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How To Execute Successful Data MigrationsSuccessful migrations require careful planning to meet business needs and maintain data integrity.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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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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ML and AI Implementation Insights for Bio/Pharma ManufacturingA survey was conducted to examine the adoption of machine learning and artificial intelligence in the bio/pharma manufacturing industry.
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Put a Cap on CAPAsData may be used to improve (or remove) a corrective action/preventive action.
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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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Viral Clearance & Viral Safety: Industry Trends & Key EventsWith regulators embracing next-generation sequencing, how will the ICH Q5A(R2) guidelines reshape viral safety strategies for gene and cell therapies?
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Formulating Autologous Therapies for CancerAutologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
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Exploring How CPC Progresses Green Chemistry PracticesCPC presents a green alternative to chromatography that supports sustainable operations.
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Staffing Shortages: Major Hurdle for Bioprocess Contract Manufacturing Services in 2023More than a third of CMOs are struggling to keep skilled technical and production staff.
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Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure SystemsThis study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.
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1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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A New Route to Pharma GDP Compliance and StandardizationA consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
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Outlining Successful Steps for Scale-Up and BLA FilingsSuccessful scale-up and BLA filings for products manufactured by microbial biomanufacturing require strategic planning.
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Cleaning Process Design for Peptide TherapeuticsThis article explores a grouping strategy for therapeutic peptides incorporating theoretical and experimental methodology and results to define a practical and scientifically justified cleaning procedure.
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How Integrated Project Delivery Enables Speed: A Phase-By-Phase GuideBy eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
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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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Verifying Compendial MethodsExperts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.
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Logistical Considerations in mRNA Vaccine DevelopmentDespite its success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.
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Formulating Autologous Therapies for CancerAutologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
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Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging ParvovirusesA series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
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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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Isolation of Tumor-Infiltrating Lymphocytes from Dissociated Tumor CellsTumor-infiltrating lymphocytes may hold the key to treating solid tumors with cell therapies, and BioIVT’s DTC product line is a great source for TILs. In this white paper, you’ll read about defining what TILs are, their potential therapeutic applications, the characterization of BioIVT’s current donor pool by TIL content and the frequency of TILs by tumor tissue type.
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Etihad Cargo Achieves IATA CEIV Pharma Recertification for Pharmaceutical LogisticsEtihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.
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Plasmid DNA—The Versatile Building BlockPlasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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Introducing a Novel HipH Resin for Bispecific Antibody PurificationWebinar Date/Time: Wed, Dec 13, 2023 10:00 AM EST
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Considerations for US Fetal Bovine Serum SourcingExtensive work has greatly expanded the possibilities for fetal bovine serum sourcing.
