# ASKA Biotech - Custom Antibodies, Proteins & Assays (ISO 13485)

> ASKA Biotech is your German ISO 13485-certified partner for the development and production of custom antibodies, recombinant proteins, and immunoassays. We specialize in IVDR-compliant solutions, "Made in Germany".

## Service Portfolio
- [Service Portfolio](https://www.aska-biotech.de/services/): Overview of ASKA Biotech’s independent ISO 13485:2016-certified CMO pillars: Protein Production, Antibody Development, Transfection Services, and Custom Assays.

## Core Services: Antibody Production
- [Custom Antibody Production](https://www.aska-biotech.de/services/antibody-production/): Comprehensive services for monoclonal and recombinant antibody development (Hybridoma & Phage Display).
- [Monoclonal Antibodies](https://www.aska-biotech.de/services/antibody-production/monoclonal-antibodies/): High-affinity mAb development including immunization, fusion, and screening strategies.
- [Recombinant Antibody Expression](https://www.aska-biotech.de/services/antibody-production/recombinant-antibodies/): Fast and scalable expression in CHO and HEK cells for diagnostic and research applications.

## Core Services: Recombinant Proteins
- [Recombinant Protein Production (Hub)](https://www.aska-biotech.de/services/recombinant-protein-production/): ISO 13485-certified contract manufacturing (CMO) for Pharma, Biotech, and Diagnostics (Human, Veterinary, Food).
- [CHO Cell Line Development](https://www.aska-biotech.de/services/recombinant-protein-production/cho-expression/): Stable, high-yield production (g/L range). Gold standard for long-term manufacturing and IVDR-compliant diagnostic raw materials.
- [Transient HEK Expression](https://www.aska-biotech.de/services/recombinant-protein-production/hek-expression/): Rapid prototyping (8–10 weeks) for research and target validation. Authentic human glycosylation and native folding.
- [E. coli Production & Refolding](https://www.aska-biotech.de/services/recombinant-protein-production/e-coli-expression/): Fast (4–6 weeks) and cost-effective microbial expression. Specialist in **Inclusion Body Refolding** and low-endotoxin purification for in-vivo applications.

## Core Services: Transfection & Cell Lines
- [Custom Transfection Services](https://www.aska-biotech.de/services/transfection/): Expert services for plasmid transfection and cell line development.
- [Transient Transfection](https://www.aska-biotech.de/services/transfection/transient-transfection/): Rapid protein expression solutions for short timelines and proof-of-concept studies.
- [Stable Transfection](https://www.aska-biotech.de/services/transfection/stable-transfection/): Development of stable cell lines (CLD) for consistent long-term production and manufacturing.

## Core Services: Assay Development (IVDR compliant)
- [Custom Assays](https://www.aska-biotech.de/services/custom-assays/): End-to-end development of quantitative assays under ISO 13485.
- [Immunoassays (ELISA, LIA, LFA)](https://www.aska-biotech.de/services/custom-assays/immunoassays/): Tailored development of Sandwich, Competitive, and Indirect formats. From Feasibility to Validation.
- [Functional Bioassays](https://www.aska-biotech.de/services/custom-assays/bioassays/): Cell-based assays to test biological activity and potency of your molecules.
- [Study Sample Analysis](https://www.aska-biotech.de/services/custom-assays/study-sample-analysis/): Measurement of study samples using validated proprietary or commercial kits.

## Quality & Company
- [ISO 13485 Certification](https://www.aska-biotech.de/iso-13485-contract-manufacturer/): We work strictly according to ISO 13485 standards ensuring full compliance for your diagnostic products.
- [About ASKA Biotech](https://www.aska-biotech.de/about-us/): Located in Hennigsdorf (Berlin), Germany.
- [Contact & Quote](https://www.aska-biotech.de/contact/): Get in touch for project inquiries.

## Other Languages
- [German / Deutsch](https://www.aska-biotech.de/llms-de.txt): Full technical summary in German for localized LLM processing.