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
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 OP

GMP-grade Cells and Model Viruses

Thousands Square Meters GLP Laboratory

Multiple Virus Clearance Validation Suites

High-quality Virus Production

End Point Test-Molecular Assay

End Point Test-Infection Assay

Experiences

Domestic and International IND/BLA Application Success Cases

>7 Years Experience for VC Service

>30 Customers

>100 Completed Projects

>50 Application Success Cases

100%Success Application

100%Pass in Quality Audit

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