ISO 13485 & IVDR-compliant Contract Manufacturing & Antibody Expression Services
Do you need high-quality antibodies for diagnostic or preclinical applications? As an ISO 13485-certified partner for Antibody Contract Manufacturing based in Germany, we offer flexible and high-quality antibody production – tailored to your specific requirements and fully compliant with IVDR standards.
Whether you require Monoclonal Antibody Production from existing hybridoma cell lines or Recombinant Antibody Expression from a DNA sequence – we are your reliable partner for all aspects of antibody production.
Expertise in Antibody Expression & Diagnostic Solutions
Your Starting Point in Focus
At the beginning of each project, we assess your specific situation to determine the optimal production strategy:
- Cell line already available – we take care of cultivation, production, and purification of your antibodies.
- Antigen available – we develop a suitable cell line and generate specific antibodies based on it.
- Antibody sequence available – we use appropriate expression systems to produce highly pure and functional antibodies.
Whether you need Monoclonal Antibody Production from hybridomas or Recombinant Antibody Expression – we provide tailor-made solutions with the highest quality standards.
Your Benefits with Our Custom Antibody Production Services
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ISO 13485 certified – Meets the highest quality and safety standards, especially for IVD applications
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Customized – Precisely tailored to your requirements, with flexible modifications (e.g., isotypes, mutations)
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Human-like functionality – Authentic glycosylation for optimal biological activity
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Reproducible results – Years of experience ensure batch-to-batch consistency
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Cost-efficient & scalable – Through optimized workflows, demand-driven production, and on-demand delivery models
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Fast project execution – First results often available within 6–8 weeks
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Markets and Application Areas
Our services are primarily aimed at:
- Industrial customers in in vitro diagnostics (human diagnostics, veterinary diagnostics, food diagnostics)
- Research & Development (R&D) – including university institutions and start-ups
- Preclinical studies – for the development of innovative diagnostics or therapeutics
FAQ – Frequently Asked Questions about Custom Antibody Production
How long does custom antibody production take?
Timelines vary by service. Initial test production for monoclonal antibodies (monA-T) typically takes 6–8 weeks. Recombinant antibody expression (CHO/HEK) usually takes 8–10 weeks, depending on vector complexity and scale.
What production scales are possible for contract manufacturing?
We offer flexible production quantities:
- For Monoclonal Antibody Production from hybridomas: from 1 mg up to several grams per batch.
- For Recombinant Antibody Expression from CHO or HEK cells: fully adaptable to your needs.
What quality controls (QC) are included?
Quality is paramount. Standard QC includes purity testing via capillary gel electrophoresis (CGE-SDS) and aggregate analysis using SEC-HPLC. Optional tests include endotoxin levels (LAL), binding activity, and stability testing.
Is ASKA Biotech an ISO 13485 certified antibody manufacturer?
Yes. As a specialized contract manufacturer in Germany, we are ISO 13485:2016 certified. We meet all regulatory requirements for producing antibodies used in IVD and diagnostic kits.
Do you produce antibodies according to IVDR requirements?
Yes, our production processes are IVDR-compliant. We ensure full documentation and traceability, enabling you to use our antibodies as critical raw materials for in vitro diagnostics.
In what format will I receive my antibodies?
By default, antibodies are supplied in a standard liquid buffer (e.g., PBS pH 7.4). However, as a custom service provider, we can adjust concentration, buffer composition, and storage conditions to your specifications.
Do you offer antibody engineering and modifications?
Yes, we offer comprehensive modification services: from isotype switching and affinity tagging (His/Strep) to conjugations with biotin, HRP, or fluorophores for diagnostic assays.
What shipping options do you offer?
We ship worldwide. Depending on product stability, we use cooled or dry ice shipping via certified logistics partners to ensure the integrity of your biological materials.
Do you offer project planning and process development
Yes, our team supports you from the initial concept to scalable production. We advise on expression systems, buffer formulations, and regulatory strategies (IVDR) to ensure project success.
How is the pricing for antibody services structured?
Our pricing is tailored to the scope, complexity, and required specifications of your project. We are happy to provide a non-binding quote with transparent cost breakdown – from test production to large-scale batches. Only services actually rendered will be invoiced.
Can we sign a confidentiality agreement (NDA)?
Absolutely. Protecting your intellectual property is standard procedure for us. We are happy to sign an NDA before discussing any specific project details.