An Integrated Single-Use Platform for Manufacturing Plasmid DNA (pDNA)

Plasmid DNA (pDNA) plays a critical role in the delivery of gene therapies into targeted cells. The development and delivery of large quantity, high-quality pDNA vectors are in high demand.

Cytovance has developed and integrated Single-use Platform for manufacturing Plasmid DNA (pDNA) using the HyperGRO™ high cell density process that is licensed from Nature Technologies, an industry leader in the field. The fermentation process reduces the risk of recombination events that are common with pDNA containing inverted repeats, such as those associated with Lentiviral Vectors. The fermentation is performed in single use fermenters. The platform purification employs off-the-shelf disposable technologies that ensure a low shear process.

In this webinar, the presenters will describe how the implementation of the imPULSE™ mixer from Thermo Fisher Scientific and the BIA Systems Monolith technologies combine to produce high quality pDNA. In addition to Research Grade and cGMP grade pDNA, Cytovance has worked with its Quality Assurance team to address the industry need for material in between GMP and R&D grade to develop a defined set of Quality standards for Critical Reagent Grade™ pDNA.

Speakers

Jesse McCool, PhD, Chief Technology Officer, Cytovance Biologics

Dr. Jesse McCool has over 17 years’ experience in microbial process development, characterization and technology transfer. Prior to Cytovance, Jesse was the director of process development at Lonza Biologics; while there, he expanded offerings in microbial R&D services and improved market presence through driving new technologies development such as strain development, Design of Experiments (DoE) and late-stage program support. He helped to adopt a Quality by Design (QbD) framework for supporting pre-validation activities, supported numerous current Good Manufacturing Practice (cGMP) campaigns as a subject matter expert and has significant experience in six-sigma and operational excellence. As an established speaker, he has chaired and presented at various industry conferences. He has written and contributed to numerous published papers on topics including fermentation process design and microbial expression technologies.

Prior to Lonza, Jesse was a scientist at Mascoma Corporation and postdoctoral research associate at the Thayer School of Engineering at Dartmouth College. He holds a Bachelor of Science in Environmental Sciences and a PhD in Microbiology, both from the University of Massachusetts Amherst and recently completed advanced coursework in microbial physiology and fermentation technology at Technische Universiteit Delft in The Netherlands.

Message Presenter

Frank Agbogbo, PhD, Director, Microbial Bioprocess, Cytovance Biologics

Dr. Frank Agbogbo has over 16 years of experience in academia and industry. He is currently the director of process development at Cytovance Biologics and has been with the company since May 2014. Prior to Cytovance, Frank was a scientist at Novozymes, ICM, Inc. and Mascoma Corporation. He also served as an application technology manager at Mascoma Corporation where he contributed to the US Food and Drug Administration (FDA) approval and launch of two commercial products.

His background includes microbial process development, DoE, process optimization, process characterization and scale-up from R&D to manufacturing (cGMP and non-cGMP). He was co-chair at scientific conferences such as the Society for Industrial Microbiology and Biotechnology Annual Meeting (SIMB) and Recent Advances in Fermentation Technology (RAFT) on many topics including process optimization, scale-up, DoE, process characterization, and process analytical technologies. Frank oversees the microbial bioprocess development group at Cytovance Biologics and has been responsible for transferring processes from clients to R&D and to cGMP manufacturing. He has co-authored 15 peer-reviewed publications and contributed to five patents. Frank holds a Bachelor of Science in Chemical Engineering from Kwame Nkrumah’ University of Science and Technology and a Chemical Engineering PhD from Texas A&M University.

Message Presenter

David Schmidt, Director, Analytical Development, Cytovance Biologics

David Schmidt has over nine years’ experience in industry at Cytovance Biologics and over six years’ experience working in pathology laboratories at Integris Medical Center and Excalibur Pathology Labs. He has hands-on and managerial experience with over 80 different biologics including monoclonal antibodies, antigen-binding fragments (Fabs), fusion proteins, enzymes, cytokines, PEGylated proteins, enzymes, growth factors, viral vectors, pDNA and many different novel therapeutics.

David currently oversees the analytical development lab at Cytovance, which is responsible for all analytical services within Cytovance’s R&D services. During his time with Cytovance, David has been involved with analytical method development, transfer, optimization, verification, evaluation, qualification and/or validation of over 400 test methods for in-process, release and characterization testing. Many of these test methods have been successfully transferred to internal and external quality control laboratories and applied to preclinical, Phase I/II/III, process characterization, process validation and two commercial processes. In addition to method development services, David has expanded Cytovance’s analytical service offerings to include clinical support such as PK, PD, and anti-drug antibody (ADA) analyses under full GLP/GCP compliance. David has a Bachelor of Science in Microbiology from the University of Oklahoma.

Message Presenter