Authors
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:
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.
Latest:
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making is compared with a QbD approach.
Latest:
Industrializing Design, Development, and Manufacturing of Therapeutic ProteinsThe authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.
Latest:
Why Bottles with Desiccant Outperform Foil-Foil Blister PackagingWhile cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
Latest:
Why Bottles with Desiccant Outperform Foil-Foil Blister PackagingWhile cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
Latest:
Why Bottles with Desiccant Outperform Foil-Foil Blister PackagingWhile cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
Latest:
Why Bottles with Desiccant Outperform Foil-Foil Blister PackagingWhile cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
Latest:
Why Bottles with Desiccant Outperform Foil-Foil Blister PackagingWhile cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
Latest:
How to Get the Most from Regulatory OutsourcingRegulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
Latest:
How to Get the Most from Regulatory OutsourcingRegulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
Latest:
How to Get the Most from Regulatory OutsourcingRegulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
