing until April 28, 2022.***
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Pharmaceutical Compounding Calculations in a Workplace EnvironmentAn ordered process describing calculations activities for compounded dosage forms is described.
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Improving the Efficacy of Genetic MedicinesShawn Davis, CEO of Liberate Bio, shares some insights into the world of drug discovery, development, and delivery, as well as process optimization
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Blockchain and IoT: Determining ROI in the Pharma Supply ChainFor pharmaceutical manufacturers and their contract partners, blockchain and the Internet of Things promise to enable return on investment, not only by preventing counterfeiting and verifying returns but by enabling real-time condition monitoring and automating supply contracts.
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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
