Custom Protein Expression Services - Your ISO 13485 & IVDR Specialist
ASKA Biotech is your ISO 13485-certified partner for the contract manufacturing (CMO) of recombinant proteins. Using state-of-the-art technologies and flexible processes, we manufacture your proteins to your exact specifications, specializing in mammalian cell line development, rapid transient protein expression, and microbial production & refolding.
Our Expression Systems at a Glance
We offer full flexibility in selecting the appropriate expression system – depending on your application, quality requirements, and required quantity. This ensures that your project is built on the most efficient and scalable foundation from the very beginning, allowing for a seamless transition from initial research and process development to large-scale clinical or commercial manufacturing. Discover our specialized platforms to find the ideal solution for your project requirements:
Your Benefits with Our Recombinant Protein Manufacturing
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ISO 13485 certified – ensuring the highest quality standards and full IVDR compliance.
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Flexibility – we support you in selecting the appropriate expression system and tailor processes to your needs
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Scalability – from milligram-scale research quantities to gram-scale production
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Wide range of modifications – tags, conjugations, and much more
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Fast project execution – from cloning to delivery
Your Project with Recombinant Proteins – Contact Us Now!
Do you need recombinant proteins for your current or upcoming project? Then get in touch with us. Our experienced team will provide you with personalized consulting, analyze your requirements together with you, and develop a tailor-made solution – fast, reliable, and to the highest quality standards.
Need matching antibodies for your recombinant proteins? Our expertise in custom antibody generation delivers specific high-affinity monoclonal antibodies – precisely tailored to your target structure.
Do you need to verify bioactivity? We also support you with functional bioassay development for quality control.
Typical Applications of Our Recombinant Proteins
- Diagnostic tests (e.g., as antigens or standards in ELISA, LFA, LIA)
- Research & Development (R&D) – for target validation or screening
- Preclinical studies – for efficacy or safety testing
Our Services
- Cloning into expression vector (HEK, CHO, E. coli)
- Purification (affinity chromatography, ion exchange, SEC)
- Quality control: purity, endotoxins, aggregation status
- Optional functional assays as per customer requirements
FAQ - Frequently Asked Questions about Recombinant Protein Production
Which expression systems do you use for recombinant protein manufacturing?
We provide expert consultation to select the right system. For complex proteins requiring human-like glycosylation, we use mammalian systems (HEK, CHO). For simpler proteins, E. coli is a cost-effective alternative.
What is the typical timeline for protein production?
From gene synthesis to purified protein, our timeline is typically 6-12 weeks, depending on complexity and scale. We also offer express services for urgent projects.
Do you offer protein engineering and modifications?
Yes, we can customize your proteins with various tags, conjugates, or modifications – from His-tags to specific mutations.
Is your protein manufacturing ISO 13485 certified?
Yes. As a specialized contract manufacturer in Germany, our entire protein production process is ISO 13485:2016 certified. This guarantees full traceability and documentation – making our proteins ideally suited as critical raw materials for IVDR-compliant diagnostics.
Can your proteins be used for IVDR diagnostic kits?
Yes. We produce under strict ISO 13485 guidelines and provide all necessary documentation (CoAs, production protocols) to support your technical file and regulatory compliance under IVDR.
