TRAINING SEMINARS *
Introduction to Biologics Formulation and Delivery
The course will focus on strategies to plan and execute preformulation and formulation development studies for biologics, which require co-optimization of multiple physical, chemical and conformational stability attributes while operating under accelerated timelines to deliver the drug to the clinic. The course begins with an overview of biophysical and biochemical properties of proteins. A typical development workflow (including statistical analysis and DOE elements) will be outlined to demonstrate the core elements employed during protein formulation. The course concludes with real-world examples from formulation development projects for both liquid and lyophilized products.
- Basics of protein biochemistry, with focus on folding mechanism, stability and structural hierarchy
- Degradation pathways relevant to biologics shelf life
- Biophysical and analytical characterization tools
- Typical workflow for biologics formulation development projects
- Introduction to common delivery devices
View sample slides from this training seminar presentation
Pooja Arora, Ph.D., Senior Manufacturing Technical Specialist, Genentech-A member of the Roche Group
Pooja Arora is a Senior Manufacturing Technical Specialist in the Global Biologics Manufacturing Science and Technology-Drug Product at Genentech. Pooja has more than twelve years of experience in protein biophysical and analytical characterization. Her responsibilities at Genentech include technical transfer of commercial Drug Product manufacturing process to both internal and external manufacturing sites. Pooja has extensive experience in development of robust drug product and manufacturing process for protein therapeutics, including identification of optimum formulation conditions that impart stability to achieve the desired shelf-life, use time stability and selection of primary packaging components. At KBI Biopharma, Pooja was the technical lead for projects that focused on preformulation/formulation development and stability studies. Pooja earned her Ph.D. in Chemistry from Duke University.
Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Tim has over 20 years of experience in protein and nucleic acid characterization. In his role at KBI Biopharma, Tim is responsible for analytical development, formulation development, and quality control. Prior to joining KBI Biopharma, Tim held the position of Director of Quality Control for Diosynth Biotechnology, where we was responsible for method validation, in-process control, release, and stability of clinical and commercial biopharmaceutical products. Tim’s experience also includes the analytical development, formulation development, characterization and/or production of more than 200 clinical and commercial protein therapeutics, including monoclonal antibodies, enzymes, cytokines, fusion proteins, PEGylated proteins, protein vaccines, and peptides. Tim has led the successful formulation development of over 95 clinical and commercial biopharmaceutical products, including liquid and lyophilized dosage forms for intravenous and subcutaneous administration, at protein concentrations ranging from 10µg/mL to 200mg/mL. Tim earned his Ph.D. in Molecular Genetics & Biochemistry from Georgia State University.
Course Information: Each course is 1.5 days, and lunch is provided on the first full day. Course attendees will each receive a handbook with instructor presentation materials.
* Separate registration is required.