TUESDAY, MARCH 5 AND WEDNESDAY, MARCH 6
DAY 1: 1:30PM – 6:00PM | DAY 2: 8:30AM – 5:30PM

TS2:
Monitoring and Control of Particulates, From Aggregates to Visible Particles

Instructor: Patricia Winter Cash, Ph.D., Independent Consultant

Objectives:

This 1.5 day class will present a comprehensive overview of the latest research on particle formation, analysis, and control in Biopharmaceutical Development and manufacturing. Formation of protein particles is recognized as an inherent quality attribute. All proteins therapeutics contain particles of varying sizes. This class will explore the causes of aggregate formation, mitigation strategies and regulatory expectations for all size particles, from dimers to large visible particles. Methods of characterizing the particles will be explored, as well as the latest regulations on particle control and how a company can meet those expectations. Visible and sub-visible methods used for QC Release and stability testing will be discussed. The emphasis will be on practical solutions to control sub-visible and visible particles, but smaller aggregates will also be discussed.

Topics to be Covered:

• What are the regulations concerning visible particles? Do they vary by country? What about new regulations in US, China, Russia, Japan, etc.?
• Why should regulations around particle presence in protein products be any different than small molecule products? What about visible particle testing for lyophilized products or filled devices?
• How do aggregates form? Do larger particles always form from small aggregates further aggregating together?
• What are the analytical test methods for particles of different sizes? What methods are used to characterize particles?
• Do we need to have a release test for 2-10 micron particles?
• What is the danger of particles in the body? What size particles are most dangerous clinically?
• Why do we do a QC release test for visible particle after performing an AQL? What is the purpose of the release test?
• If we see a particle in a protein product, do we always need to characterize it as proteinaceous?
• What are some of the current particle findings and trends in the biotechnology industry?

Who Should Attend:

This course is a must for analysts involved in release testing of biotherapeutics, particularly visible appearance testing for QC release and stability. Regulatory and QA professionals as well as Biopharmaceutical Development and Manufacturing Professionals and Management will also benefit from discussion of the latest trends and cross-cultural Regulatory expectations.

The manufacturing control of particles through AQL will be discussed but the course emphasizes the product development and registration aspects of particle analysis.

About the Instructor:

Dr. Patricia W. Cash, Ph.D. is a senior leader with over 25 years experience in all aspects of analytical development, specification setting, quality control testing and preparing and defending regulatory filings. She has served as senior director in the Analytical Biochemistry Department at MedImmune, where her group was responsible for developing and implementing analytical methods used for characterization, lot release, and in-process testing of all protein projects at various stages of development. She was also a director of analytical development at Sanofi Pasteur and worked as a scientist at BMS. She is currently an independent consultant, working with multiple biotechnology companies. She is an expert in visible particle identification and control, particularly in protein-based products (as confirmed by winning of the 2016 Fred Simon award for a paper on visible particle analysis).

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.