Viral vector manufacturing is one of the biggest production challenges in cell and gene therapy. Companies are under pressure to increase vector yield, reduce facility footprint, shorten manufacturing timelines and lower cost per dose.

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Process intensification is becoming a major solution. It includes technologies such as perfusion, high-cell-density production, continuous harvest, tangential flow depth filtration (TFDF), intensified upstream processing, closed systems and integrated downstream workflows.

In the United States, companies such as Repligen, Catalent, Forge Biologics and Andelyn Biosciences are among the most relevant players. They approach intensification differently: Repligen primarily provides enabling bioprocess technology, while Catalent, Forge and Andelyn combine process development with CDMO manufacturing services.

Top Companies at a Glance

Company	U.S. focus	Process-intensification capability	Viral vector focus
Repligen	Bioprocess technology	TFDF, perfusion and continuous harvest	AAV, lentivirus and other vectors
Catalent	CDMO	Intensified upstream development and scalable platforms	AAV, LVV and other viral vectors
Forge Biologics	AAV-focused CDMO	High-throughput, closed-system and scalable processing	AAV
Andelyn Biosciences	Viral vector CDMO	Optimized scalable process development	AAV and other viral vectors
Thermo Fisher Scientific	Bioprocess technology and services	Single-use and integrated bioprocessing	Cell and gene therapy
Cytiva	Bioprocess technology	Perfusion, filtration and scalable single-use systems	Viral vector manufacturing

Note: The first four companies have particularly visible public evidence of direct viral-vector manufacturing or process-development capabilities. Technology suppliers such as Thermo Fisher and Cytiva play an important enabling role across the manufacturing workflow.

1. Repligen – One of the Most Direct Process-Intensification Specialists

Repligen stands out because process intensification is a central part of its bioprocessing strategy.

For viral vectors, the company highlights its KrosFlo® TFDF® technology, which can support intensified production and continuous harvest workflows. Repligen states that its approach can help mitigate cell-density effects, simplify clarification and improve virus production for AAV and lentiviral vector processes.

Key published company metrics

Repligen reports:

>10× potential increase in virus production in certain intensified workflows
Approximately 20× reduction in production scale compared with a 200 L batch process in cited applications
86× more TU/L of bioreactor for a lentiviral vector TFDF example
3–10× AAV production improvement across multiple serotypes
Approximately 100% biomolecule transmission during continuous viral-vector harvest in described TFDF applications

Why Repligen matters

Repligen is particularly relevant for companies trying to move from:

Traditional batch production → intensified perfusion → continuous harvest

Its systems can be used from process development through larger-scale GMP manufacturing.

2. Catalent – Large-Scale Viral Vector CDMO Infrastructure

Catalent combines process development with large-scale viral vector manufacturing.

The company supports AAV, lentivirus, baculovirus, adenovirus, herpesvirus and retrovirus, using both suspension and adherent production systems.

Catalent’s scale

The company reports:

55+ gene therapy innovators supported
90+ clinical and commercial gene therapy programs
3,000+ upstream cGMP AAV batches
2,500+ commercial AAV batches
16 cGMP suites
500,000+ sq. ft. of manufacturing space
Suspension-based production up to 2,000 L
2,500+ cGMP iCELLis 500 bioreactor runs

Catalent also describes upstream development capabilities that include N-1 perfusion process intensification, although not every intensified biologics process is necessarily specific to viral vectors.

Why Catalent matters

Catalent is a strong option for developers needing:

Process development
Technology transfer
Clinical manufacturing
Commercial-scale manufacturing
Multiple vector platforms

Its UpTempo™ AAV platform is designed to standardize development and simplify the manufacturing pathway, with the company stating that vialed drug product can be delivered in as little as 9 months in applicable programs.

3. Forge Biologics – High-Throughput AAV Manufacturing

Forge Biologics is one of the most specialized U.S. players for AAV manufacturing.

Its FUEL™ platform is designed to support faster and more efficient process development and scale-up. The company combines proprietary AAV manufacturing approaches with single-use technologies and optimized closed-system processing.

