Authors
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Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical TrialsThe authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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AAV Vectors: Challenges and Solutions for Gene Therapy ManufacturingThis White Paper covers all aspects surrounding AAV vectors including the challenges associated with their manufacturing and explores analytical methods for quality control.
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Streamlining and Standardizing Process CharacterizationUnderstanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.
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A Step Closer to Closure in BioprocessingAs biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.
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Sustainability Using Zero-Carbon Biopharma FacilitiesHow can sustainability and zero-carbon initiatives be achieved?
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Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried FormsAFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
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Packaging for Stability Studies: to Outsource or Not?Manufacturers should consider the benefits and risks of contract packaging for stability studies.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Threading the Needle Between DIY and CDMOIn the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing.
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Improving IR Spectroscopy as a Tool for Biopharmaceutical AnalysisMicrofluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure.
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Assessing the Quality of CAR-T Cells Using ddPCRCAR-T cell therapy development is a complex process that requires standardization.
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Ensuring Quality in Contracted SupportThis article looks at the relationship between a CDMO quality organization and the client.
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Evolution of Analytical Procedure Validation Concepts: Part IIThis article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
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Digitalization of QbD Risk AssessmentsThe digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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Platform-Specific Risk Assessment of SARS-CoV-2 Vaccines Using FMEAAmid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.
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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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Streamlining Method Transfer Across Global SitesThis article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.
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Optimization of Clarification Step in Pneumococcal Polysaccharide Conjugate Vaccine Manufacturing: Evaluating the Performance of Depth FiltersThis research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.
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Navigating the Preclinical CRO Outsourcing ProcessThe need for preclinical testing expertise is growing as molecular complexity increases.
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Webinar: Reinventing Aseptic Aliquoting in BiopharmaLearn about advanced fluid management technologies that increase safety and process efficiency at all volumes, such as ATMP aliquoting, bulk media and buffer addition, seed train intensification, high-volume bacterial fermentation, and more.
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Untold Tales Behind Therapeutic Antibody Production and Screening with Twist BioscienceCreating a new therapeutic drug can take a decade or more to get to patients. Antibody production and discovery play an integral role in setting the stage for success at later stages of development. If a high affinity, functional antibody candidate is discovered early, the timeline to a finished targeted and effective therapeutic drug may be significantly reduced. In this podcast we will go through the untold tales of antibody production and discovery, as well as how Twist has optimized a process for antibody production and screening for potential therapeutics.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Protecting Biologics at Every TurnCold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.
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Detecting Residual HCPs Demands a Holistic ApproachGene therapy products present a unique set of challenges for the control of host cell protein impurities.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried FormsAFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
