Allele Biotech
Allele Biotechnology and Pharmaceuticals is a San Diego-based, privately held cell therapy CDMO that develops and manufactures clinical-grade iPSC lines using proprietary mRNA reprogramming, serving pharmaceutical, biotech, and academic customers through cGMP manufacturing, licensing, and research reagent sales.
- Company typePrivate
- Founded1999
- HeadquartersSan Diego, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Allele Biotech does
Allele Biotechnology and Pharmaceuticals, founded in 1999 and headquartered at 6404 Nancy Ridge Drive in San Diego, California, is a privately held cell therapy CDMO built around induced pluripotent stem cell (iPSC) technology. The company's core platform is a proprietary, non-integrating mRNA reprogramming method for generating clinical-grade iPSCs, complemented by a MAD7-CRISPR-based genome editing capability and more than two dozen validated differentiation protocols spanning neuroprogenitor, hepatocyte, cardiomyocyte, lung epithelial, and pancreatic β-cell lineages. In 2018 Allele commissioned what it describes as the world's first commercial cGMP facility purpose-built for clinical manufacturing of pluripotent stem cells and their derived products; the company operates under an FDA-registered quality management system with ISO7-certified cleanrooms and 11+ years of continuous cGMP experience.
The company monetizes across four revenue streams: (1) CDMO services and custom cGMP iPSC manufacturing for cell therapy developers, (2) sale of off-the-shelf and custom GMP iPSC lines and banks, (3) e-commerce and licensing of research reagents including nanoantibodies (nAb), fluorescent proteins such as mNeonGreen, and mRNA products, and (4) technology licensing of its mRNA reprogramming, differentiation, and editing platforms. Customers include pharmaceutical and biotech partners, academic research institutions, and California regenerative medicine developers served through the CIRM Industry Alliance Program. Major recent milestones include a January 2026 partnership with UC San Diego on an up to $25.8 million ARPA-H PRINT award for 3D bioprinted livers, and two U.S. patents granted in 2025 covering mRNA-directed pancreatic β-cell differentiation and a novel antibody/TCR fragment identification method.
Allele Biotech firmographics
Firmographics- Name
- Allele Biotech
- Legal name
- Allele Biotechnology & Pharmaceuticals, Inc.
- Website
- https://allelebiotech.com
- Company type
- Private
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Allele Biotechnology and Pharmaceuticals is a San Diego-based, privately held cell therapy CDMO that develops and manufactures clinical-grade iPSC lines using proprietary mRNA reprogramming, serving pharmaceutical, biotech, and academic customers through cGMP manufacturing, licensing, and research reagent sales.
- Ownership category
- akta.pro rank
Allele Biotech industry classification
Industry- Product category
- Cell Therapy CDMO & iPSC Manufacturing
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Cell Therapy CDMO (Autologous/Allogeneic Manufacturing) (HLAGAGAA)
- akta.pro secondary industries
- mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)
Keywords
Where Allele Biotech is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Allele Biotech business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales, Supply Chain
Revenue model
- CDMO Services: Contract Development and Manufacturing Organization services for cell therapy product development, including process development, technology transfer, cGMP manufacturing, and quality control testing for iPSC-based therapeutics.
- GMP iPSC Products: Sale of clinical-grade iPSC lines and banks, including off-the-shelf GMP iPSC lines, custom iPSC line development, and autologous iPSC generation services.
- Research Reagents: Sale of research tools including nanoantibodies (nAb), fluorescent proteins, mRNA products, genotyping reagents, and iPSC-derived cells through e-commerce platform.
- Fluorescent Protein Licensing: Licensing of proprietary fluorescent proteins including Basic Single User License ($300-400), Advanced User License ($600-700), and Department/Site licensing for academic and commercial use.
- Technology Licensing: Licensing of patented mRNA reprogramming and differentiation technologies, genome editing platforms, and β-cell differentiation methods to pharmaceutical and biotech partners.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | Basic Single User License for fluorescent proteins |
| One time/ perpetual license | Pay-as-you-go | Advanced User License for fluorescent proteins |
| Unit Pricing | Pay-as-you-go | Nanoantibody products |
| Subscription | Multi-year contract | CDMO and GMP iPSC services |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels7 records
Allele Biotech product offering
Product offeringCore offering
Allele Biotechnology and Pharmaceuticals operates an all-in-one iPSC-focused platform providing clinical-grade iPSC lines, mRNA-based reprogramming and differentiation technologies, and contract development and manufacturing (CDMO) services for cell therapy developers. The company manufactures GMP-compliant iPSCs and derived cell products in its purpose-built cGMP facility and supplies research reagents (nanoantibodies, fluorescent proteins, mRNA products) to academic and commercial laboratories worldwide.
