2019 Archived Content

DAY 1: 2:00 - 5:30 PM | DAY 2: 8:15 AM - 6:05 PM
Room: Aqua 314

TS10B: Introduction to Biologics Formulation Development


Donald E Kerkow, Ph.D., Director, Biopharmaceutical Development, KBI Biopharma, Inc.

CHI’s Introduction to Biologics Formulation Development training seminar focuses on strategies to plan and execute preformulation and formulation development studies for biologics. Such projects require co-optimization of multiple physical, chemical, and conformational stability attributes under accelerated timelines to ensure rapid delivery of a stabile product to the clinic. The seminar begins with an overview of biophysical and biochemical properties of proteins and protein structure, setting the stage for the concepts and goals at the core of protein formulation. The course then continues with an exploration into the theory and application of the relevant analytical and biophysical techniques that support preformulation and formulation development studies. The primary focus of the seminar is an in depth discussion of typical formulation development workflows, including statistical analysis and use of DoE. The formulation development section of the course then concludes with examination of real-world case studies. Attendees of the training seminar should leave with a greater understanding of the biologics formulation field, in general, as well as with specific knowledge and strategies for setting up successful formulation development studies in their own labs.

Topics Include:

An Introduction to Biologics Formulation Development

Overview of Proteins

  • Chemical Properties
  • Folding and Structure
  • Degradation Pathways

Techniques for Analyzing Proteins

  • Biophysical Methods
  • Analytical Methods
  • Forced Degradation Studies (Includes 2 Case Studies)

Biologics Formulation Development

  • Buffers and Excipients
  • Routes of Administration
  • Preformulation Development
  • Design of Experiments (DoE)
  • Liquid Preformulation Case Study
  • Lyophilization Development (Includes 2 Case Studies)
  • Final Dosage Form Development and Considerations

Instructor Biography:

Donald E. Kerkow, Ph.D., Director, Biopharmaceutical Development, KBI Biopharma Inc.

Don Kerkow has over 15 years research experience with a strong emphasis on protein and nucleic acid biochemistry, protein structure and function, formulation and characterization of biopharmaceuticals, and recombinant protein expression and purification. In his role at KBI Biopharma, Don is responsible for formulation development, analytical development, characterization, comparability/biosimilarity studies, and quality control functions. In the realm of formulation development, Don and his team over the past 6 years have successfully developed liquid and lyophilized formulations for over 25 different clinical biopharmaceutical products ranging from high concentration (>200 mg/mL) mAbs to very low concentration enzymes, and including unique molecules like PEGylated growth factors and engineered peptide fusions. Because KBI Biopharma believes successful formulation development is inexorably linked to a deep understanding of the molecule’s analytical profile, Don and his team are directly involved in the biophysical, biochemical, and QC analytical characterization of the formulated products they develop. Don earned his Ph.D. in Biochemistry from the Scripps Research Institute in La Jolla, CA.

Training Seminar Information

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 engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.