The rise of gene therapies for rare diseases, cancer, and neurological disorders has driven growing demand for scalable, high-quality adeno-associated virus (AAV) vector production. For biopharma companies, especially those advancing toward clinical stages, manufacturing has become a critical challenge.

Asia offers cost advantages, emerging expertise, and expanding GMP infrastructure—but the region’s regulatory diversity and variable capabilities make choosing the right contract development and manufacturing organisation (CDMO) a strategic priority. AAV production is complex, requiring end-to-end control over plasmid prep, vector packaging, purification, and quality testing. Transitioning from research to GMP-grade material demands more than technical skill—it calls for a partner with robust systems and regulatory experience.

In this blog, we outline the key criteria for selecting an AAV manufacturing partner in Asia, and highlight what to look for in a trusted CDMO.

What to Look for in an AAV Manufacturing Partner

When evaluating a CDMO for AAV production in Asia, it’s important to go beyond surface-level capabilities. A strategic partner should not only meet your current needs but also scale with your program as it progresses through preclinical, clinical, and commercial phases. Below are the core criteria to assess:

1. Platform Specialisation and Technical Expertise

AAV manufacturing requires domain-specific knowledge that goes far beyond general biologics expertise. CDMOs with a dedicated gene therapy focus are more likely to have optimised platforms, streamlined workflows, and personnel deeply familiar with vector-specific nuances.

When evaluating a potential partner, look for:

• Experience with diverse AAV serotypes, including conventional (AAV2, AAV8, AAV9) and novel capsids tailored to specific tissues or delivery routes.
• Proprietary or proven high-yield production platforms that ensure consistency and scalability from lab-scale to GMP.
• Optimised cell lines and transfection methods, such as HEK293-based systems with dual- or triple-plasmid setups, engineered for productivity and viral genome integrity.
• Demonstrated capability in developing custom AAV constructs, supporting flexibility in gene cassette design and packaging constraints.

A CDMO with deep technical foundations can help troubleshoot early issues, optimise yield, and accelerate your path to IND readiness.

2. GMP-Compliant Infrastructure with Scalable Capacity

Compliance and scalability go hand in hand in viral vector manufacturing. GMP-certified cleanroom facilities must adhere to stringent design principles, but they also need to be flexible enough to grow with your program—from early clinical to commercial stages.

Consider these infrastructure and operational factors:

• Bioreactor capacity options (e.g., 50L, 200L, up to 500L) that match your clinical demand and offer headroom for scale-up.
• Cleanroom features such as unidirectional personnel and material flow, segregated HVAC, and single-use systems, which reduce contamination risk and enable faster turnaround.
• A proven track record of GMP batch production, including clinical-grade vectors delivered at scale, and successful regulatory audits or inspections.

A facility that’s GMP-compliant and built for flexibility reduces both time and cost as your program matures.

3. Integrated Plasmid and AAV Production Workflow

AAV manufacturing begins with plasmid DNA—the quality and reproducibility of which can make or break downstream performance. CDMOs that produce plasmids in-house offer greater control over timelines, batch-to-batch consistency, and regulatory traceability.

Key considerations:

• Availability of end-to-end services, from vector design, plasmid construction, and purification through to AAV packaging.
• High-yield, low-endotoxin plasmid production using scalable platforms compliant with GMP or research-grade requirements.
• A seamless workflow between plasmid and AAV teams, which reduces friction during tech transfer and minimises production delays.

Look for a CDMO that can offer a single integrated solution to avoid the coordination headaches of multiple vendors.

4. Analytical Development and Quality Control

Regulatory agencies demand robust, validated analytical data to support each batch of gene therapy product. Your CDMO should have in-house analytical expertise capable of supporting product release, stability testing, and regulatory filings.

Analytical capabilities to look for:

• Genome titer and integrity using validated qPCR, ddPCR, or AUC methods.
• Full/empty capsid analysis, which directly impacts therapeutic potency and dosing.
• Detection of residual host cell DNA, plasmid backbone, or proteins, ensuring product safety and compliance.
• Potency, sterility, and impurity assays, with traceable standards and method validation reports.

Advanced CDMOs may also serve as reference standard providers to national regulatory agencies, indicating high analytical credibility.

5. Regulatory Experience and Documentation Support

Even the most technically competent CDMO may fall short without regulatory experience—particularly in navigating complex gene therapy submissions such as INDs. A partner familiar with your target region’s regulatory landscape will help you avoid delays and reduce risk during filing.

Evaluate:

• Number of INDs supported across FDA, EMA, NMPA, and other agencies.
• In-house expertise in CMC documentation, QMS development, and process validation.
• A track record of passing client or regulatory audits, indicating compliance readiness and transparency.

6. Communication, Project Management, and IP Protection

The success of your manufacturing campaign depends heavily on how well your CDMO communicates and safeguards your intellectual property. In high-stakes, time-sensitive projects, you need a responsive, structured, and secure collaboration model.

