The Bioprocessing Summit

Cambridge Healthtech Institute’s Inaugural
Cell Therapy Bioproduction
Addressing the Development, Manufacturing and Scale Up/Out Dilemma
Part of CHI's 6th Annual The Bioprocessing Summit

August 21-22, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts


The cell therapy industry is no longer a niche sector but has grown into a significant and sustainable component of the global biopharmaceutical industry. Today, its prospects are strong with annual revenues over US$1billion. As more and more cell therapy companies advance beyond phase 1 & 2 clinical trials, their focus begin to shift toward the challenges in the scale up and manufacture of these cell therapeutics.

The inherent nature of the cells makes manufacturing them a huge challenge. Not only are their MOAs not easily understood, the cell’s behavior in vitro are not indicative of their behavior in vivo. Coupled with the adherent nature of the cells and the difference between allogeneic and autologous cells which makes scaling up/out and process optimization a big challenge, the industry is also faced with issues such as the lack of standardization, high COGS and commercialization challenges.

CHI’s Cell Therapy Bioproduction conference offers a platform for you and your colleagues to come together to exchange ideas and solutions that will help resolve the challenges and bottlenecks in your development and manufacture of cell therapies, from potency assays to scaling up/out, from process optimization to commercialization.


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 

Suggested Short Course*

Biophysical Characterization in Developing Biopharmaceuticals: The Path to Developability, Stability and Comparability 

Thursday, August 21, 6:30- 9:00 pm


*Separate registration required


Thursday, August 21

1:55 pm Chairperson’s Remarks

Robert Deans, Ph.D., Executive Vice President, Regenerative Medicine, Athersys, Inc.


FEATURED PRESENTATIONS

2:00 Towards Bioengineered Control of Cell Fate Post Transplantation

Jeffrey KarpJeffrey M. Karp, Ph.D., Associate Professor of Medicine, Brigham and Women’s Hospital, Harvard Medical School

Control of cell fate and its extracellular environment following transplantation is critical for maximizing efficacy of cell based therapy. This talk will explore methods to enhance the engraftment and tracking of systemically infused stem cells through engineering the cell surface and through functionalizing cells with contrast agents and depots containing phenotype altering agents.

2:45 Precision Manufacturing of Living Materials – Working It Out for Cell Therapies

David WilliamsDavid J. Williams, Ph.D., Professor, Healthcare Engineering, Centre for Biologics Engineering, Loughborough University

The presentation will introduce key concepts of precision manufacturing in particular that of process capability. It will then discuss the key manufacturing scenarios for cell therapies with respect to the fundamentals of Good Manufacturing Practice and variation and it’s control with a focus on biological variation. It will close by identifying the particular issues on which the cell therapy community should work together pre-competitively in order to facilitate the development and manufacturing of cell therapies.

3:15 The Dawn of a New Day for Tissue Engineering: Applications Enabled by Cell Manufacturing Innovations

Jon A. Rowley, Ph.D., Chief Executive and Technical Officer, RoosterBio

The cell therapy Product Innovations of the early 2000s has led to the expected Manufacturing Process Innovations over the last few years. The latter has led to increased lot sizes and a focus on decreasing COGS of the cellular products that are moving through late stage clinical trials. As the cost of therapeutic cells decreases and availability of cells increases, new fields that require abundant and affordable high quality cells, such as tissue engineering and bioprinting, will begin to accelerate.


3:45 Sponsored Presentation (Opportunity Available)

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Breakout Discussions

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. At the end of the session, each moderator will summarize the topics being discussed, the findings and conclusions (if any), and share with the audience.

5:15 Presentation to be Announced

5:45 End of Day


5:45 – 6:30 Dinner Short Course Registration

6:30 – 9:00 Dinner Short Course*: Biophysical Characterization in Developing Biopharmaceuticals: The Path to Developability, Stability and Comparability 


*Separate registration required




Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios