Cell & Gene Therapy Manufacturing Faces Deepening Bottlenecks: AmplifyBio, Exothera Close; Thermo Fisher Cuts Viral Vector Jobs, but FDA Eases Regulations to Support Growth

August 2, 2026

Endpoints News Global

Overview

Despite cell and gene therapies becoming a commercial reality, manufacturing remains the primary bottleneck. The CDMO sector is struggling with overcapacity and underfunding, leading to closures like AmplifyBio and Exothera, and Thermo Fisher cutting hundreds of viral vector-related jobs. Concurrently, new entrants such as Mytos and BioNexus are emerging, and the FDA is easing manufacturing regulations to support the scale-up of personalized therapies. Major players like Lonza, Roche, and Samsung Bio are also expanding U.S. capacity and reassessing global supply chains due to tariff pressures.

In Depth

Key Findings

While cell and gene therapies have transitioned from scientific promise to commercial reality, their manufacturing processes continue to pose the industry’s most significant bottleneck. Within the Contract Development and Manufacturing Organization (CDMO) sector, a challenging landscape has emerged, marked by overcapacity and underfunding, leading to the closure of companies such like AmplifyBio and Exothera, and Thermo Fisher Scientific reducing hundreds of viral vector-related positions. However, in response to these challenges, new entrants such as Mytos and BioNexus are emerging, and the U.S. Food and Drug Administration (FDA) is actively easing manufacturing regulations to support the scale-up of personalized therapies.

Technical/Clinical Details

CDMO Market Challenges: The issues of overcapacity and underfunding in cell and gene therapy manufacturing are particularly acute in specific modalities, such as adeno-associated virus (AAV) vectors. While many CDMOs expanded capacity, failures in clinical trials and difficulties in securing funding have resulted in lower-than-projected demand, leading to closures like AmplifyBio and Exothera, and hundreds of job cuts related to viral vectors at Thermo Fisher Scientific.
New Entrants and Automation Progress: Mytos’s iDEM platform is transforming traditional iPSC manufacturing into a closed, automated system, delivering consistent, GMP-compliant cells, which improves manufacturing efficiency and quality consistency. I Peace, with its fully closed automated iPSC manufacturing system capable of concurrently mass-producing clinical-grade iPSC lines, exemplifies the active pursuit of automation and standardization to resolve manufacturing bottlenecks.
Regulatory Response: The FDA is implementing more flexible manufacturing regulations to facilitate the rapid development and market entry of personalized therapies like cell and gene therapies. This aims to reduce the time it takes for innovative treatments to reach patients and to enhance manufacturing flexibility.
Global Capacity Expansion: Major pharmaceutical and CDMO companies, including Lonza, Roche, and Samsung Bio, are expanding their manufacturing capabilities within the U.S. while simultaneously being compelled to re-evaluate their global supply chains due to tariff pressures. For example, Samsung Biologics has acquired PolyPeptide for $1.8 billion, entering peptide manufacturing to strengthen its supply capabilities in specific modalities.

Background & Context

Cell and gene therapies have developed rapidly due to their groundbreaking therapeutic potential, but the complexity of producing these therapies at a commercial scale has been a significant barrier. Particularly for personalized treatments targeting small patient populations, manufacturing processes require flexibility and cost-efficiency. The CDMO industry has invested heavily to meet this demand, but market uncertainties and technical challenges have led to difficulties for some companies. Concurrently, the introduction of automation, digital twins, and AI-driven solutions is optimizing and streamlining manufacturing processes.

Strategic Significance & Outlook

The cell and gene therapy manufacturing industry is undergoing a period of consolidation and realignment. While some CDMOs are scaling back or exiting due to intensifying competition and funding challenges, companies with innovative technologies like Mytos are filling market gaps through automation and efficiency. The FDA’s regulatory easing will further support growth in this sector. In the future, more highly automated, data-driven manufacturing platforms are expected to become standard, reducing the cost of cell and gene therapies and improving access, ultimately enabling these revolutionary treatments to reach more patients.

Source: https://endpoints.news/topic-hub/cell-and-gene-therapy-manufacturing-scaling-the-next-frontier/page/24/

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