Authors
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Part 1 of 4: Pharma 4.0 and Digital TransformationAn Overview with Aubrey Hogan Verista’s Head of Regulatory Compliance and Product Lifecycle Management
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QPSHARE: a new way to share auditsShared audits of suppliers offer several advantages, but networking to conduct such an audit can be challenging.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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How Regulatory Oversight Protects CBD ConsumersMany consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.
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DSCSA’s Next Big HurdleInteroperability by 2023 depends on data standardization and systems compatibility between trading partners.
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Guest Editorial: Interphex Focuses on Evolution of the Life SciencesShow blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.
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Assessment of Nanosuspension Formulation for Intranasal AdministrationResearch suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
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Lab Digitalization: From Source to ScientistIntegrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.
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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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Continued Process Verification for Cleaning Validation– Challenges and PitfallsContinued process verification for a cleaning validation program begins once the validation study is complete.
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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Optimizing Quality by Design in Bulk Powders and Solid DosageCase studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.
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Viewpoint: Data Integrity and Its Ties with Personal IntegrityThe root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual.
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Converging InformationTechnology & Automation TeamsGetting IT, engineering, and manufacturing on the same page requires a delicate balance.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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Industry 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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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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Continuous Mixing of Solid Dosage Forms via Hot-Melt ExtrusionThe author describes the benefits, processes, and practicality of using hot-melt extrusion to mix active pharmaceutical ingredients with pharmaceutical-grade polymers.
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Online TOC Comparison: Sensors and AnalyzersThis application note shows how Sievers TOC analyzers and common sensors in the industry recover 11 different compounds most often used in water and product analysis.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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E&L Analytical Testing ConsiderationsE&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Guidelines for Selecting Normal Flow FiltersProper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.
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Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulationsTesting the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.
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Development of Orally Disintegrating Tablets Based on a New ExcipientThe authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.
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Improving Solid Dosage Forms With Dry GranulationAlthough tablet manufacture is traditionally a batchbased wet granulation process, there are many advantages to be gained by adopting dry granulation, including lower costs and increased yields.
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Value-Added Medicines: From Development to ApprovalWebinar Date/Time: Tue, Sep 24, 2024 10:00 AM EDT 7am PDT | 3pm BST | 4pm CEST
