Using micro-dosing technology and powder-in-capsule (PIC) or bottle (PIB) approaches, biopharmaceutical companies have the ability to increase speed to clinic, quickly assess their candidate compounds, and remain cost-conscious in early stage development. Lonza has utilized its Xcelodose® Precision Powder Micro-dosing Systems and PIC/PIB approaches to advance hundreds of compounds to phase I across a myriad of API parameters. Best practices have been developed for a number of PIC challenges expanding the overall application space for micro-dosing. Best practices have also been developed for rapid scale-up from Xcelodose systems to larger volume encapsulation systems such as the Harro Hoefliger Modu-C.
The following topics will be discussed in this webinar:
- Micro-dosing systems and potential time and cost savings
- PIC / PIB best practices with a focus on neat API in capsule approach
- Rapid encapsulation transfer from clinic to commercial scale
Attendees working with an oral solid dosage development and manufacturing will benefit from this educational webinar. This webinar will also be informative to attendees with responsibilities for rapid first-in-human studies with oral solid drug product.