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Viral Vector CTDMO Services

Our Viral Gene Therapy Offering

With 30+ years of gene therapy experience, we bring expertise in viral vector manufacturing and testing as well as a global organization to integrate regulatory, safety, and process development to fit your needs.

  • Pre-clinical through commercial manufacturing and testing services
  • Experience with Lentivirus, Adenovirus, AAV, and more
  • Customer-centric experts dedicated to your program’s success

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Processing Development

Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your viral vectors.

Scientist working on gene therapy in laboratory

Gene Therapy Process Development

The breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization.

Learn more about Gene Therapy Process Development

Manufacturing

Our viral and gene therapy manufacturing team has produced over 1,000 batches of virus, meeting rigorous timelines with a complete range of services, a state-of-the-art cGMP facility, and deep regulatory understanding.

Large Scale Gene Therapy Manufacturing

With over 30 years of viral vector manufacturing experience, we have charted multiple programs, clinical to commercial. Our experts will guide you through upstream and downstream development while keeping you from running aground on unexpected regulatory hurdles. With the launch of our large-scale CDMO facility, we’ll take you through the clinic and scale up to successfully bring your therapy to patients.

Learn more about Large Scale Gene Therapy Manufacturing

Related Services

Raw Material Testing
Our raw material testing helps ensure the quality and purity of materials used in biologics production.
Viral Clearance Testing
Viral Clearance studies are critical to the validation of downstream processes, ensuring viral clearance process steps are effective and reproducible in the biopharma manufacturing setting.
Biorepository & Storage
Store your precious material in GMP-compliant facilities amongst three continents. A range of materials including virus and cell banks can be stored in ambient, liquid nitrogen or –80 conditions.
Cell and Gene Therapy Bulk Harvest Release Testing
We offer cGMP-compliant bulk harvest release testing support for cell and gene therapies utilizing AAV, retrovirus/lentivirus, and adenovirus, as well as a wide range of regulatory and technical support services that bring your therapy to the clinic and beyond.
Cell and Gene Therapy Final Product Release Testing
From first-in-human clinical trials to scaling up for commercial launch, our final product release testing for cell and gene therapy provides the geographic footprint, experience, and expertise to bring your therapy to patients.
Blazar® Rapid Molecule Detection
Accelerate the biosafety testing of your biologic therapy by replacing traditional testing with our unique Blazar® platform featuring multiplex degenerate PCR.
Next Generation Sequencing
Our next-generation sequencing (NGS) biosafety testing services deliver deep insights into biologic therapeutics such as monoclonal antibodies, viral vectors, and novel vaccines, rapidly characterizing your process while identifying known and unknown agents with pinpoint precision and accuracy.

Related Resources

Navigating the Road to Gene Therapy Commercialization
BioReliance® Gene Therapy Services
Integrated Vector Production Capabilities
Your Gene Therapy Partner From Discovery to Commercialization
Scaling Up Your Viral Vector Therapy
Selecting the Right CMO For Your Gene Therapy

The Future of Our Gene Therapy CDMO Through the Lens of History
The Importance of Scalability in Viral Vectors
Understanding the Road to Commercialization - Infographic
How We Handle Quality Inspection Readiness
Overcoming the Biggest Hurdles in Gene Therapy Manufacturing
Updated US FDA Guidance For the Gene Therapy Industry: Key Changes and Areas of Increased Focus

Related Applications

Gene Therapy Manufacturing
Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
Cell Therapy Manufacturing
Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
Viral Vector Characterization and Biosafety Testing
As gene therapy products continue to show promise, biosafety testing and characterization remain a critical part of the development process. These vital steps help mitigate safety concerns and provide a better understanding of products and processes well in advance of patient administration.

Related Services

Cell Design Studio® Cell Engineering Services
Cell Design Studio® is the leading provider of custom cell lines. Sigma-Aldrich® Advanced Genomics genome engineers can deliver even the most challenging edits in any cell line

Related Product Categories

CRISPR & Gene Editing
Easy online ordering of predesigned or custom CRISPR guides guaranteed to produce a gene knockout at an industry leading price. Plasmid and SygRNA® synthetic formats are available to complement our extensive portfolio of Cas9 proteins, plasmids and lentivirus
Bioprocessing Cell Lines
Our ready-to-use, off-the-shelf cell line systems greatly reduce the time, cost, and risk of developing new cell lines for production. Whether you are producing antibodies, recombinant proteins, or viral vectors for gene therapies, our cell line platforms can accelerate your upstream progress.
Single-Use Mixers
Our complete range of Mobius® single-use mixing solutions can meet your needs for mixing pharmaceutical ingredients from intermediate to final drug products, as well as preparation of process solutions such as buffers and media.
Bioprocessing Single-Use Bioreactors
Mobius® single-use bioreactors are scalable, configurable, and reliable, able to perform fed-batch and perfusion bioprocessing at any scale from benchtop to full-scale production.
Tangential Flow Filtration Holders & Systems
Our tangential flow (crossflow) filtration systems are engineered for low hold-up volume, maximum volume concentration, and optimal product recovery in single-use and multi-use applications from process development to large-scale manufacturing, with compatible holders available for expendables.
Viral Vector Upstream Platforms
A transfection-based solution to viral vector production using a suspension cell line, chemically defined medium, and a process with proven performance at scale.
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