Cart
This product is not clubbable with other items in cart. Please remove this or other items to proceed further.
Deleting

No Items In Cart
This product is not clubbable with other items in cart. Please remove this or other items to proceed further.
No Items In Cart
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.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
Matthew Woods
Manager, Extractables and Leachables
Organizations today are far more vulnerable to cyber threats due to the digital information and technology that are so heavily integrated into the daily workplace. The attacks themselves, which target both information and critical infrastructure, are becoming far more sophisticated.
Renee Welsh
Program Manager, R&D and D&T
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
Matthew Woods
Manager, Extractables and Leachables
Organizations today are far more vulnerable to cyber threats due to the digital information and technology that are so heavily integrated into the daily workplace. The attacks themselves, which target both information and critical infrastructure, are becoming far more sophisticated.
Renee Welsh
Program Manager, R&D and D&T