ISO 13485 Certified Capabilities
With our ISO 13485-certified services, we support diagnostic manufacturers and research institutions in realizing complex projects. Our focus lies on the validated manufacturing of biological components – from initial development to IVDR-compliant production.
- Protein Manufacturing: Scalable high-yield CHO cell line production and HEK protein production.
- Antibody Solutions: Expert monoclonal antibody manufacturing (mAbs) and sequence-based recombinant antibody expression.
- Custom Assay Solutions: Specialized diagnostic immunoassay services (ELISA, LIA & LFA), bioassay development, and comprehensive study sample analysis.
- Cell Line Engineering: Expert for stable cell line development and transient expression services.
Your benefit: You receive IVDR-compliant starting materials, produced flexibly and according to the strictest regulatory standards, tailored exactly to your specific project requirements.
Development and production according to ISO 13485 – IVDR compliant
Years of experience in protein and antibody production as well as assays
We deliver exactly according to your specifications – tailored to your project.
From Development to Bulk Production
FAQ - Frequently Asked Questions about our Biotechnological Services
What contract manufacturing services does ASKA Biotech offer?
ASKA Biotech is a specialized contract manufacturer (CMO). We offer end-to-end services: development and production of monoclonal/recombinant antibodies, recombinant proteins, custom immunoassays (ELISA/LFA), and transfection services – all under ISO 13485.
Is your production suitable for IVD raw materials (GMP vs. ISO)?
Yes. We operate under a strict DIN ISO 13485:2016 quality system. This standard is specifically designed for the medical device and IVD industry, ensuring full traceability and regulatory compliance without the excessive costs of full GMP pharma manufacturing.
Do you support the entire lifecycle from pilot to bulk?
Absolutely. We adhere to a ‘scale-up’ philosophy. We support you with pilot quantities for R&D and seamlessly scale up to gram-scale bulk production for routine diagnostic manufacturing.
How does ASKA Biotech handle project initiation and confidentiality?
We start with a confidential consultation (NDA available). Based on your requirements (assay type, target quantity, timeline), we create a transparent project plan with defined milestones and clear cost structures.
Are your services fully customizable?
Yes. Unlike catalogue suppliers, we are a custom service provider. Buffer formulations, concentration, QC parameters, and packaging are fully tailored to your specific technical specifications.
Why should I outsource to a German contract manufacturer?
Outsourcing to ASKA Biotech in Germany guarantees you high communication standards, legal certainty, reliable logistics (cold chain), and a quality management system that withstands international audits.
What is the typical timeline for a service project?
Timelines depend on complexity. While simple productions take a few weeks, complex developments (e.g., new cell lines) can take several months. We provide a realistic Gantt chart with your proposal.