Forge’s manufacturing scale

Forge reports:

20 GMP suites
A 200,000+ sq. ft. GMP facility
AAV manufacturing from 50 L to 5,000 L
Process development scales from 1 L to 1,000 L
Research-grade production from 1–40 L
25+ AAV assays performed in-house

Process-intensification approach

Forge’s strategy focuses on:

Scalable upstream production
Optimized production processes
Closed systems
Single-use technologies
High-throughput operations
Reduced process variability

The company’s process-development organization has mapped 50+ upstream and downstream studies to optimize yield, purity and recovery.

4. Andelyn Biosciences – Process Development to Commercial Scale

Andelyn Biosciences is another important U.S.-based viral vector CDMO.

Its strategy focuses on developing robust, scalable and cost-effective processes for clinical and commercial cell and gene therapy production.

Key company data

Andelyn reports:

85+ INDs supported
70+ active programs
500+ cGMP clinical batches
Up to 2,000 L manufacturing scale
16 cGMP manufacturing suites
Approximately 225,000 sq. ft. of combined facility space

Process technologies

Andelyn uses:

Suspension processes
Adherent processes
Single-use stirred-tank bioreactors
Affinity chromatography
Ion-exchange chromatography
Tangential-flow filtration
Advanced clarification and purification workflows

Its process-development approach incorporates quality-by-design principles to optimize production yield, cost and scalability.

5. Thermo Fisher Scientific – Integrated Manufacturing Technology

Thermo Fisher Scientific is a major supplier of technologies used across cell and gene therapy manufacturing.

Its relevance to process intensification comes from its broader portfolio across:

Single-use bioreactors
Cell-culture technologies
Bioprocess controllers
Filtration
Analytics
Gene-therapy manufacturing services

Rather than being solely a viral-vector process-intensification specialist, Thermo Fisher is an important enabling technology and manufacturing ecosystem competitor for companies building intensified workflows.

6. Cytiva – Perfusion and Scalable Single-Use Systems

Cytiva plays an important role in viral vector manufacturing through its bioprocessing equipment.

Its technologies are used across:

Single-use bioreactors
Perfusion systems
Filtration
Cell culture
Process development
Scale-up

Cytiva is particularly relevant where manufacturers want to integrate intensified upstream processing with scalable single-use infrastructure.

Andelyn, for example, lists Cytiva Allegro STR systems among the suspension bioreactor technologies used at its Columbus manufacturing site.

How Process Intensification Works in Viral Vector Manufacturing

Traditional viral vector production can require large manufacturing footprints and significant equipment capacity.

Process intensification attempts to increase productivity per unit of manufacturing volume.

Key approaches include:

Perfusion

Fresh media is continuously supplied while waste products are removed, supporting higher cell densities.

High-cell-density production

More producer cells can potentially generate more viral vector within the same bioreactor footprint.

Continuous harvest

Vectors can be harvested during production rather than relying entirely on a single end-of-run harvest.

TFDF

Tangential flow depth filtration can enable cell retention and clarification while supporting intensified perfusion processes.

Closed processing

Reducing open handling can support scalability and lower contamination risk.

Integrated downstream processing

Combining clarification, concentration and purification more efficiently can reduce processing bottlenecks.

A published study on lentiviral vector manufacturing concluded that process intensification using perfusion with a stable producer cell line and tangential flow depth filtration could increase cell density and enable continuous vector separation from producer cells.

Why the Technology Is Important

The key objective is to produce more therapeutic doses without proportionally increasing:

Bioreactor volume
Facility space
Cleanroom capacity
Labor requirements
Manufacturing cost

This is particularly important for AAV and lentiviral vectors, where manufacturing economics remain a major challenge.

Process Intensification Metrics to Watch

Metric	Why it matters
Vector yield	Determines potential dose output
TU/L or vg/L	Measures productivity
Space-time yield	Measures output per manufacturing volume and time
Cell density	Indicates upstream intensification potential
Recovery rate	Measures vector retained through downstream processing
Full-to-empty capsid ratio	Critical AAV quality attribute
Batch duration	Affects facility utilization
Cost per dose	Determines commercial viability
Manufacturing footprint	Important for facility economics

Competitor Landscape

The U.S. competitive landscape can be divided into three groups.

