CRDMOs offer a continuum of services from early discovery to clinical manufacturing, addressing solubility and stability challenges in NCE development. Advanced technologies like spray drying and ...

Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...

Stability is a critical factor in drug formulation, with implications for product quality, lifecycle management, and ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

Siddhant Sojitra, Alexion, defines in an AAPS PharmSci 360 2025 presentation an agitation model to reliably test stability for early-stage biologics. Mechanical stress testing is essential because ...