The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. For example, an intranasal mAb formulation is in phase 1 clinical trials for progressive Multiple Sclerosis.
This course will address the challenges associated with formulation and clinical trial manufacture of biologics for delivery to the nasal cavity. The course will also highlight barriers to cell penetration and absorption and identification of an ideal target product profile.
The pros and cons for liquid versus powder formulations will be discussed. In addition, the course will focus on strategies for maintaining stability and prolonging retention in the nasal cavity. Device selection for preclinical and clinical studies using predictive tools such as nasal casts will be presented.
Finally, the session will help prepare the audience with manufacturing strategies for clinical trials with a nasally administered biologic.
Agenda
Challenges and Opportunities
- Define biologics scope
- Challenges to target cells and/or achieve absorption
- Overcoming barriers
- Identify target product profile
Jag Shur, Nanopharm
Formulation Strategies
- Liquid vs powder formulations (pro/cons and formulation development techniques overview)
- Stabilizing biologics
- Retention and targeting strategies
- Case studies
Irene Rossi, Nanopharm
Delivery to the Patient
- Device selection
- Bridging animal and human studies
- Nasal deposition
- Supporting care with training and digital health applications
Julie Suman, Aptar Pharma
How to Get Ready for a Clinical Trial with a Biologic
- Drug product manufacturing
- Drug product release testing
- Stability studies
- Regulatory considerations
Paul Shields, Enteris BioPharma, Inc
Q & A Discussion
Speakers
- Jag Shur, Nanopharm
- Irene Rossi, Nanopharm
- Julie Suman, Aptar Pharma
- Paul Shields, Enteris BioPharma, Inc
Who Should Attend
- Research and Development
- Formulation Development
- Clinical Development
- CMC Managers
- Program Management
- Development Engineers
- Clinical Trial Manufacturing
