bioX

What bioX does

bioX is a privately held, integrated biotech engineering, analytical testing, and early-phase CDMO solutions provider founded in 2019 and headquartered in Salem, New Hampshire (Greater Boston Area). The company serves biotech and pharmaceutical developers — spanning cell and gene therapies (CGT), mRNA/siRNA/tRNA, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), exosome therapeutics, microbiome products, ATMPs, and single-use technology (SUT) suppliers — with a vertically segmented go-to-market. Its stated core technology centers on Single-Use Technology consulting and a 14,000 sq/ft ISO-7 applications lab that supports pilot-scale manufacturing feasibility testing, comparison testing of unit operations (mixing, cell harvest, transfection/transduction, filtration, bioreactor, chromatography), and a comprehensive USP/ASTM/ISO testing suite including USP <1207> container closure, USP <665> forced extraction, USP <85> endotoxin, USP <61>/<62>/<71> bioburden, USP <788> particulate, MTBF and spallation testing, and mixing characterization.

The company's product portfolio comprises eight integrated service lines: Bio-Process Engineering and Consulting, Early Phase CDMO Services, Pilot Scale and Applications Lab, Quality Engineering and Consulting (CQV, validation, qualification), Strategic BioEngineering (owner's project management, master planning, Industry 4.0 initiatives), Manufacturing Process Improvement, Automation Strategy Development, and Consulting and Training. BioX operates under a 21CFR Part 11 and ISO 9001:2015 compliant quality management system, which qualifies it for cGMP-related regulatory submissions and PPQ support. The firm is founder-led: Mark McElligott serves as Founder, Owner, and Principal Process Engineer.

bioX makes money through project-based professional services and managed services engagements, priced on a custom quote basis with multi-year contracts. Pricing is not publicly disclosed. The go-to-market is enterprise-focused, consultative field sales targeting biotech and pharma companies, with global service delivery claimed from the Salem, NH headquarters (primary market served is North America). Marketing relies primarily on the corporate website (bioxeng.com), an email newsletter subscription, and direct quote-based inquiry, with no disclosed partnerships, channel relationships, named customers, or completed funding rounds in the input data.

Name

bioX

Legal name

bioX

Website

https://bioxeng.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

bioX is a Salem, NH-based biotech engineering, analytical testing, and early-phase CDMO services provider serving developers of cell and gene therapies, mRNA, monoclonal antibodies, ADCs, exosomes, microbiome, and ATMPs, anchored by an ISO-7 applications lab and SUT consulting expertise.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Engineering & CDMO Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

akta.pro secondary industries

mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF), Cell Therapy CDMO (HLAGABAD), Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Bioprocess engineering services
• Analytical testing services
• Contract development manufacturing
• Single-use technology consulting
• Biopharma process development

Headquarters

HQ city

Salem

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Process Engineering and Consulting Services: Provides bio-process engineering, single-use technology consulting, quality engineering, and methods development/analytical testing services on a project basis. Revenue generated through consulting engagements, feasibility studies, and technical advisory services.
2. Early Phase CDMO Services: Contract development and manufacturing organization services including tech transfer from bench to pilot scale, process optimization, regulatory submission support, and agile manufacturing capabilities. Revenue generated through project-based manufacturing and development contracts.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

bioX delivers integrated Bio-Process Engineering, Analytical Testing, Process Development, and Early Phase Contract Development and Manufacturing Organization (CDMO) services for the biopharmaceutical industry. The company operates a proprietary 14,000 sq/ft ISO-7 Applications Lab that runs USP/ASTM/ISO product release, physical/mechanical, biological, and chemical testing, as well as pilot-scale manufacturing feasibility campaigns. Services span Cell Banking through DP (Drug Product) bottling for advanced therapy, RNA, monoclonal antibody, ADC, exosome, microbiome, and ATMP developers.

Product overview

bioX is a biotech engineering, analytical testing, and Contract Development and Manufacturing Organization (CDMO) solutions provider. The company offers a portfolio of integrated services including Bio-Process Engineering and Consulting, Early Phase CDMO Services, a Pilot Scale and Applications Lab, Quality Engineering and Consulting, Strategic BioEngineering Services, Manufacturing Process Improvement, Automation Strategy Development, and Consulting and Training. The services are designed to work together as a single-source solutions provider, enabling clients to move from analytical development and methods qualification through feasibility testing to detail design and early phase manufacturing.

