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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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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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Multivariate data analysis easily retrieves insight from a wealth of dataStatistics are often viewed as confusing and complicated, but multivariate data analysis (MVA) methods can be used to amass knowledge simply.
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Advancing Oral Drug Development Using MIFDModel informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate DihydrateThe authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.
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Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment QualificationEquipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.
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Defining and Presenting Overkill Cycle ValidationSterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.
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Reducing Uncertainty of an Analytical Method through Efficient Use of ReplicationA well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
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Exploring the Skills Gap in Statistical Programming OrganizationsInteroperability difficulties resulting from discrepancies in preferred programming languages can be resolved via statistical computing environments.
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Streamlining Biopharma MS Workflows Using Connected Software SolutionsThe acquisition and analysis of MS data can be made more efficient with the integration of modern software tools.
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The Impact of Material Management on Extractables and LeachablesA comprehensive understanding of potential material change can mitigate its impact on patient safety.
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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.
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The Quest for Cleanroom FlexibilityContextualizing what type of flexibility is needed is paramount when considering cleanroom design.
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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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Focusing on the Fundamentals of FormulationThis article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.
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Specification Equivalence: A Practical Approach to Method and Acceptance Criteria EquivalenceThe authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.
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Time for a World Tooling StandardAfter two centuries, there's no reason to maintain two tablet compression tooling standards.
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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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You're Telling Us...PharmTech's polls feature user feedback on issues facing the pharmaceutical industry.
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Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for ImpactOn April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
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Dielectric Spectroscopy: Choosing the Right ApproachThis tutorial paper is meant to aid in dielectric-sensor selection
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Running a Marathon in Flip-Flops – Part 1: The Value of Incorporating Prerequisites into Process ValidationUndertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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Spectrophotometric Determination of LeadThe authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.
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Automate Aseptic Filling: Closing the System at Full ModularityShifting to automated, closed modular manufacturing systems is growing increasingly crucial for biopharmaceutical production.
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Core2Scan® System: Precise Asset Management for Regulated IndustriesCreated specifically for the pharma biotech industry by Veltek Associates, Core2Scan is the tracking, asset management, and process improvement solution that boosts bottom lines and so much more. Powered by RFID, Core2Scan keeps tabs on any onsite physical asset your organization wants to track. Better yet, its invaluable data can drive smarter processes and savings throughout your entire G-M-P facility.
