Leader in Viral Vector Manufacturingįormerly 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. Our comprehensive secure biostorage program covers restricted key-card access and diesel-powered emergency generator. Freezer units are continuously monitored via a networked system of data loggers with remote temperature information and alarm notifications. The facility has controlled temperature freezers of -80 ☌ and -20 ☌ along with on-site liquid nitrogen dewars for storage of final drug substance with complete freezer inventories and full documentation. 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. We have global capabilities and capacity to successfully support clients’ projects from product characterization and validation to commercial release testing. ![]() 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. As a full service gene therapy CDMO, we integrate BioReliance® testing services into our workflow to support you at every step of drug development. MilliporeSigma has a deep understanding on regulatory expectations of safety evaluations of viral vectors. 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. Sterile fill finish is one of the most critical processes in safeguarding the sterility and delivering drug substances intended for use in patient. 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. 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. We also manufacture key intermediates including master and working cell and viral banks. We have averaged more than twenty new tech transfer projects annually and have helped clients achieve faster speed-to-market. The tech transfer team delineates acceptance criteria for engineering and cGMP programs and works collaboratively with our manufacturing team and clients. 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 breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization. ![]() Our PD capabilities include different upstream bioprocessing and downstream purification approaches involving various virus types and diverse modes of adherent or suspension cultures. advancinglifescience.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 new product portfolio brand structure and visual identity sets the tone for the future of our business – as an organization that is pioneering, imaginative, bold and unique, and which creates diverse and innovative experiences for our customers.Īside from these changes, nothing about the functionality or characteristics of the products, or how they are ordered, will change.įor more information on the packaging and labeling changes, please see the following pages, or contact Customer Service, email or contact your dedicated account manager.įor additional information on the portfolio brand strategy, visit: The rebranding of our product packaging and labeling, in conjunction with the realignment of our products into our six portfolio brands, follows the launch of our new brand in 2015 and the integration of Sigma-Aldrich into our life science business, the largest acquisition in our history. This will ensure that our products and packaging are visibly, boldly and undeniably MilliporeSigma and that you will start to see a consistent brand presence across the entirety of MilliporeSigma. At MilliporeSigma, we are rebranding all of our life science products, packaging, labeling and related documentation to reflect consistent corporate branding and relevant portfolio branding.
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