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
Thursday, August 21
1:55 pm Chairperson’s Remarks
Robert Deans, Ph.D., Executive Vice President, Regenerative Medicine, Athersys, Inc.
2:00 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.
2:45 Precision Manufacturing of Living Materials – Working It Out for Cell Therapies
David 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 Understanding Cell Therapy Cost of Goods – Linking Detailed Analysis to Industry Challenges
Mark McCall, Ph.D., Enterprise Fellow, Loughborough University
The presentation will introduce how detailed analysis of manufacturing systems and business models can produce reliable estimates of Cost of Goods for cell therapies. It will then discuss several scenarios with specific case studies performed using an activity based cost model. . It will finish by identifying the particular issues that this model has identified as current production bottlenecks for the cell therapy community and propose mitigation strategies to address these.
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.
Global Harmonization of Cell-based Biopharmaceuticals for Clinical Trials
Moderator: Ralf Huss, M.D., Ph.D., CSO, apceth GmbH & Co. KG
• Different classification of cell-based therapeutics in EU and US
• Positioning of Non-US / Non-EU authorities in this regulatory environment
• Comparison of investigator initiated trials (hospital exemption) and industrial trials
• How to compare what’s out there?
BioPrinting of Tissues and Organs
Moderator: Jon A. Rowley, Ph.D., Chief Executive and Technical Officer, RoosterBio
Additive manufacturing could revolutionize the manufacturing of tissues and organs. This roundtable will focus on
• Bioprinting hardware, software, and biological "ink" - where are the opportunities to standardize the various moving pieces today?
• What are the immediate applications that can benefit from a bioprinting manufacturing process?
• Does bioprinting actually bring any benefits over the traditional methods of tissue engineering?
• How will additive manufacturing impact the scalability and Cost of Goods of bioprinted products?
Leveraging Existing Local Infrastructure for Delivery of Cell Therapies
Moderator: Lee Buckler, LL.B., Founder and Managing Director, Cell Therapy Group
• Whether in fresh or frozen formats, cell therapy products are time and temperature sensitive. Despite their unique specifications, their handling requirements are not so unique that existing infrastructure and personnel cannot be leveraged, adapted, and trained to handle these products
• Some of the existing local infrastructure (aside from the hospitals) that should be considered in the delivery of cell therapies include blood centers, biorepositories, infusion clinics, stem cell transplant labs, other cell therapy companies, etc
• Local handling may include controlled short-term storage, long-term storage, some level of product processing (thaw, wash, volume reduce, etc), or even further manufacturing.
Adoptive T Cell Therapy for Tumors
Moderator: Pranay Khare, Ph.D., Director, Research, Cancer Immunotherapy and Gene therapy cGMP Facility, Roger Williams Medical Center
• Achievements, Challenges and Advancement
• Activation, modification and expansion
• Chimeric Antigen Receptor (CAR), T cell receptor (TCR) and BiAb Conjugation
From Formulation to Final Destination: Cryopreservation, Stability, and Transport of Cell Therapy Products
Moderator: Brian Majors, Ph.D., Process Engineer/Manager, Engineering and Manufacturing Sciences, Novartis Pharmaceutical Corp.
• Considerations for cryopreservation success
• Managing the transport, tracking, and associated data
• Methods for improving stability of cell therapy products
• Final destination: Controlling cell therapy quality at the patient bedside
5:45 End of Day
Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios