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Custom Diagnostic Antibody Development & Manufacturing Services

Overcome Process Challenges

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.

Antibody Development for IVDs 

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.

Cartoon of 96 well plate showing different colored wells to indicate differential staining of cells in as

Custom Cell Line Development

  • Raw Materials for ELISA, CLIA, PCR, Point of Care, Blood Typing Assays and IHC Assays
  • Molecular Biology
  • Vector Construction for Recombinant Protein Production
  • Recombinant Protein Expression
  • B-cell Cloning Platform
  • Transient Transfection Expression Platform
  • Antibody Reverse Engineering
  • Stable Cell Line Generation & Optimization
Cartoon of small bioreactor for diagnostic antibody scale up

Diagnostic Antibody Scale Up for Production

  • Contract Manufacturing
  • Fermentation Optimization
  • Purification Optimization
  • Serum-free Adaptation
  • GMP Cell Banking
  • Custom QC
  • Bulk and Custom Packaging
Cartoon of box packed with antibody vials indicating diagnostic antibody production

Diagnostic Assay Antibody Manufacturing

  • Risk Mitigation
  • Large Scale Contract Manufacturing
  • Order and Inventory Management Support
  • Quality Services & Support
  • Biomonitoring for Sterile & Non-sterile Manufacturing

Cell Marque™ Tissue Diagnostic Antibody Development 

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.

Blood Typing Antibody Development

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.

Additional Antibody Contract Manufacturing Services

  • Tissue Culture-Cell Banking and Inoculum Prep
  • Fermentation-Batch and Continuous
  • Downstream Processing-Clarification, Concentration, Diafiltration, Purification, Custom Conjugation
  • Filtration in ISO14644 Class 7 Cleanroom, Class
  • 5 LAF Hoods
  • QC Testing-including Micro ID, Serology, pH, Protein, ELISA, HPLC, IEC, Western blot, IHC, Custom specificity assay development
  • Product Release-Batch Review, CoA Generation, Worldwide Distribution

Contract Manufacturing Services for IVD Assay Development

When R&D priorities shift or diagnostic assay development or manufacturing becomes too resource-intensive, contract manufacturing (CMO) may be an option.

OEM & CMO Services include:

  • Critical raw material sourcing
  • Supply chain management
  • Risk mitigation
  • Scale-up technical support
  • Component or whole kit manufacturing
  • QC services

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.

OEM & Contract Manufacturing

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