- Overview of Fujifilm Diosynth Biotechnologies & Shattuck Labs
- Quality/regulatory aspects of manufacturing vaccines and cell/gene therapies
- Unprecedented collaborations to meet global needs
- Redirecting resources - people, raw materials & supplies, manufacturing space, etc.
- Role with COVID-19 vaccine therapy development & manufacturing
Mark Yates, Ph.D., Associated Director Manufacturing Technology & Support at Fujifilm Diosynth Biotechnologies is a Contract Drug Manufacturing Organization currently manufacturing a COVID-19 vaccine supports part of Operation Warp Speed. Mark has been involved with vaccine production for 20 years for adult and pediatric indications, as well as production of biomolecules for oncology treatments and other protein therapies. Mark’s group is responsibility for ensuring the process equipment is ready for production, providing SME support while manufacturing process is running, and troubleshooting any issues that occur during processing. Additionally, his group ensure the facilities, utilities and equipment meet all regulatory requirements and engineering specifications as well as support numerous audits from internal auditing groups, clients, and global Boards of Health.
Mark holds a BS in Chemistry from the University of Virginia and a Ph.D. in Chemistry/Toxicology from NC State University. He had a Post-Doctoral Fellowship in Toxicology in Radiation Oncology at UNC Hospital. Mark has also been a Professor at Campbell University in their Pharmaceutical Sciences program and currently teaches a course in the Bioprocess Engineering program at East Carolina University.
Kelli Collin is the Vice President, Head of Quality at Shattuck Labs, taking on this role in January of 2021. Previously, she was the Executive Director of Quality Assurance at Liquidia Technologies, leading the quality department for GMP, GCP and GLP operations. She has over 17 years of experience in quality assurance, covering all aspects of the pharmaceutical product lifecycle. She was recognized by Quality Progress as part of the Fresh Faces Class of 2016 for her contributions for the field of Quality.
Her professional and academic credentials include a Bachelor’s degree in Biological Engineering and a Masters of Bioinformatics from North Carolina State University. She also h