Product overview
Allele Biotechnology and Pharmaceuticals operates as a cell therapy CDMO (Contract Development and Manufacturing Organization) with a platform-plus-services architecture built around induced pluripotent stem cell (iPSC) technology. The core offerings center on GMP iPSCs and mRNA-based reprogramming and differentiation technologies, supported by CRISPR genome editing capabilities. The product portfolio includes: (1) Clinical-grade iPSC lines (off-the-shelf and custom) and manufacturing services, (2) Cell Therapy CDMO+ platform offering end-to-end development, tech transfer, cGMP operations, and quality control, (3) Nanoantibodies (nAb) for fluorescent protein research including GFP-nAb, RFP-nAb, mNeonGreen-nAb, and mTFP-nAb in various formats, (4) Fluorescent proteins and expression vectors (mNeonGreen, mTurquoise2, mScarlet3, LanYFP, LanRFP, mTFP1, mWasabi), (5) mRNA products for cell programming, and (6) Research reagents including Mitochondria Isolation Kit and genotyping buffers. The company also participates in high-profile partnerships including the ARPA-H PRINT program for 3D bioprinted organs and CIRM Industry Alliance Program for regenerative medicine support.
Differentiator
Problem solved
Functional benefit
Brands
- nAb (Nanoantibodies): Single-domain VHH antibodies derived from camelidae (camels, llamas, alpacas) used for research tools and applications including immunoprecipitation, ChIP-CHIP assays, and protein interaction studies.
- Allele Reagents
- Orbigen
- EcoCulture
- Sapphire
- Gryphon
- IceCube
- HiTiter
- Ampicon
- AllHPLC
Products and services
- cGMP iPSC Lines Clinically compliant induced pluripotent stem cell (iPSC) lines and banks offering long-term safety and performance stability, sold to pharmaceutical partners and academic institutions for use in cell therapy development and research.
- cGMP iPSC Manufacturing Service Contract cGMP-compliant iPSC expansion and manufacturing services supporting cell therapy programs from clinical preparation through scalable production using ISO7-certified cleanroom infrastructure; production scales from millions to billions of cells.
- cGMP iPSC Single Cell Cloning Service
Quantifiable outcome
- Superior reprogramming efficiency and iPSC performance in large-scale processing compared to industry partners
- +2 more outcomes
Companies that use Allele Biotech
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles2 records
Allele Biotech technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Allele Biotech partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and minor.
- UC San DiegocoreAllele Biotechnology partnered with UC San Diego on a $25.8 million ARPA-H PRINT program award to develop patient-specific, 3D bioprinted livers for transplantation. Allele serves as the manufacturing partner, producing iPSCs using its patented mRNA reprogramming method and generating liver-specific cell types in quantities reaching tens of billions per organ. The five-year project aims to eliminate donor organ shortages and immunosuppression requirements.
- California Institute for Regenerative Medicine (CIRM)coreAllele serves as an Industry Resource Partner (IRP) under CIRM's Industry Alliance Program, providing CIRM grantees priority access to Allele's mRNA reprogrammed cGMP iPSC lines, mRNA technologies for reprogramming, differentiation, gene editing, and end-to-end cell therapy CDMO services at discounted rates.
- Chromotek (Distribution Partnership)minorInitial distribution partnership to introduce GFP-trap and other VHH products to the US market through Chromotek distribution network. This early partnership helped establish Allele's nanoantibody products in the research market.
Scale indicators6 records
Recent moves6 records
Expansion highlights5 records
Allele Biotech competitors and assessment
Company assessmentDirect peers
- Fujifilm Cellular Dynamics: Commercial iPSC manufacturer offering iPSC lines, differentiated cell products, and iPSC-derived CDMO services. Direct competitor to Allele in off-the-shelf GMP iPSCs and custom iPSC development, with a similar business model spanning research-grade catalog and clinical-grade manufacturing.
- REPROCELL: Japan-based provider of iPSC-derived products and services including research-grade iPSCs, differentiation kits, and CDMO services. Directly comparable to Allele's reagent and iPSC product business with similar catalog offerings for stem cell researchers.