Differentiator

Problem solved

Functional benefit

Products and services

• Bio-Process Engineering and Consulting Provides bio-process engineering, single-use technology program development, process and product development, bio-process applications testing, quality engineering, and methods development/analytical testing services for biotech and pharmaceutical clients.
• Early Phase CDMO Services Contract Development and Manufacturing Organization services including tech transfer from bench to pilot scale, 21CFR compliant QMS for MBR and MFG compliance, in-house equipment supporting multiple manufacturing modalities and analytical testing, process optimization, regulatory submission and PPQ support, and agile manufacturing capabilities. Has a proven track record from Cell Banking through DP bottling.
• Pilot Scale and Applications Lab A 14,000 sq/ft ISO-7 classified applications lab providing pilot scale manufacturing feasibility testing, comparison testing of similar unit operations, hold/stability testing, container closure testing, sterility program development, MTBF testing, spallation testing, mixing characterization, forced extraction, endotoxin testing, bioburden testing, particulate testing, and autoclave services.
• Quality Engineering and Consulting Provides commissioning, qualification and validation (CQV), quality plan and systems development, shipper and shipping qualification, equipment and automation qualification, validation master planning, and user requirement specifications development for biotech and pharma manufacturing operations.
• Strategic BioEngineering Services Provides owner's project management for capital project design and execution, project and process design lead/subject matter expertise, master planning for biotech and pharma, environmental sustainability planning, and Industry 4.0 strategic initiatives for digital transformation.
• Manufacturing Process Improvement Analyzes current manufacturing processes and identifies areas for improvement to increase efficiency and reduce costs for biopharma manufacturing clients.
• Automation Strategy Development Develops software solutions for embedded systems and control/automation systems to ensure product reliability and efficiency in biotech manufacturing operations.
• Consulting and Training Provides comprehensive consulting and training services for process and product design, manufacturing process improvement, and technology transfer to biopharma client teams.

Quantifiable outcome

• Reduced costs through agile manufacturing innovation
• +1 more outcomes

Segments8 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Others

• Cytiva: Danaher-owned bioprocess equipment and services supplier serving the same biotech manufacturing customers as bioX. An adjacent ecosystem participant rather than a direct CDMO competitor, but competes for SUT-related service and consulting budgets.

Direct peers

• Tunnell Consulting: Biopharma-focused management and process consulting firm serving similar biotech clients on process improvement, tech transfer, and operational strategy. Most direct comparable to bioX on the consulting/engineering side rather than the CDMO side.
• Forge Biologics: Gene therapy CDMO offering process development, analytical services, and cGMP manufacturing for AAV and other viral vectors. Closely comparable to bioX on cell/gene therapy focus and pilot-to-commercial pathway.
• Resilience: National Resilience is a technology-focused biomanufacturing company offering end-to-end process development, analytical, and clinical manufacturing services for biologics, vaccines, and advanced therapies — directly comparable to bioX's early-phase CDMO offering.
• Andelyn Biosciences: Specialist CDMO focused on cell and gene therapy development and manufacturing, including viral vectors and plasmid DNA. Overlaps with bioX's cell/gene therapy process development and early-phase CDMO services.
• Curia (formerly AMRI): Contract development and manufacturing organization providing process development, analytical services, and small- and large-molecule manufacturing — overlapping with bioX's analytical testing and pilot-scale capabilities.
• Center for Breakthrough Medicines: Specialized CGT and biologics CDMO offering process development, analytical testing, and manufacturing for cell, gene, and viral vector therapies. Directly comparable to bioX on integrated early-phase services.

Broad incumbents

• Catalent: Global CDMO with substantial early-phase development and clinical manufacturing capabilities across biologics and cell/gene therapy. BioX directly competes in pilot-scale and tech-transfer work but Catalent offers far greater scale, multi-site footprint, and late-phase capacity.
• Lonza: One of the world's largest CDMOs with deep biologics, cell, and gene therapy manufacturing capability. BioX competes at the early-phase / pilot-scale entry point; Lonza is the typical 'upstream' competitor clients eventually migrate to for commercial production.
• WuXi Biologics: Global biologics CDMO with end-to-end discovery, development, and manufacturing capabilities including mAb and recombinant protein services. Competes with bioX for early-phase work but operates at vastly larger scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bioxllc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 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 bioX