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Brazilian Regulation of Biosimilar Products: What Is Important to KnowThis article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
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The Optimal Metric of Space-Time YieldSpace-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.
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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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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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The Future of Manufacturing, Safety, and CollaborationThe panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.
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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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Getting to the Root of the Matter for Bio/Pharma Quality IssuesBio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.
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Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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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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Michael J. Hennessy: MM&M 40 Under 40 AwardMichael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to BioPharm International, named to MM&M’s second annual 40 Under 40 list.
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Solving for Speed in Translational CMCWebinar Dates/Times: May 23rd 2023 8am PST | 11am EST | 5pm CET
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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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Phase-appropriate Compliance for Cell and Gene TherapiesUnderstanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
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CPHI Annual Survey Finds Global Pharma Resilient with India the Chief Beneficiary of Macro ChangesThese results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.
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Cryogenic Cold Solutions are Enhancing Vaccine Efficacy & YieldsPaper examines how cryogenic cold-temperature solutions are gaining favor versus traditional mechanical refrigeration methods in the manufacturing, storage, and distribution of vaccines due to their enhanced efficacy, stability and yield.
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Selecting an Off-Site cGMP Storage ProviderThis whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.
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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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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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Extractable and Leachable Challenges in Lyophilized Drug ProductsThe authors examine the risks of extractables and leachables and present solutions that emphasize the importance of a strategic multi-prong approach.
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The Importance of Process Intensification and PAT for Achieving Real-Time ReleaseCreativity and collaboration are required to overcome complex method development challenges.
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Final Thoughts and Looking Forward: The Future of Pandemic PreparednessSustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
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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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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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Assessing Data Integrity Risks in an R&D EnvironmentA data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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Efficient Method Development of OligonucleotidesThis article describes how to achieve optimal separation of oligonucleotides and related impurities by utilizing a dedicated method development software package based on AQbD.
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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
