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 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).
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 VECTORS
We are dedicated to accelerating viral vector development and manufacturing. Through our de-risked, streamlined, and optimized upstream and downstream platforms, we can seamlessly and robustly scale-up to clinical and commercial manufacturing, while improving overall yield and quality.
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 technology
- 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.
- Clinical and commercial manufacturing expertise
- Lentivirus platform technology
- 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
Leverage our diverse viral vector expertise and experience working with a range of alternative viral vectors, such as reovirus and more, and are open to working with other distinctive viral vectors. Contact us to explore our capabilities and discuss your 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.