Newsletter | October 30, 2025

10.30.25 -- The 9 Fastest-Growing Outsourcing Segments

SPONSOR

Improving Methodologies For iPSC Manufacturing & Differentiation

Induced pluripotent stem cells (iPSCs) represent one of the most exciting breakthroughs in modern biotechnology, offering unprecedented opportunities for advancing regenerative medicine and cell-based therapies. Realizing the therapeutic promise of iPSCs is far from straightforward. Next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and enable pharmaceutical innovators to overcome the hurdles of scalability and consistency. Learn more now.

FOCUS ON OUTSOURCING

The 9 Fastest-Growing Outsourcing Segments

Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

Phase-Appropriate Approaches To Manufacturing And Testing

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that align with regulatory expectations and support efficient progression.

Cell Therapies In The Treatment Of Autoimmune Diseases

Uncover how cell therapies are unlocking new possibilities for autoimmune disease treatments by overcoming barriers from self-antigen recognition to complex inflammatory microenvironments.

Accelerating Gene Therapy Development For NEDAMSS

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

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.

CDNPs Enable Versatile And Robust T Cell Expansion For CAR-T Manufacturing

Adopt next-generation, physiologic T cell activation strategies to enable faster, more consistent, and scalable CAR-T manufacturing that improves expansion, persistence, and patient access.

From Research To Reality: Overcoming CMC Challenges In Cell & Gene Therapy

See the importance of adopting a Quality by Design (QbD) approach in the development process while integrating regulatory and CMC strategies for maximum efficiency and benefit.

Demonstrating Value Throughout The Product Development Lifecycle

Assimilate how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

SPONSOR

Webinar: Navigating Commercial Cell Therapy Manufacturing: ElevateBio Expert Q&A

Join this ElevateBio webinar to hear from leaders in manufacturing, quality, and site operations as they share how an integrated approach drives commercial readiness and operational excellence. Learn how ElevateBio ensures quality and control in multi-product facilities, scales production to meet growing partner demands, and uses digital capabilities to enhance collaboration and efficiency across manufacturing operations. Click here to learn more.

OUTSOURCING SOLUTIONS

Research And Development Services For Gene Therapies - Pace® Life Sciences

Excellos Capacity Update: Cell & Gene Therapy - Excellos

Analytics-Driven AAV Development And Manufacturing - Ascend & ABL Inc.

GS Discovery® Transient Expression System - Lonza

A New Horizon In AAV cGMP Gene Therapy Manufacturing - Viralgen

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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