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Latest:
Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical ManufacturingThis article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.
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Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating TabletsThis article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
Latest:
Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating TabletsThis article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
Latest:
Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating TabletsThis article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
Latest:
Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating TabletsThis article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
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Using Lab Informatics and Instrumentation to Optimize Upstream BioprocessingAdvanced technologies, such as artificial intelligence and synthetic biology, can be used to their full potential in upstream bioprocessing, provided that data and knowledge management can be effectively managed.
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Obtaining User-Defined Particle Size Distribution Using Dry GranulationThe author examines the effect of compaction force, gap width, and sieve setup on granule size.
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Paving the Way for Modernized Drug-Product Manufacturing Through ExcipientsCommonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.
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Paving the Way for Modernized Drug-Product Manufacturing Through ExcipientsCommonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.
Latest:
Paving the Way for Modernized Drug-Product Manufacturing Through ExcipientsCommonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.
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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.
Latest:
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.
Latest:
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.
