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IIT and IND Filing Services

AAV

IIT non-registered clinical study / investigational new drug (IND) application / gene therapy commercialization
uBriGene has proficient and experienced Regulatory Affair teams in North America and China. We filed 2 out of the 4 approved IND applications for AAV gene therapy products in China in 2021. In 2022, we will file four more IND applications to FDA on behalf of our clients. 

Service
Research-Grade
IIT
IND
Traceable Suspension Cell Bank
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AVV Upstream Manufacturing Technique Optimization
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Transfection Optimization
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AVV Downstream Purification Optimization
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Manufacturing Process Confirmation; Batch Production
Based on client's inquiry
√
AVV Production and Verification (For Application)
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√
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Quality Standards Fully Meet
Based on client's inquiry
√
Client's Needs
√
√
Batch Production Records
Based on client's inquiry
√
Batch Inspection Records
Based on client's inquiry
√
Quality Inspection Records
√
Based on client's inquiry
√
Relevant Traceable Documentation
Based on client's inquiry
√

Lentivirus

IIT non-registered clinical study / investigational new drug (IND) application / gene therapy commercialization

uBriGene has proficient and experienced Regulatory Affair teams in North America and China. We filed 2 out of the 4 approved IND applications for AAV gene therapy products in China in 2021. In 2022, we will file four more IND applications to FDA on behalf of our clients.

Service
Research-Grade
IIT
IND
Traceable Suspension Cell Bank
√
√
Lentivirus Upstream Manufacturing Techniques
√
√
Optimization
√
√
Transfection Optimization
√
√
Lentivirus Downstream Purification Optimization
Based on client's enquiry
√
Manufacturing Process Confirmation; Batch Production
√
√
√
Lentivirus Production And Verification (for Application)
√
√
Quality Standards Fully Meet Client's Needs
Based on client's enquiry
√
Batch Production Records
Based on client's enquiry
√
Batch Inspection Records
Based on client's enquiry
√
Quality Inspection Records
√
Based on client's enquiry
√
Relevant Traceable Documentation
Based on client's enquiry
√
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