Direct process-intensification technology specialists

Repligen
Other filtration and bioprocess technology specialists

Viral vector CDMOs with process-development capabilities

Catalent
Forge Biologics
Andelyn Biosciences
Other specialized cell and gene therapy CDMOs

Broad bioprocess technology competitors

Thermo Fisher Scientific
Cytiva
Sartorius
Merck Millipore

These companies compete differently. Some sell the equipment and consumables, while others sell the development and manufacturing service.

Who Are the Actual Buyers?

The main buyers of process-intensification solutions are not only large pharmaceutical companies.

1. Gene Therapy Developers

Companies developing:

AAV gene therapies
Lentiviral therapies
In vivo gene therapies
Rare-disease treatments

These companies need to increase vector output before entering larger clinical trials or commercial manufacturing.

2. Cell Therapy Companies

Lentiviral vectors are widely used in ex vivo cell-therapy manufacturing.

Buyers may include companies developing:

CAR-T therapies
TCR therapies
Gene-modified cell therapies

3. Viral Vector CDMOs

CDMOs are major buyers of:

Perfusion systems
Filtration equipment
Single-use technologies
Process analytics
Automation systems

They need flexible platforms capable of supporting multiple client programs.

4. Large Pharmaceutical Companies

Large pharmaceutical companies are increasingly building internal capabilities for:

Gene therapy
Rare diseases
Oncology
Genetic medicines

These organizations may invest in intensified manufacturing to reduce future capacity constraints.

5. Academic and Translational Manufacturing Centers

Universities and research hospitals also require smaller-scale intensified platforms to move programs from research into IND-enabling development.

What Should Buyers Compare?

Before selecting a company or technology, buyers should evaluate:

Vector type: AAV, lentivirus and other vectors have different process requirements.

Production platform: Transient transfection versus stable producer-cell systems.

Scale: Early process development and commercial production require different infrastructure.

Yield improvement: Ask for vector-specific data rather than general biologics productivity claims.

Continuous capability: Determine whether the system supports perfusion, continuous harvest or both.

Downstream compatibility: Intensified upstream production can create additional purification challenges.

GMP readiness: Equipment and workflows must support validated manufacturing.

Technology transfer: The ability to move the process between development and commercial sites is critical.

The Strategic Takeaway

Process intensification is becoming an important competitive strategy in viral vector manufacturing.

Repligen stands out as a direct technology specialist, with publicly stated examples of >10× higher virus production, 86× more TU/L in a lentiviral example and 3–10× AAV improvement across multiple serotypes.

Catalent brings extensive multi-vector CDMO infrastructure, including 3,000+ upstream cGMP AAV batches and manufacturing up to 2,000 L.

Forge Biologics offers a specialized AAV platform with production scales up to 5,000 L and a 200,000+ sq. ft. GMP facility.

Andelyn Biosciences combines process development and commercial manufacturing, reporting 85+ INDs, 70+ active programs and 500+ cGMP clinical batches.

For buyers, the central question is no longer simply:

“Who can manufacture our viral vector?”

It is:

“Who can increase vector productivity while maintaining product quality, scalability and regulatory readiness?”

How Towards Healthcare Research & Consulting Can Help

Towards Healthcare Research & Consulting can help companies track:

Viral vector manufacturers
Process-intensification technologies
AAV and lentiviral capacity
CDMO facilities
Bioreactor technologies
Perfusion and continuous manufacturing
Manufacturing investments
Competitor capabilities
Buyer and supplier intelligence
Cell and gene therapy pipelines

The objective is to connect manufacturing technology, supplier capabilities, competitor activity and buyer demand to identify the next opportunities in cell and gene therapy.

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Top U.S. Companies Specializing in Process Intensification for Viral Vector Manufacturing