Antibody Product

mAb, ADC, RDC, etc.
The production of antibody drugs involves complex processes. From cell line establishment to process scale-up, quality control at each step critically impacts product safety. To ensure antibody drug safety, it is essential to establish rigorous biosafety evaluation systems, employ advanced detection technologies, and continuously optimize quality control strategies.

Biosafety Strategy for Antibody Production

Virus Clearance Study

Reliable virus clearance processes and reasonable virus clearance process validation (Virus Clearance Study) are ensuring the patient’s safety. Considering the application of rodent cell lines for recombinant protein and antibodies production, it is necessary to evaluate the effectiveness of virus removal and virus inactivation steps in the process comprehensively.

Virus Clearance Validation Studies for IND/BLA Application

High-quality Model Viruses

Virus Virus Family Envelope Genome Approx.Size(nm) Shape Titer(Log10TCID50/mL)
MVM
Parvo
No SSDNA 18-24 Icosahedral 8.00-9.00L0g
X-MuLV
Retro
Yes SSRNA 80-110 Spherical 7.50-8.50L0g
Reo3
Reo
No dsRNA 60-80 Spherical 8.00-9.00L0g
PrV
Herpes
Yes dsDNA 120-200 Spherical 8.00-9.00L0g

BRC Virus Clearance Studies

BRC Biotech provides a comprehensive virus clearance validation service, ensuring the quality and safety of the drug production and protecting the patient safety.
Capabilities

✓ Standard Service Model

✓Complete Service Model

✓ ND Virus Clearance Validation Service

✓BLA Virus Clearance Validation Service

✓VC for Antibody Process

✓ VC for AAV Process

✓VC for Insect Cell Process

Advantages

✓ In Compliance with EMA GMP QP

✓ GMP-grade Cells and Model Viruses

✓ Thousands Square Meters GLP Laboratory

✓ Multiple Viral Clearance Validation Suites

✓ High-quality Virus Production

✓ End Point Test-Molecular Assay

✓ End Point Test-Infection Assay

Experiences

✓ International IND/BLA Application Success Cases

✓ >7 Years Experience for VC Studies

✓ >30 Customers

✓ >100 Completed Projects

✓ >50 Application Success Cases

✓ 100%Success Application

✓ 100%Pass in Quality Audit

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