CordenPharma—A QbD Approach to Identify Critical Attributes
CordenPharma International (CPI) is a full-service CDMO offering pharmaceutical services organized under six technology platforms including highly potent, oncology, peptides/lipids/carbohydrates, injectables, small molecules, and antibiotics.
Its formulation development and manufacturing expertise centers on oral formulations, for tablets, capsules, and a combination of the two. Oral formulation capabilities complement expertise in sterile drug products that range from liquids and emulsions to lyophilized and powder-filled products, explains Dr. Roberto Margarita, Director, Global Antibiotics& Oncology Platforms, CPI.
CordenPharma’s development studies are performed according to the Quality by Design (QbD) approach based on scientific understanding. “We use this methodology to construct the best quality target profile and to identify and confirm the quality critical attributes. In so doing, we deliver process knowledge at multiple levels to achieve product quality, characteristics definition, and process parameters for our customers,” says Dr. Margarita.
CPI is helping one customer bring a glycol-free formulation of a lyophilized oncology product to market, which will improve the safety of the drug and its applicability to patients who can’t access it due to undesired side effects, says Dr. Margarita.
Read the full online article here.
Read the full online issue, April 2015, Volume 15 of Drug Devlepment & Delivery here.