Excipients for Respiratory Delivery of Biologics

Excipients play a crucial role in the stability, safety, and efficacy of these therapies.

Register Free: https://www.pharmtech.com/pt_w/respiratory-delivery-of-biologics

Event Overview:

Local administration of biologic Active Pharmaceutical Ingredients to the lung via inhalation has grown in recent years. Dry and liquid dosage forms of protein-, peptide-, and nucleic acid-based therapies have been developed for respiratory delivery in clinical trials and as final commercial products. Excipients play a crucial role in the stability, safety, and efficacy of these therapies. However, there are still some challenges surrounding excipients within the respiratory arena, mostly driven by regulatory and technical aspects. This webinar will cover:

• Regulatory landscape for respiratory excipients
• Role of excipients in biologic API stabilization
• Specific considerations for formulating liquid and dry dosage forms
• Challenges and opportunities for respiratory excipients

Key Learning Objectives:

• Understand the regulatory status of key inhalation excipients
• Recognize the role of excipients in stabilization of biologic APIs
• Differentiate between the formulation needs of liquid and dry powder dosage forms for inhalation

Who Should Attend:

• CMC leads
• Biotech CSOs
• Principal Scientists
• Analytical and Formulation Chemists

Speakers

Kimberly Shepard, PhD
Director, Respiratory Delivery
Lonza Small Molecules

Kimberly Shepard, PhD, is the Director of Respiratory Delivery at Lonza Bend, leading a group which specializes in dry powder inhaler delivery of small and large molecules to the lung and nose. Prior to this role, Kim worked in the research and development group at Lonza Bend for 8 years, on programs involving the spray drying of proteins, amorphous solid dispersion formulations for solubility enhancement, and the spray drying process development. Kim obtained her PhD in chemical and biological engineering from Princeton University, focusing on polymer physics and amorphous materials. She earned her B.E/M.E from Stevens Institute of Technology, also in chemical engineering.

Michael Shultz, PhD
Inhalation, Respiratory Delivery
Lonza Small Molecules

Michael Shultz, PhD, is a Manager for Respiratory Delivery at Lonza Bend, focusing on formulation and characterization of spray-dried biologics for respiratory delivery. Prior to working with Lonza, Michael worked in various capacities in the biotechnology industry, academia, and government for nearly 20 years. In these roles, he primarily focused on high-throughput nucleic acid and protein diagnostics research and development. He obtained his PhD in pharmacology and toxicology from the University of California, Davis, focusing on species susceptibility differences by cytochrome P450-activated lung toxicants.

Diana Fernandes, PhD
Technical Project Lead
invoX Belgium

Diana Fernandes, PhD, is a founder of and consultant at OnResp, Copenhagen, Denmark, currently working as a Technical Project Lead at the invoX Respiratory Innovation Center of Belgium. She is responsible for the portfolio of innovator and research programs of soft mist inhalation combination products (biologics and small molecules). She also works with respective teams and supply chain, from early-stage development to regulatory submission. Previously, Diana worked within the pharma contract development and manufacturing organization sector. She also has experience with research and development services as a Drug Product Development Scientist at Hovione Farmaciência, Lisbon/Loures, Portugal. Here, she led the experimental design, tech-transfer, and scale-up development of dry powder inhalation programs, namely formulation and spray drying processes of biological clinical products, from lab to pilot and production. She earned her industrial PhD in pharmaceutical technology from Faculty of Pharmacy, University of Lisbon in collaboration with Hovione Farmaciência. She also holds an MSc and BSc in biological engineering from Instituto Superior Técnico, University of Lisbon, Portugal.

Register Free: https://www.pharmtech.com/pt_w/respiratory-delivery-of-biologics