A-Cell Webinar Series

A-Cell Overview

Many of the hurdles to streamlined, cost-effective manufacture of cell and gene therapy products derive from a lack of standardized methodologies and training around CMC programs. To help address this, ARM has published A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs. A-Cell emulates previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene), bringing best practices in CMC to a case study of a CAR-T therapy manufacturing.

In conjunction with the A-Cell document, ARM will host a six-part live webinar series highlighting specific A-Cell chapters which will culminate in a workshop in June of 2023.

Upcoming A-Cell Webinars

Generation of Quality Target Product Profile, Risk Assessment and Critical Quality Attribute Identification

October 26, 2022 | 11:00am – 12:00pm ET

Speaker:
Pinar Cicalese, Ph.D., Director CMC Commercial Strategy, Immatics
This webinar will cover the elements of Quality by Design for cell-based therapies, including the QTPP as a product development and life cycle management tool, and risk assessment approaches to identify product CQAs and critical process parameters (CPPs). The speaker will then explain how developing a good understanding of the inter-relationships between CPPs, CQAs and clinical outcomes is fundamental to the implementation of an effective control strategy, leading to greater assurance of product quality.

Manufacturing of Cell-Based Therapies

November, 2022

This webinar will discuss the manufacturing process overview of a CAR-T cell product. The speakers will describe the manufacturing steps and unit operations, as well as process and technological considerations to produce the desired product yield to meet the clinical dose requirements, while maintaining the product quality.

Lentiviral Vector Manufacturing Process

December, 2022

This webinar will discuss the manufacturing process overview of lentiviral vectors (LVs), including the upstream production & downstream purification, and its use as a drug substance in CAR-T cell manufacturing. The speaker will describe the Quality by Design (QbD) approach to process understanding and scaling, as well as LV testing and characterization.

Ancillary Materials

February, 2023

This webinar will provide an overview of the ancillary materials (AM) landscape in the Cell & Gene Therapy field, including the principles and risk management strategies. The presenters will introduce case studies to further strengthen the case for AM standardization through best practices for AM suppliers and users.

Analytical Technologies for Cell Therapies

March, 2023

This webinar will cover approaches to analytical assay development, progress of analytical technologies, and challenges related to process and product characterization for cell-based therapies, with focus on a CAR-T example. A Quality by Design (QbD) approach to phase-appropriate, fit-for purpose assay development will be discussed.

Control Strategy

May, 2023

This webinar will discuss the development of a robust integrated control strategy for a CAR-T cell therapy product in the setting of current regulatory framework and guidelines. The presenter will cover various concepts within risk-based approach to control strategy generation, including various process characterization tools and correlative analysis between product CQAs to clinical outcome.

A-Cell Workshop

June, 2023

Questions?

Please contact Savannah Bryant at sbryant@alliancerm.org