Course Description

Protein Formulation and Stability

June 10-11, 2020
Edison, NJ

Course Offering 200610NJ2885
Course ID 2885

In-Person Course

Who Should Attend?
This course is intended for professionals in the Pharmaceutical, Biopharmaceutical, Diagnostic and Vaccine industries , especially those working in departments such as: Chemistry, Biochemistry, Analytical, Engineering, and Biology. Chemists, Biochemist, Biologists, Formulators and Engineers working in product and process development and engineering will benefit greatly by attending this intensive training.

Course Description
Many of the new molecules being developed by pharmaceutical and diagnostic discovery groups are biologically based, including monoclonal antibodies, proteins, enzymes, etc. Unlike small molecules, these products are much more sensitive to the normal stresses that a product encounters both over the shelf life of the product and during the manufacturing process.

Both the formulation (stabilizers, surfactants, proper pH) and how the product is processed (reduced oxygen, lyophilization, spray drying, minimizing shear, and others) can have an impact on the success or failure of a product.

This 2-day, accredited training will begin with a brief overview of basic protein chemistry and degradation pathways followed by a short discussion on the different upstream techniques for growing and purifying the biomolecules of interest. The requirements for starting the development process will then be broken down followed by an in-depth discussion of the analytical tools necessary for development and finished product testing. A discussion on the formulation development process for a biomolecule will be had, which will cover pre-formulation and formulation development strategies utilizing high throughput screening techniques. Process development will be discussed, including product compatibility with manufacturing equipment/product contact components, and lyophilization and spray drying as a means of long-term stabilization. A section will be dedicated to discussing the importance of container closure systems and potential interactions with the product, followed by a discussion on aggregates and particulate matter issues and concerns.

Course Director
J. Jeff Schwegman, Ph.D., Founder and CEO, AB BioTechnologies

J. Jeff Schwegman, Ph.D. is the founder and chief executive officer of AB BioTechnologies where he manages the day to day operations of the company.

Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization. Dr. Schwegman received his Ph.D. from Purdue University in 2003 and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. He specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules.

In November 2005, he left Baxter and formed a life science company which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he formed AB BioTechnologies.

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Course Director
Dr. Marie-Eve Beaulieu, Co-founder and Chief Scientific Officer, Peptomyc S.L.

Dr. Marie-Eve Beaulieu, is Co-founder and Chief Scientific Officer, Peptomyc S.L. Dr. Beaulieu has a strong background in R&D project management and coordinates the scientific team at Peptomyc. Her experience in biochemistry and peptide and protein structure and production enabled her to manage the in-house and outsourced scientific activities at Peptomyc since 2014. Marie-Eve developed the manufacturing protocols for OMO-103 (Peptomyc’s innovative proprietary cell-penetrating Myc inhibitor) at lab scale and oversaw its swift implementation at the manufacturing CRO. She also previously worked in the pharmaceutical industry (Theratechnologies Inc.) where she contributed to the development and study of novel formulations for a now commercialized peptide-based drug. Marie-Eve co-authored 4 patent applications, 19 peer-reviewed publications (two as corresponding author), was awarded 9 prizes for presentations and recently (June 2018), a young entrepreneur award.

Venue Information
ExitCertified (Attune formerly Microtek)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey 08837
Phone: 800-207-9620 (for directions and parking info only)

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.

Directions: Visit the Hotel Venue topic on our FAQ page.