- Axol Bioscience: UK-based provider of iPSC-derived cell products including neurons, cardiomyocytes, and hepatocytes for research applications. Directly comparable to Allele's research reagent business in differentiated iPSC-derived cell products for academic and commercial researchers.
Broad incumbents
- Lonza Cell & Gene Technologies: Global CDMO with expanding cell and gene therapy manufacturing services, including iPSC and allogeneic cell therapy capabilities. Competes with Allele for large enterprise CDMO contracts, though Allele is specialized in iPSC while Lonza offers a broader biologics and cell therapy portfolio.
- Catalent (cell therapy): Large CDMO with established cell therapy manufacturing facilities and iPSC-adjacent capabilities serving pharma and biotech clients. Overlaps with Allele in providing GMP manufacturing services to cell therapy developers, though Catalent's portfolio spans many modalities beyond iPSC.
- Thermo Fisher Scientific (Cell Therapy Services): Major life sciences tools and CDMO player offering cell therapy development and manufacturing services through its Pharma Services segment. Competes with Allele in supporting cell therapy developers with manufacturing scale-up and GMP production capabilities.
Emerging players
- Century Therapeutics: Clinical-stage cell therapy developer using iPSC-derived allogeneic therapies, particularly in oncology. Could become both a peer (as iPSC technology developer) and a potential customer of Allele's CDMO services for clinical manufacturing of iPSC-derived cell products.
- Fate Therapeutics: Clinical-stage iPSC-derived cell therapy developer focused on immuno-oncology. Overlaps with Allele's therapeutic areas of focus and represents both a peer in iPSC technology and a potential CDMO client for clinical-grade iPSC manufacturing.
- bit.bio: UK-based synthetic biology company developing iPSC-derived cell products using proprietary transcription factor-based reprogramming. Comparable technology stack (mRNA/RNA-based reprogramming) and similar focus on providing iPSC-derived cells for research and therapeutic applications.
- CellGenix: Manufacturer of GMP-grade raw materials and cell processing reagents for cell and gene therapy manufacturing. Adjacent peer serving overlapping customers (cell therapy developers) with complementary rather than directly competing products.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Allele Biotech social profiles
Digital presenceAllele Biotech compliance and trust
Trust signalCompliance3 records
Allele Biotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
Allele Biotech leadership team
Management profileNumber of profiles
Profiles2 records
Allele Biotech funding detail
Funding detailFunding overview
Funding rounds3 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Allele Biotech M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Allele Biotech
What does Allele Biotech do?
Allele Biotechnology and Pharmaceuticals operates an all-in-one iPSC-focused platform providing clinical-grade iPSC lines, mRNA-based reprogramming and differentiation technologies, and contract development and manufacturing (CDMO) services for cell therapy developers. The company manufactures GMP-compliant iPSCs and derived cell products in its purpose-built cGMP facility and supplies research reagents (nanoantibodies, fluorescent proteins, mRNA products) to academic and commercial laboratories worldwide.
Is Allele Biotech a public or private company?
Allele Biotech is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Allele Biotech founded?
Allele Biotech was founded in 1999. It employs 11 to 50 people.
Where is Allele Biotech based?
Allele Biotech is headquartered in San Diego, United States, in the North America region.
How does Allele Biotech make money?
Five revenue lines are on record. CDMO Services are the primary driver. The others are GMP iPSC Products, research Reagents, fluorescent Protein Licensing and technology Licensing.
Who are Allele Biotech's main competitors?
Direct peers on record are Fujifilm Cellular Dynamics, REPROCELL and Axol Bioscience. Broad incumbents are Lonza Cell & Gene Technologies, Catalent (cell therapy) and Thermo Fisher Scientific (Cell Therapy Services). Emerging players are Century Therapeutics, Fate Therapeutics, bit.bio and CellGenix.
Does Allele Biotech have an API?
No public API is recorded for Allele Biotech.
What industry is Allele Biotech in?
Allele Biotech's product category is Cell Therapy CDMO & iPSC Manufacturing. Its primary akta.pro industry code is HLAGAGAA, Cell Therapy CDMO (Autologous/Allogeneic Manufacturing), with a secondary code of HLAGABAF, mRNA/LNP & Nucleic Acid Therapeutics CDMO. Its NAICS code is 325414 and its SIC code is 2834.