IBioNe is excited to inform you of community updates, including upcoming conferences and training opportunities. Funding is available through the IBioNe international exchange program to help cover the cost of attendance to these events. Learn more at ibione.org.

Have news you would like to share? Please send to ibione@uml.edu and we will include in the following newsletter.

IBioNe welcomes new member: ARC Digital Bioprocess Development Hub

The ARC Digital Bioprocess Development Hub addresses key bioprocessing research challenges and develops new process and digital models that can predict and optimise manufacturing processes, resulting in greater yields, faster and more flexible processes and enhanced product stability.

The ARC Digital Bioprocess Development Hub will undertake research which aims to transform Australia’s biopharmaceutical manufacturing industry by increasing digital innovation, productivity and competitiveness through the development of digitally integrated advanced manufacturing processes and a platform for industry adoption which will target rapid translation and up-take of sector-focused outputs. 

 A series of 10 projects led by a total of 11 chief investigators will be conducted across two research themes – Bioprocessing Research and Digital Processing Research.

IBioNe in the News!

BioProcess International wrote an article in their March 2024 issue about the IBioNe Modeling of Biotherapeutic Manufacturing Processes webinar by Cleo Kontoravdi (researcher from Imperial College in London, UK) and Dong-Yup Lee (associate professor of the School of Chemical Engineering at Sungkyunkwan University), held in November, 2023.

Upcoming Conferences

28th ESACT Meeting

• Date: 23-26 June 2024
• Location: Edinburgh

Secure your place at ESACT 2024—the premier event for professionals in the biotechnology and cell therapy industries! 

Quality by Design (QbD) and Process Analytical Technology (PAT) for Biopharmaceuticals: Concepts and Applications in Development and Commercialization

• Date: May 6-7, 2024
• Location:  University of Massachusetts Club (1 Beacon Street #32nd floor Boston, MA 02108)

Instructors: Anurag Rathore (IIT, India), Seongkyu Yoon (UMass Lowell)

Course Description:

Two day short course for individuals that are involved in product and process development, regulatory, quality assurance and control and manufacturing of biotech therapeutics. Attendees from academia and regulatory agencies may also benefit depending on their areas of interest and level of experience.

This course aims to clarify the key concepts that interplay in defining and implementing QbD and PAT towards development and manufacturing of biotech products. This will be achieved via a sequence of lectures and group work. Concepts discussed include: Critical Quality Attributes (CQA), Design Space, Risk Assessment, Process Characterization, Process Analytical Technology, Scale-up, and Technology Transfer. At the end of the course, the audience will be able to explain what these concepts mean, the role they play in QbD/PAT implementation and the interplays amongst them.

Industrial Bioprocessing Training 2024

• Date: July 29 - August 2, 2024
• Location: UMass Lowell North Campus, Lowell, Massachusetts, U.S.A.

Instructors: Industry professionals from BMS, Pfizer, MilliporeSigma, UMass Biologics and UMass experts.

Course Description:

This course teaches key principles and concepts of industrial bioprocessing of protein, cell and gene therapies. The course covers recent technologies and practices of upstream, downstream, and analytical tools in the bioprocessing industry. In addition, FDA initiatives of PAT (Process Analytical Technology), Quality by Design, and Emerging Technology will be covered.

Metabolic and Bioprocess Modelling for Animal Cells Course, 2nd edition 

• Date: October 13-17, 2024
• Location: Llafrank, Spain

Coordinators: Dong-Yup Lee (Sungkyunkwan University, KP), Ioscani Jiménez del Val (University College Dublin, IR) and Emma Petiot (Université de Lyon, FR)

Course Description:

This is an introductory course intended to cover the main modelling approaches relevant to animal cell systems. The course will cover the following topics:

• Kinetic and stoichiometric modelling
• Flux balance analysis
• Data-driven and hybrid-modeling of cell bioreactors
• Chemometrics and their use to support integration of Process Analytical Technologies
• Machine learning approaches for analyzing multiomics datasets



The course will consist of lectures on the topics and computer-based hands-on workshops with case studies.

Recent Publications

1.   Seo-Young Park, Dong-Hyuk Choi, Jinsung Song, Meiyappan Lakshmanan, Anne Richelle, Seongkyu Yoon, Cleo Kontoravdi, Nathan E. Lewis, Dong-Yup Lee, Driving towards digital biomanufacturing by CHO genome-scale models, Trends in Biotechnology, 2024, https://doi.org/10.1016/j.tibtech.2024.03.001

2.    Yongdan Wang, Qiang Fu, So Young Park, Yong Suk Lee, Seo-Young Park, Dong-Yup Lee, Seongkyu Yoon, Decoding cellular mechanism of recombinant adeno-associated virus (rAAV) and engineering host-cell factories toward intensified viral vector manufacturing, Biotechnology Advances, Volume 71, 2024, https://doi.org/10.1016/j.biotechadv.2024.108322

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