Authors
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.
Latest:
Classifying Potent and Highly Potent MoleculesDetermining how much containment is needed for API handling requires evaluation of multiple factors.
Latest:
Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
Are we moving towards global patenting?Patents are an important tool for protecting innovative products, uses or processes intended for commercialization.
Latest:
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.
Latest:
Multi-Purpose Biopharmaceutical Manufacturing Facilities Part II: Large-Scale ProductionA matrix of multi-functional cleanrooms can be adapted for launching products.
Latest:
Overcoming the Challenges of Capsule Filling in Preclinical and Clinical StudiesThe authors discuss the challenges of capsule filling in preclinical and clinical studies.
Latest:
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.
Latest:
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.
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:
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.
Latest:
Risk-Averse Fill/Finish Industry Embraces ChangeSingle-use technologies, modular systems, and robots are on the rise.
Latest:
Risk-Averse Fill/Finish Industry Embraces ChangeSingle-use technologies, modular systems, and robots are on the rise.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
