ISO 13485 Certified Recombinant Protein Production
Flexible, Scalable Protein Manufacturing for IVD and Medical Device Applications
Multiple expression systems: CHO, HEK293, E. coli | ISO 13485:2016 certified | cGMP production | mg to multi-gram scale | Complete IVDR/MDR documentation
Medical Device Grade Recombinant Protein Manufacturing
Need antigens, enzymes, or other recombinant proteins for your IVD device or medical diagnostic platform? Our ISO 13485-certified protein production services ensure your components meet stringent regulatory requirements while delivering the quality, purity, and consistency critical for diagnostic accuracy.
Through our partnership with a specialized German manufacturer, we provide flexible expression systems (mammalian and bacterial), scalable production (mg to multi-kg), and comprehensive documentation suitable for FDA, EMA, and notified body submissions.
Why Choose Our Protein Production Services
- Multiple Expression Systems: Choose optimal host for your protein (CHO, HEK293, E. coli, others available)
- ISO 13485 Certified Facility: Full compliance for medical device component manufacturing
- cGMP Production: Current Good Manufacturing Practice for consistent, reproducible results
- Endotoxin Control: Routinely achieve <0.1 EU/mg for diagnostic applications
- Scalability: Seamless transition from development (mg) to commercial production (multi-gram)
- Complete Documentation: Full technical files for regulatory submissions
- German Quality: Made in Germany standards for reliability and precision
Expression System Options
Select the optimal expression system for your protein based on post-translational modifications, yield requirements, and application needs:
CHO Cells
Chinese Hamster Ovary
Best for:
- Complex glycoproteins
- Antibodies and Fc-fusion proteins
- Proteins requiring mammalian PTMs
- High-value therapeutic proteins
Advantages:
- Human-like glycosylation
- Excellent scalability to kg levels
- Regulatory acceptance (IVD/therapeutic)
- Stable long-term production
Typical yield: 1-5 g/L
HEK293 Cells
Human Embryonic Kidney
Best for:
- Rapid protein production
- Difficult-to-express proteins
- Proteins for structural studies
- Viral antigens and VLPs
Advantages:
- Fast transient expression (7-10 days)
- Human glycosylation patterns
- High expression levels
- Excellent for screening variants
Typical yield: 0.5-3 g/L (transient)
1-4 g/L (stable)
E. coli
Bacterial Expression
Best for:
- Non-glycosylated proteins
- Simple antigens
- Enzymes without PTM requirements
- Cost-sensitive applications
Advantages:
- Fastest production (days)
- Highest yields (up to 10+ g/L)
- Most cost-effective
- Simple scale-up to kg levels
Typical yield: 2-10 g/L
Note: Requires endotoxin removal for IVD use
Not Sure Which System to Choose?
Our experts will help you select the optimal expression system based on:
- Protein characteristics (size, modifications, structure)
- Required yield and timeline
- Budget constraints
- Regulatory requirements
- Application needs (sensitivity, stability)
Our Protein Production Workflow
Development Phase
Establishing Optimal Production
- Gene Design & Optimization
- Codon optimization for host
- Signal peptide selection
- Tag strategy (purification, detection)
- Vector Construction
- Expression vector design
- Regulatory element optimization
- Quality control sequencing
- Cell Line/Strain Development
- Transfection/transformation
- Clone screening (expression, stability)
- Master cell bank creation
- Process Optimization
- Culture condition optimization
- Purification method development
- Quality attribute definition
Timeline: 10-16 weeks
Deliverable: Validated production process + documentation
Production Phase
ISO 13485 Certified Manufacturing
- Cell Culture Production
- Bioreactor runs (1L to 200L scale)
- In-process monitoring and controls
- cGMP documentation
- Purification
- Multi-step chromatography
- Endotoxin removal (if needed)
- Viral inactivation (mammalian systems)
- Formulation & Fill
- Buffer exchange and concentration
- Sterile filtration
- Aliquoting per specifications
- Quality Control Release
- Comprehensive analytical testing
- Certificate of Analysis
- Regulatory documentation package
Timeline: 4-8 weeks per batch
Deliverable: Purified protein + full documentation
Quality Control & Analytics
Every protein batch undergoes comprehensive testing to ensure it meets specifications for medical device applications:
| Test Category | Analytical Methods | Typical Specifications |
|---|---|---|
| Identity |
• Western blot • Mass spectrometry (LC-MS/MS) • N-terminal sequencing |
Confirmed identity |
| Purity |
• SDS-PAGE (reducing/non-reducing) • SEC-HPLC • Capillary electrophoresis (CE-SDS) |
>95% (typical) >98% (premium) |
| Concentration |
• UV absorbance (A280) • BCA/Bradford assay • Amino acid analysis |
As specified ±10% |
| Aggregation |
• SEC-HPLC • Dynamic light scattering (DLS) • Analytical ultracentrifugation |
<5% aggregates <2% (premium) |
| Endotoxin |
• LAL assay (kinetic chromogenic) • Recombinant Factor C assay |
<0.1 EU/mg (IVD) <1.0 EU/mg (research) |
| Bioactivity |
