Take your molecule from DNA to tox drug substance in only 9 months* and IND in 14 months*
New molecular formats, such as fragment antigen-binding (Fab) and Fc-fusion proteins, are extremely diverse and present unique challenges during process development and manufacture. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat.
To address these needs and achieve an accelerated path to IND, this program relies upon tightly integrated delivery across all CMC functions. Initiating key activities early in the development cycle is an important approach to achieving this, and a hybrid approach of using applicable platform processes with alternative toolboxes available allows a product-specific tailored package. Our goal is to actively manage risk across the timeline using our expertise and powerful proven solutions to guide the program to successful IND submission.
*From DNA transfection to Delivery of IND-Enabling CMC Modules. Indicative timelines. Subject to molecule evaluation and terms & conditions