Viral Vector CTDMO Services
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 experience, capabilities, and knowhow to advance cell and gene therapies to market.
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
30
Years of viral vector development and manufacturing
2,000 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.
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 assessments, 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 and downstream process development
- Pilot lab capabilities up to 1,000L
- IND-enabling and toxicology support studies
- Optimized, scalable vector platforms
Analytical Development
Our Analytical Development services are tailored to support the success of cell and gene therapies with individualized phase-appropriate testing and support.
- On-site bio assay and chemistry analytics
- Assay development and method optimization
- Characterization assays
- Comparability studies
Manufacturing
GMP Manufacturing
Our flexible operations and capacity support clinical through commercial upstream and downstream GMP manufacturing for cell and gene therapies.
- Small to large scale capabilities
- Suspension manufacturing: 50L to 2,000L
- Adherent manufacturing: various scales
- Single-use bioreactors and systems
- Tailored approach to tech transfers
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.
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).
Viral Vector Platforms
We are dedicated to accelerating the development timelines for cell and gene therapies. Discover how we leverage our 30 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.
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
- Scalable lentivirus platform
- Robust and optimized processes
- Best-in-class for high yield and quality
- Less than 12 months to clinical product
- Comprehensive analytics
Adeno-Associated Virus (AAV)
We have significant experience in AAV development and manufacturing to quickly progress gene therapy programs from development to manufacturing.
- Experience with a range of AAV serotypes
- Clinical manufacturing expertise
- Technical expertise for tech transfers
- Comprehensive analytics
Adenovirus
Our teams have supported over 115 adenovirus clinical programs and have produced over 100 GMP batches. This deep expertise and understanding allows us to develop optimized approaches for adenoviral vector manufacturing.
- Experience with various host cells
- Clinical manufacturing expertise
- Scalable platform approach
- Optimized processes
- Comprehensive analytics
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 Resources
- Webinar: Viral Vectors For Gene and Cell Therapies: Capabilities & Expertise
In this webinar, we explore our capabilities and expertise in viral vector development and manufacturing. Discover our end-to-end preclinical through commercial solutions and how we tailor our processes to meet your therapeutic need.
- Webinar: Make More Lentivirus and Make it Right the First Time
In this webinar we share how the superior performance of our scalable, end-to-end VirusExpress® lentivirus platform enables success for your cell or gene therapy.
- Webinar: 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.
- Webinar: 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.
- Webinar: Strategies to Accelerate Development & De-Risk Gene Therapy Manufacturing
Join our viral vector process and analytical development (PAD) team for this on-demand webinar to discover our strategies for developing robust processes and analytics to ensure efficient and de-risked manufacturing.
External Resources
- Balancing phase-appropriate needs with commercial readiness in viral vector manufacturing
In this article, we outline 4 recommendations to consider as your therapeutic moves through drug development towards a commercialized product.
- 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.
- 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.
- Automation in Analytics: Streamlining & Enhancing Gene Therapy Production
In this white paper, learn why is important to establish an analytics program in early clinical development, and how partnering with an experienced CDMO that can establish an data-driven, streamlined analytics approach is key in accelerating program development.
- 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.
- 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.
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