Custom Diagnostic Antibody Development & Manufacturing Services

Your end-to-end antibody partner

Bringing an antibody from concept to commercial supply is a complex, high-stakes process — one that demands deep scientific expertise, robust quality systems, and manufacturing infrastructure capable of growing with your program. Merck is built to support every stage of that journey.

We are, first and foremost, a diagnostic manufacturer. With one of the world's most comprehensive antibody portfolios — spanning monoclonal, polyclonal, and recombinant formats — and decades of in-house manufacturing experience, we apply the same scientific rigour, quality systems, and regulatory expertise to your program that we apply to our own commercial products. From initial technical feasibility assessment through to sustained commercial supply, a dedicated project team manages every milestone, every technical decision, and every quality requirement — so you can stay focused on what matters most: getting your product to market.

At a glance

End-to-end partnership — From antibody discovery through to commercial manufacturing, you have a single dedicated team behind your program — so there are no handoffs, no gaps, and no time lost bringing new partners up to speed. We grow with your program, not just the parts that suit us.

The science to solve your toughest targets — Our proprietary B cell cloning platform, matched-pair screening capability, and recombinant CHO expression systems are designed for the exact performance requirements of your assay. Whether you are working on a challenging new target or converting an existing antibody to a more robust format, we have the tools and the expertise to get you there.

Scale when you need it — From microgram discovery batches to kilogram commercial production, our manufacturing infrastructure expands with your program. With 2L to 1,000 L+ fermenter capacity and ISO Class 7 fill and finish, you will never outgrow us.

Quality built in — Our quality and regulatory teams are embedded in your program from day one — not brought in at the end. With ISO 13485, 21 CFR 820, EU IVDR, and FDA/CBER Biologics License coverage, your quality requirements are built alongside your product, not after it.
 

How we work: Your dedicated project team

Every engagement is built around a single, committed team. From the moment your project begins, you are assigned a dedicated team who stays with you for the life of the project.

Your team typically includes:

Dedicated project manager — Your primary contact throughout the project. Responsible for timeline management, milestone reporting, risk escalation, and coordination across our development, manufacturing, quality, and regulatory functions.

Technical lead scientist — A senior-level scientist with domain expertise in your target area who co-designs your development strategy, troubleshoots challenges in real time, and provides the scientific rationale behind every project decision.

Commercial partners — As your project approaches commercialization, your commercial partners establish long-term quality and supply agreements, manage inventory forecasting, and ensure uninterrupted commercial production.
 

Our service model: Development through commercial supply

Engage us at any stage — or let us manage the full workflow. Our three-stage model is designed to flex around your needs, whether you are starting from scratch or need a manufacturing partner for an existing antibody.

Stage 1 — Development

• Immunogen and antigen design consultation
• Immunization program development
• B cell cloning with single-cell antigen sorting
• Clone generation, screening and selection
• Matched-pair antibody screening
• Subcloning and recombinant expression

Stage 2 — Scale-up and cell line generation

• Stable cell line generation (proprietary high-yield CHO; UCOE^® technology for stable, high-level expression)
• Serum-free media adaptation
• Fermentation optimization and purification development
• Validation batches, comparability testing and stability studies

Stage 3 — Commercial manufacturing

• Large-scale contract manufacturing: 2 L – 1,000 L+ fermentation (batch and continuous)
• Downstream processing: clarification, UF/DF, affinity/IEX purification
• Custom conjugation to dyes, labels, gold nanoparticles, and fluorescent tags
• Fill and finish in ISO Class 7 cleanroom
• Long-term supply agreements, inventory management, worldwide distribution and batch release with CoA

Service portfolio

Access complementary expertise across the full antibody value chain — whether you bring starting materials and scientific input or need us to manage everything from the ground up. Our flexible engagement models reduce time to market, capital expenditure, and supply risk.

Custom antibody development

Next generation monoclonal antibody programs, from antigen design to recombinant expression.

• Immunogen and antigen design consultation for challenging targets
• Monoclonal Ab programs: proprietary B cell cloning platform
• Matched-pair antibody discovery — critical for ELISA and LFA assay formats
• Recombinant expression in CHO cells; animal-free media available

Recombinant conversion 

Supporting manufacturers transitioning hybridoma or animal-derived antibodies to recombinant formats. Structured conversion pathway for fully characterized recombinant alternatives.

• Hybridoma → sequence identification → recombinant expression
• Comparability data: binding, affinity, specificity, stability
• GMP cell banking following conversion
• Regulatory documentation support: sequence certificates, development reports, quality agreements

Stable cell line generation

Robust, scalable solutions for transitioning from discovery to commercial production.

