Establishing a phase-appropriate analytical development strategy that balances adequate product characterization with development speed and flexibility is a key challenge for CGT developers. Our team brings a wealth of experience across multiple assay types, product platforms, and stages of development to address your analytical development challenges.
Our experts assist in identifying and selecting appropriate analytical methods for your product and in developing and optimizing such methods to be fit-for-purpose.
We help you identify product critical quality attributes (CQAs) and assays best suited for release or 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.
We design protocols for performance verification of your analytical method, oversee method qualification/validation studies, and write or review technical reports summarizing study results.
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.
We design a customized strategy to enable establishment of comparability 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.
For clients currently without internal leadership focused on this core capability, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.