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Steven has a BSc in Pharmacology and a Masters in Bioscience from the University of Leeds, as well as a Ph.D. in Pharmacy from the University of Nottingham. After finishing his Ph.D. he spent two years working at an agency as a medical writer. Wanting to further develop his communication skills he joined Technology Networks as a science writer in 2023. In his current role, he is responsible for creating custom written content and also contributes to the development of digital content.
Cell and gene therapies (CGT) represent a revolutionary approach to treating previously incurable diseases, with the market projected to reach nearly $100 billion within the next decade.
However, manufacturers face significant challenges in scaling production while maintaining quality and regulatory compliance.
This infographic explores the complete CGT manufacturing journey, from source material acquisition to final product preparation, highlighting key challenges and emerging technological solutions.
Download this infographic to explore:
The five stages of the CGT manufacturing process and their unique quality control requirements
Major manufacturing challenges including scalability, cost efficiency and regulatory compliance
How emerging technologies like artificial intelligence are revolutionizing production workflows
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Cell and Gene
Therapy
Manufacturing
Getting Products
to Patients
By Steven Gibney, PhD | Designed by Luiza Augusto
Cell and gene therapies (CGT) represent a
revolutionary approach to treating previously
incurable diseases. These groundbreaking
treatments are maturing from clinical trials to
commercial success stories, rapidly increasing
demand for efficient, scalable manufacturing
processes. This infographic explores the CGT
manufacturing journey, from the early stages
to final product preparation, highlighting the
challenges CGT manufacturers face and the
tools that help overcome them.
An ever-growing market
The CGT market is experiencing unprecedented growth, driven by increasing clinical success and regulatory approvals.
4,099
2033
97.33
therapies in
development
billion
2023
18.13
billion
Over the next decade, the cell and
In 2024, more than 4,000 gene, cell and
Cell and gene therapies are making
gene therapy market is predicted to
RNA therapies were in the development
significant strides in treating cancer,
grow to almost $100 billion.
pipeline, from preclinical through to pre
infectious diseases and autoimmune
.1
registration.
conditions
2
.3
A multi-step manufacturing process
The CGT manufacturing process combines cutting-edge biotechnology with rigorous quality controls. Each step presents unique
challenges and opportunities for innovation.
Source material acquisition
The quality of the initial material fundamentally
impacts the entire manufacturing process and
1
final product efficacy.
Samples must be handled with care, preserved
and tracked to ensure strict quality control.
Genetic modification/editing
Once the source material arrives at
the manufacturing facility, genetic
modification begins.
2
Quality control at this stage involves
multiple checks to verify the accuracy of
genetic modifications and absence of off
target
effects.
Cell expansion & culture
The cell expansion phase transforms
small populations of modified cells into
3
therapeutic quantities.
This scaling process takes place in specialized
bioreactors that precisely control temperature,
pH, oxygen levels and nutrient concentrations.
Purification & quality control
Therapeutic cells must be separated from
process-related impurities while maintaining
cell viability and functionality.
4
This stage employs a combination of advanced
separation technologies, including magnetic
activated
cell sorting (MACS), fluorescence
activated
cell sorting (FACS) and tangential
flow filtration.
Final product preparation
The final stage focuses on preparing the
5
therapy for patient administration, requiring
careful consideration of product stability and
delivery requirements.
Key manufacturing challenges
With such a complex multistep process, it is unsurprising that a range of challenges arise.
Regulatory compliance
Scalability
Manufacturers must
Current technologies
navigate stringent global
struggle to consistently
standards that require
produce large
extensive documentation,
therapeutic batches,
rigorous validation protocols
requiring significant
and continuous adaptation
investments in
to emerging regulatory
automated solutions and
frameworks.
advanced facility design.
MANUFACTURING
CHALLENGES
Quality and consistency
Cost efficiency
Biological variability
Complex supply chains,
introduces significant
specialized equipment
challenges, with each
requirements and the
batch potentially
need for a highly skilled
showing distinct cellular
technical workforce
characteristics.
drive up expenses.
Looking forward
Advances in technology are making the complex manufacturing more manageable and easier to navigate.
Single-cell analytics
Single-cell analytics track individual
cell characteristics, while advanced
AI
genomic and proteomic analysis
techniques offer a detailed
understanding of product attributes.
Artificial intelligence
Artificial intelligence (AI) and machine
learning systems are beginning to
optimize manufacturing processes in
real time.
This makes it possible to analyze
thousands of parameters to predict
batch outcomes and suggest process
adjustments before issues arise.
Streamlined regulatory approval
Regulatory agencies are developing new
guidelines for advanced manufacturing
technologies, including AI-driven process control
and continuous manufacturing.
Overcome the complexities of CGT manufacturing
to bring life-changing therapies to patients.
References
1. Nova1Advisor. Cell and Gene Therapy Market Size Report, 2024-2033. Novaoneadvisor.com. Published 2024. https://www.novaoneadvisor.
com/report/cell-and-gene-therapy-market. Published 2024. Accessed March 21, 2025.
2. American Society of Cell and Gene Therapy. Gene, Cell, & RNA Therapy Landscape Report Q3 2024 Quarterly Data Report. https://www.
asgct.org/global/documents/asgct-citeline-q3-2024-report.aspx. Accessed March 21, 2025.
3. Chancellor D, Barrett D, Nguyen-Jatkoe L, Millington S, Eckhardt F. The State of Cell and Gene Therapy in 2023. Molecular Therapy. 2023;31.
doi: 10.1016/j.ymthe.2023.11.001
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