What PackGene Biotech does

PackGene Biotech Inc. is a privately held, Houston, Texas-based contract research and development/manufacturing organization (CRO/CDMO) that provides viral vector and nucleic acid solutions — primarily AAV (adeno-associated virus), lentivirus, mRNA/LNP, and plasmid DNA — to gene therapy and cell therapy developers. Founded in 2014 and operating from a 120,000 sqft facility, the company has delivered more than 50,000 projects to over 1,000 clients globally, including large biopharmaceutical companies (Biogen, Intellia, Decibel) and academic institutions (University of Sydney), and supports 25+ IND programs and 30+ IIT programs.

The company's service portfolio spans the full gene therapy manufacturing value chain, from vector design and plasmid preparation through research-grade and GMP-grade AAV/lentivirus production, mRNA synthesis and LNP formulation, and analytical/batch release testing. It is differentiated by three proprietary technology platforms — π-Alpha 293 (high-yield AAV production, up to 10-fold yield improvement and up to 1e+17vg per batch), π-Omega (high-yield plasmid production), and π-Icosa (AI-driven AAV capsid engineering) — plus the TP011 dual-plasmid system. Capabilities cover 70+ AAV serotypes and 40+ QC assays, and GMP plasmid is DMF-registered.

PackGene monetizes through project-based, quote-based fees across research, preclinical, and GMP service tiers, distributed via direct sales, an online ordering portal (order.packgene.com), global distributor partners, and regional websites for China, Japan, and South Korea. The go-to-market is sales-led, supplemented by heavy conference presence (ASGCT, AACR, BIO, Advanced Therapies Congress) and content marketing. The company has raised at least six funding rounds since 2019 — most recently a disclosed $14.1M Series C in December 2023 led by CMG-SDIC Capital Management — and is in active scale-up mode following its 2023 cGMP facility groundbreaking.

Name

PackGene Biotech

Legal name

PackGene Biotech Inc.

Website

https://packgene.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

251–500 employees

Short description

PackGene Biotech is a Houston-based CRO/CDMO providing AAV, lentivirus, mRNA/LNP, and plasmid DNA manufacturing services to gene therapy developers, having delivered over 50,000 projects to 1,000+ clients globally from research through GMP.

Ownership category

akta.pro rank

Product category

Gene Therapy CDMO Services

akta.pro primary industry

Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE)

akta.pro secondary industries

Gene Therapy CDMO (Viral Vector Manufacturing) (HLAGAGAB), Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ)

Keywords

• Viral vector manufacturing
• AAV packaging services
• Gene therapy CRO
• CDMO services
• Plasmid DNA production

Headquarters

HQ city

Houston

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. AAV Vector Services: AAV packaging and production services for research grade, NHP grade, and GMP manufacturing. Revenue generated through project-based fees for vector design, production, purification, and quality control services.
2. Lentivirus Services: Lentivirus packaging and production services including express gene-to-lentivirus service and custom lentiviral plasmid design.
3. mRNA and LNP Services: Custom mRNA synthesis and mRNA-LNP development services from research grade through GMP production.
4. Plasmid DNA Services: Plasmid preparation and manufacturing services ranging from research grade to GMP, with scales from 100µg to 100g.
5. AAV Testing and Analytical Services: Comprehensive analytical testing services including mass photometry, genome titer by ddPCR, empty/full capsid ratio by AUC, genome integrity by CE, and genome sequencing by nanopore.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

PackGene Biotech is a contract research organization (CRO) and contract development and manufacturing organization (CDMO) specializing in cell and gene therapy solutions. The company provides AAV vector packaging, lentivirus production, custom mRNA/LNP synthesis, and plasmid DNA services from research grade through GMP manufacturing, supported by proprietary high-yield production platforms and comprehensive analytical characterization.

Product overview

PackGene Biotech is a world-leading CRO and CDMO offering comprehensive cell and gene therapy solutions. The company's integrated platform spans from vector design and construction to AAV, lentivirus, mRNA, and plasmid services, supporting early-stage drug discovery through GMP manufacturing. The portfolio centers on three proprietary technology platforms: π-Alpha 293 (high-yield AAV production), π-Omega (high-yield plasmid production), and π-Icosa (AI-powered AAV capsid engineering). Core service offerings include AAV production and packaging (research, NHP, and GMP grades), lentivirus packaging, custom mRNA and LNP services, and comprehensive analytical testing. The company operates a 120,000 sqft GMP facility in Houston, Texas, and has delivered over 50,000 projects to more than 1,000 clients globally.

