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Viral Vector Contract Testing, Development, & Manufacturing Services (CTDMO)

Viral Vector manufacturing and testing

Advancing Cell and Gene Therapies for Patients

Millipore® CTDMO Services delivers expertise and flexible solutions for viral vector development and manufacturing to advance cell and gene therapies from preclinical through commercial production.

Our proficiency with adeno-associated virus (AAV), lentivirus, adenovirus, and other vectors helps streamline the development and manufacturing of cell and gene therapies. From early preclinical through clinical and commercial manufacturing, we offer the comprehensive resources, capabilities, and know-how to advance current and future cell and gene therapies to market.

Our track record includes successful regulatory inspections by the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the Australian Therapeutic Goods Administration (TGA), and the Brazilian Health Regulatory Agency (ANVISA).

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Our Track Record

4

Gene therapy commercializations supported since 2017

9

Successful inspections by 6 global regulatory agencies

1000+

GMP viral vector batches produced for 200+ clients

25+

Years of viral vector development and manufacturing

1,000+ L

Clinical to
commercial
scalability

1

One of the first to
support
commercially-
approved CAR-Ts


From Preclinical through Commercialization

Our viral vector experts are dedicated to supporting the advancement of cell and gene therapies throughout the product lifecycle. Discover how we apply our unparalleled experience, track record, and solutions to de-risk production from pre-IND to commercial supply.

Identify and evaluate process improvements to accelerate production timelines

Manufacturability Assessment

Our viral vector experts work with our clients to identify and evaluate improvements to current processes in order to streamline therapeutic production, address risk, and accelerate cell and gene therapies to the clinic. Through our Manufacturability Assessment, we:

  • Incorporate platform technologies for streamlined, scalable production
  • Review critical process parameters (CPPs) and critical quality attributes (CQAs)
  • Recommend adjustments in process design and testing requirements
  • Address other potential risks such as or raw material constraints

Viral Vector Platforms

We are dedicated to accelerating the development timelines for cell and gene therapies. Discover how we leverage our over 25 years of experience, knowledge and expertise in viral vector development and manufacturing to provide a de-risked, reproducible and streamlined path to clinical and commercial manufacturing through our viral vector platforms.

Manufacturing operator in PPE operates a 1,000L single-use bioreactor during AAV production

Adeno-Associated Virus (AAV)

We have significant experience in AAV development and manufacturing to quickly progress cell and gene therapy programs.

  • Experience with a range of AAV serotypes
  • Clinical manufacturing expertise
  • AAV platform
  • Reduce process development time
  • Transfection-based solution
  • Suspension-adapted cell line

Global FootPrint

A Global Footprint

We are a single organization with a global network to deliver CDMO services across all stages of the molecule value chain. Our recently expanded viral vector CDMO campus in Carlsbad, California, USA increases production capacity and allows us to provide end-to-end solutions for viral cell and gene therapies in a single facility.

Carlsbad, CA
Carlsbad, CA

Offering end-to-end viral vector services, our 157,000 sq. ft. state-of-the-art facilities house upstream and downstream production suites, along with fill/finish, warehousing, QC labs, in addition to process and analytical labs to support early phase development to commercial manufacturing of suspension and adherent-based cell and gene therapy platforms.

scientists in a manufacturing facility
Tour our large scale facility

Connect with us to explore first-hand our large-scale manufacturing facility and quality control labs to learn how our team delivers safe and reliable cell and gene therapy products.

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Our transformative journey from research to large-scale production

Watch this video to discover our journey in becoming a leader in clinical and commercial viral vector manufacturing and how we have supported cell and gene therapy innovators since the industry’s beginnings.


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