Formulation
No matter what kind of biologics you're working on,
chances are, you have to optimize their final formulation.
This is the buffer environment the biologic will be stored
and/or delivered in.
Formulation work is an additional screening step that looks
at different pHs, buffer systems, and additives. Entire buffer
screens have been developed to expedite this process,
but that means another round of narrowing down the best
option – this time, for the chemical environment
of your candidate.
Choosing one buffer over another once again requires
examining the subtle changes to the thermal unfolding
profile of your biologic. In many cases, this goes beyond
simply evaluating increases in T
m1
, and instead evaluating
the overall thermal stability profile. Additives may have a
modest but meaningful impact on stability, so it's of
continued importance to have high-resolution data
to evaluate.