• ELISA • SPR/BLI binding assays • Cell-based assays • Enzyme activity assays |
Application-specific Batch-to-batch CV <15% |
| Glycosylation (mammalian) |
• LC-MS glycan analysis • Lectin blotting • HILIC-HPLC |
Consistent profile Meets specifications |
| Sterility | • USP <71> (14-day incubation) | No growth |
| Host Cell Proteins (HCP) |
• ELISA (host-specific) • LC-MS/MS |
<100 ppm <50 ppm (premium) |
| DNA Content |
• qPCR • Fluorescent DNA binding assay |
<10 ng/mg protein |
Documentation Provided
- Certificate of Analysis (CoA): Complete QC results with acceptance criteria
- Manufacturing Batch Record: Full production documentation per cGMP
- Analytical Methods: Validated test methods and protocols
- Stability Data: Accelerated and real-time stability studies
- Process Validation: Consistency and reproducibility data (3+ batches)
- Raw Material Traceability: Complete chain of custody documentation
- Safety Data Sheet (SDS): Handling and storage information
- Regulatory Support Files: Documentation suitable for FDA/EMA submissions
Applications in IVD and Diagnostics
Diagnostic Reagents
- Antigens: Infectious disease markers (viral, bacterial)
- Calibrators/Standards: Quantitative assay references
- Controls: Positive and negative assay controls
- Detection Reagents: Enzyme conjugates, reporter proteins
- Capture Proteins: Protein A/G, streptavidin variants
Assay Development
- ELISA Components: Coating antigens, detection enzymes
- Lateral Flow: Antigens, conjugate proteins
- Immunoassays: Target proteins, binding partners
- Biosensors: Immobilization proteins, reporters
- Point-of-Care: Stable, robust protein formulations
Biomarker Proteins
- Cardiac Markers: Troponin, BNP, CK-MB
- Tumor Markers: PSA, CEA, CA125, HER2
- Inflammation: CRP, PCT, cytokines
- Metabolic: Hormones (insulin, HbA1c)
- Infectious Disease: Viral/bacterial antigens
Enzymes & Functional Proteins
- Detection Enzymes: HRP, alkaline phosphatase
- Proteases: Thrombin, trypsin, proteinase K
- Polymerases: DNA/RNA polymerases for molecular diagnostics
- Restriction Enzymes: Molecular biology applications
- Reporter Proteins: Luciferase, fluorescent proteins
Scalability: From Development to Commercial Production
Seamless scale-up from initial development to commercial manufacturing volumes:
| Scale | Volume | Typical Yield | Timeline | Applications |
|---|---|---|---|---|
| R&D Scale | Shake flasks 1-5 L |
10-100 mg | 2-3 weeks | • Initial characterization • Assay development • Proof of concept |
| Pilot Scale | Bioreactor 10-50 L |
100 mg - 1 g | 3-4 weeks | • Process validation • Clinical samples • Regulatory submissions |
| Small Commercial | Bioreactor 50-200 L |
1-10 g | 4-6 weeks | • Market launch • Limited production • Specialty diagnostics |
| Large Commercial | Bioreactor 200-1000 L |
10-100+ g | 6-8 weeks | • High-volume production • Global distribution • Multiple products |
Scale-Up Advantages
- Process Transfer: Validated processes transfer smoothly between scales
- Batch Consistency: Maintain quality attributes across all production scales
- Cost Optimization: Economics improve at larger scales while maintaining quality
- Flexible Scheduling: Accommodate market demand changes
- Supply Security: Multiple production campaigns ensure continuous supply
Pricing & Investment Guide
Protein production costs depend on expression system, scale, complexity, and timeline. We offer transparent, project-based pricing:
E. coli Expression
Most Cost-Effective
Development + Production:
- 100 mg: €8,000 - €15,000
- 1 g: €12,000 - €25,000
- 10 g: €20,000 - €45,000
Production Only:
(from established process)
- €1,000 - €3,000 per gram
- Volume discounts at >10g
Includes endotoxin removal, standard QC
HEK293 Expression
Fast & Flexible
Development + Production:
- 100 mg: €15,000 - €30,000
- 1 g: €25,000 - €50,000
- 10 g: €60,000 - €120,000
Production Only:
(from established process)
- €3,000 - €8,000 per gram
- Scale-dependent pricing
Transient expression available for rapid turnaround
CHO Expression
Premium Quality
Development + Production:
- 100 mg: €20,000 - €40,000
- 1 g: €35,000 - €70,000
- 10 g: €80,000 - €150,000
Production Only:
(from established cell line)
- €4,000 - €10,000 per gram
- Best economics at >10g
Includes cell line development, extensive characterization
What's Included in Project Cost
- Gene design, synthesis, and optimization
- Expression vector construction and validation
- Cell line/strain development and banking
- Process development and optimization
- ISO 13485-certified production
- Multi-step purification
- Comprehensive QC testing (see table above)
- Complete documentation for regulatory use
- Project management and technical support
Additional Services Available:
- Accelerated timelines (expedite fees apply)
- Specialized analytics beyond standard QC
- Custom formulation development
- Long-term stability studies
- On-site validation support
Ready to Start Your Protein Production Project?
Our protein engineering experts will help you select the optimal expression system and production strategy.
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