Authors
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Classifying Potent and Highly Potent MoleculesDetermining how much containment is needed for API handling requires evaluation of multiple factors.
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Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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CCS 10-80 RCThe Granulating Line CCS 10-80 RC by DIOSNA, a granulation line for pilot scale with a highly flexible range of batch sizes.
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How to Address Roadblocks During Technology Transfer: A CDMO’s PerspectiveReal-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.
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Are we moving towards global patenting?Patents are an important tool for protecting innovative products, uses or processes intended for commercialization.
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Improving Prospective Product Development Methods Derived from Management-Based Regulatory GuidelinesTo rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
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Multi-Purpose Biopharmaceutical Manufacturing Facilities Part II: Large-Scale ProductionA matrix of multi-functional cleanrooms can be adapted for launching products.
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Overcoming the Challenges of Capsule Filling in Preclinical and Clinical StudiesThe authors discuss the challenges of capsule filling in preclinical and clinical studies.
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Are You Ready for Inspection?Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.
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Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Methods for the Automated Manufacturing of an Autologous Dendritic-Cell ImmunotherapyThe authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.
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Risk-Averse Fill/Finish Industry Embraces ChangeSingle-use technologies, modular systems, and robots are on the rise.
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Risk-Averse Fill/Finish Industry Embraces ChangeSingle-use technologies, modular systems, and robots are on the rise.
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In-line UV Spectrometry Monitoring in Cleaning ValidationThe authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Cleaning Chromatography Resin Residues from SurfacesLaboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Rethinking Cleaning Validation for API ManufacturingThis article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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Sartorius In-Line Lysis System: The Easiest Alternative to Batch Alkaline LysisWebinar Date/Time: Tue, Jun 11, 2024 10:00 AM EDT