Differentiator

Problem solved

Functional benefit

Brands

• π-Alpha: 293 AAV High-yield Production Platform leveraging uniquely designed RC and helper plasmids, engineered production cell lines, and QbD optimizations to significantly enhance total AAV yield.
• π-Omega
• π-Icosa

Products and services

• π-Alpha 293 AAV High-yield Production Platform A proprietary high-yield AAV production platform that amplifies AAV production by up to 10-fold, yielding up to 1e+17vg per batch. Used by gene therapy developers requiring scalable viral vector manufacturing.
• π-Omega Plasmid DNA High-yield Production Platform A proprietary high-yield plasmid DNA production platform that improves plasmid yield, quality, and biosafety. Used by gene therapy developers requiring GMP-grade plasmid manufacturing.
• π-Icosa AAV Serotype Screening Platform An AI-powered AAV capsid engineering platform that enhances AAV infectivity and specificity through screening and validation in animal models, supported by AI-driven predictions of novel capsid sequences. Used by gene therapy developers seeking enhanced tissue targeting and manufacturability.
• AAV Production Services Comprehensive AAV vector production services offering high-quality vectors with reliably low empty capsid content across 70+ serotypes with 40+ QC assays. For biopharma and academic gene therapy developers.
• AAV Packaging – Research Grade Research-grade AAV packaging with delivery in as little as 12 days from miniprep to purified virus, featuring high purity, low endotoxin levels, and minimal empty capsids. For academic and early-stage research programs.
• AAV Packaging – NHP Grade GMP-like AAV vectors for non-human primate studies with enhanced quality controls for preclinical toxicology studies. For biopharma preclinical programs.
• Express Gene-to-AAV Service Accelerated AAV production service enabling rapid transition from gene sequence to purified AAV vector. For researchers needing fast-turnaround AAV production.
• Off-the-Shelf AAV Products Pre-packaged AAV products including control AAV vectors available for immediate ordering. For research labs needing ready-to-use viral vectors.
• AAV Testing Services Comprehensive analytical testing for AAV vectors including mass photometry, genome titer by ddPCR, empty/full capsid ratio by AUC, genome integrity by CE, and genome sequencing by Nanopore. For gene therapy developers needing characterization and QC testing.
• Capsid Engineering Custom AAV capsid engineering services to develop novel capsids with enhanced tissue targeting, reduced immunogenicity, and improved therapeutic properties. For gene therapy researchers advancing novel AAV vectors.
• AAV Capsid Discovery Kits Pre-packaged kits for AAV capsid screening and discovery enabling rapid evaluation of capsid variants. For research labs conducting capsid selection studies.
• AAV Capsid & Gene Library Services Services for creating and screening custom AAV capsid and gene libraries for targeted applications. For gene therapy discovery programs.
• Lentivirus Packaging Lentiviral vector production with delivery in 8-12 business days, accurate titer via post-transduction qPCR, and enhanced safety features. For cell therapy developers and gene delivery researchers.
• Express Gene-to-Lentivirus Service Accelerated lentivirus production service for rapid gene delivery applications. For researchers needing fast turnaround on lentiviral vectors.
• Custom mRNA Service Custom mRNA synthesis with high-quality mRNA, full QC panel, custom scales, stability, and modifications for research and preclinical applications. For vaccine developers and gene therapy researchers.
• Custom mRNA-LNP Service mRNA encapsulation in lipid nanoparticles for enhanced stability, protected mRNA delivery, increased uptake, and reduced immunogenicity. For vaccine and gene therapy developers.
• mRNA and LNP Products Pre-formulated mRNA and LNP products available for immediate use in research and development. For research labs needing ready-to-use mRNA reagents.
• Fast mRNA Service for Gene Editing Rapid mRNA synthesis service optimized for gene editing applications including CRISPR components. For gene editing researchers.
• piVector Designer Online vector design tool for designing AAV and lentivirus plasmids with application-specific elements. For researchers designing gene delivery constructs.
• AAV Plasmid Design and Construction Custom AAV plasmid design and cloning services for efficient gene delivery constructs. For gene therapy developers needing customized plasmid backbones.
• Lentivirus Plasmid Design and Construction Custom lentiviral plasmids for gene overexpression and silencing supporting CRISPR, shRNA, and miRNA applications. For gene therapy and functional genomics researchers.
• Plasmid Preparation Flexible plasmid preparation services from 100µg to 2g for research and preclinical grades. For research labs and biopharma developers.
• Preclinical Grade Plasmid Higher purity plasmid DNA for preclinical studies with enhanced quality controls. For biopharma preclinical development programs.
• Process Development AAV process development services for scalable manufacturing including cell line development, high-cell-density transfection, and robust purification process development. For gene therapy developers advancing to GMP manufacturing.
• AAV Analytical Development Analytical method development and validation for AAV product characterization and release testing. For biopharma developers requiring regulatory-grade analytics.
• GMP Plasmid Manufacturing cGMP plasmid production up to 200L with flexible scaling, isolated production lines, and advanced single-use technology. Over 10 years of expert plasmid manufacturing; DMF (Drug Master File) registered. For biopharma clinical and commercial programs.
• GMP AAV Manufacturing High-productivity GMP AAV manufacturing with scalable production platform, cost-effective solutions with in-house GMP plasmid manufacturing and comprehensive release testing. For gene therapy developers in clinical and commercial stages.
• AAV One-Stop Solution Integrated end-to-end AAV manufacturing from process development through GMP production including aseptic fill-finish and cell banking. For biopharma seeking a single CDMO partner for full AAV programs.
• GMP AAV Batch Release Testing Comprehensive batch release testing services for GMP AAV products meeting regulatory requirements. For biopharma submitting IND or BLA filings.
• GMP mRNA & LNP GMP manufacturing services for mRNA and LNP products supporting clinical and commercial applications. For vaccine developers and gene therapy programs.

