Monoclonal Antibodies – From Hybridoma Cell Line to Ready-to-Use Antibody
Whether for research, diagnostics, or preclinical development – monoclonal antibodies (mAbs) are essential tools in modern biotechnology. With our ISO 13485-certified production platform, we offer efficient and quality-assured manufacturing of monoclonal antibodies based on hybridoma cell lines. Thanks to our long-standing experience and modular service structure (monA-T / monA-P), we reliably support you from cell banking to the final product – scalable, reproducible, and precisely tailored to your requirements.
If you already have a hybridoma cell line or are developing one with us, our monA service offers comprehensive support:
Test Production (monA-T)
We carry out an initial test production and guarantee at least 10 mg of purified antibody within 6–8 weeks – including a certificate of analysis.
Scaled Production (monA-P)
Based on the successful test production, we manufacture your antibodies in flexible batch sizes (1 mg to several grams) according to your specifications.
Our Quality Features in Monoclonal Antibody Production
We offer the highest quality standards for monoclonal antibody production – from cell line cultivation to comprehensive quality control of the final product. Our processes are IVD-compliant and ideal for preclinical studies and diagnostic applications.
Thanks to our ISO 13485 certification and many years of experience in monoclonal antibody production, we are your reliable partner – from cell line to ready-to-use antibody.
Cell Line Quality Features:
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Serum-free and antibiotic-free cultivation – ideal for clinically relevant applications
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Mycoplasma testing – ensures contamination-free cell lines
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Cell line security – long-term archiving to ensure batch consistency
Antibody Quality Features:
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Subclass determination (e.g., IgG1, IgG2a, IgG2b)
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Purification via Protein A or G
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Sterile filtration and endotoxin testing for highest purity
Quality Controls:
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Purity by capillary gel electrophoresis
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Aggregate analysis using analytical size exclusion chromatography (SEC)
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Protein content determination via A280
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Function test via ELISA activity determination
Your Advantages with Our Monoclonal Antibody Production
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ISO 13485-Certified Quality – Ideal for applications in in vitro diagnostics and regulatory-sensitive projects.
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Custom Process Design – We develop production strategies tailored precisely to your project goals.
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Scalability – From milligram amounts for research to gram-scale quantities.
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Years of Experience in Antibody Production – Rely on our experienced team focused on reproducibility and consistency.
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Efficient & Demand-Oriented Manufacturing – Scalable workflows and flexible call-off models help reduce costs and optimize resources.
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Short Production Timelines – Streamlined processes allow initial results within 6–8 weeks.
Your Monoclonal Antibody Project – Get in Touch Now!
Do you need monoclonal antibodies for a current or upcoming project? Contact us today. Our experienced team will advise you individually, analyze your requirements, and develop a custom solution – fast, reliable, and to the highest quality standards.
For projects involving recombinant antibodies, we also offer comprehensive services – from strategy development to scalable production.
FAQ – Frequently Asked Questions about Monoclonal Antibodies
How long does monoclonal antibody production take?
Initial test production (monA-T) typically takes about 6–8 weeks. Subsequent scaled production can be flexibly adapted to your quantity and quality needs.
What production volumes are possible?
We produce monoclonal antibody batches in flexible quantities – from 1 mg to several grams, depending on your needs.
What quality controls do you perform?
Our quality control for monoclonal antibodies includes purity (capillary gel electrophoresis), aggregate analysis (analytical SEC), and optional endotoxin testing or activity assays. Additional analyses can be added as needed.
What certifications do you hold?
Our monoclonal antibody production is certified according to ISO 13485 – a quality standard specifically for IVD products.
Are your processes IVDR-compliant?
Yes, our production processes are fully IVDR-compliant, making them ideal for use in in vitro diagnostics.
In what format is the antibody delivered?
We supply monoclonal antibodies in a liquid formulation (e.g. PBS, pH 7.4). Other formats, concentrations, and buffer compositions are available upon request.
How is shipping handled?
We ship worldwide – chilled or frozen, depending on antibody stability. Special packaging like dry ice shipment is also available.
How is pricing structured?
Our pricing is based on the scope and complexity of your project. You’ll receive a transparent quote with detailed cost breakdown – no hidden fees.
Is a confidentiality agreement (NDA) possible?
Yes, we are happy to sign an NDA to protect your project data and intellectual property from the outset.