ISO 13485–Certified Contract Manufacturer for Proteins, Antibodies and Assays
Quality and regulatory compliance are top priorities at ASKA Biotech. Our ISO 13485:2016 certification confirms that our quality management system meets all requirements for the development and manufacturing of proteins, immunoassay kits, and the measurement of human serum and plasma for in-vitro diagnostics.
This certification applies to all major service areas – from our Immuno Services, Antibody Production and Recombinant Protein Production to Transfection Services. It ensures that our processes are standardized, traceable, and performed at a consistently high quality level.
What Does ISO 13485 Certification Mean?
ISO 13485 is the internationally recognized quality standard for manufacturers and suppliers in medical technology and in-vitro diagnostics (IVD). Companies certified to this standard must demonstrate that their development and production processes are:
- fully documented,
- risk-based,
- validated and traceable,
- and auditable at any time.
For customers, this means maximum process reliability, minimized regulatory risk and dependable compliance with European and international requirements.
ISO 13485–Certified Contract Manufacturing at ASKA Biotech
Our ISO 13485 certification covers all key biotechnology service areas at ASKA Biotech:
- Immuno Services: Measurements, immunoassays, recalibration and custom assay development
- Antibody Production: Monoclonal and recombinant antibodies (IgG, Fab, scFv)
- Recombinant Protein Production: Expression in various systems (E. coli, HEK, CHO)
- Transfection Services: Transient and stable transfections for research and diagnostic applications
All projects are planned in close collaboration with our customers and executed according to ISO-compliant procedures – ensuring maximum data integrity, reproducibility and fast project turnaround.
Why Choosing an ISO 13485 Contract Manufacturer Matters
In protein, antibody and assay development, precise process control is essential. ISO 13485 ensures:
Standardized and validated workflows
All critical steps – from cell culture to expression and final quality control – are strictly monitored and performed according to documented SOPs.
Full traceability throughout the entire production process
Every batch, reagent and customer lot is completely traceable.
Minimization of regulatory risks
ISO 13485 certification fulfills key requirements for many medical and IVD applications.
Reliable and reproducible results
Reproducibility and lot-to-lot consistency are essential for research, diagnostics and product development.
Your Benefits: Certified Quality Made in Germany
For international partners, we serve as a reliable ISO 13485 Certified Contract Manufacturer for advanced biotech and IVD projects. Based in Hennigsdorf near Berlin, we offer:
-
short communication routes
-
high delivery reliability
-
German quality standards
-
state-of-the-art laboratory environment
Download ISO 13485 Certificate
Häufig gestellte Fragen (FAQ) zur ISO 13485 Zertifizierung
What does ASKA Biotech’s ISO 13485 certification confirm?
It confirms that our development and manufacturing processes for proteins, antibodies and assays are fully quality-assured, documented and auditable.
Which services are covered by the certification?
The certification applies to immuno services, antibody production, recombinant protein production, assay manufacturing and transfection services.
Is ASKA Biotech an “ISO 13485 Contract Manufacturer” in Germany?
Yes. Our certification according to ISO 13485:2016 is internationally recognized and valid for customers worldwide.
Can I download the certificate?
Yes – the certificate is available on this page as a PDF.