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Cambridge Healthtech Institute’s Inaugural

Cell Therapy Analytics and Manufacturing
( 細胞治療藥的分析和製造 )

Analysis, Process Development, Scale-Up, and Commercialization of Cell Therapies

1月23日~24日

Part of the Cell & Gene Therapies pipeline

Cambridge Healthtech Institute’s Inaugural Cell Therapy Analytics and Manufacturing conference will discuss opportunities, advances, and challenges facing the analysis and manufacture of autologous and allogenic cell therapies. The conference will discuss analytical, CMC, and quality control challenges of cell therapies. The conference will also discuss commercialization aspects, such as manufacturing, scale-up, bioreactors, next-generation production technologies, automation, supply chain, and other manufacturing-related issues.

Final Agenda

 

1月23日(四)

7:45 am Registration and Morning Coffee

Strategies, Regulations, and Guidance

8:10 Organizer’s Welcome Remarks

Nandini Kashyap, Conference Director, Cambridge Healthtech Institute

8:15 Chairperson’s Opening Remarks

Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International

 

KEYNOTE PRESENTATION

8:20 Manufacturing Challenges for the Commercialization of Cell and Gene Therapy Products

Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International

Achieving and meeting the requirements of manufacturing control for Cell and Gene Therapy product at commercial scale prior to licensure necessitates intensive focus and resources throughout the product development lifecycle. In my talk, I will attempt to highlight key challenges in consistent manufacturing of Cell and Gene Therapy products at commercial scale and provide possible solutions to some of these challenges, particularly as it is related to the collection of starting materials, establishing manufacturing control, and dealing with manufacturing changes during the product development lifecycle.

9:00 USP Standards for Cell Therapy

Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia

USP Standards Development for Cell Therapies - This presentation will provide updated information on existing USP Standards relevant to developers of Cell Therapies, such as Chapter <1046> Cell and Gene Therapy Products, as well as Chapter <1043> Ancillary Materials for Cell-, Gene-, and Tissue-Engineered Products. It will also cover USP’s development of new physical reference materials to aid developers of Cell Therapies.

9:30 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

SOLID TUMORS

11:00 Reprogramming Natural Killer Cells for Immunotherapy of Solid Tumors

matosevic_sandroSandro Matosevic, PhD, Assistant Professor, Department of Industrial and Physical Pharmacy, Purdue University

Natural killer (NK) cell infiltration into and anti-tumor immunity against solid tumors is often low. Functional and metabolic impairment of NK cells is induced by the suppressive microenvironment of solid tumors due to, among others, hypoxia, metabolites, such as adenosine, and the expression of inhibitory NK checkpoints. Here, we discuss our work in redirecting NK cells to overcome immunosuppressive solid tumor by genetically rewiring their functional and immunometabolic responses.

11:30 PANEL DISCUSSION: Next-Generation Production Technologies and Process Development

Discussion Points:

  • Next-Gen Cell Therapy Pipeline
  • Next-Gen Processes for Better and Faster Optimization
  • Next-Gen Scale-Up and Production Technologies

Moderator:

Heidaran_MoMo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International


Panelists:

Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia

Sra_KuldipKuldip Sra, PhD, Senior Director, Crispr Therapeutics


Kemp_KellyKelly Kemp, PhD, Director, Process Development, ViaCyte


Shestopalov_IlyaIlya Shestopalov, PhD, Associate Director, Cell Analytics, bluebird bio

 


12:00 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Ice Cream Break in the Exhibit Hall with Poster Viewing

Analytical Toolbox and CMC Strategies

2:15 Chairperson’s Remarks

Sandro Matosevic, PhD, Assistant Professor, Department of Industrial and Physical Pharmacy, Purdue University

2:20 Characterization and Qualification of Cell Banks and Other Critical Reagents Used in Potency Assays

Kelly Bowen, M.S., Sr. Associate Scientist, Analytical Development, bluebird bio

 

Cells are highly critical and complex reagents that are the foundation for any cell-based assay. To ensure operational consistency and limit the variability in cell-based assays, cell banks and cell lines require stringent characterization and control strategies. This presentation will focus on strategies to characterize, qualify, and manage cell banks used in potency assays.  

 

2:50 Analytical Methods and CMC for Cell Therapies

Sra_KuldipKuldip Sra, PhD, Senior Director, Crispr Therapeutics

For autologous cell therapy products, each patient is a product batch. Manufacturing is a very tedious and manual process. The urgency to release the product quickly to the patient is very high. The presentation will cover the implementation of rapid analytical methods to release the final product in the desired timeframe to patients.

