Manufacture
Gene Therapy Contract Development and Manufacturing Organization

Our BioReliance® viral and gene therapy manufacturing site at Carlsbad is a contract development and manufacturing organization (CDMO) that provides a complete range of services in the viral and gene therapy life cycle. Our responsibilities take us through each step of a client’s journey towards treating patients and ultimately a commercial product.

Clinical and Commercial Manufacturing

As a product innovator and CDMO with more than 20 years experience, we have produced more than 500 batches of virus within the last decade to support gene therapy development from clinical through commercialization. Backed by the deep know-how with a broad range of virus types and different processes, our production engineers employ an array of single-use bioreactor and purification technologies. Our cGMP state-of-the-art facility accommodates separate facility area for scale-up, process validation, phase III trials and commercial launch. With successful history of technology transfers, deep regulatory understanding and extensive experience in Process Performance Qualification (PPQ), we continue to partner with leading innovators in gene therapy to meet rigorous commercialization timelines.

Process Development

Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your viral vectors. Our PD capabilities include different upstream bioprocessing and downstream purification approaches involving various virus types and diverse modes of adherent or suspension cultures. The breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization.

Technical Transfer

We have established a full tech transfer team to ensure successful knowledge transfer and scaling up of developed production/purification processes for cGMP manufacturing. The tech transfer team delineates acceptance criteria for engineering and cGMP programs and works collaboratively with our manufacturing team and clients. We have averaged more than twenty new tech transfer projects annually and have helped clients achieve faster speed-to-market.

Cell and Viral Banking

We also manufacture key intermediates including master and working cell and viral banks. Our services include screening for clonal derivatives early in the development process, viral seed stock characterization, and cGMP production and banking of cell and viral banks. With our global presence, we have access to additional banking storage in Rockville, Maryland, USA, and Glasgow, Scotland, UK, adding extra capacity and flexibility if needed by clients.

Sterile Fill Finish

Sterile fill finish is one of the most critical processes in safeguarding the sterility and delivering drug substances intended for use in patient. With fill capacity of up to 2,000 vials/ day, filtering, filling and finishing of bulk drug substances is performed by highly trained operators in two dedicated Class 1000 (ISO 6) fill suites, one of which is designed for commercial fills.

Viral Vector Testing

Merck has a deep understanding on regulatory expectations of safety evaluations of viral vectors. As a full service gene therapy CDMO, we integrate BioReliance® testing services into our workflow to support you at every step of drug development. We offer a comprehensive array of biosafety assays, performed to cGMP guidelines using novel methods and state-of-the-art equipment to meet all clinical and regulatory compliance standards. We have global capabilities and capacity to successfully support clients’ projects from product characterization and validation to commercial release testing. Coupled with Carlsbad manufacturing facility, our BioReliance® biosafety testing services provide full in-house cGMP-compliant services for viral vector characterization and testing, including virus seed stock characterization, droplet digital PCR for virus titer and custom-designed potency assays.

Secure Biostorage

The facility has controlled temperature freezers of -80 °C and -20 °C along with on-site liquid nitrogen dewars for storage of final drug substance with complete freezer inventories and full documentation. Freezer units are continuously monitored via a networked system of data loggers with remote temperature information and alarm notifications. Our comprehensive secure biostorage program covers restricted key-card access and diesel-powered emergency generator.

Leader in Viral Vector Manufacturing

Formerly known as Molecular Medicine Bioservices, Inc and SAFC Carlsbad, we have more than 20 years of track record in developing and manufacturing viral vectors and vaccines. As a viral vector manufacturing pioneer since gene therapy clinical trials began in the 1990s, the facility continues to drive significant investment in new technologies and production capacity. We completed a major expansion in 2016, with first client production from the expansion occurring in 2017. These new production suites were designed to enable integration of future bioprocessing technologies. In October 2017, our facility completed both a U.S. Food & Drug Administration (FDA) Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization inspection.

For more information, view the Carlsbad facility insert.