Newsletter | February 11, 2020

02.11.20 -- Develop, Commercialize Cell And Gene Therapies At Scale


Good day Cell & Gene readers,


In part one of this two-part series, learn how the accelerated development in cell and gene therapies is causing a fundamental shift in the traditional biopharmaceutical business model. This article explores the capabilities to develop and commercialize cell and gene therapies at scale while rethinking the end-to-end system.


CCRM executives reflect on the cell and gene sector’s ground breaking decade and detail the progress we need including innovations in manufacturing, logistics, and reimbursement optimized with the patient journey in mind.


Erin Harris, editor in chief
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Industry Insights
Commercial Scale Manufacturing Of Allogeneic Cell Therapy
White Paper | By Gary M. Pigeau, Elizabeth Csaszar, and Aaron Dulgar-Tulloch, CCRM

Allogeneic cell therapy products are generating encouraging clinical and preclinical results. Many of these therapies are also expected to have large market sizes and require cell doses of ≥109 cells. As therapeutic technologies mature it is essential for the cell manufacturing industry to correspondingly develop to adequately support commercial-scale production. To that end, there is much that can be learned and adapted from traditional manufacturing fields. In this review, we highlight key areas of allogeneic cell therapy manufacturing, identify current gaps, and discuss strategies for integrating new solutions.

Considering Options And Alternatives For The Design Of Complex Biopharma Facilities
White Paper | By Tom Piombino and Sue Behrens, IPS-Integrated Project Services

The movement of viral vectors, cell therapies, and other antibody-based next-generation drug products toward commercialization is driving the need for new and different technologies and facilities. Engineering and design firms with the right skillsets can help you maintain the right balance in your facility design to maintain flexibility, which is essential to meet diverse processing needs for biopharmaceutical manufacturing.

Key Considerations When Designing A Phase 1 Oncology Trial
Article | By Luke Gill, Premier Research

Selecting a safe starting dose must be balanced against the proportion of patients treated at subtherapeutic doses. This is especially important for agents that demonstrate minimal toxicity in preclinical testing or for drugs that are unlikely to ever reach maximum tolerated dose. This approach has the potential to reduce the number of dose escalations while preventing patients from being treated at overly toxic doses that lack incremental biological activity.

Scale Your Bioproduction With Large-Format High-Flow Connectors
Application Note | By Nick Johnson, CPC

Looking to scale up your liquid bioprocessing and decrease transfer times? Learn how high-flow, genderless, large-format connectors make scale and efficiency easy and reliable.

Developing Immunotherapies For Cell-Based vs. Non-Cell-Based Therapies
Article | Thermo Fisher Scientific

Both cell-based therapies and non-cell-based therapies are developed as immunotherapies and therefore share some similar challenges in development.

Reduce Product Variability And Control Temperature Rates To Improve Cell Therapies
Webinar | GE Healthcare Life Sciences

Reduced input variability and careful selection of freezing and thawing rates are critical in T-cell processing. Backed by science and data, our experts examine how control of these factors can influence and optimize mononuclear cell enrichment and cryopreservation.

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