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 ...

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 ...

Early on, the drug substance (DS) manufacturer will provide a wealth of preliminary characterization data. And if the drug is active in early nonclinical and preclinical testing, a larger quantity of ...

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

Dave Miller, PhD, explains how early formulation planning, novel platforms, and tailored approaches secure long-term protection against generics. In this final part of our 5-part interview series on ...