Understanding CMC Challenges
in Vaccine Development
Author:
Zeb Younes
Head of CMC & Principal Consultant
The COVID-19 pandemic has led to unprecedented public investments, at-risk investment in (clinical) development and manufacturing, and the streamlining of regulatory processes, resulting in rapid, focussed, and collaborative development of COVID-19 vaccines and acceptability of new vaccine platforms.
Moving forward, these experiences and the lessons learned may also be applied for vaccine development in general. With our multidisciplinary team of development experts, Scendea has contributed extensively to (COVID-19) vaccine programs. All aspects in this respect were (and continue to be) supported: regulatory, clinical, nonclinical, and chemistry and controls (CMC)).
In this whitepaper we focus on and summarise some of the commonly encountered CMC issues and provide guidance to developers how to avoid these…