To date, over 79 therapeutic mAb have been approved by the US
FDA as marketable drugs
15
. The research devoted to developing
more effective mAb-based biotherapeutics continues to grow. In
addition to supporting the identification and discovery of potential
new targets, it is equally important to monitor the formulation
for stability and aggregation of the mAb target molecules early
on in the drug development process. While there are many
methodologies available to monitor stability, it is important to
select the one(s) that best address your needs. Some key features
to consider are sample size, the addition of an extrinsic reagent, the
time to results, throughput needs, and assay costs. Additionally,
proper formulation needs to be optimized to keep the drug
product stable during storage.
Collectively, selecting the best methodology, along with a clear
understanding of the various factors that impact stability, helps to
accelerate the mAb development process and bring more effective
biotherapeutic drugs to patients sooner.
Conclusion
