ANALYTICAL DEVELOPMENT

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.

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. 

Flow cytometry plot2 example
example of Cell aggregate immunostaining

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.

Flow cytometry plot2 example

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.

example of Cell aggregate immunostaining

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. 

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