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.

Featured Speakers

Mark Cappucci

Team Leader, Preformulation Product Development
Lonza

Since 2004, Mark Cappucci has been a Team Leader of Preformulation Product Development for Lonza Pharma & Biotech. Mark’s expertise focuses on drug substance characterization, polymorph identification and micro dosing techniques. Mark has 23 years of Pharmaceutical experience and holds a degree in Chemistry for the Ohio State University. 

Alyssa Botta

Process Engineer II, GMP Manufacturing
Lonza

Alyssa is a Process Engineer with a background in pharmaceutical manufacturing of oral solid dosage forms. Experience with Powder in Capsule / Micro-dosing from feasibility stages through registration and preparation of validation (Process Performance Qualification) batches. 

Rebecca Henry

Process Engineer, GMP Manufacturing
Lonza

Rebecca is a Process Engineer with a background in pharmaceutical manufacturing of oral solid dosage forms and equipment validation. Experience with Powder in Capsule / Microdosing from Xcelodose through preparation of validation (Process Performance Qualification) batches with the Harro Hoefliger. 

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