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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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On the Brink of Commercialization: How do we bring ground-breaking cell and gene therapies to market faster?Tue, Sep 27, 2022 2:00 PM EDT | 11am PT | 2pm ET | 7pm BST Many novel cell and gene therapies (CGTs) are now entering the commercialization stage but, as developers look to recoup investment and quickly deliver life-saving therapies to the patients that need them, they face a myriad of challenges. In this webinar, learn how advanced therapy medicinal product (ATMP) platforms, using single-use systems, are delivering streamlined, efficient and cost-effective manufacturing solutions in this dynamic sector.
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Rapid Monitoring of Critical Quality Attributes Using Octet® BLIOctet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.
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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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Top 10 Cleanroom Problems That Can Be Prevented via Preventative MaintenanceCleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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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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Fully-Connected Continuous Manufacturing™ as the Key to Cost Efficiency and Scalability in BiotechInnovative Fully-Connected Continuous Manufacturing™ technology and advanced facilities are revolutionizing biomanufacturing and driving cost efficiency, especially in monoclonal antibody production.
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Considering a Coating Technology as an Alternative to Silicone OilA coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.
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Elements for a Sustainable Environmental Monitoring ProgramAsking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.
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Therapeutic Delivery for Brain-Related ConditionsAt BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with BioPharm International to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.
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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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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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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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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.
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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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How a Lack of Critical Thinking is Hindering Regulatory ComplianceWhy critical thinking must be applied before technology to ensure regulatory compliance.
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Strong Quality Culture: A How-To for Busy ManagersBuilding employee participation and forming good habits contribute to a company-wide quality culture that pays off.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021***
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Using Modeling to Improve Data Analytics for Upstream Bioprocessing WorkflowsRecent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
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Bioreactor, PAT and Lucullus Control SynergiesThe Lucullus process information management system facilitates bioprocess development and optimization by centralizing data management and control of multiple BR1000 bioreactor systems that each employ dynamic PAT-driven glucose feeding
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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Challenges in Bulk Drug Substance ManagementHow can liquid drug substances be safety stored and transported between downstream and fill/finish processes?
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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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Valuing Specialized Experience in ADC DevelopmentBringing promising ADC candidates to market faster hinges on the biopharma industry investing in linker design capabilities.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Stability Studies: An Essential Step for Quality Management in Drug DevelopmentSufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
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Virus-like Particles as Therapeutic Moieties of the FutureAnalytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