• Proprietary high-yield CHO line with UCOE^® technology
• Serum-free adaptation
• GMP cell banking
• Resolves lot-to-lot variability and low-yield challenges
• Fermentation optimization with full yield and purity characterisation

Large-scale contract manufacturing

Contract manufacturing for regulated antibody production —at a scale that grows with you.

• 2 L – 1,000 L+ fermentation: batch and continuous systems
• Downstream processing: clarification, UF/DF, affinity, IEX, and size-exclusion purification
• Custom conjugation: dyes, labels, gold nanoparticles (bulk up to 24 L OD 10), fluorescent tags
• Fill and finish in ISO Class 7 cleanroom — 0.5 mL cryovials to 2 L PETG and beyond
• Worldwide distribution, CoA, and long-term supply agreements

Assay development and validation

Full assay development and validation services integrated with our custom antibody programs — delivering submission-ready documentation. We develop and validate immunoassay formats aligned with your regulatory pathway:

• Assay development across the full range of immunoassay formats
• Lot release testing: raw materials, unprocessed bulk, purified bulk, and filled finished product
• Regulatory documentation support
• Custom QC methods: ELISA, HPLC, IHC, SDS-PAGE, Western Blot, endotoxin and bioburden, etc.

Quality and regulatory services

Comprehensive quality management and documentation frameworks for regulated industries.

• M-Clarity™ Program: full portfolio transparency and structured change notification
• Legally binding Quality Agreements (MQ300+), 5-year QAA terms
• Standardised Change Notification Program with individualised letters for active agreements
• Real-time shelf-life stability testing and validation batch documentation
• Audit support, regulatory submission assistance, and post-approval change management

Diagnostic OEM and CMO services

Single-source supply chain for manufacturers — a single commercial relationship covering every critical raw material in your kit

• Bulk and custom formulation: buffers, blockers, stabilisers, reagents
• Lateral Flow Membrane: Hi-Flow Plus master rolls
• Estapor^® Microspheres: custom particle development for LFA and other formats
• Private labelling, automated packaging and compliant handling of regulated materials
• Integrated supply management across antibodies, membranes, and reagent components
   

B cell cloning — Next-generation antibody discovery

Our proprietary B cell cloning platform represents a genuine technological advance over traditional hybridoma methods — delivering guaranteed monoclonality, recombinant scalability, and improved animal welfare in a single workflow. For manufacturers building programs that need to last decades, this is the right foundation.

• Guaranteed 100% monoclonality — tight control of antibody specificity via DNA engineering
• Stable DNA antibody source — no virus involved; no genetic drift over time
• Natural heavy/light chain pairing preserved — superior to display library methods
• Highly efficient for generating antibodies against challenging targets
• Recombinant CHO expression with animal-free, serum-free media
• Improved animal welfare vs. traditional hybridoma or ascites production

Batch-to-batch reproducibility guaranteed from a single clonal cell line.

Why partner with Merck?

Our custom antibody services are built on a simple principle: your program deserves the same scientific standards, manufacturing rigour, and regulatory commitment that we apply to our own commercial regulated products. Here is what that means in practice.

A comprehensive antibody portfolio at your disposal — With a catalogue of 3,000+ antibodies — spanning monoclonal, polyclonal, and recombinant formats across oncology, infectious disease, hematology, and more — we bring an extensive, application-tested starting point to every custom program. If an existing validated antibody meets your needs, we can supply it. If your application requires something novel, our development teams build it from the ground up.

Deep IVD manufacturing experience — Our scientists, facilities, and quality systems have been producing highly regulated antibodies for decades. That institutional knowledge is applied directly to your project — informing every technical decision from immunization strategy through to final batch release and translating into faster resolution of challenges, fewer development cycles, and more robust outcomes.

Recombinant conversion capability — For programs requiring a transition from hybridoma or animal-derived starting materials to recombinant production, we offer a structured conversion pathway — from sequence identification through CHO expression, GMP cell banking, and a full comparability data package to support your regulatory submission.

Manufacturing that scales with you — From 2 L feasibility batches through to 1,000 L+ commercial production, our manufacturing infrastructure is designed to grow alongside your product — without requiring a change of site, quality system, or project team at any stage.

Single-source supply confidence — Long-term supply agreements and dedicated manufacturing sites provide the supply continuity your commercial program depends on. And because we supply antibodies, lateral flow membranes, microspheres, buffers, and reagents under one commercial relationship, your supply chain is simpler, more resilient, and easier to manage.

Access world-class infrastructure without the capital investment — Fermentation, downstream processing, fill and finish, and analytical services are all available as part of your program — with no capital expenditure required. Your investment stays where it matters: in your product, your regulatory submissions, and your route to market.

Ready to accelerate your path to market?

Whether you need a new antibody developed from scratch, an existing hybridoma converted to a recombinant format, a cell line optimised for large-scale manufacturing, or a reliable long-term supply partner with proven expertise — our team is ready to start the conversation.