Authors
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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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Handling Challenging Powders in Tableting OperationsTests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.
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Digitalization of QbD Risk AssessmentsQuality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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Dissecting Dissolution TestingAdvances in dissolution testing equipment are helping to meet user demands to a certain degree; however, more innovation in the space may be necessary for novel therapies, such as biologics.
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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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Strategic Insights for 2025Alec McChesney (BD Director, SCORR Marketing) discusses goal setting and alignment between life sciences marketing and business development teams.
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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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EPCAM: A Strategy to Enable Manufacturing-Process Control TransformationEnterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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MOBILIZE YOUR DATA. MODERNIZE YOUR LAB.Thursday October 27, 2022 at 11am ET | 10am CT | 8am PT When it comes to freely accessing and sharing lab data, there’s a lot working against you out there. To create infrastructure that truly mobilizes your data and modernizes your lab, you need a new kind of solution.
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Lab Digitalization: From Source to ScientistIntegrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.
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Lean Compliance And Adopting A True Risk-Based Approach To ValidationWith the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.
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The New EMA Bioequivalence Guideline: Key ConsiderationsA new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Focusing on Effectiveness for CAPAsCompliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.
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Comparing Methods for Determining Out-of-Trend Stability Test ResultsThis article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Buy vs. Build: Bioanalytical labWith so many outsourcing/insourcing options across drug development workflows, pharmaceutical companies are faced with finding the right partner to fit the needs of their unique molecule. There are criteria to consider when outweighing the benefits and risks associated with buying or building a bioanalytical lab.
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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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Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and MoreSascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and Bryce Sady, VP of Product Development at PSL Group go behind the headlines to talk CAR-T advancements, exciting M&A developments, and the impact of lost research funding on innovation.
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Selecting container closure components with confidence: A data-driven approach to container closure integrityDrug products in development require compatible packaging to meet milestones and gain approval. West supports pharmaceutical partners with a data-driven process to give you confidence with closure containment that meets requirements in the modern regulatory landscape.
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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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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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What DADI Means for the Pharmaceutical IndustryThe move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.
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Empowering Pharmaceutical Quality Control Laboratories through Strategic Change ManagementChange management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?
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Exploring Options for Optimizing Cell Line DevelopmentBiopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development.
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BIOne Single-Use SolutionAccelerate process development with a customizable, liner-based, BIOne single-use solution.
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Containing and Enhancing Potent Particles with MicronizationA multilayered processing approach ensures safe handling and content uniformity of highly potent APIs.
