Webinar:

Reducing Inhalation Burden Through High-Dose, Carrier-free Spray Dry Powders

Sponsored by: Catalent Pharma Solutions

Focused on:

  • Spray Dry Powders

Date: 13 July

Days to go: 30

Time: 10AM Los Angeles / 1PM New York

As industry adoption of Dry Powder Inhaler (DPI) treatments continues to grow, drug developers need to balance powder performance characteristics with patient considerations. Historically, carriers have been used to facilitate flowability, aerosolization and dispersibility by attempting to keep small API particles from sticking to one another. However, a significant proportion of API often remains adhered to the carrier during inhalation. In order to achieve sufficient deep lung delivery, correspondingly larger doses may be required potentially leading to higher patient burden and lower compliance.

This Catalent webinar will explore how spray dried particles provide an attractive, carrier-free option for highly dispersed delivery of API to deep lung regions, utilizing an alternative approach to large, porous particles. The speakers will discuss how spray dry methodologies can generate light, low-density and aerodynamically favorable particles and will look at the technologies that are enabling high dose loading of DPI capsules.

Acorda Therapeutics will discuss their ARCUS® platform, geometric and aerodynamic particle size distributions (GPSD/APSD) and how they were able to make large, high surface area particles penetrate the lungs like small particles, enabling higher dosage. Catalent will talk about spray dry versus micronization for inhalation and explain how to optimize drying kinetics to maintain Target Product Profiles (TPPs) during scale-up activities. Catalent will also discuss more generally the impact that scale-up and tech transfer can have on the relationship between Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) based on experience from inhouse scale-up capabilities. Additionally, Catalent will also discuss techniques used to reduce processing steps and increase the Fine Particle Fraction (FPF). Lastly, Harro Hofliger will talk about using high-speed lines for spray dry powders, the associated challenges and how to optimize relevant process parameters.

Following the talk, the panel of industry experts will address Q&A in a roundtable format. Register early to submit your question to the panel!

ARCUS is a registered trademark of Acorda Therapeutics, Inc.

Presented by

Fahad Gilani,

Lead Research Engineer at Catalent, Boston

Fahad has 7+ years experience in spray dried Drug Formulation for DPI, Pharmaceutical Process Development, and Process Scale-up. He has headed cross-departmental projects in understanding the large-scale Pharmaceutical Spray Drying, Filling, and Packaging unit operations at Catalent’s Boston site using a statistically robust DOE approach that was successfully defended in front of the FDA. He was a major contributor in internal inhaled dry powder manufacturing scale-up efforts. As for lab scale work, he has worked extensively on novel spray dried drug formulations for DPI and lab scale investigations of fundamental spray drying questions. Fahad holds a BS degree in Chemical Engineering from University of Massachusetts Amherst.

Kelley Muise,

Director of Quality Control at Catalent, Boston

Kelley has 15+ years experience in Analytical Development and Quality Control supporting GMP Manufacturing. She has contributed to production scale-up, process qualification and process validation activities for both Clinical Phase and Commercial manufacturing of DPI technologies. She currently works with Quality Control team to provide technical expertise and support for particle engineering and production scale up of spray dry processes as well as DPI optimization. Kelley holds a BS degree in Chemistry from Villanova University and a MS in Chemistry from University of Saint Joseph.

Kevin D. Kee,

Executive Director, Analytical Development and Quality Control at Acorda Therapeutics

Since 2001, Kevin has held key roles in the development, manufacture and characterization of multiple DPI candidates spanning early phase/POC/tox through commercial. Kevin was directly involved in the development of Inbrija® from the POC stage to an approved commercial drug product in both the US and EU markets. During the same period, he helped drive the development of several other DPI candidates formulated with small molecules to large proteins with various clinical success spanning early to late phase milestones. Kevin holds a bachelor’s degree in Biology with a minor in Mathematics from Northeastern University.

Michael Tauber,

Associate Director, Pharmaceutical Development and Technical Operations at Acorda Therapeutics

Since 2002, Michael has worked in various areas of pharmaceutical development including early and late stage development, pre-formulation and formulation for solid oral development, formulation and scale up of spray dried engineered particles for inhalation delivery and management of CMC related activities supporting the development and commercialization of Inbrija®. Additionally, he has served as the solid state chemistry technical lead on numerous projects over the years and has established solid state labs as well as instructed many peers on this topic. More recently he has managed all aspects of the extractables and leachables program for Inbrija® through NDA/MAA approval. Michael holds a B.S in Chemistry from UMass Boston and an M.S. in Chemistry from Northeastern University.

Patrick Goncalves,

Senior Sales Manager, Inhalation Technology at Harro Hofliger

Patrick has been working as a sales engineer in the pharmaceutical industry for more than 7 years now. He has experiences in the field of capsule filling, in the handling of various powder properties and also in the world of dry-powder inhalation. Patrick holds a bachelor degree in business administration and a MBA in sales engineering.


Key Learning Objectives

  • Explore methods enabling higher dose loading
  • Understand the advantages of spray drying for inhaled powders
  • Address factors to consider for scale-up and powder handling

Audience

  • Director or Senior Manager or VP of Formulation/Development
  • Senior Scientist
  • CMC Manager
  • Principal Scientist
  • Head of Formulation
  • Project Leader
  • Global Technology Director
  • Senior Scientific Investigator
  • CEO/CSO
  • Operations or Quality