Authors
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Tactics and Strategies for Designing an Ideal Lentiviral Vector PlatformThere is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
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Taking a Closer Look at Lipid Nanoparticle CharacterizationAn orthogonal approach to lipid nanoparticle analysis is recommended to optimize drug development success.
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Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.
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Extractables Protocol for Single-Use Disc-Stack SeparatorsThis case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted.
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Qualifying AI Algorithms in Pharmaceutical ManufacturingQualified algorithms enable validation of machine learning models that can be used for process optimization.
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Real-Time Post-Apheresis Documentation Decreases ErrorsDocument integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.
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Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical 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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How Artificial Intelligence Impacts the Global Regulatory EnvironmentResponsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.
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Challenges When Outsourcing Viral Safety ServicesAssessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
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Guidance on Quality Culture StandardsMatt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
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1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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The Evolving Cost-Benefit Landscape of Biosimilar Drug DevelopmentWith more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.
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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.
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Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key LearningsUse of a small-scale filler can result in increased filling efficiency.
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Medical Devices Case StudyOn average, cargo is handled seven times between a manufacturer and a client. As medical equipment moves through the supply chain and hospitals, it can experience mishandling which effects the performance and calibration of the product. With medical devices becoming increasingly sophisticated, they’re more likely to be damaged unless proper precautions are taken. RFID impact indicators alert teams to possible damage due to impact as well as track equipment in use, lowering the loss of due to misplaced or stolen devices.
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Best Practice Tech Transfer Methods for CGTsA look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.
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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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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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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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Facility Design ConsiderationsJohn Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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Proposing a New Method of Detecting Pinholes in Single-UseThe increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
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Viral Clearance Studies: Challenges and BeyondThe design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
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Biologics Quality Control: The Growing Need for Accessible ProteomicsThere is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
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Specialty Polymers Add Value to Single-use Technologies for Biopharmaceutical ProcessingSpecialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.
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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.
