MONDAY, APRIL 25, 8:30 AM-5:30 PM –
TUESDAY, APRIL 26, 8:30 AM-12:30 PM
Instructors:
Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Donald E. Kerkow, Ph.D., Associate Director, Biopharmaceutical Development, KBI Biopharma Inc.
The course focuses 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 liquid and lyophilized products.
Topics include:
- 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
Instructor Bio:
Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Tim Kelly 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 he 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.
Each CHI Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and NOT engaging in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.