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Strategy for Derivation and Optimization of a Clonal HEK293 Suspension Cell Line for High Yield AAV ProductionThis commentary summarizes the derivation of clonal HEK293 suspension cell lines, selection of clones for rAAV production, and design of experiments-based optimization strategies for characterization of one clonal isolate for high yield rAAV manufacture. Data shown provides proof of concept for the success of this strategy, its applicability for manufacturing different rAAV serotypes and lays the foundation of further clonal cell line characterization for scale up of production.
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Fueling Innovation Through Client CentricityChristiane Bardroff, Chief Operating Officer and Patrick Meyer Global Head of Business Development—both at Rentschler Biopharma SE—share their insights into the company’s client-centric approach.
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Frontrunners in Automated Cell and Gene Therapy ManufacturingInnovative solutions are making personalized cell and gene therapies accessible to all.
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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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Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process OptimizationIn this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
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Transforming CDMO partnerships through qualityThis whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables
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Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
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Sensitive fluorescent quantitation of DNA with the Quant-iT PicoGreen dsDNA Assay KitHere, we demonstrate how you can reliably measure concentrations as low as 50 pg/mL of double-stranded DNA with our SpectraMax® Multi-Mode Microplate Readers and the Quant-iT Pico Green assay.
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The First Optimized Self-Replicating RNA (srRNA) TechnologyThis inaugural edition of the Pivotal Paper series features leading vaccine experts discussing a groundbreaking study on next-generation self-replicating RNA (srRNA) vaccine technology. The panel explores the study’s key findings, highlighting srRNA’s potential for lower-dose, single-dose vaccines with enhanced immune response, expanding the applications beyond infectious diseases.
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The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial SuccessSmall pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
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Automated Inspection of Pre-filled Syringes and Biologics During Fill/FinishShifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
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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.
