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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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Major Growth & Investment at Pace® Life SciencesDean Bornilla, Pace® Life Sciences, highlights his organization's future role in supporting biopharmaceutical development and manufacturing coast-to-coast.
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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, Part Two–Bulk DrugsBulk drug calculations for different types of active moieties and drugs require different calculations and labeling.
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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.
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The IKA CMX 2000Newest Innovation Of Solid-Liquid Mixers – Outstanding Powder Wetting In Batch Process
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Demystifying Systems Integrators and Automation Design Engineers: Understanding the DifferencesWhen you’re partnering with a design firm to support your product development and manufacturing needs through automation, it’s important to decide whether you should work with a systems integrator or an automation design engineering firm.
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Biosimilars: Is It Worth Taking On The Regulators?The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.
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Extractable and Leachable Challenges in Lyophilized Drug ProductsThe authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.
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Addressing the Key Pitfalls Hindering Technology Transfer SuccessIn this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.
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Improving IR Spectroscopy as a Tool for Biopharmaceutical AnalysisA recent innovation in infrared spectroscopy, Microfluidic Modulation Spectroscopy has been shown to improve characterization of secondary protein structure.
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SMEDDS incorporated polymer matrix: A floating dosage form solution for drugs with poor gastric solubilityA new kind of gastro-retentive dosage form for drugs with poor aqueous solubility was developed and evaluated, with the aim of achieving gastro-retention.
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The Benefits and Challenges of PEGylating Small MoleculesPolyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.
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Suppositories: The Incomplete StoryA reference book omits important information and ignores advanced testing procedures.
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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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Optimizing Loss-in-Weight Feeding of Poorly Flowing MaterialsPrior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
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Pelletization: Revolutionizing Drug Formulation and DeliveryPelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.
