What Prodo Laboratories does

Prodo Laboratories, Inc. is a privately held, Delaware-incorporated diabetes biotechnology and services company founded in 2006 by Dr. David Scharp and headquartered in Aliso Viejo, California (relocated from an Irvine R&D facility in January 2016). The company processes and supplies high-quality human and animal islets to the diabetes research community, serving biotechnology and pharmaceutical companies for in vitro and in vivo drug development, as well as academic and government-funded investigators (JDRF, NIH/NIDDK). Human research pancreases are sourced through contracts with Organ Procurement Organizations from UNOS-listed cadaver donors refused for primary transplantation, with the company demonstrating the ability to process highly purified islets (85–90% purity, ~95% viability) even from donors with extended cold ischemia times (~14 hours average).

The company's core technology is its proprietary cGMP Prodo Islet Media (PIM®) product line, developed specifically for islet recovery, culture, and transport: PIM(R)® for the first 48 hours of recovery, PIM(S)® for long-term culture (2–21 days), and PIM(T)® for cold storage/shipping (3–4 days), supported by required supplements PIM(ABS)® (Human AB Serum), PIM(G)® (Glutamine/Glutathione), and PIM(3X)® (triple antibiotic mixture), available individually or bundled as PIM Complete. The media carries an FDA Biological Master File (IND-15016) granted in March 2012 and has been shown to outperform CRML-based media in University of Pittsburgh testing.

Prodo monetizes through multiple streams: transaction-based Human Islets for Research (HIR) service contracts (Preferred Recipients receive monthly volumes at lower pricing and higher priority; Ad Hoc Recipients order as-needed), sale of proprietary cGMP PIM media products, contract research services (assays, human and animal islet processing, and Scharp consulting), and the Islet Testing Authority (ITA) certification service operated through the affiliated Scharp-Lacy Research Institute. Go-to-market is sales-led via direct corporate contracts and academic distribution through Scharp-Lacy (JDRF, NIDDK IIDP, where Prodo is the sole corporate laboratory partner), with international reach through distributors in Japan (Eolas Biosciences) and Europe (Tebubio, Tissue Solutions). The company employs 11–50 people and has been funded via a $300,000 SBA loan (2007) and NIH/SBIR and QTDG grants rather than venture capital.

Name

Prodo Laboratories

Legal name

Prodo Laboratories, Inc.

Website

https://prodolabs.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Prodo Laboratories is a diabetes biotechnology service company supplying high-quality human and animal islets and proprietary cGMP islet culture media (PIM®) to biotechnology, pharmaceutical, academic, and government-funded diabetes researchers for drug development and transplantation research.

Ownership category

akta.pro rank

Product category

Diabetes Research Services & Islet Supply

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Proteomics & Mass Spectrometry Services (HLAGANAB)

Keywords

• Human islets supply
• Islet culture media
• Diabetes research services
• CGMP media products
• Animal islet isolation

Headquarters

HQ city

Aliso Viejo

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Human Islets for Research (HIR): Direct service business providing high quality human islets to biotechnology and pharmaceutical companies for in vitro and in vivo testing in diabetes drug development. Also provides human islets from Type 2 diabetes donors. Islets held on tissue culture for 2-3 days for quality assurance before shipping.
2. cGMP Prodo Islet Media Products: Sale of proprietary cGMP islet culture media (PIM(R), PIM(S), PIM(T)) and supplements. Products available individually or as simplified PIM Complete bundles.
3. Contract Research Services: Assays, islet processing, and consulting services. Includes human islet processing, animal islet processing (porcine, rat), and Scharp Consulting.
4. Islet Testing Authority (ITA): Testing and certification service for tissue culture media, factors, reagents, pancreas processing solutions, enzymes, and reagents. Division of Scharp-Lacy Research Institute.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

Prodo Laboratories operates a service business providing high-quality human pancreatic islets (including normal and Type 2 diabetes donor islets) to biotechnology and pharmaceutical companies for in vitro and in vivo diabetes drug development testing, and to academic and government-funded researchers for diabetes research. It also produces and sells a proprietary cGMP islet culture media product line (Prodo Islet Media / PIM®) — including recovery, standard culture, and transport media plus required supplements — used by islet researchers globally.

