Innovation and Quality by Design

QbD Beyond Manufacturing

Quality by Design (QbD) is a well-known concept in regulatory circles. The FDA “strongly encourages” all ANDA applicants to use a Quality by Design approach. Similarly, the European Medicine Agency (EMA) has been pushing QbD concepts heavily in recent years.[...]

Case studies


Case Study - University of North Carolina

School of Medicine

Researchers at the University of North Carolina School of Medicine needed testing, scale-up and manufacturing of intra-nasally administered Oxytocin for a clinical study involving children with Autism. The research, funded by NICHD (National Institute of Child Health and Human Development), originally involved a commercial pharmaceutical company.[...]

white papers


Topical Drug Delivery Considerations for Biologics

According to the analyst firm Global Information, the demand for biologics and biosimilars is estimated to grow to more than $100 billion in 2015, continuing the double-digit growth rate seen in the last decade. As the industry continues to grow, alternative delivery methods are of increasing interest—particularly the topical delivery of large molecules. [...]