20 Critical Questions: Helping You Optimize Reference Standards For Your Biopharmaceutical Across Its Development Life Cycle

Biopharmaceuticals hold immense promise for treating a wide range of diseases. However, guaranteeing their quality and consistency throughout development and production presents unique challenges. This white paper explores a critical element of biopharmaceutical quality control: reference standards.

Unlike traditional small molecule drugs, biopharmaceuticals are far more intricate, making their characterization for reference purposes a nuanced task. Further complicating matters is their inherent biological instability, necessitating specific storage conditions and well-defined replacement strategies.

To navigate these complexities and ensure a smooth manufacturing process, a comprehensive reference standard strategy is paramount. This white paper proposes a tiered approach, strategically utilizing secondary standards for routine testing while reserving precious primary standards for critical applications. Notably, the ideal reference standard for a biopharmaceutical evolves throughout its life cycle, demanding a flexible strategy that adapts to its changing purpose.

The paper also highlights a significant hurdle in the biopharmaceutical industry: the scarcity of formal guidance on reference standards. To address this gap, the paper calls for more standardized practices, emphasizing their importance in safeguarding patient safety.

By addressing these crucial considerations, researchers and manufacturers can ensure the integrity of biopharmaceutical products, ultimately paving the way for better patient outcomes.