Regulatory Digital Transformation Dispatch

CBER Advanced Technologies Team (CATT) is a new program designed to address regulatory challenges associated with development of advanced technologies for manufacturing and testing of CBER regulated products.  

Cell and gene therapy products are highly complex, so to assure consistent manufacturing of these emerging products at commercial scale, advanced manufacturing and testing platforms will most likely require further development. These platforms may involve new technologies including but not limited to continuous manufacturing platforms, unit operation and end-to-end automation and platforms designed to support advanced analytical testing of these product types. Traditionally, FDA has become aware of these novel manufacturing platforms informally and manufacturers have not had an opportunity to engage FDA and receive regulatory feedback in a context of existing FDA meetings including INERACT, Type B or C meeting, as these meetings are primarily designed to provide regulatory feedback in the context of a well-defined product and its indication of use.

To provide a mechanism by which manufacturers can receive individualized, substantive regulatory feedback about their advanced platform technologies, independent of a specific product or an indication, FDA/CBER has initiated a new program entitled “CBER Advanced Technologies Team” or CATT. This program in CBER provides yet another example of the agency’s willingness to discuss innovative emerging technologies in the development, manufacturing and testing of the drug products at FDA. 

As FDA notes, the purpose of CATT is to promote dialogue and education, between CBER and prospective innovators/developers of advanced manufacturing technologies. This goal is expected to be accomplished through discussion of, and responses to, inquiries pertaining to advanced manufacturing and analytical testing technologies “for those products or classes of products for which the center has limited experience”.

Manufacturers are encouraged to engage CBER by submitting information about their platform, why this technology is uniquely positioned to address manufacturing and product testing challenges, and how it could potentially impact the field, along with a summary of the manufacturing and development plan. The request should not exceed two pages and should be submitted to FDA electronically to Industry.Biologics@fda.hhs.gov.