Due to their size, nature, and biological origin, biologics or biopharmaceuticals are inherently complex in terms of quality attributes. Establishing and monitoring the quality attributes of a biologics is essential to ensure its efficacy and safety.

Frontage offers the technical expertise and state-of-the-art instrumentation necessary for biologics characterization and analytical method development/validation. The biopharmaceuticals Frontage has supported include polysaccharides, fusion proteins, monoclonal antibodies, antibody drug conjugates (ADCs), vaccines, and gene therapy products.

In this white paper, we introduce the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, Sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.

Frontage’s CMC portfolio of services spans drug product development, analysis, delivery and supply, from proof-of-concept, preclinical stages through Phase III clinical trials and commercialization support. With proven success in developing drug products for novel, generic and consumer products, we focus our efforts on clients’ specific needs.

Our formulation development experience and capabilities cover a wide range of dosage forms at IND, NDA, ANDA and 505(b)(2) project stages and applications.