Newsletter | January 13, 2025

01.13.25 -- Key Considerations For Early-Stage CGT Companies When Selecting A CDMO

SPONSOR

With over 450 unique products in clinical development and 50 anticipated approvals by 2030, the evolving regulatory landscape for cell and gene therapies is more critical than ever. Don't miss your chance to gain expert insights! Join the next Cell & Gene Live for an exclusive digital panel discussion exploring forward-looking perspectives on this transformative field. Registration is free—thanks to the support of Thermo Fisher Scientific.

FOCUS ON OUTSOURCING

Key Considerations For Early-Stage CGT Companies When Selecting A CDMO

For preclinical or early-stage cell or gene therapy companies, proper evaluation of each CDMO candidate should include the raw materials program, QC testing, and more.

A Digital Thread Centric Integrated IT/OT Foundation

By adopting unified digital platforms, implementing standardized data models, and enabling seamless system integrations, see how organizations can establish continuous digital threads.

The Potential Of Intensified Scalable Adherent Cell Culture — Part 2

Intensified adherent cell culture offers a promising solution to the limitations of traditional suspension culture, with the potential to improve efficiency, reduce costs, and accelerate development.

4 Key Autologous Manufacturing Challenges (Plus How To Solve Them)

The manufacturing process for autologous therapies is complex and highly customized, requiring well-orchestrated transport, careful planning, and tight control of many discrete and manual processing steps.

Quality Agreements: Defining Governance In CDMO Partnerships

Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.

Allogeneic Vs. Autologous Cell Therapy: Deciding On Your Product Strategy

As you develop your future cell therapy drug, consider the risks and benefits of using autologous or allogeneic methods to best suit your development and manufacturing needs.

Streamlined Cell Therapy Development: Part I

The first in a two-part series, this article focuses on how to move from candidate selection to a Phase 1 Investigational New Drug (IND) application.

De-Risk Your Path To Clinic With An AAV Suspension Platform

Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, PhD, Head of Viral Vectors Commercial Development.

Exploring The Cost Considerations Of Immune Cell Therapies

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

The Importance Of Gene Editing In Successful Cell Therapy

Gene editing makes off-the-shelf cell therapies feasible by modifying cells to evade immune attack, improve overall compatibility, and prolong the survival of transplanted cells.

OUTSOURCING SOLUTIONS

Services Capacity Update October 2024: Fill/Finish - Novartis Contract Manufacturing

Capacity Update October 2024: Fill/Finish - Ajinomoto Bio-Pharma Services

IDT Biologika Capacity Update October 2024: Cell & Gene Therapy - IDT Biologika

Viralgen Capacity Update October 2024: Cell & Gene Therapy - Viralgen

Technologies That Smartly Scale iPSC To Benefit Human Health - Cellistic

Connect With Cell & Gene: