GMP AAV Batch Release Testing
- End-to-End GMP Compliance: All testing follows FDA/EMA guidelines and ICH Q2(R1) standards for regulatory readiness.
- Integrated Workflow: Co-located manufacturing and QC accelerate lot release and reduce time-to-clinic.
- Comprehensive Assay Coverage: Over 60 qualified and validated methods ensure identity, potency, purity, and safety.
Key Benefits
-
Accelerated Lot Release
Co-located manufacturing and QC dramatically shorten timelines compared to outsourced models. -
Regulatory Readiness
All assays are qualified or validated per ICH Q2(R1), supporting IND/BLA submissions with robust data packages. -
Comprehensive CQA Coverage
From compendial safety tests to advanced capsid analytics, we address every Critical Quality Attribute (CQA) required for human administration.
Our Release Testing Panel
-
Safety & Compendial Testing
Ensuring Patient Safety
We adhere to pharmacopeial standards (USP/EP/JP) for mandatory safety testing:- Sterility (USP <71>)
- Endotoxin (USP <85>)
- Mycoplasma (USP <63>)
Developing a custom safety assay? Visit Analytical Development.
-
Potency & Titer Quantification
-
Product Purity & Characterization
-
Identity & Genomic Integrity
Related Service
-
AAV Testing Services
- Comprehensive AAV testing covering titer, purity, safety, and more
- Fast, reliable results with expert guidance
- Tailored solutions ensuring top quality and safety standards
-
GMP Plasmid
- cGMP plasmid production up to 200L, with flexible scaling for any project size.
- Strict contamination control by isolated production lines and advanced single-use technology.
- 10+ years of expert plasmid manufacturing, with comprehensive process and technical support.
-
GMP AAV Manufacturing
- High-productivity GMP AAV manufacturing with a scalable production platform.
- Cost-effective solutions featuring in-house GMP plasmid manufacturing and comprehensive release testing.
- Rapid timeline to GMP AAV production and clinical application, backed by a strong record of successful delivery.
-
Process Development
- Optimized high-yield processes using data-driven DoE
- Customized solutions with seamless GMP scale-up
- IND-ready data documented in electronic lab notebooks
-
AAV Analytical Development
- Comprehensive testing for identity, purity, potency, and safety
- Custom, validated assays aligned with regulatory needs
- Fast turnaround with GMP-grade QC and release support
Resource
REQUEST A QUOTE
Confidentiality Commitment from PackGene:
The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.