Quantifiable outcome

• AAV production yield increased by up to 10-fold using π-Alpha platform
• +3 more outcomes

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature4 records

Partnerships

One partnership is on record.

• Kudo BiotechnologycoreStrategic or Co-development Partner · 19 September 2023PackGene Biotech and Kudo Biotechnology partnered to offer customized mRNA manufacturing services, combining PackGene's viral vector expertise with Kudo's specialized capabilities in mRNA development.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• VectorBuilder: VectorBuilder is a global CRO/CDMO offering AAV, lentivirus, mRNA, and plasmid services with proprietary vector design tools. It directly competes with PackGene across research-grade and GMP-grade gene therapy manufacturing, with overlapping customer bases in academic and biotech segments.
• GenScript ProBio: GenScript ProBio is the CDMO arm of GenScript offering cell and gene therapy services including AAV and lentivirus manufacturing, plasmid production, and GMP capabilities. It competes head-to-head with PackGene in the global gene therapy CDMO market with comparable service breadth from research to GMP.
• Andelyn Biosciences: Andelyn Biosciences is an AAV and lentivirus CDMO operating a 200,000+ sqft GMP facility in Columbus, Ohio. As a US-based gene therapy CDMO with comparable AAV focus, it competes with PackGene for the same biopharma and academic customers seeking GMP-grade viral vector manufacturing.
• WuXi Advanced Therapies Unit: WuXi AppTec's Advanced Therapies Unit offers viral vector and cell therapy CDMO services including AAV and lentivirus manufacturing at scale. It competes with PackGene across the full gene therapy manufacturing value chain and is one of the largest global players in this segment.
• Vigene Biosciences (Charles River): Vigene Biosciences, now part of Charles River Laboratories, specializes in AAV and lentivirus production services for gene therapy. Acquired by Charles River to scale its gene therapy CDMO offering, it directly overlaps with PackGene's core AAV/lentivirus service portfolio.

Broad incumbents

• Lonza Cell & Gene: Lonza is one of the world's largest CDMOs with a significant cell and gene therapy business offering viral vector and cell therapy manufacturing. It competes with PackGene primarily for large commercial-stage GMP programs, offering broader scale and longer regulatory track record.
• Catalent (Novo Holdings): Catalent, recently acquired by Novo Holdings, operates large-scale gene therapy manufacturing facilities offering AAV and lentivirus production. As an established broad CDMO incumbent, it competes with PackGene for enterprise customers seeking integrated drug development and manufacturing solutions.
• Charles River Laboratories: Charles River Laboratories is a large CRO/CDMO with viral vector manufacturing capabilities through its Vigene acquisition and broader cell and gene therapy services. It offers PackGene-comparable AAV/lentivirus services as part of a much wider preclinical and manufacturing portfolio.
• Thermo Fisher Scientific (Patheon/Brammer Bio): Thermo Fisher Scientific acquired Brammer Bio to enter viral vector CDMO and offers AAV manufacturing as part of its pharma services portfolio. As a global pharma services giant, it competes with PackGene for large enterprise gene therapy sponsors.

Emerging players

• Resolian: Resolian is a specialist bioanalytical CRO offering gene therapy characterization services including AAV capsid analysis and impurity testing. It is a partial competitor and ecosystem partner to PackGene for analytical and testing services supporting gene therapy CMC.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key highlights7 records

Customer concentration

• Xx.com/PackGeneBiotech
• LinkedInlinkedin.com/company/packgene-biotech-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds6 records

Investors15 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PackGene Biotech