Simplify cell line development, scale up and antibody manufacturing with a partner who understands diagnostic immunoassay development. Whether its new development, or scale up and manufacturing of an existing assay, we can supplement your IVD capabilities and shorten your time to commercialization.
We can work with you directly to develop solutions and build antibodies to your specifications (minimums may apply). Backed by decades of experience in antibody development for medical and pharma applications, our products are created in-house under GMP manufacturing. Your custom antibodies are created with sustainable cell line production within an ISO 13485 manufacturing environment compliant with 21 CFR Part 820 quality guidance and documentation to support MDSAP audits.
With decades of experience in antibody scale-up and manufacturing, lateral flow membrane, and reagent manufacturing, we are uniquely qualified to help develop and optimize your immunoassay components. Our services and production steps are all performed in-house by our teams of qualified, trained specialists.
Cell Marque™ IVD antibodies for immunohistochemistry (IHC) have been a market leader in high-performance tissue diagnostics testing for decades. Through our extensive knowledge, diverse expertise, and robust quality and regulatory systems we have provided biomedical researchers, Contract Research Organizations (CROs), and pharmaceutical & diagnostic developers with reliable, reproducible antibodies for applications ranging from classical IHC to advanced multiplexed ion beam imaging (MIBI).
Leverage our industry-leading technical expertise and deep knowledge of antibody-based applications to engineer or refine your specific antibody.
We can support your antibody project at any stage, from ideation through full scale-up to manufacturing. We can work with existing antibodies or custom-engineer antibodies to suit your specific performance characteristics. Each project is supported by robust quality and regulatory systems and validated by a team of dedicated tissue diagnostics technical specialists and two in-house histopathologists.
The Millipore® portfolio of blood typing intermediates for further manufacturing use (FFMU) are standardized cell culture supernatants from cell lines expressing human or murine monoclonal antibodies. These FFMU intermediates are for use in formulating finished blood typing reagents or devices. By dilution, blending (where appropriate), and chemical additions, manufacturers can formulate their own finished reagents or devices with reactivity profiles suitable for their specific applications. The potency of each batch is carefully controlled to match that of an internal reference batch. All FFMUs contain 0.1% (w/v) sodium azide as a preservative.
Most of the FFMU series of antibodies are currently licensed with the US Food and Drug Administration under shared manufacturing arrangements.
When R&D priorities shift or diagnostic assay development or manufacturing becomes too resource-intensive, contract manufacturing (CMO) may be an option.
We are proud to partner with the world’s largest diagnostics manufacturers as well as helping new diagnostics companies navigate compliance requirements and launch the products that will transform healthcare.
To continue reading please sign in or create an account.Don't Have An Account?