2024 ABCAB Bioprocessing Symposium:
“Sustainability & Advanced CMC Considerations for Biomanufacturing of the Future”

*** THIS EVENT IS AT FULL CAPACITY ***

On Behalf of Amita Goel, ABCAB Chair (Founder & CEO, Celltheon Corp.) and Dr. Sue Behrens, George B. and Joy Rathmann Professor in Bioprocessing and Director of KGI’s Amgen Bioprocessing Center:

You are cordially invited to attend KGI’s 2024 Amgen Bioprocessing Center Advisory Board (ABCAB) Bioprocessing Symposium “Sustainability & Advanced CMC Considerations for Biomanufacturing of the Future”

Multiple Industry Speakers and KGI’s student research work will be featured at the symposium.

In-Person Symposium
Friday, January 26, 2024
8:00 a.m. – 5:00 p.m.

535 Watson Drive,

Claremont CA 91711

*517 Bldg., Founders Room

Speakers

“Solving a Decade Old Cell Growth Issue: A Comprehensive Approach to Root Cause Investigation”

Flaka Radoniqi, Process Development Principal Scientist, Group Lead, AMGEN

Flaka Radoniqi is a Principal Scientist and a group lead at Amgen within Pivotal Drug Substance Biologics. After completing her Ph.D. at Keck Graduate Institute, Flaka joined Amgen in 2018 supporting various programs throughout their life cycle management and late-phase stages. Flaka has contributed to various modalities and process modes, enabling tech transfer, commercial manufacturing, and regulatory filings for critical programs. Flaka has also had a significant role in technology advancements at Amgen, including harvest and continuous manufacturing development. Outside of pipeline contributions, Flaka is involved in initiatives for cross functional process efficiency improvements and agile ways.

“We’re Cookin’ Now – Considerations Along a Path to Commercializing Cultivated Meat Products”

Dr. Bob Kiss, Executive Vice President of Technical Operations, UPSIDE Foods

Bob is Executive Vice President of Technical Operations at UPSIDE Foods, a leading company in the development and commercialization of cultured meat products.  He has more than 30 years of industrial biotechnology experience.  Prior to UPSIDE, Bob spent 4 years at Sutro Biopharma as Sr. VP of Process Sciences responsible for industrializing the Sutro cell-free protein synthesis platform, and 24 years at Genentech, where his final role was as Sr. Director & Distinguished Engineer leading Late Stage Cell Culture Development.  His areas of focus within biotechnology have included control of protein glycosylation, barriers to virus contamination, and fermentation / cell culture scale-up, and he is currently re-focusing his biotechnology skills toward industrializing the UPSIDE technologies for delivering cultured meats as viable consumer products.

Bob received a Chemical Engineering B.S. from UC Davis, and M.S. and Ph.D. degrees in Chemical Engineering from MIT.  He is an elected member of the National Academy of Engineering, an elected fellow in the American Institute of Medical and Biological Engineering, was recognized by UC Davis as a Distinguished Engineering Alumni, and is a licensed Professional Engineer. 

“Accelerating Scale-up: The First Successful 100X Scale-Up of Bovine Muscle Cells for Cultivated Meat Production in One Week”

Nur Guven-Kuzey, Head of Bioprocess Development, Orbillion Bio

Nur GUVEN KUZEY is Head of Bioprocess Development in Orbillion Bio Inc. She is currently responsible for leading scale-up strategies,
spearheading a PD team, driving the initiatives in cell culture media and upstream process development. Before joining Orbillion Bio, she worked in different roles including Drug Substance Formulation Scientist, Production Planning Executive and CSV Project Facility Leader in the European biopharma industry for 10+ years. She formulated several different small & large molecule drugs and experienced many GMP/FDA/EMA inspections in different countries. She also worked as an ISO-certified taster in the food industry to taste and analyze a variety of final food products early in her career. Nur earned an MEng Bioprocessing degree from Keck Graduate Institute in the Claremont Colleges, and MSc & BSc degrees from Ankara University, Turkiye. She also holds a PhD Candidacy in Inorganic Chemistry on Metal-Organic Frameworks and Lipid Nanoparticle synthesis.

