Course Description:
Continuous processing is a viable alternative manufacturing method to batch production for small-molecule API. This webinar provides exploration of Pharmaceutical Continuous Manufacturing (PCM) specifically tailored for Drug Substance (DS) manufacturing.
Participants will delve into the principles, technologies, current landscape, risk and challenges associated with the adoption of PCM technology in the development and manufacture of drug substance.
PCM for Drug Substance per ICH Q13
We will revisit the ICHQ13 for a closer look on the definitions and fundamentals of PCM drug substance processing.
What technologies are available for DS PCM
Review of the available unit operations for DS, including equipment choices and selection criteria.
The current PCM DS landscape
What do we know today about products in commercial manufacturing, publications, and literature?
Challenges to adoption
We will examine recognized implementation hurdles for PCM DS applications.
The business case for PCM DS
A closer look at PCM business cases for drug product and for drug substance.
Who should participate:
Professionals involved in drug substance development and manufacturing, including decision-makers, head of R&Ds and manufacturing, process chemists, process engineers, analytical scientists, manufacturing, and quality specialists.
Individuals interested in understanding and exploring adoption of PCM technology on drug substance part.
Though this course is being made available on USP’s
Education site, the course content was developed by Pharmatech Associates, a
USP company. USP has not independently reviewed or verified the accuracy
of the course content.