Wednesday, August 17, 2016
Location: Agensys, Inc.
1800 Stewart Street, Santa Monica, CA
Host: David Steinberg, Director, Engineering & Facilities, Agensys, Inc.
Program Managers: Justin Cantor, Director, PSC Biotech
Paul Crissman, Principal, Biotechnical Solutions
Speaker: Dr. Fiona Greer, SGS Life Sciences
5:45 – 6:30 pm Registration and Networking Reception with Appetizers
6:30 – 7:30 pm Program
7:30 – 8:00 pm Q&A and Networking
Biosimilar development requires initial comprehensive characterization of the target molecule to determine the exact structure, post-translational modifications and variability of quality attributes to establish the Quality Target Product Profile (QTTP). The engineered biosimilar should match this profile.
For regulatory approval, comparative data for the biosimilar side-by-side with the originator is required. Initially this includes both structural and functional activities.
Analytical strategies for primary and higher order structure determination will be discussed particularly for antibodies where their size and complexity requires LC/MS/MS approaches. Appropriate orthogonal analytical techniques which address regulatory requirements for “finger-print like” assessment, both conventional and emerging technologies, will be reviewed.
Dr Fiona Greer was a founding Director of M-Scan (Mass Spectrometry Consultants and Analysts), contract analytical laboratories specializing in biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences.
Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) she joined M-Scan to establish and direct biologics characterization services. Here, she pioneered and applied new developments in Mass Spectrometry for structural analysis and sequencing of proteins and carbohydrates resulting in numerous publications and patents. She was instrumental in expansion of the group, establishing a US facility where she was appointed VP.
With over 35 years experience in glycoprotein analysis using mass spectrometry and other instrumental techniques, she has been involved with a diverse range of biotechnology products, both novel and biosimilar and consults to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings. In 2016 she was named in the Medicine Makers “Power List – Top 100 influencers”.
Free for Agensys Employees: Please register prior for the event so we have enough food for the group and can prepare name badges.
________$60 ISPE Members
________$25 Students and Government (and additional Agensys employees)
________$40 ISPE Young Professional (YP) Member
________Free for 1st 15 Agensys Employees
________$500 Event Sponsor: Sponsors receive a 6′ exhibit table and two admissions to the meeting.