Authors
Latest:
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.
Latest:
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.
Latest:
The Importance of Process Intensification and PAT for Achieving Real-Time ReleaseCreativity and collaboration are required to overcome complex method development challenges.
Latest:
Balancing Sustainability and Pricing Pressures in the Pharma IndustryChristine S. Yore of Ecolab discusses products and solutions that help pharmaceutical companies address sustainability and cost challenges, along with other key issues in today’s market.
Latest:
Final Thoughts and Looking Forward: The Future of Pandemic PreparednessSustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
Latest:
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
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization SolutionsExplore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.
Latest:
Ask the Expert: Key Considerations for Building Sustainable CleanroomsSteve Griffiths, Global VP of Business Development at GCS, discusses the essential environmental factors involved in cleanroom construction. Viewers will gain insight into the decisions that influence sustainability from selecting materials to optimizing energy use.
Latest:
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.
Latest:
Ensuring Cell Line Stability for Protein TherapeuticsStable cell line development can benefit from applying integrated analytical technologies.
Latest:
Evolving Complexities In BioAnalysis: Addressing Sensitivity, Selectivity and Sample ComplexityEvolving therapeutic modalities increase bioanalytical complexity, making ion mobility spectrometry–mass spectrometry (IMS-MS) crucial for enhanced sensitivity and selectivity.
Latest:
Tactics and Strategies for Designing an Ideal Lentiviral Vector PlatformThere is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
Latest:
Executive Summary: Addressing Regulatory Requirements for CRISPR sgRNA Purity with Orthogonal ChromatographyThe increasing demand for high-purity, regulatory-compliant guide RNA (gRNA) manufacturing in the CRISPR gene editing market underscores the need for advanced production capabilities.
Latest:
Connected Software Solutions Streamline Biopharma MS WorkflowsThe integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.
Latest:
The Evolution of Cellular Therapies in a New Clinical Research EnvironmentThe clinical trial research environment has evolved because of specific solutions designed to overcome uncertainty.
Latest:
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?
Latest:
Leveraging Blow-Fill-Seal Technology for Biologic DeliveryThe rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.
Latest:
Virus-like Particles as Therapeutic Moieties of the FutureAnalytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
Latest:
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.
Latest:
Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
Latest:
Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility StudyContinuous SEC was shown to increase productivity with the same product quality and yield.
Latest:
Points to Consider for Continuous Downstream BioprocessingIt is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.
