In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about the continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.
Strong Leadership
Coordinates between key stakeholders
Drives on-time schedule completion
Expects the unexpected
Coordinate Communications
Ensure platforms are compatible
Strategize formal and informal communication during the process
Technology
Choose an intuitive video conferencing platform w
These common terms are often used incorrectly.
What is the impact of the Delta Variant?
A comparison of two types of cell sources. Key considerations for scale up for cell and gene therapy.
Regulations mandate that methods for analysis of drug substance and drug product are stability indicators.
When considering a CDMO partner keep in mind your future needs.
A graphic representation of the FDA’s Emergency Use Authorization Process.
Instituting good documentation policies early on when developing your biologic drug product can save time and distress when putting together your regulatory submissions.