Course Description:
As a company producing Oral Solid Dose drug product, how can Pharmaceutical Continuous Manufacturing (PCM) solve specific problems and help your business thrive? This webinar will guide you along the many advantages of PCM and how to achieve them. We will warn about barriers to adoption, and highlight business strategies specific to your organization.
Innovator Companies
Improve the cost profile of an existing product or solve specific issues with a product. Developing a new product immediately in a continuous process can speed to market and reduce transfer and commercial manufacturing costs.
Generics, OTC, Nutraceutical Companies
To deal with low margins, high competition, and a large and diverse portfolio, flexible batch size PCM can help cope with unpredictable volumes: strong process knowledge will minimize firefighting and product losses.
CDMOs
Outsourcing plays a great role to bridge the period of uncertainty in bringing a product to market for innovators or lower the investment risk for companies ready to start with a Continuous Manufacturing process. CDMOs need a flexible solution that helps them serve a broad customer base. We will discuss how this can be done and the best moment to start.
Learning Objectives:
- Understand business case drivers, which choices to make, and when to implement PCM
- Develop a starting point to build a business case for using PCM for OSD drug product in various situations
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH. : Decision-makers for PCM – innovators, OTC, CDMOs; VP R & D; Manufacturing; Senior R & D; head of technology; CTO; COO; Technical services; technical operations; CFO; Finance
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.