Sales and development of validated ELISA kits for therapeutic drug monitoring, immunogenicity and rare diseases
AlpinaBioTech GmbH
76199 Karlsruhe, Schauinslandstraße 12New on Amplifa
About AlpinaBioTech
AlpinaBioTech GmbH, based in Karlsruhe, is the exclusive European commercial distribution partner for ImmunoGuide® ELISA technologies. The company supplies clinical laboratories, research institutions and biotech companies with validated ELISA kits for therapeutic drug monitoring (e.g. adalimumab, aflibercept, bevacizumab, certolizumab pegol) and anti-drug antibody assays (immunogenicity), as well as enzyme activity assays for rare disease programs. All products are manufactured by ImmunoGuide under ISO 13485-certified quality systems; all kits are For Research Use Only. In addition to sales, AlpinaBioTech offers regulatory and consulting services for assay development and validation, as well as support in selecting the analytical platform (e.g. Gyrolab microfluidics versus plate assays for ADC bioanalysis). Furthermore, the company conducts research and development of innovative diagnostic technologies including multiplex assays, biosensors and automation solutions. The GmbH was founded in 2026, is registered with the Amtsgericht Mannheim under HRB 757253 and employs 2 to 10 staff.
- Site
- Karlsruhe
- Processes
- Drug-level ELISA (therapeutic drug monitoring, e.g. adalimumab, aflibercept, bevacizumab,, Anti-drug antibody (ADA) ELISA / immunogenicity assays, Enzyme activity assays (among others for rare diseases/lysosomal storage diseases: diagnosis,, Assay design and validation support, regulatory consulting for bioanalysis (TDM,, Commercial distribution of validated ELISA kits (exclusive European distributor of ImmunoGuide, ISO, R&D of innovative diagnostic technologies: multiplex assays, biosensors and automation solutions, Consulting on platform selection for immunoassays (Gyrolab microfluidics vs. conventional plate, Sales of ELISA kits
- Materials
- Therapeutic Drug Monitoring, Anti-Drug Antibody Assays, Enzyme Activity Assays, ADC Bioanalysis Consulting, Analyte Families
- Certificates
- ISO 13485, ISO 13485 (manufacturer ImmunoGuide)
- Founded
- 2026
- Employees
- 2-10
- Industries
- Biotechnology research, In vitro diagnostics, Clinical laboratories, Research institutions, Oncology, Rare diseases
- 01
Sales of validated ELISA kits (exclusive European distributor of
- 02
Import/export including customs handling (EORI registration)
- 03
Regulatory and consulting services for assay development and
- 04
R&D for multiplex assays, biosensors and automation solutions
Services & Analytes
Therapeutic Drug Monitoring
Free drug level assays for adalimumab, aflibercept, bevacizumab and certolizumab pegol from serum/plasma.
Anti-Drug Antibody Assays
Immunogenicity assays for the detection of anti-drug antibodies against TNF-alpha inhibitors and VEGF inhibitors.
Enzyme Activity Assays
Assays for diagnosis, pharmacokinetics, pharmacodynamics and gene therapy efficacy in lysosomal storage disease programs.
ADC Bioanalysis Consulting
Cross-analyte consulting on platform selection between Gyrolab microfluidics and plate assays for total antibody, conjugated antibody, free payload and ADA.
Analyte Families
Kit catalog covering biomarkers such as TNF-alpha, VEGF, EGFR and HER2 for inflammation and oncology research.
Locations
Karlsruhe
DEHeadquarters and European distribution center
- Materials
- ELISA kits (ImmunoGuide)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Drug-level ELISA (therapeutic drug monitoring, e.g. adalimumab, aflibercept, bevacizumab,Testing | – | – | – | – | Biological samples (serum/plasma, per analyte: |
| Anti-drug antibody (ADA) ELISA / immunogenicity assaysTesting | – | – | – | – | Biological samples (analytes: adalimumab, bevacizumab, |
| Enzyme activity assays (among others for rare diseases/lysosomal storage diseases: diagnosis,Testing | – | – | – | – | Biological samples |
| Assay design and validation support, regulatory consulting for bioanalysis (TDM,Testing | – | – | – | – | Biological samples |
| Commercial distribution of validated ELISA kits (exclusive European distributor of ImmunoGuide, ISOTesting | – | – | – | – | – |
| R&D of innovative diagnostic technologies: multiplex assays, biosensors and automation solutionsTesting | – | – | – | – | – |
| Consulting on platform selection for immunoassays (Gyrolab microfluidics vs. conventional plateTesting | – | – | – | – | Antibody-drug conjugates (ADC): total antibody, |
Additional services
Quality & Certification
All distributed ELISA kits are manufactured by ImmunoGuide under ISO 13485-certified quality systems to ensure compliance with international medical device standards and consistent performance. All kits are For Research Use Only.
| Evidence | Karlsruhe |
|---|---|
| ISO 13485 (manufacturer ImmunoGuide) |
History
- 2026
Foundation of AlpinaBioTech GmbH (07.01.2026) in Karlsruhe; exclusive European distribution partner for ImmunoGuide ELISA kits.
- 2026
Completed: EORI registration, own freight accounts and tracking processes to improve delivery reliability.
- 2026
Commercial register change on 11.02.2026 at the Amtsgericht Mannheim.