Product overview

Prodo Laboratories is a biotechnology company providing a comprehensive portfolio of products and services for the diabetes research community. The core offering consists of the proprietary cGMP Prodo Islet Media (PIM®) product line, which includes three specialized media formulations—PIM(R)® for recovery, PIM(S)® for standard long-term culture, and PIM(T)® for transport/cold storage—along with required supplements PIM(ABS)® (Human AB Serum), PIM(G)® (Glutamine/Glutathione), and PIM(3X)® (Triple Antibiotics), available individually or as the combined PIM Complete solution. The company also provides Human Islets for Research (HIR) as its primary service, Animal Islets for Research (AIR) including rodent and porcine preparations, and the Islet Testing Authority (ITA) certification service for testing biological reagents on human islets. Contract research services and scientific consulting from Dr. David Scharp complement the product portfolio.

Differentiator

Problem solved

Functional benefit

Brands

• Prodo Islet Media (PIM): cGMP islet media product line including PIM(R) for recovery, PIM(S) for standard culture, and PIM(T) for transport.
• Human Islets for Research (HIR)
• Animal Islets for Research (AIR)
• Islet Testing Authority (ITA)

Products and services

• PIM(R)® — Islet Recovery Medium Islet-specific recovery medium manufactured under cGMP conditions, designed for the first 48 hours of tissue culture at 37°C to accelerate recovery of islets following processing and purification. Demonstrates rapid rounding up with increased glucose responsiveness, insulin content, and suitability for implantation. Contains 5.8 mM glucose and no animal proteins or growth factors. For diabetes researchers using Prodo Labs' islet supply or third-party islets.
• PIM(S)® — Standard Culture Medium Islet-specific standard culture medium manufactured under cGMP conditions for long-term tissue culture of islets from 2 to 21 days at 37°C. Enhanced with specific components that maintain glucose responsiveness, insulin content, and suitability for implantation. Contains 5.8 mM glucose and 5% Human AB Serum, with no animal proteins or growth factors. For diabetes researchers requiring extended islet culture.
• PIM(T)® — Transport Medium Proprietary islet medium manufactured under cGMP for cold storage of isolated islets, permitting both short and long-term islet shipping and storage. Provides 3-4 days of cold storage without loss of islet compactness and supports long-term cold tissue culture for approximately 3 weeks. Islets can be directly transferred to tissue culture incubator at 37°C without media removal. For researchers needing to ship or store islets.
• PIM(ABS)® — Human AB Serum Supplement Required cGMP additive for PIM(R), PIM(S), and PIM(T) islet-specific tissue culture media. Human AB serum collected, screened, and frozen until cGMP manufacturing, including heat inactivation and sterile filtration. All lots screened for compatibility with human islets prior to release. For diabetes researchers using PIM media.
• PIM(G)® — Glutamine/Glutathione Supplement Required cGMP additive for PIM(R), PIM(S), and PIM(T) islet-specific tissue culture media. Shipped separately as a frozen component to permit extended shelf life. For diabetes researchers using PIM media.
• PIM(3X)® — Triple Antibiotic Supplement cGMP triple antibiotic mixture required to supplement PIM(R), PIM(S), and PIM(T) for islet culture. Shipped separately as a frozen component to permit extended shelf life. For diabetes researchers using PIM media requiring contamination control.
• PIM Complete Simplified ordering solution combining base medium (PIM(R)® for Recovery, PIM(S)® for Standard, or PIM(T)® for Transport) and all required supplements (PIM(ABS)® Human AB Serum, PIM(G)® Glutamine/Glutathione, PIM(3X)® Triple Antibiotics) under a single catalog number. For diabetes researchers purchasing the full PIM media system.
• Human Islets for Research (HIR) Primary service business providing high quality human islets to biotechnology and pharmaceutical companies for in vitro and in vivo testing in diabetes drug development, and to academic and government-funded researchers for diabetes research. Islets sourced from cadaver organ donors with documented informed consent, processed to documented purity of 85-90% and viability of 95%. Includes Type 2 diabetes donor islets (added October 2010). Islets held on tissue culture for 2-3 days for quality assurance before shipping. Available as Preferred Recipient (monthly specified amounts, lower pricing, higher priority) or Ad Hoc Recipient (as-needed) arrangements.
• Animal Islets for Research (AIR)

