Cambridge Healthtech Institute’s 6th Annual

Continuous Processing in Biopharm Manufacturing

Toward end-to-end integrated and intensified processing

August 24-25, 2020

 

Technology and regulatory gaps continue to challenge the implementation of continuous processing for clinical-scale biomanufacturing, despite advances in single-use technologies, up- and down-stream process optimization and intensification.

CHI’s 6 th Annual Continuous Processing in Biopharm Manufacturing invites researchers to discuss the challenges and requirements for transitioning from bench to clinical scale and share their latest pursuit of technologies and approaches to close the gap – including real-time monitoring, process control, process intensification/optimization strategies, process validation and quality considerations. Examples of applications of continuous/intensified processing for new/emerging modalities, vaccines and biosimilars will also be explored.

Preliminary Agenda

DEVELOPMENT OF END-TO-END AND INTEGRATED BIOPROCESSING

KEYNOTE PRESENTATION: Viral Clearance Validation in End-to-End Continuous Manufacturing of mAb for a Phase 1 Trial

Maarten Pennings, MS, CTO, Biosana Pharma

Bayer’s Approach to Address the Transition of Bioprocessing towards Integrated Processing

Benjamin Minow, PhD, Bio-Technology Strategy & Projects, Product Supply, Pharmaceuticals, Biological Development WUP, Bayer AG

Update on ICH Q13 Development and Its Impact on Continuous Manufacturing for Biopharmaceuticals

Ganapathy Mohan, PhD, Head, Global CMC, Merck

CASE STUDIES – CONTINUOUS UP- & DOWN-STREAM PROCESSING

Ampr 250 High Throughput Perfusion Systems

Jared Franklin, PhD, Senior Research Engineer, Sanofi

Development of an Integrated Continuous Capture Step for an Enzyme Second-Generation Manufacturing Process

Thomas Liao, MS, Senior Research Engineer, Purification Process Development, Sanofi US

Continuous and Integrated AAV Purification Process: Challenges and Opportunity

Ricardo Silva, PhD, Researcher, Downstream Process Development, Instituto de Biologia Experimental e Tecnologica (iBET)

PROCESS CONTROL AND MODELING OF CONTINUOUS/INTEGRATED PROCESSING

Modelling of Propagation of Process Disturbances in Continuous Integration Biomanufacturing

Alois Jungbauer, PhD, Professor, Biotechnology, BOKU and Austrian Centre of Industrial Biotechnology

Utilizing RAMAN for Feedback Control on Benchtop Bioreactors

Gregory Lane, PhD, Senior Research Investigator, Bristol-Myers Squibb

Model-Based Process Development and Control for Continuous Chromatography

Dong-Qiang Lin, PhD, Professor, College of Chemical and Biological Engineering, Zhejiang University

DIGITALIZATION AND REAL-TIME PROCESSING

A Case Study in Continuous Digital Biomanufacturing of Monoclonal Antibodies

Moo Sun Hong, M.S.CEP, Graduate Researcher, Chemical Engineering, MIT

In-Line Real Time Protein and Excipient Concentration Monitoring during the UFDF Unit Operation

Neha Puri, PhD, Scientist, Process Development Analytics, Bristol-Myers Squibb

In-Line Reconstitution of Media and Buffer Directly from Solids

Daniel Komuczki, PhD Candidate, University of Natural Resources & Life Sciences, Vienna (BOKU)




For more details on the conference, please contact:
Mimi Langley
Senior Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-972-5439
Email: mlangley@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



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