Authors
Latest:
Want Faster and Cheaper with Higher Quality? Get it Right the First TimeWeak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Latest:
CPhI Worldwide 2017Latest:
Improving Content Uniformity of Morphologically Challenging APIs by Excipient ChoiceWebinar Date/Time: Tues Jan 14, 2025 11:00 AM EST
Latest:
Treating Halogenated Hydrocarbon Emissions from Pharmaceutical ProductionRegenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.
Latest:
Avoiding Investigational Failure/Discrepancy-Related Form 483 ObservationsInvestigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Latest:
Speeding Time to Market With Better Pharmaceutical Project ManagementElevating the project management function can improve transparency and enable companies to react faster to internal and external change.
Latest:
Understanding the Potential of Artificial Intelligence Across the Pharmaceutical LifecycleArtificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.
Latest:
A Continuous Improvement Metric for Pharmaceutical ManufacturingStatistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
Latest:
Lifecycle-Based Process Validation Emphasizes the Need for Continued Process VerificationA year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
Latest:
Lifecycle-Based Process Validation Emphasizes the Need for Continued Process VerificationA year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
Latest:
A Continuous Improvement Metric for Pharmaceutical ManufacturingStatistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
Latest:
Avoiding Investigational Failure/Discrepancy-Related Form 483 ObservationsInvestigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Latest:
Executive Summary: Commercial Tech Transfers in OSD ManufacturingCollaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.
Latest:
Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Latest:
Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Latest:
Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Latest:
Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Latest:
Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Latest:
Innovations Maintain the Cold ChainRecent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
Latest:
Four Challenges for Pulmonary Drug DeliveryPulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how-with the right knowledge and expertise-these challenges can be overcome.
Latest:
Applying QbD in Process DevelopmentInformatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Latest:
Applying QbD in Process DevelopmentInformatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Latest:
Applying QbD in Process DevelopmentInformatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Latest:
A Multifunctional Mineral ExcipientFunctionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.
Latest:
Early Efforts Identify Unstable APIsForced degradation tests, conducted in early development stages, can provide insight into degradation pathways and products of a drug substance.
Latest:
QbD: Improving Pharmaceutical Development and Manufacturing Workflows to Deliver Better Patient OutcomesImplementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.