Quantifiable outcome

• Purity averaging 85-90% and viability averaging 95% for shipped human islets
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Eolas Biosciences Co., Ltd.coreChannel Partner/ Reseller/ DistributorExclusive distributor for Prodo Labs products (islets and media) in Japan. Located at 2-21-18 Kita-Matsudo, Matsudo-shi, Chiba Prefecture 271-0063, Japan. Contact: TEL: +81-47-308-2204, FAX: +81-47-308-2104, www.eolas-bio.co.jp
• Tebubio (Europe)coreChannel Partner/ Reseller/ DistributorMulti-country European distributor network covering Belgium, Luxembourg, France, Germany, Austria, Switzerland, Italy, Netherlands, Portugal, Spain, UK, Ireland, and Rest of Europe. Offices include Tebubio Belgium & Luxembourg (Lier), Tebubio Sas-France (Le Perray En Yvelines), Tebubio Germany/Austria/Switzerland (Offenbach), Tebubio Italy (Magenta), Tebubio Netherlands (Heerhugowaard), Tebubio Portugal (Lisboa), Tebubio Spain (Barcelona), Tebubio UK & Ireland (Peterborough).
• Tissue Solutions, Ltd.minorChannel Partner/ Reseller/ DistributorUK-based distributor for Prodo Labs products. Located at Suite 1.2 First Floor, Fleming Pavilion, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA. Tel: +44 (0)141 299 0055.
• Scharp-Lacy Research Institute (SLRI)coreStrategic or Co-development PartnerCollaborative partnership where SLRI handles academic distribution of human islets to JDRF and NIDDK funded researchers. SLRI's Islet Testing Authority (ITA) division provides testing and certification services for tissue culture media, reagents, and processing solutions. Formerly known as Invenio Institute; name changed in June 2008 to honor Paul Lacy and David Scharp's collaborative research history.
• National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK)coreStrategic or Co-development PartnerPartnership through Interactive Islet Distribution Program (IIDP). Prodo Labs is the only corporate laboratory partner, collaborating with SLRI to supply human islets to NIDDK funded diabetes investigators.
• Juvenile Diabetes Research Foundation (JDRF)coreStrategic or Co-development PartnerJDRF contracted with Invenio Institute (now SLRI) to distribute human islets to JDRF funded investigators. Prodo Labs processes the human islets for this distribution program. Distributed 5 million human islets during first contract in 2007.
• Organ Procurement Organizations (OPOs)coreOthersContracts with specific Organ Procurement Organizations to deliver human research pancreases from UNOS listed cadaver organ donors refused for primary transplantation. Required criteria include freedom from specific diseases, appropriate blood test and drug screen results.
• Washington University School of MedicineminorStrategic or Co-development PartnerDr. Scharp trained and worked at Washington University for nearly 30 years. Collaborative studies with late Paul E. Lacy pioneered early progress in islet transplantation. Company founders maintain academic research connections.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• Sernova Corp: Develops Cell Pouch System for islet transplantation in Type 1 diabetes. Adjacent player in diabetes cell therapy research that uses human islets for preclinical testing, creating indirect customer relationship with Prodo Labs' islet supply service.
• ViaCyte: Develops stem cell-derived islet cell replacement therapies for Type 1 diabetes. While not a direct service competitor, ViaCyte's stem cell-derived beta cells represent a future alternative to cadaver-derived human islets that Prodo Labs supplies for research.
• Beta-O2 Technologies: Develops encapsulated pancreatic beta cell implants (βAir) for Type 1 diabetes treatment. Operates in the diabetes cell therapy space that intersects with Prodo Labs' human islet research services and shares the same end-research customer base.

Broad incumbents

• Thermo Fisher Scientific: Major life science tools company producing cell culture media, reagents, and laboratory consumables through brands like Gibco. Overlaps with Prodo Labs' media product line but serves far broader research markets with greater resources and distribution scale.
• Lonza Group: Global leader in cell and gene therapy manufacturing services and cell culture media production. Comparable to Prodo Labs as a broad incumbent providing cell-based services and biological products to pharma/biotech, though Lonza operates across many therapeutic areas rather than specializing in islets.
• Merck KGaA (Sigma-Aldrich): Global life science tools giant producing cell culture media, reagents, and laboratory consumables. Competes broadly with Prodo Labs' media products while serving vastly larger and more diversified research customer base.

Direct peers

• PromoCell: Provides primary human cells, animal cells, and specialized cell culture media for research applications. Direct peer offering comparable cell-based products and culture media to diabetes and broader biomedical research markets.
• STEMCELL Technologies: Specializes in cell culture media, primary cells, and tissue-specific reagents for life science research. Direct peer to Prodo Labs' islet media business with comparable specialized cell biology products serving research customers.
• CellGenix: Manufactures cell culture media, cytokines, and reagents for cell and gene therapy applications. Comparable to Prodo Labs' cGMP media manufacturing with focus on regulated cell therapy markets and pharmaceutical customers.
• Discovery Life Sciences: Provides human biospecimens, including tissues and cells, for biomedical research and drug development. Direct peer offering comparable human tissue procurement, processing, and distribution services to pharma/biotech customers similar to Prodo Labs' islet supply business.

Market position

Strengths5 records

Weaknesses2 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 Prodo Laboratories