Authors
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Right the First Time: Bioreactor Scale and Design TranslationThe authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.
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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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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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Refining Microbiological Control for Non-Sterile ProductsSubsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.
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Streamlining and Standardizing Process CharacterizationUnderstanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.
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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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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in BiopharmaThe nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
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Conformational and Colloidal Stability Studies to Predict the Best Biopharmaceutical FormulationEstablishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.
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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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Construction Efficiency with The floorlessPOD: A G-CON Prefabricated Cleanroom SolutionG-CON’s floorlessPOD is a free-standing structure that provides direct integration with the host facility floor, eliminating the need for ramps, platforms and stairs typically required with prefabricated structures that have integrated floors. With fully integrated MEP, the floorlessPOD is an ideal solution when the cleanroom cannot be structurally supported by the host facility.
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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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MHC-Associated Peptide Proteomics: Immunogenicity and Vaccine DesignThis article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.
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Parker – Solving Production Bottlenecks With Innovative Single-Use SolutionsZachary Welch, Parker Bioscience, highlights single-use bioprocessing solutions presented at INTERPHEX 2022. Watch this video for insight regarding:
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From Design to Qualification: Creating the Most Efficient Single-Use FacilitiesThrough collaboration and transparency, engineering and automation companies can achieve great efficiencies and success for their customer by integrating intelligent design into a facility.
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Demystifying Complex Clinical Trial Kit PrepBest practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
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Addressing Limitations of Sterility TestingUnderstanding both the challenges and solutions of aseptic manufacturing.
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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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FDA Approves Kedrion's Bolognana Plant for Production of PLGD-1 TherapeuticWith FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.
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Refining Microbiological Control for Non-Sterile ProductsSubsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.
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From Design to Qualification: Creating the Most Efficient Single-Use FacilitiesThrough collaboration and transparency, engineering and automation companies can achieve great efficiencies and success for their customer by integrating intelligent design into a facility.
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Right the First Time: Bioreactor Scale and Design TranslationThe authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.
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Media Selection Made Easy: Selecting the Best Media for Your Aseptic Process SimulationMedia fill tests ensure the safe production of parenteral drugs. Learn factors to consider when selecting media for aseptic process simulations including US and European regulatory requirements and eser requirement specifications for equipment and instruments. Tuesday Sept. 29, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 29, 2021.
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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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Helium Leak Detection Technology for Today’s High-Risk PharmaceuticalsThis article will discuss pharmaceutical package testing specifically Helium leak detection technology and how it solves cold supply chain challenges of today’s high-risk pharmaceutical products. This article also addresses the importance of phase appropriate leak testing from manufacturing through product lifecycle.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Comparability in Accelerated or Stressed Stability Studies Using a Quality RangeA statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.