Look for:

• Dedicated project managers with experience in AAV programs who act as your point of contact from on boarding through batch release.
• Real-time communication and document-sharing systems, with visibility into production timelines and deviations.
• A robust data and IP protection framework, such as ISO27001-certified systems with encryption, access control, and audit trails.
• Clear contractual assurances that the CRO/CDMO does not operate competing therapeutic programs, minimising IP conflict risk.

Why We Chose To Work With PackGene Biotech as an AAV Manufacturing Partner

After rounds of screening through several CRO/CDMO for AAV production in Asia, Atlantis Bioscience has finally decided to partner with PackGene Biotech to distribute their AAV & MRA-LNP services and products across Southeast Asia.

Packgene Biotech emerged as the clear strategic choice, excelling across all six pillars critical for successful AAV manufacturing. They are gene therapy focused, has global GMP infrastructure, and deep regulatory expertise. Their AAVs are set as the QC standard for AAVs production across China. With a proven track record across 50+ multinational companies and 1,500+ biotech and academic institutions, PackGene Biotech offers a streamlined, end-to-end path from plasmid design to clinical-grade vector delivery.

AAV-Focused Platform and Innovation

This is how Packgene Biotech aligns with our core criteria for excellence:

• OCA and PCS production cell lines, optimised for high-yield viral production
• Packgene’s proprietary π-Alpha™ 293 AAV High-Yield Platform delivers industry-leading titers (≥1E+17 vg/L) while maintaining capsid integrity—directly addressing scalability challenges.
• A dual-plasmid AAV system engineered for consistency and scalability
• >100 Proprietary novel AAV serotypes developed for enhanced transduction efficiency and tissue targeting
• Low empty capsid rate, improving vector quality and reducing dosing concerns
• Full support for custom AAV design and capsid engineering

These innovations accelerated our process development and de-risked yield variability upfront. They also gave us the confidence that Atlantis Bioscience’s clients and partners can achieved high-purity & high-potency AAV vectors to their therapeutic goals.

PackGene operates GMP-certified manufacturing facilities in Guangzhou and Houston, US with cleanroom designs where audits confirmed robust adherence to FDA, EMA, and NMPA regulatory standards. The infrastructure supports flexible batch sizes—up to 1E+17 vg per batch—ensuring a smooth transition from early-stage clinical supply to commercial readiness.

Unlike many CDMOs that outsource key steps, PackGene maintains full in-house control over the entire process. Its integrated plasmid development and AAV packaging workflows eliminated supply chain bottlenecks hence reducing turnaround time, streamline tech transfer, and their in-house linearized ITR plasmids enhanced vector genomic fidelity.

With more than 60 validated analytical assays and a comprehensive all-in-one in-house testing platform, PackGene’s track record of successful INDs/IMPDs (including U.S., EU, and China filings) and participation in regulatory standards committees (e.g., NIFDC) ensured compliance confidence. Their documentation templates and audit support simplified client’s tech transfer and accelerated agency submissions. The company has successfully supported 20+ IND applications—including 8 with the FDA and 12 with China’s NMPA.

PackGene offers flexible AAV vector grades to support every stage of development. From research-grade AAV for early discovery and proof-of-concept studies, to NHP-grade AAV designed for large animal research with enhanced purity and quality control, and GMP-grade vectors tailored for clinical trials and commercial manufacturing—PackGene provides scalable solutions to match diverse application needs.

PackGene’s ISO27001-certified information security framework ensures strict data protection, while its dedicated project management teams provide responsive, transparent communication throughout every phase. Importantly, PackGene operates no internal therapeutic pipeline, eliminating potential conflicts of interest and safeguarding client IP.

Learn more about AAV from Packgene:

Conclusion

As the gene therapy field accelerates, AAV manufacturing has emerged as both a technical bottleneck and a strategic differentiator. For biopharma companies operating in or looking to Asia, selecting the right CDMO is essential—not only to meet regulatory and production demands but also to reduce risk, save time, and position your program for long-term success.

PackGene Biotech brings together the core elements of an ideal AAV manufacturing partner: technical depth, GMP scalability, regulatory track record, and secure, transparent collaboration. Whether you’re preparing for IND submission or planning for clinical-scale production, PackGene offers the capabilities and experience to move your program forward with confidence.

By choosing PackGene, we secured more than a CDMO—we gained a collaborative partner for Atlantis Bioscience clients and partners who is capable of accelerating our path to clinic while mitigating regulatory and supply-chain risks inherent in AAV manufacturing. Their Asia-based footprint delivers cost efficiency without compromising on global quality standards, making them the ideal catalyst for researchers success across Asia.

References

Clément N, Grieger JC. Manufacturing of recombinant adeno-associated viral vectors for clinical trials. Mol Ther Methods Clin Dev. 2016 Mar 16;3:16002. doi: 10.1038/mtm.2016.2.

Stone D, Mietzsch M, Ronzitti G. Advancing AAV technology: From capsid design to scalable manufacturing. Mol Ther Methods Clin Dev. 2025 May 7;33(2):101477. doi: 10.1016/j.omtm.2025.101477.