Cell and gene therapies (CGTs) represent one of the most transformative areas of modern medicine. These advanced therapies offer the potential to treat or even cure diseases that were previously considered untreatable, including certain cancers, genetic disorders, and rare diseases. However, the complexity of these therapies also presents unique manufacturing and quality challenges.

Unlike traditional pharmaceutical products, cell and gene therapies often involve living cells, viral vectors, or genetically modified materials. This biological complexity makes quality assurance and manufacturing control significantly more demanding. As the number of CGT products entering clinical trials and commercial markets continues to grow, ensuring consistent product quality has become a top priority for manufacturers and regulators alike.

In 2026, organisations developing and manufacturing cell and gene therapies are adopting specialised quality frameworks, advanced monitoring technologies, and risk-based strategies to maintain high standards of safety, efficacy, and regulatory compliance.

Unique Quality Challenges in Cell and Gene Therapy

Cell and gene therapy manufacturing differs significantly from conventional drug production. Traditional pharmaceuticals often involve well-defined chemical processes, while CGT products rely on complex biological systems that can be highly variable.

Some of the most significant quality challenges include:

  • Biological variability in donor materials and cell populations

  • Short product shelf life, requiring rapid processing and delivery

  • Small batch sizes or patient-specific manufacturing models

  • Highly specialised manufacturing environments

  • Complex supply chains involving biological materials

For autologous therapies, where a patient’s own cells are used, each batch may effectively represent a single patient treatment. This makes consistency, traceability, and contamination control critical throughout the manufacturing process.

Strengthening Good Manufacturing Practice (GMP) Compliance

Regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require cell and gene therapy manufacturers to follow Good Manufacturing Practice (GMP) standards similar to those applied in traditional pharmaceutical manufacturing.

However, CGT manufacturing often requires additional controls due to the biological nature of the products.

Key GMP priorities in 2026 include:

Environmental monitoring and contamination control
Cell-based products are highly sensitive to contamination. Manufacturers must maintain strict environmental monitoring programmes within cleanrooms and controlled manufacturing environments.

Robust documentation and traceability
Given the personalised nature of many therapies, maintaining accurate records of patient samples, processing steps, and product release criteria is essential.

Material and supply chain control
Raw materials such as viral vectors, reagents, and cell culture media must meet strict quality standards and be sourced from qualified suppliers.

These GMP practices help ensure that each therapy meets safety and quality requirements before reaching patients.

Implementing Advanced Quality Control Strategies

Traditional quality control testing methods can be challenging to apply in CGT manufacturing due to the limited availability of product samples and the short timeframes for product release.

To address these challenges, manufacturers are increasingly adopting advanced testing strategies, including:

Rapid microbiological testing
New technologies allow for faster detection of microbial contamination, enabling quicker product release decisions.

In-process monitoring
Rather than relying solely on end-product testing, manufacturers monitor critical parameters throughout the production process.

Potency and functional assays
These tests evaluate whether a therapy performs its intended biological function, ensuring its effectiveness.

By integrating these methods into their quality frameworks, organisations can maintain strong product oversight despite the complexities of CGT manufacturing.

Leveraging Automation and Digital Technologies

Automation and digital tools are becoming essential components of modern cell and gene therapy manufacturing. These technologies help reduce manual handling, improve consistency, and enhance data traceability.

Examples of digital innovations supporting CGT quality include:

  • Automated cell processing systems

  • Digital batch records and electronic data capture

  • Real-time monitoring of critical manufacturing parameters

  • Advanced analytics for process optimisation

Automation is particularly valuable in reducing human error and improving reproducibility in complex biological processes.

Developing Skilled Quality and Manufacturing Teams

The rapid growth of the cell and gene therapy sector has created strong demand for highly skilled professionals in quality assurance, regulatory affairs, manufacturing science, and process development.

Ensuring quality in CGT manufacturing requires multidisciplinary teams with expertise in:

  • Molecular biology and cell culture

  • GMP compliance and regulatory standards

  • process development and scale-up

  • quality risk management

Many organisations are investing in specialised training programmes and cross-functional collaboration to ensure that staff can effectively manage the complexities of advanced therapy production.

Looking Ahead: The Future of CGT Quality Management

As the cell and gene therapy sector continues to expand, maintaining consistent quality will remain one of the industry’s greatest challenges. Future manufacturing models will likely rely on greater automation, decentralised production facilities, and digital quality management systems.

Regulators are also continuing to refine guidance for advanced therapies to ensure that safety and efficacy standards keep pace with scientific innovation.

By adopting strong GMP frameworks, advanced testing strategies, and digital manufacturing tools, organisations can successfully navigate the challenges of CGT production while delivering life-changing therapies to patients around the world.