ARL Bio Pharma

What ARL Bio Pharma does

ARL Bio Pharma, Inc. is a privately held pharmaceutical testing laboratory founded in 1994 and headquartered at 840 Research Parkway, Oklahoma City, with 51-100 employees. The company provides cGMP-compliant analytical, microbiology, raw material, and forensics testing services to compounding pharmacies and 503B outsourcing facilities across the United States. Its service catalog spans potency and dissolution testing, sterility and bacterial endotoxin testing, environmental monitoring, container closure integrity testing, microbial identification, particulate matter analysis, stability and beyond-use-date studies, and drug diversion forensics. The firm holds ISO 17025:2017 laboratory accreditation and operates a pharmaceutical-grade cleanroom for sterility testing.

The laboratory's technology base combines established analytical chemistry instrumentation (HPLC, UHPLC), compendial microbiology methods aligned with USP chapters <71>, <85>, <1207>, and a licensed rapid sterility platform from Charles River (Celsis ATP detection system) that compresses sterility turnaround from the traditional 14-18 days to 6 days. A proprietary Potency Drug Database indexes over 1,800 active pharmaceutical ingredients available for testing. The company has extended its scope through a wholly-owned subsidiary, ARL Biologics (arlbiologics.com), which provides biologics drug product development and commercialization services.

ARL operates a fee-for-service, quote-based revenue model with no subscription component. Customers submit samples via the ARL client portal (portal.arlok.com), with Certificates of Analysis delivered for regulatory release. Go-to-market is sales-led and consultative, combining direct phone/email engagement, a content-rich Education Center, industry conference participation (ASHP, AAPS PharmSci 360, ACA, ACVP, Premier Breakthroughs, Compounders on Capitol Hill), and SEO-optimized service pages. The company does not publish pricing, has no disclosed external funding, and appears to be founder/management-owned. Leadership includes Thomas Kupiec (CEO, President & Director) and David Baer (CFO).

Name

ARL Bio Pharma

Legal name

ARL Bio Pharma, Inc.

Website

https://arlok.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

51–100 employees

Short description

ARL Bio Pharma is an ISO 17025:2017-accredited Oklahoma City-based pharmaceutical testing laboratory founded in 1994, serving compounding pharmacies and 503B outsourcing facilities with analytical, microbiology, raw material, and forensics testing services, plus a biologics development subsidiary.

Ownership category

akta.pro rank

Product category

Pharmaceutical Testing Services

NAICS

Testing Laboratories and Services (541380), Medical Laboratories (621511)

SIC

Services-Testing Laboratories (8734), Services-Medical Laboratories (8071)

akta.pro primary industry

Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE)

akta.pro secondary industries

Small-Molecule Analytical Development & Method Validation (CMC) (HLAGAHAF), Elemental Impurities & Trace Metals (ICP-MS) (HLAGADAJ)

Keywords

• Pharmaceutical analytical testing
• Microbiology laboratory services
• Sterility testing laboratory
• Compounding pharmacy testing
• Raw material qualification

Headquarters

HQ city

Oklahoma City

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Pharmaceutical Analytical Testing Services: ARL generates revenue through fee-for-service laboratory testing across analytical, microbiology, raw material, and forensics categories. Customers submit samples through the ARL portal and receive results (Certificates of Analysis) for regulatory compliance and product release. Testing is performed on a per-sample or per-test basis with no subscription component.
2. Education and Consulting Services: ARL provides educational resources including articles, webinars, and an education center covering testing methodologies, regulatory requirements, and best practices for pharmaceutical compounding. This content supports customer acquisition and retention in the B2B testing services model.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

ARL Bio Pharma is an ISO 17025:2017 accredited contract testing laboratory that performs analytical, microbiological, raw material, and forensic testing on compounded and outsourced pharmaceutical preparations. The firm delivers fee-for-service USP- and FDA-compliant testing — including sterility, endotoxin, potency, environmental monitoring, container closure integrity, and method suitability — to compounding pharmacies and 503B outsourcing facilities.

Product overview

ARL Bio Pharma is a drug product and biologics testing laboratory offering four core testing services: Analytical Testing (evaluating chemical and physical properties of APIs), Microbiology Testing (detecting and quantifying microorganisms), Raw Material Testing (qualifying drug substances and excipients to pharmacopeia specifications), and Forensics Testing (identifying drugs and contaminants for legal cases). The company operates ARL Biologics as a specialized sub-brand for biologics drug development. Additional offerings include potency testing with a searchable database of 1,800+ APIs, sterility testing (traditional and rapid via Celsis), endotoxin testing, environmental monitoring, container closure integrity testing, USP 71 method suitability validation, microbial identification, particulate matter testing, disinfectant cleaning challenge studies, USP 800 surface wipe sampling, and stability/beyond-use date studies. The company is ISO 17025:2017 accredited and partners with Charles River for Celsis rapid sterility technology.

