From Hybridoma Cell Line Development to GMP-compliant Manufacturing
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 manufacturing and strict quality control (QC) 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 IVDR-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 Contract Manufacturing (mAbs)
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ISO 13485-Certified Quality – Ideal for IVDR-compliant 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 (mAbs) 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 Antibody Manufacturing, we also offer comprehensive services – from strategy development to scalable production.
FAQ – Frequently Asked Questions about Monoclonal Antibodies (mAbs)
How long does in vitro monoclonal antibody production take?
For existing hybridoma cell lines, the initial test production (monA-T) typically takes 6–8 weeks. This ensures we establish the optimal in vitro culture conditions before scaling up.
What production scales are possible for hybridoma-based antibodies?
We offer flexible contract manufacturing scales: ranging from 1 mg pilot batches to several grams per batch. We use scalable in vitro systems to process your hybridoma supernatants efficiently.
What quality controls do you perform on monoclonal antibodies (mAbs)?
“Comprehensive QC is standard. We analyze purity via capillary gel electrophoresis (CGE-SDS), aggregates via SEC-HPLC, and offer optional endotoxin (LAL) or activity testing to ensure IVD-grade quality.
Is your monoclonal antibody manufacturing ISO 13485 certified?
Yes. As a specialized manufacturer in Germany, our entire monoclonal antibody production process is certified according to ISO 13485:2016, meeting strict requirements for IVD products.
Are your processes IVDR-compliant?
Yes, our production processes are fully IVDR-compliant. We provide the necessary documentation and traceability so you can use our antibodies as critical raw materials for in vitro diagnostics.
In what format is the monoclonal antibody delivered?
We typically supply monoclonal antibodies in a liquid buffer formulation (e.g., PBS pH 7.4). We can customize concentration, buffer composition, and aliquoting to fit your assay requirements.
How is shipping handled for biological materials?
We ship worldwide using certified logistics partners. Depending on stability, antibodies are shipped chilled or frozen. We also offer dry ice shipping for sensitive hybridoma clones or proteins.
How is pricing structured for contract manufacturing?
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, absolutely. We are happy to sign an NDA to strictly protect your hybridoma cell lines, project data, and intellectual property from the very beginning.