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CHALLENGES
Pharmaceutical and biopharmaceutical development and manufacturing are extremely complex. Packaging and delivery further complicate the process. By partnering with West, customers have found solutions for issues associated with sensitive molecules, reducing time to market and single source manufacturing that can help reduce total cost of ownership.
Featured Blogs
December 01, 2021
Selecting a Vial Container Closure System with the DeltaCube™ Modeling Platform
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
November 17, 2021
Regulatory guidance on particulate matter in injectable drugs
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
November 11, 2021
Using Hansen Solubility Parameters to predict excipient impacts on drug packaging and delivery devices
The drug and packaging industries have always been extremely conscientious to ensure that anything added to a delivery device to improve performance (e.g., silicone oil used to coat the inner surface of a syringe barrel), does not affect a drug’s efficacy or safety. But what about the converse? How do we make sure that the drug, or more specifically its added excipients, does not affect the delivery system’s performance? The term excipient refers to any member of a broad group of surfactants, preservatives, tonicity agents, and buffers which formulation scientists take great care to balance in order to provide the drug, such as a therapeutic protein, in its most effective and deliverable state.
December 01, 2021
Selecting a Vial Container Closure System with the DeltaCube™ Modeling Platform
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
November 17, 2021
Regulatory guidance on particulate matter in injectable drugs
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
November 11, 2021
Using Hansen Solubility Parameters to predict excipient impacts on drug packaging and delivery devices
The drug and packaging industries have always been extremely conscientious to ensure that anything added to a delivery device to improve performance (e.g., silicone oil used to coat the inner surface of a syringe barrel), does not affect a drug’s efficacy or safety. But what about the converse? How do we make sure that the drug, or more specifically its added excipients, does not affect the delivery system’s performance? The term excipient refers to any member of a broad group of surfactants, preservatives, tonicity agents, and buffers which formulation scientists take great care to balance in order to provide the drug, such as a therapeutic protein, in its most effective and deliverable state.
