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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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Specification Equivalence: A Practical Approach to Method and Acceptance Criteria EquivalenceThe authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.
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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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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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Enhancing CDMO Capabilities to Meet Evolving Client NeedsRentschler Biopharma is evolving its CDMO capabilities through strategic partnerships, infrastructure investments, and sustainability initiatives to better support clients' complex biologics programs.
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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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Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part I: Facility and Cleanroom Cleaning PracticesThis paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.
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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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Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance (May 2025)Cleanrooms 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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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.
