Establishing a phase appropriate analytical development strategy that balances adequate product characterization with development speed and flexibility is a key challenge for Cell and Gene Therapy developers. Our team brings a wealth of experience across assay types, product platforms, and stages of development to address your analytical development challenges. Common offerings include:
Method development:
Our scientists assist in identifying and selecting appropriate analytical methods for your product, and in developing and optimizing such methods to be fit-for-purpose.
Specification setting:
We help you identify critical quality attributes (CQAs) of your products and to discern assays best used for release versus product characterization. We use statistical process analysis tools, combined with a wealth of experience regarding global regulatory expectations, to help you select appropriate specifications for your individual product and phase of development.
Method Transfer:
We ‘hand carry’ your analytical method to its new home to ensure success of your method transfer. We prepare your documentation, oversee planning and execution of the method transfer, and provide in-person oversight for the transfer at your CRO/CMO.
Qualification and validation:
We design protocols for performance verification of your analytical method, oversee method qualification/validation studies, and write or review technical reports summarizing study results.
Remediation:
We advise, assist or lead methods to remediate test method failures, whether in house or at your CRO/CMO.
Comparability testing:
We design a customized roadmap for establishing equivalence to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.
Establishing a phase appropriate analytical development strategy that balances adequate product characterization with development speed and flexibility is a key challenge for Cell and Gene Therapy developers. Our team brings a wealth of experience across assay types, product platforms, and stages of development to address your analytical development challenges. Common offerings include:
Method development:
Our scientists assist in identifying and selecting appropriate analytical methods for your product, and in developing and optimizing such methods to be fit-for-purpose.
Specification setting:
We use statistical analysis tools to evaluate performance of your manufacturing process, combined with a wealth of experience regarding global regulatory expectations, to help you select appropriate specifications for your individual product and phase of development.
Method Transfer:
We ‘hand carry’ your analytical method to its new home to ensure success of your method transfer. We prepare your documentation, oversee planning and execution of the method transfer, and provide in-person oversight for the transfer at your CRO/CMO.
Qualification and validation:
We design protocols for performance verification of your analytical method, oversee method qualification/validation studies, and write or review technical reports summarizing study results.
Remediation:
We advise, assist or lead methods to remediate test method failures, whether in house or at your CRO/CMO.
Comparability testing:
We design a customized roadmap for establishing equivalence to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.