“Strategic Considerations for a Multi-Product Facility for Cell and Gene Therapy Manufacturing”

Atef Khezri, Sr. Director of Operations;  Christopher Shumway, Director, Manufacturing (Upstream)

Avid Bioservices

Atef Khezri is the Senior Director of Operations at Avid Bioservices, where he currently leads the formulation, Operational Excellence (Opex), and compliance and audit readiness initiatives at the Myford facility. He was also involved with facility design, particularly in developing contamination control strategies for the viral vector site in Costa Mesa, CA. With a comprehensive 18 years of experience in the life sciences sector, Atef has navigated roles in both startup Contract Development and Manufacturing Organizations (CDMOs) and well-established pharmaceutical companies. Prior to joining Avid Bioservices, he served as an Associate Director of Operations at Catalent Maryland, contributing significantly to gene therapy operations in both clinical and commercial manufacturing sites in Maryland. Atef played a crucial leadership role in preparing the site for the commercial manufacturing of the drug substance for the AstraZeneca Covid Vaccine. His passion is in root cause analysis, problem-solving, and leadership, Atef holds a Bachelor of Science in Pharmaceutical Sciences from the University of Toledo, Ohio, College of Pharmacy.

Christopher Shumway is Director of Manufacturing at Avid Bioservices, Inc., a dedicated commercial biologics CDMO focused on the development and cGMP manufacture of biopharmaceuticals.  He is currently responsible for directing the activities of the cGMP Manufacturing operations, from vial thaw to bulk fill, to ensure that the highest standards in safety, product quality and process efficiency are maintained.  Before joining Avid Bioservices, Inc., Christopher worked in several roles including Associate Director, Cell Therapy Manufacturing at NantKwest and Senior Manager, Manufacturing at Agensys, Inc.  Prior to Agensys, Inc., he spent 9 years at AbbVie/Abbott Laboratories in roles from Project Engineer to Operations Manager and 7 years at Bristol-Myers Squibb Company, as a Validation and Facilities Engineer.  Christopher earned a MS in Engineering Management from Syracuse University and holds a BS in Chemical Engineering from Lafayette College.

 “Facility of the Future – Design Philosophy Tensions for Genentech’s New Clinical Supply Center”

Christian Randecker, Sr. Director of Operations, Process Support, and Process Engineering in the Clinical Supply Center, Genentech

Christian is a leader at Roche/Genentech with over 23 years of experience. He has led functions within Manufacturing and MSAT organizations supporting commercial, clinical and preclinical teams at Genentech’s South San Francisco Campus. Christian is an advocate for innovation in manufacturing, driving for evolution in production technology, analytical systems, data infrastructure and organizational structures. Most recently he was part of the team that designed, built, and started up the 2023 FOYA overall winning Clinical Supply Center. Christian is a graduate of James Madison University with an MBA from Babson College.  

TRAVEL INFORMATION:

• Recommended Airport for Travel: ONTARIO INTERNATIONAL AIRPORT (ONT)
  • Conveniently located just 12 miles from KGI’s campus! Less Traffic, Less Stress than traveling through LAX.
  • https://www.flyontario.com/

• If you must fly to/from LAX, KGI is located 50 miles east of LAX, and you will need to plan with traffic accordingly. Arriving the day before the symposium is highly recommended.

• Recommended Hotels near KGI:
  • Hotel Casa 425:
    • https://www.casa425.com/
  • The Doubletree Hilton Claremont: 
    • https://www.hilton.com/en/hotels/ontcldt-doubletree-claremont/?SEO_id=GMB-AMER-DT-ONTCLDT&y_source=1_MTM3MjY3NS03MTUtbG9jYXRpb24ud2Vic2l0ZQ%3D%3D
  • The Sheraton Fairplex Hotel & Conference Center:  
    • https://www.marriott.com/en-us/hotels/ontsi-sheraton-fairplex-hotel-and-conference-center/overview/?scid=f2ae0541-1279-4f24-b197-a979c79310b0
  • The Doubletree Hilton Pomona:
    • https://www.hilton.com/en/hotels/ontpodt-doubletree-pomona/?SEO_id=GMB-AMER-DT-ONTPODT&y_source=1_ODMxNzk5MS03MTUtbG9jYXRpb24ud2Vic2l0ZQ%3D%3D