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Automation of MS Analytics for Characterization of BiotherapeuticsMarch 17th 2022 at 10am EST | 9am CST | 3pm GMT | 4pm CET • Automating and Streamlining MS-Based Developability Assessment of Biotherapeutics• Automating MS-Based Biotherapeutic Characterization Workflows for Developability
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The Ins and Outs of Syringe InspectionA best practices approach to pharma’s most challenging-to-inspect container.
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Accelerating the Development of mRNA TherapeuticsManufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.
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Current Challenges with Cell Culture Scale-up for Biologics ProductionBioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.
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Machine Learning and Data Analysis for Optimal Productivity of Pharmaceutical Water SystemsLeveraging smart technology and SMEs for significant operational and financial benefits.
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Emergence of India as a Global Manufacturing Hub for BiosimilarsThe biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.
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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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Preparing for the Future: Expanding Capacity and Facilitating Multi-modalitiesCDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.
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Phase-appropriate Analytical MethodologyA phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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EASY: a Disruptive mAb Purification Process to Reduce Cost of GoodsThe development of an innovative purification process simplifies downstream processing for biologics.
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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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Tech Transfer and Regulatory ComplianceDemand for efficient tech transfer, as well as compliant on-time delivery, is rising.
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How Modularization and Digital Delivery are Transforming Pharma ManufacturingModular and replication strategies are being utilized to meet growing demand for CDMO facilities.
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Tech Transfer and Regulatory ComplianceDemand for efficient tech transfer, as well as compliant on-time delivery, is rising.
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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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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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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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Perspectives on Process Analytical TechnologyThis article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.
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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***
Latest:
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***
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.
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Pharmatech Insights – Biosimilar Development: Interacting with the FDATo help provide patients with greater access to safe, effective biological products, the FDA approves biosimilars on an abbreviated pathway. How should you work with the FDA to navigate this pathway?
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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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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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Addressing manufacturing at scale for ATMP’sAddressing manufacturing at scale for ATMP’s. Reducing costs through reducing batch failures and shrinking footprints, and targeting more focused critical quality attributes for potency but also patient efficacy. Reducing regulatory uncertainty in an uncertain environment to increase patient access to life saving cures.
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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.
