Formulation development plays a central role in transforming a drug substance into a safe, stable, and effective therapeutic product. As biologic therapeutics continue to expand across the pharmaceutical industry, the need for specialized formulation strategies has become increasingly important to support product stability, manufacturability, and patient safety. Unlike traditional small-molecule drugs, biologics such as monoclonal antibodies and recombinant proteins are highly sensitive to environmental conditions, excipients, and manufacturing stresses. These unique challenges make formulation development a key factor in determining a biologic’s shelf life, delivery method, and overall clinical and commercial success.
In a recent article from Contract Pharma, our Director of Process Characterization, Eliza Yeung, PhD, shares the advantages of integrated, QbD-guided formulation development and key strategies for minimizing risk and maximizing success.
Read the full article here.