6
What's in a formula?
Developing antibody
formulations with
stability in mind
Protein stabilization during mAb manufacturing and long-term storage presents a challenge
for pharmaceutical scientists. The antibody drug must be formulated to ensure that
the proper dose of active antibody reaches the correct site of action in the body upon
administration, and that the drug is stable during storage. Formulation development
should be initiated as soon as product is available—even product from process
development activities that may not fully represent the final process
1
. Generally, product is
available 4-5 months a er drug discovery; at this point pre-formulation development takes
place, followed closely by clinical formulation development. Mixtures of several excipients
(pharmacologically inert substances that may provide benefits when used with active
ingredients) are generally required to stabilize mAb. Therefore, scientists must test several
formulations when producing potential therapeutics using various pH conditions, ionic
strengths, buffering agents, and stabilizing agents.
2