3:20 Networking Refreshment Break

3:45 Outcomes of Characterization of CD34-Enriched Gene Therapy Drug Products

Shestopalov_IlyaIlya Shestopalov, PhD, Associate Director, Cell Analytics, bluebird bio

Cell-based drug products manufactured with lentiviral vectors (LVVs) require advances in analytical methods to characterize their safety and efficacy. This seminar will cover implementation of novel technologies to address unique challenges posed by gene therapy drug products. Approaches to identify drug product CQAs correlating with in vivo function will be discussed.

Process Development, Scale-Up, and Manufacturing

4:15 Manufacturing and Bioproduction Challenges and Opportunities for Cell Therapies

Chiruvolu_VijayVijay Chiruvolu, PhD, Senior Vice President of Global Process Development - Cell Therapy, Kite Pharma, a Gilead Sciences Company

A process development strategy for cell therapy products, while focusing on improving safety and product quality aspects, must also consider challenges related to donor-to-donor variabilities, scale of operation, manufacturing technology, production, and product release times. This presentation will highlight the challenges faced during process development of YESCARTA. In addition, the experience gained on process automation, product comparability, and process validation will be shared.

4:45 Media Formulation and Optimization of Cellular Drug Product Manufacturing by Utilizing Metabolic and Signal Transduction Pathways

Hang_Ta-ChunTa-Chun Hang, PhD, Senior Scientist, Process Development, bluebird bio

Current commercially available media formulations are derivations of media developed specifically for culture of immune and stem cells to recapitulate physiology and phenotype in vitro. In terms of development of a manufacturing process, this is not necessarily ideal, as the outcome of the manufacturing process is to induce a natural phenomenon under atypical circumstances. The work performed at bluebird bio focuses on redesigning media formulation for cellular CAR T drug product manufacturing by utilizing compositions that can co-opt desired signaling and metabolic pathways for the appropriate T lymphocyte phenotype.

5:15 Close of Day

 

1月24日(五)

8:00 am Registration

8:00 BuzZ Sessions with Continental Breakfast

Protein therapeutics is a fast-growing global market. As the science improves, so does the complexity of the R&D organization. Ensuring product quality plus speed to market requires insights from stakeholders working across the stages of protein science R&D. Join experts representing this PepTalk pipeline, peers, and colleagues for an interactive roundtable discussion. Topics include highlights from the week’s presentations, new technologies and strategies, challenges, and future trends.

Click here for more details

Process Development, Scale-Up, and Manufacturing (Cont.)

9:00 Chairperson’s Remarks

Kelly Kemp, PhD, Director, Process Development, ViaCyte

9:05 Challenges of Scaling-Up Cell-Based Processes to Meet Pivotal Trial Requirements

Kemp_KellyKelly Kemp, PhD, Director, Process Development, ViaCyte

Product characterization and process understanding is critical when scaling a manufacturing process; for example, moving from a 2D to a 3D cell culture platform, to ensure a comparable, reliable, and robust manufacturing process. A review of the challenges, including flexibility of batch sizes to support increasing trial commercial demands, and separation of high-quality cells for cryopreservation, will be presented along with proposed solutions.

9:35 Critical Attributes To Consider In The Design Of An Allogeneic, Gene-Edited CART Manufacturing Facility

Monteith_WilliamWilliam Monteith, Executive Vice President, Technical Operations, Cellectis

This presentation will explore the design consideration to address critical attributes such as cost, aseptic control, contamination control, room classification and process flows as well as future cost of goods for an allogeneic gene edited CART manufacturing facility.

10:05 Starting and Raw Material Quality for Successful Scale-up of Clinical and Commercial Manufacturing

clarke_dominicDominic Clarke, PhD, ISCT Process & Product Committee Co-Chair and Global Head, Cell Therapy, HemaCare

Consistency of the starting source material is a vital component to ensuring the success of cell and gene therapies. As allogeneic therapies transition to multiregional clinical trials, navigating the potential regulatory barriers for access and use of the starting material presents its own set of challenges. It is important to understand as early as possible the quality and level of compliance (e.g. cGMP) required globally.

10:35 Networking Coffee Break

11:00 Speaker to be Announced

 

11:30 Development of Potency Bioassays for Cell and Gene Therapy Products

Bhattacharya_DebadityaDebaditya Bhattacharya, PhD, Group Leader, Analytical Cell & Gene Therapy, Process & Analytical Development, bluebird bio


12:00 pm Conference Wrap-Up

Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia

12:30 Close of Conference

* 活動內容有可能不事先告知作更動及調整。

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