Viral Vector Contract Testing, Development, & Manufacturing Services (CTDMO)
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).
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 helping your advance your viral gene therapy from pre-clinical through commercial production, backed by a superior regulatory track record. In fact, we’ve supported 4 out of the 13 commercially FDA-approved cell and gene therapy products from pre-IND to commercial supply.
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
Development
Process Development
Our experienced Process Development teams incorporate a virus-specific and holistic approach to develop robust and optimized processes to support preclinical through commercial needs.
- Upstream, recovery, and downstream process development
- Process characterization, demonstration, and scale-up
- IND-enabling and toxicology support studies
- Templated platform technologies
Analytical Development
Our Analytical Development services are tailored to support the success of cell and gene therapies with individualized phase-appropriate testing and support.
- Assay development and method optimization
- Characterization assays
- Comparability studies
Manufacturing
GMP Manufacturing
Our flexible operations and capacity support clinical through commercial GMP manufacturing for cell and gene therapies.
- Small to large scale capabilities
- Suspension: 50L to1,000+ L
- Adherent: CellSTACK® and HYPERFlask®
- Single-use bioreactors and systems
Fill/Finish
To streamline cell or gene therapies to market, we offer on-site clinical and commercial fill/finish services, as a continuation of GMP manufacturing.
- Drug substance formulation
- Automated and semi-automated isolator filling
- 100% visual inspection
- Automated vial labeling
Regulatory Support
Throughout the cell and gene therapy development and manufacturing lifecycle, we leverage the same expertise that has seen us through inspections by global regulatory agencies – 6 and counting – to provide dedicated and customized support for regulatory filings, inspections, and responses.
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.
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
Lentivirus
With over 300 batches produced, we have extensive lentivirus development and manufacturing experience for cell and gene therapies.
- Industry-leading titer
- Clinical and commercial manufacturing expertise
- Lentivirus platform
- Robust and optimized processes
- Best-in-class for high yield and quality
- Accelerated development timelines
- Less than 12 months to clinical product
Adenovirus
Our teams have been developing and manufacturing adenoviral vectors for over 25 years. This deep expertise allows us to efficiently support cell and gene therapy needs.
- Experience with various host cells
- Clinical manufacturing expertise
- Adherent and suspension processes
Other viral vectors
Our team of viral vector experts are accomplished in the development and manufacture of a diverse range of viral platforms, such as HSV, reovirus, echovirus, and more. We have supported more than 1,000 viral vector batches from process development to manufacturing with know how to support your viral vector therapeutics. Contact us to explore our capabilities and discuss your project needs.
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.
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.
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.
Related Webinars
- Industry Leading Lentiviral Titers through our Optimized VirusExpress® Platform
In this webinar, our viral vector innovation team examines how they optimized and defined upstream and downstream processes to deliver a de-risked, reproducible, and accelerated path to GMP manufacturing, while providing high yield and quality lentivirus.
- Streamlining Viral Vector Development and Manufacturing
Hear from our viral vector experts as they showcase our capabilities and solutions for cell and gene therapy production and highlight key features of our technologies and GMP facility.
External Resources
- Addressing Manufacturing Challenges in Gene Therapy Development
Learn how our Manufacturability Assessment can help identify and address development and manufacturing challenges when bringing new therapies to market.
- Applying High Throughput Processes to Optimize AAV Titers
In this article, we explore how establishing an innovative DoE approach helped optimize the transfection and scale up of an AAV-based gene therapy.
- 5 Ways Experience Matters in Gene Therapy Manufacturing
Discover how partnering experienced viral vector CTDMO can help guide you through the complexities of manufacturing and overcome regulatory hurdles to bring new therapies to patients.
- An Optimized & Streamlined Approach for Upstream & Downstream Lentiviral Production
Watch the video and read the poster to learn how we optimized our VirusExpress® platform for lentiviral vectors to maximize titers, enrich recovery, and reduce time to GMP manufacturing.
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