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Upstream Processing: Biochemicals and Raw MaterialsExperts reveal how to identify the “right” biochemical, the process of sourcing biochemicals, sourcing challenges, and what industry professionals should know about the space.
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Oligonucleotide Production FacilitiesAs oligo manufacturers scale up production from lab-scale to clinical and commercial scales, they may require volumes of hazardous materials that drive additional facility design considerations.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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EASY: a Disruptive mAb Purification Process to Reduce Cost of GoodsThe development of an innovative purification process simplifies downstream processing for biologics.
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Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 2The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
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Frontrunner in Therapies for Complement-Mediated DiseasesA novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.
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Is Collaboration the Key to Accelerating Biotherapeutic Development?Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.
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Extractables Protocol for Single-Use Disc-Stack SeparatorsThis case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted.
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The Era of Digital Data in Bio/Pharma ManufacturingLaks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.
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Succeeding with Remote AuditsPreparation is key for remote vendor and contract partner audits.
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Elements that are Key for Successful Assay TransferThe COVID-19 pandemic generated partnerships among organizations with the goal of changing the way in which assay development and tech transfer of these assays are conducted moving forward.
