SCTbio and Fortrea Forge Strategic Collaboration to Accelerate Cell and Gene Therapy Development and Delivery

Rhea-AI Summary

SCTbio and Fortrea (FTRE) announced a strategic collaboration on December 4, 2025 to align CDMO manufacturing and CRO clinical development for cell and gene therapies. The partnership aims to streamline development timelines, harmonize GMP manufacturing readiness with trial logistics, and reduce program risk by enabling early protocol alignment, supply‑chain resilience, and coordinated planning from first‑in‑human trials toward commercialization.

The agreement stresses synchronized execution across manufacturing, apheresis, viral vectors and global clinical operations to accelerate delivery of advanced therapies to patients.

Insights

Cell & Gene Development Strategist

Strategic CRO–CDMO alignment should reduce development friction and improve time-to-clinic for cell and gene programs.

The collaboration links Fortrea's global clinical development infrastructure with SCTbio's GMP cell-therapy manufacturing capabilities to create coordinated planning from protocol design through manufacturing release. This arrangement can shorten handoffs between clinical operations and manufacturing by aligning logistics, supply‑chain planning and study setup, which typically cause delays in advanced-therapy programs.

Key dependencies include client uptake of the integrated service model and effective operational integration between the partners; execution failures or limited market demand would limit benefits. Watch for early joint program announcements, scope of offered end-to-end services, and any published timelines for first coordinated client studies as the near-term indicators of traction.

PRAGUE, Czech Republic and DURHAM, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- SCTbio, a leading European CDMO specializing in GMP manufacturing for cell-based products, and Fortrea, a leading global contract research organization (CRO), today announced a strategic collaboration agreement between the two companies. This partnership aims to streamline development, accelerate timelines and bring advanced therapies to patients faster.

This collaboration represents a forward-looking model for how CDMOs and CROs can collaborate to deliver synchronized solutions that help to de-risk programs, streamline planning, expedite study setup and optimize cost-efficiency across the entire development lifecycle. According to The American Society of Cell & Gene Therapy, there are more than 4,400 gene, cell and RNA therapies currently in development.

“By combining Fortrea’s global clinical reach with SCTbio’s manufacturing expertise in cell therapy, viral vectors and apheresis, we’re creating a framework for smarter protocol design, more resilient supply chains and faster, safer delivery of therapies to patients worldwide,” said Luděk Sojka, CEO of SCTbio. “We share the same vision: that early alignment between CDMO and CRO can transform complexity into opportunity.”

“Our collaboration with SCTbio represents a significant step forward in enhancing the cell and gene therapy ecosystem,” said Mark Morais, chief operating officer and president, Fortrea Clinical Development. “This collaboration is structured to empower customers with the right resources and relevant experience needed to accelerate their therapies from first-in-human trials to commercialization. This strategic collaboration enables us to address the most pressing challenges in the development of advanced therapies.”

The collaboration will harmonize clinical trial logistics with GMP manufacturing readiness, ensuring that cell and gene therapy programs benefit from synchronized planning and flawless execution. Together, the companies will work closely with clients to evaluate and optimize the pathway from early-stage development to first-in-human trials, later-stage clinical advancement and geographical expansions. By uniting Fortrea’s deep development experience from first-in-human studies to product approval, with SCTbio’s specialized manufacturing and release capabilities, the partnership aims to set a new benchmark for operational excellence in advanced therapy development.

About SCTbio

SCTbio is a leading Contract Development and Manufacturing Organization (CDMO) specializing in Advanced Therapy Medicinal Products (ATMPs). With over 15 years of experience in cell therapy manufacturing, SCTbio delivers end-to-end GMP services — from apheresis materials, vector production, and process development to manufacturing, quality control, release, storage, and logistics. As a trusted partner, SCTbio guides clients through every stage of clinical and commercial development, ensuring the highest standards of quality, reliability, and compliance.
SCTbio is a member of the PPF Biotech Group. To learn more, visit www.sctbio.com.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).

SCTbio media contact:

Richard Kapsa
T: +420 224 174 448
M: +420 725 736 310                        
E: media@sctbio.com         

SCTbio business contact:

Pascale Charbonnel                 
Chief Business Officer        
M: +420 720 029 922
E: partnering@sctbio.com

Fortrea Contacts:

Tracy Krumme (Investors) – 984-385-6707, Tracy.Krumme@fortrea.com
Sue Zaranek (Media) – 919-943-5422, media@fortrea.com
Kate Dillon (Media) – 646-818-9115, kdillon@prosek.com

FAQ

What did Fortrea (FTRE) and SCTbio announce on December 4, 2025?

They announced a strategic collaboration to align CDMO manufacturing and CRO clinical development for cell and gene therapies, aiming to accelerate timelines and harmonize GMP readiness with trial logistics.

How will the FTRE and SCTbio collaboration affect first‑in‑human cell therapy trials?

The collaboration intends to enable earlier protocol alignment and synchronized manufacturing logistics to expedite study setup and reduce program risk for first‑in‑human trials.

Does the FTRE partnership include manufacturing capabilities for viral vectors and apheresis?

Yes; the announcement cites SCTbio’s manufacturing expertise in cell therapy, viral vectors and apheresis as part of the collaboration.

Will the FTRE and SCTbio agreement support commercialization of advanced therapies?

Yes; the collaboration is structured to support the pathway from early development through later‑stage clinical advancement toward commercialization.

What practical benefits does the FTRE collaboration claim to provide to sponsors?

The companies say sponsors will benefit from de‑risked programs, optimized planning, resilient supply chains and cost‑efficient synchronized solutions across development lifecycles.