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Merck
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We’ll help you navigate your journey to gene therapy commercialization

Introducing Large-Scale Gene Therapy CDMO Services

You've developed your viral vector gene therapy and now it's time to embark on the voyage to manufacturing. But gene therapy production is uncharted territory, and you need someone to help navigate through the process. We can help.

With over 25 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 clinic and scale-up, to successfully bring your therapy to patients. Embark with us on the voyage to commercialization.

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The Promise of Gene Therapy: Accelerating the Path to Cures

Learn about our facility and commitment to serve our clients

Slide 1 of 4
Introducing Large Scale Manufacturing
Introducing Large Scale Manufacturing
We are pioneering the path from treatment to cures.
Tour of Our Large-Scale Facility Capabilities
Tour of Our Large-Scale Facility Capabilities
Explore our large-scale manufacturing capabilities, and Quality Control laboratories to learn how our team delivers safe and reliable gene therapy products.
How our Facility Design promotes Quality and Risk Reduction
How our Facility Design promotes Quality and Risk Reduction
Safety and compliance are top values within our organization. Learn how we reduce risk and enforce high quality standards.
How we Combine our Expertise with Best-in-class Technology to Build our Partnership.
How we Combine our Expertise with Best-in-class Technology to Build our Partnership.
Hear what our leaders have to say about our commitment to customer service and the latest innovations we’ve employed to best serve our clients.

Our BioReliance® Viral and Gene Therapy Manufacturing site in Carlsbad, California is a contract development and manufacturing organization (CDMO) that provides a complete range of services in the viral and gene therapy life cycle.

Our cGMP state-of-the-art facilities accommodate separate facility areas for scale-up, process validation, phase III trials and commercial launch. Additionally, our large-scale facility supports viral vector manufacturing up to 1,000 L using single-use bioreactors (SUBs). With our successful history of technology transfers and extensive experience in Process Performance Qualification (PPQ), we continue to partner with leading innovators in gene therapy to meet rigorous commercialization timelines.

Our track record includes successful regulatory inspections by the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Australia’s Therapeutic Goods Administration (TGA).

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Contact us today to learn how our BioReliance Viral and Gene Therapy Manufacturing services can help you get your product to market quickly and safely.

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