What BioAnalysis does

BioAnalysis LLC is a Philadelphia-based, privately held non-clinical contract research organization founded in 2017, employing 11-50 staff and operating under the leadership of Founder and President Lake Paul and Director of Quality Dorie Morgan. The firm provides experimentation and problem-solving analytical services for scientific experiments, with a specialization in Analytical Ultracentrifugation (AUC) for biopharmaceutical and gene therapy developers. Its commercial focus is narrow and vertical: it targets companies that require GMP-grade analytical characterization and quality control for gene therapies and biotherapeutics.

The company's core offering is BASIS 2.0, a next-generation, GMP-compliant software platform launched in March 2026 and designed to deliver higher throughput, one-click workflows, and full compliance with FDA 21 CFR Part 11 for electronic records and electronic signatures in GMP environments. BASIS 2.0 integrates with SEDFIT, the globally recognized AUC analysis engine, and is engineered to remove the Computer Software Validation burden from clients by providing a pre-validated analytical toolchain. The platform is positioned as the firm's primary technical differentiator and anchors its analytical services delivery model.

BioAnalysis monetizes BASIS 2.0 exclusively through its own analytical services division rather than as a standalone software license, bundling software, instrumentation, and regulatory-compliant execution into a professional services engagement sold via enterprise field sales to biopharmaceutical and gene therapy clients. Pricing is not publicly disclosed, and the company has no recorded funding rounds, named enterprise customers, or disclosed revenue. Distribution is direct and global in scope but executed through the firm's own service delivery rather than third-party channels, with marketing primarily driven through industry press releases.

Name

BioAnalysis

Legal name

BioAnalysis LLC

Website

https://bioanalysisllc.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

BioAnalysis LLC is a Philadelphia-based non-clinical CRO offering Analytical Ultracentrifugation services bundled with its proprietary GMP-compliant BASIS 2.0 software, serving biopharmaceutical and gene therapy companies requiring FDA 21 CFR Part 11 compliant analytical characterization.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Analytical Software & Services

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD)

akta.pro secondary industry

Bioanalytical Testing (PK/ADA/NAb) (HLAGADAA)

Keywords

• Analytical ultracentrifugation
• GMP-compliant software
• Biopharmaceutical analytical services
• Gene therapy characterization
• FDA 21 CFR Part 11

Headquarters

HQ city

Philadelphia

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Analytical Services (Software-Enabled): BASIS 2.0 is available exclusively through BioAnalysis's analytical services, suggesting the company generates revenue by providing analytical testing services that leverage their proprietary GMP-compliant software. This bundled model eliminates the need for clients to perform their own Computer Software Validation.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

BioAnalysis provides analytical ultracentrifugation (AUC) services for gene therapy and biotherapeutics developers, delivered through its proprietary GMP-compliant software platform BASIS 2.0. The platform enables higher-throughput analytical cycles with one-click workflows and full FDA 21 CFR Part 11 compliance, eliminating the need for clients to perform their own Computer Software Validation. BASIS 2.0 is available exclusively through BioAnalysis's in-house analytical services division.

Product overview

BioAnalysis provides analytical services centered around its BASIS 2.0 software platform for Analytical Ultracentrifugation (AUC). BASIS 2.0 is a GMP-compliant solution designed for gene therapy and biotherapeutics development, offering higher throughput and one-click workflows with full regulatory compliance.

Differentiator

Problem solved

Functional benefit

Brands

• BASIS 2.0: Next-generation GMP-compliant software platform for Analytical Ultracentrifugation (AUC) designed for gene therapy and biotherapeutics development, offering higher throughput, one-click workflows, and full regulatory compliance with FDA 21 CFR Part 11 requirements.

Products and services

• BASIS 2.0

Quantifiable outcome

• Eliminates client-side Computer Software Validation burden

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature1 record

Partnerships

One partnership is on record.

• SEDFITcoreTechnology or IntegrationBASIS 2.0 integrates with SEDFIT, the globally recognized AUC analysis engine. This integration provides access to established analytical algorithms and methodologies for analytical ultracentrifugation analysis, ensuring compatibility with industry-standard analysis approaches.

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• Labcorp Drug Development (Fortrea): Fortrea (formerly Labcorp Drug Development) is a major CRO with bioanalytical and biologics characterization capabilities supporting gene therapy sponsors. It is comparable to BioAnalysis because both deliver regulated analytical testing services to biopharma clients, though Fortrea operates across the full clinical and non-clinical spectrum.
• Malvern Panalytical: Malvern Panalytical (part of Spectris) supplies analytical instruments and software for particle characterization, including technologies used alongside AUC for biologics. It is comparable to BioAnalysis because both target biologics QC workflows with software-led analytical solutions.
• Intertek Pharmaceutical Services: Intertek provides GMP analytical testing and biologics characterization services for the pharmaceutical industry. It is comparable to BioAnalysis because both offer analytical services supporting biopharma QC and release testing, though Intertek serves a broader testing portfolio beyond AUC.
• Eurofins Scientific: Eurofins BioPharma Product Testing provides GMP-compliant analytical and bioanalytical services for biologics, including gene therapies. It is comparable to BioAnalysis because both offer outsourced characterization and QC testing for biopharmaceutical manufacturers, with Eurofins operating globally and at much larger scale.
• PPD / Thermo Fisher Scientific (PPD): Thermo Fisher (via PPD) offers bioanalytical and biologics characterization services for pharmaceutical and gene therapy sponsors. It is comparable to BioAnalysis because both deliver regulated analytical services to biopharma, though Thermo Fisher operates at massive global scale.
• Wyatt Technology: Wyatt Technology is a leading manufacturer of light scattering and AUC instruments and also offers related analytical services for biopharma. It is comparable to BioAnalysis because both serve the biologics characterization and AUC-adjacent QC market, though Wyatt is instrument-centric while BioAnalysis focuses on software-enabled services.
• Beckman Coulter Life Sciences: Beckman Coulter (part of Danaher) manufactures the Optima AUC instruments that are industry standard and supports biopharma characterization workflows. It is comparable to BioAnalysis because its instruments underpin the same AUC workflows BioAnalysis services, making it a potential OEM partner or competitor in software.
• Charles River Laboratories: Charles River is a large non-clinical CRO offering bioanalytical, biologics characterization, and cell/gene therapy services. It is comparable to BioAnalysis because both serve biopharma clients needing GMP-compliant analytical testing for novel biologics, though Charles River operates at vastly greater scale.

Emerging players

• Sartorius BIA Separations: Sartorius offers analytical and purification technologies for biopharmaceutical development, including services and consumables for gene therapy analytics. It is comparable to BioAnalysis because both serve the biologics and gene therapy QC market with enabling analytical solutions.
• Cergentis: Cergentis provides specialized gene therapy analytics and characterization services, including targeted integration site analysis for cell and gene therapies. It is comparable to BioAnalysis because both are niche analytics providers serving the gene therapy/biologics market with specialized assays.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks4 records

Key highlights6 records

Customer concentration

• Xx.com/BioAnalysisLLC

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

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 BioAnalysis