Differentiator

Problem solved

Functional benefit

Products and services

• Analytical Testing Comprehensive analytical testing to evaluate the chemical and physical properties of active pharmaceutical ingredients (APIs), including potency, dissolution, stability, photostability, HPLC analysis, particulate matter, and TOC. Used by compounding pharmacies and outsourcing facilities for USP compliance and product release.
• Microbiology Testing Comprehensive microbiology testing that detects, identifies, and quantifies microorganisms, including sterility testing (USP <71>), endotoxin testing (USP <85>), environmental monitoring, microbial identification, and antimicrobial effectiveness testing. Used by compounding pharmacies and outsourcing facilities for sterility assurance and USP compliance.
• Raw Material Testing Qualification of drug substances, excipients, and drug products to meet pharmacopeia specifications, including identity testing, compendial testing, atomic absorption, and API vendor qualification. Used by compounding pharmacies and outsourcing facilities to qualify raw material suppliers and meet USP requirements.
• Forensics Testing Testing to identify and quantify drugs, adulterants, and contaminants in samples for legal cases, including drug diversion investigations with chain of custody documentation. Used by pharmacies, legal counsel, and regulators responding to suspected drug diversion or contamination incidents.
• ARL Biologics Specialized drug product development and commercialization services for biologics, operated as a separate division under the ARL corporate umbrella at arlbiologics.com.
• Rapid Sterility Testing (Celsis) Rapid sterility testing using the Charles River Celsis system, an alternative to USP <71> that delivers sterility results in 6 days instead of 14–18 days through ATP fluorescence detection. Used by compounding pharmacies and outsourcing facilities for faster batch release.
• Container Closure Integrity Testing (CCIT) USP <1207> compliant container closure integrity testing for IV bags, syringes, cassettes, and vials using both probabilistic (dye ingress) and deterministic (vacuum decay) methods, with vacuum decay sensitivity down to 5 microns. Detects microorganism entry, product leakage, and gas leaks non-destructively.
• USP 71 Method Suitability Testing Formulation-specific sterility test method validation demonstrating a method's capability to detect viable microorganisms in a specific pharmaceutical formulation, using six compendial challenge microorganisms and either closed membrane filtration or direct inoculation methods.
• Environmental Monitoring (EM) Services Incubation and enumeration testing for environmental monitoring samples, growth promotion testing of media, and microbial identification to support environmental monitoring programs for compounding facilities under USP <797> and <1116>.
• Bacterial Endotoxin Testing (USP <85>) Testing for bacterial endotoxins using kinetic turbidimetric method following USP <85> procedures, performed with depyrogenated glassware, product-specific reagents, and standard/negative/positive controls for accurate endotoxin quantification.
• API Vendor Qualification Services Comprehensive testing, documentation review, and quality-focused expertise to support vendor qualification programs for compounding pharmacies and outsourcing facilities sourcing active pharmaceutical ingredients.
• Microbial Identification Services Identification of microbial contaminants for environmental monitoring isolates, raw material bioburden assessment, and OOS investigations to genus and species level, supporting root cause analysis and sterility assurance programs.
• Particulate Matter Testing (USP <788>/<789>) Testing for particulate matter in parenteral solutions using light obscuration (Method 1) or microscopic methods (Method 2) per USP <788> and <789>, with specifications for particles ≥10µm and ≥25µm.
• Microbial Disinfectant Cleaning Challenge Studies Use-dilution and surface challenge testing to demonstrate efficacy of cleaning agents and procedures, validating facility SOPs for removing microbial contamination from compounding surfaces.
• USP 800 Surface Wipe Sampling Test Environmental wipe sampling for hazardous drug surface residue verification per USP <800>, using TexWipe TX714K swabs and charged at $200 per swab per hazardous drug.
• Stability Studies and Beyond-Use Date Testing Stability-indicating method development and validation, including forced degradation studies and stability chambers for determining scientifically valid beyond-use dates for compounded preparations per USP <795> and <797>.

Quantifiable outcome

• Reduces sterility test turnaround from 14-18 days to 6 days
• +2 more outcomes

Named customers3 records

Segments1 record

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

One partnership is on record.

• Charles River (Celsis)coreTechnology or IntegrationARL Bio Pharma licenses and operates the Celsis rapid microbial detection system from Charles River for rapid sterility testing services. The Celsis system detects microbial Adenosine Triphosphate (ATP) to deliver sterility test results in 6 days compared to traditional 14-18 day USP <71> methods. ARL's validation strategy is based on USP <1223> and the Celsis system has been approved by regulatory agencies worldwide including the FDA. The partnership enables ARL to offer differentiated rapid sterility testing services to compounding pharmacies and outsourcing facilities.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Market position

Weaknesses5 records

Competitive moat5 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 ARL Bio Pharma