Description

Product Name: Recombinant KexII Protease API
Molecular Weight Range: 28-32 kDa (depending on glycosylation status)
Appearance: Clear to slightly opalescent liquid solution or lyophilized powder
Functions:
1.Precision Protein Processing: Specifically cleaves at paired basic residue sites (KR, RR) for accurate pro-protein activation
2.Therapeutic Peptide Production: Essential for maturation of recombinant peptide therapeutics and hormone precursors
3.Bioprocess Optimization: Enhances yield and purity in recombinant protein manufacturing processes
4.Vaccine Development: Facilitates processing of viral envelope glycoproteins for vaccine applications
5.Industrial Biocatalysis: Serves as specialized catalyst for targeted peptide bond hydrolysis in fermentation processes
6.Research Applications: Enables precise protein engineering and structural studies in academic and industrial research
Molecular Formula: Protein (amino acid sequence based on recombinant expression in microbial system)
Molecular Weight: Approximately 30.5 kDa (theoretical based on amino acid sequence)

Our Product Superiority: Why Choose Us?

1. Advanced Recombinant Expression System:
Our KexII Protease is produced using proprietary microbial expression technology that ensures high yield, exceptional purity (>95% by HPLC), and complete lot-to-lot consistency. The recombinant production method eliminates variability associated with native sources and provides homogeneous enzyme preparations free from animal-derived contaminants. Advanced purification protocols including affinity chromatography and multiple polishing steps guarantee removal of host cell proteins and process-related impurities.

2. Enhanced Enzymatic Characteristics:
Through protein engineering and process optimization, we have developed a KexII Protease with superior functional attributes:
• Specific Activity: ≥100 U/mg (towards specific fluorogenic substrates)
• Optimal pH Range: 6.0-8.5 with peak activity at pH 7.2
• Temperature Optimum: 37°C with maintained activity up to 45°C
• Calcium Dependence: Requires 1-5 mM Ca²⁺ for optimal activity and stability
• Kinetic Parameters: Km <50 μM for preferred dibasic substrates

3. Comprehensive Quality Assurance:
We maintain the highest standards of manufacturing excellence with ISO 9001, ISO 22000, HACCP, HALAL, GMPC, and U.S. GRAS certifications. Our facility operates under pharmaceutical cGMP guidelines with complete documentation traceability from cell bank to final product. Each batch undergoes comprehensive characterization including:
• Purity analysis by HPLC and SDS-PAGE
• Activity validation using standardized substrates
• Contaminant testing (endotoxins, host cell proteins, DNA)
• Structural confirmation by mass spectrometry

4. Technical Expertise and Custom Solutions:
Our team of enzyme specialists provides comprehensive technical support including:
• Process optimization and scale-up assistance
• Custom formulation for specific application requirements
• Analytical method development and validation support
• Regulatory documentation preparation
• Application-specific performance testing and validation

5. Reliable Supply Chain and Manufacturing Scalability:
With state-of-the-art fermentation facilities and flexible manufacturing platforms, we ensure consistent supply for all development phases from research to commercial production. Our robust quality management system and validated supply chain provide assurance of consistent product quality and reliable delivery schedules for critical manufacturing processes.

Packaging & Storage
Packaging Options:
• Liquid formulation: 0.5 mL, 1 mL, 5 mL vials (5-15 mg/mL in optimized storage buffer)
• Lyophilized powder: 0.5 mg, 1 mg, 5 mg, 25 mg vials
• Custom packaging available for bulk manufacturing requirements
Storage Conditions:
• Liquid formulations: Store at -20°C ± 5°C; avoid repeated freeze-thaw cycles (maximum 3 cycles recommended)
• Lyophilized powder: Store at -20°C ± 5°C in dry conditions; stable for 24 months
• Working solutions: Stable for 48 hours at 2-8°C in appropriate reaction buffers

 

Handling Instructions:
1.Maintain strict temperature control during storage and transportation
2.Thaw frozen solutions gradually at 2-8°C when required
3.Use sterile techniques for pharmaceutical applications
4.Prepare working solutions under controlled conditions with appropriate calcium supplementation
5.Monitor enzyme activity during manufacturing processes using validated methods
6.Follow aseptic processing guidelines for critical biopharmaceutical applications

Recombinant KexII Protease FAQ

1. What is Recombinant KexII Protease and its primary function?

Answer:
Recombinant KexII Protease is a calcium-dependent serine protease that specifically cleaves at paired basic residues (KR- and RR- sites). It is widely used for pro-protein activation, peptide maturation, and processing of recombinant therapeutic proteins.

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2. How does Recombinant KexII differ from native KexII or other proteases?

Answer:
Our recombinant KexII is produced via advanced microbial expression systems, offering higher purity, consistency, and enzymatic activity than traditional native enzymes. It also minimizes non-specific proteolytic activity, ensuring precise cleavage.

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3. What are the main applications of Recombinant KexII Protease?

Answer:
Key applications include:

• Pro-insulin conversion

• Monoclonal antibody processing

• Activation and maturation of recombinant therapeutic proteins

• Peptide-based therapeutics and protein engineering

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4. What is the purity and quality control of your Recombinant KexII Protease?

Answer:
Each batch undergoes rigorous QC, including mass spectrometry, peptide mapping, and functional activity assays. The enzyme meets stringent pharmaceutical standards for purity, activity, and batch-to-batch consistency.

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5. What certifications and regulatory standards does your KexII Protease comply with?

Answer:
Our enzyme is manufactured under cGMP conditions and complies with:

• ISO 9001 & ISO 22000

• HACCP & HALAL certifications

• GMPC compliance

• U.S. GRAS recognition

This ensures safety, reliability, and regulatory compliance for global biopharmaceutical manufacturing.

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6. Can KexII Protease handle sensitive proteins or harsh conditions?

Answer:
Yes. It is highly stable across a range of pH and temperatures, and maintains excellent activity in various buffer systems. Its specificity and stability make it ideal for processing sensitive biopharmaceutical products.

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7. How is Recombinant KexII Protease supplied and packaged?

Answer:
We offer flexible packaging options suitable for research, pilot, and commercial-scale production, ensuring enzyme stability and integrity during storage and transport.

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8. Is technical support available for using KexII Protease in bioprocessing?

Answer:
Yes. Our technical team provides comprehensive support including protocol optimization, troubleshooting, and guidance for scaling up production processes.

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9. Why choose your Recombinant KexII Protease over other proteases?

Answer:
Our KexII Protease combines high purity, precise specificity, robust stability, and recombinant safety. It supports efficient, reproducible, and cost-effective bioprocessing for peptide therapeutics and recombinant proteins, helping manufacturers maintain competitive advantage in global markets.