ISO 13485 Certified Antibody & Protein Manufacturing
Overcome the Medical Device Regulation Challenge with German cGMP Production
ISO 13485:2016 Certified
IVDR Compliant | Made in Germany | Full Documentation
The Problem: Tightened ISO 13485 regulations for medical devices have created a massive bottleneck. Most manufacturers avoid the investment required for cGMP antibody production.
Our Solution: SeamlessBio partners with an ISO 13485-certified German manufacturer to provide compliant, high-quality antibody and protein production for IVD and medical device applications.
The ISO 13485 Regulatory Bottleneck for Medical Devices
If you're developing in vitro diagnostic (IVD) devices or medical devices requiring antibodies or proteins, you're facing a critical challenge:
- Tightened EU MDR/IVDR Regulations: The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) now require stringent ISO 13485 compliance for all components used in medical devices
- Limited Certified Suppliers: Most antibody and protein manufacturers lack ISO 13485 certification and won't invest in the expensive infrastructure and quality systems required
- High Compliance Costs: Achieving ISO 13485 certification requires significant investment in quality management systems, cleanroom facilities, documentation, and ongoing audits
- Market Gap: Research-grade antibodies cannot be used in medical devices, but few suppliers offer medical-device-grade alternatives
- Risk for Your Projects: Using non-certified components puts your entire medical device approval at risk and can delay market entry by years
The Impact on Your Business
Without ISO 13485-certified antibodies and proteins, you face:
- Regulatory rejection during medical device certification
- Forced re-development with compliant suppliers (months to years of delay)
- Lost investment in product development using non-compliant reagents
- Inability to enter EU markets due to IVDR requirements
- Competitive disadvantage against companies with certified supply chains
Our Solution: ISO 13485 Certified Manufacturing Partnership
SeamlessBio has partnered with a leading German contract manufacturer with full ISO 13485:2016 certification. Together, we provide the compliant antibody and protein manufacturing services your medical device projects require.
ISO 13485:2016 Certified
Full certification for medical device component manufacturing
Made in Germany
German engineering and quality standards
IVDR Compliant
Meeting EU In Vitro Diagnostic Regulation requirements
Complete Documentation
Full technical files for regulatory submissions
cGMP Production
Current Good Manufacturing Practice compliance
Quality Tested
Comprehensive QC including endotoxin, sterility, purity
Why This Partnership Solves Your Problem
You don't need to build ISO 13485-certified facilities – we provide turnkey services
Certified processes ensure your medical device approval isn't delayed
From antibody development through final production and QC
Consistent quality, on-time delivery, long-term supply security
Comprehensive Manufacturing Services for Medical Devices
Monoclonal Antibody Production
ISO 13485-certified production of monoclonal antibodies for IVD and medical device applications
- Hybridoma development & screening
- Scale-up from mg to grams
- Purification (Protein A, Protein G, affinity)
- Full characterization & documentation
- Stability studies
Recombinant Antibody Production
Modern recombinant antibody development with consistent, scalable production
- Antibody discovery & optimization
- CHO & HEK293 expression systems
- Stable cell line development
- cGMP-compliant production
- Advanced analytics (SEC, CE-SDS, MS)
Recombinant Protein Production
Custom production of proteins, enzymes, and antigens for diagnostic applications
- Mammalian (CHO, HEK293) expression
- Bacterial (E. coli) expression
- Protein engineering & optimization
- Multi-gram scale production
- Endotoxin removal (<0.1 EU/mg)
Custom Assay Development
Development and manufacturing of custom immunoassays for IVD devices
- ELISA development & optimization
- Lateral flow assay (LFA) development
- Luminescence immunoassays (LIA)
- Bioassay development
- Assay validation per ISO 13485
Cell Line Development
Stable cell line generation for consistent protein production
- Transient & stable transfection
- CHO & HEK293 cell line development
- Clone screening & selection
- Master & working cell banks
- Cell line characterization
Clinical Sample Analysis
ISO 13485-compliant analysis of clinical study samples
- Biomarker quantification
- Immunogenicity testing
- Pharmacokinetic analysis
- Study sample measurement
- GLP/GCP-compliant documentation
Standard Research Grade vs. ISO 13485 Medical Device Grade
| Feature | Research Grade Antibodies | ISO 13485 Medical Device Grade |
|---|---|---|
| ISO 13485 Certification | ✗ Not certified | ✓ Fully certified facility & processes |
| IVDR/MDR Compliant | ✗ Not compliant | ✓ Meets all EU regulations |
| cGMP Production | ✗ Basic GMP at best | ✓ Current Good Manufacturing Practice |
| Quality Management System | ✗ Minimal or none | ✓ Comprehensive QMS per ISO 13485 |
| Documentation | Basic CoA only | ✓ Complete technical file for regulatory submission |
| Batch-to-Batch Consistency | Variable, limited testing | ✓ Validated processes, extensive QC |
| Traceability | Limited | ✓ Full traceability from raw materials to final product |
| Regulatory Acceptance | ✗ Not suitable for medical devices | ✓ Accepted by regulatory agencies (FDA, EU, etc.) |
| Supply Security | Variable, may be discontinued | ✓ Long-term supply agreements available |
| Use in IVD Devices | ✗ Prohibited | ✓ Specifically manufactured for IVD use |
Critical Warning
Using research-grade antibodies in medical devices will result in:
- Immediate rejection during regulatory review
- Requirement to re-develop with compliant components
- 12-24 month delay in market entry
- Lost investment in product development
- Inability to sell in EU markets under IVDR
Don't risk your medical device project – start with ISO 13485-certified components from day one.
Why German ISO 13485 Manufacturing Matters
Regulatory Expertise
Germany has strictest implementation of EU MDR/IVDR – certification here ensures global acceptance
Engineering Excellence
German precision in process development, validation, and quality control
Documentation Standards
Comprehensive technical files meeting highest regulatory standards
Long-Term Partnerships
German companies prioritize stable, long-term business relationships
IP Protection
Strong intellectual property protections under German and EU law
EU Market Access
Manufacturing in Germany facilitates EU regulatory approvals
Target Applications & Industries
In Vitro Diagnostics (IVD)
- Immunodiagnostic assays (ELISA, LIA)
- Point-of-care testing devices
- Lateral flow assays
- Biomarker detection kits
- Infectious disease testing
Medical Devices
- Therapeutic antibodies (diagnostics companion)
- Antibody-drug conjugate components
- Medical device surface coatings
- Capture/detection antibodies for devices
Pharmaceutical Development
- Pharmacokinetic assay reagents
- Immunogenicity testing
- Clinical trial sample analysis
- Reference standards
Biotech Startups
- Diagnostic platform development
- Regulatory strategy support
- Scalable manufacturing pathway
- Investor-ready documentation
Ready to Overcome the ISO 13485 Bottleneck?
Our experts will help you navigate medical device regulations and develop a compliant manufacturing strategy for your antibodies and proteins.
Fast Response: Feasibility assessment within 48 hours | Full project quotes within 1 week
About Our ISO 13485 Manufacturing Partnership
SeamlessBio provides premium cell culture reagents and biological products to research and biopharmaceutical markets. For medical device and IVD applications requiring ISO 13485 certification, we partner with a specialized German contract manufacturer with full ISO 13485:2016 certification.
About Our German Manufacturing Partner
Our partner is an independent, ISO 13485-certified German biotech company based near Berlin. They specialize in:
- Monoclonal and recombinant antibody production
- Recombinant protein manufacturing
- Custom assay development and production
- Transfection and cell line development
- Clinical sample analysis
With decades of combined expertise, our partner serves IVD companies, research institutions, and biotech startups worldwide with "Made in Germany" quality.
Contact Information:
📧 Email: info@seamlessbio.de
📞 Phone: +49 851 37932226
🛒 SeamlessBio Shop: shop.seamlessbio.de
📍 Location: Passau, Bavaria, Germany
Additional Partners:
innoME GmbH – Laboratory consumables and cell culture vessels (ISO 13485 certified)