BioCytics

What BioCytics does

BioCytics, Inc. is a privately-held biotechnology company founded in 2005 by Dr. John Powderly and headquartered in Huntersville, North Carolina. It operates as a vertically integrated contract services platform that combines a Phase I clinical research clinic (operated through co-located Carolina BioOncology Institute), a high-complexity CLIA-certified clinical and translational laboratory, and a cGMP manufacturing facility within a single Huntersville site. The company serves biotech and pharmaceutical sponsors developing cellular immunotherapies, particularly for solid tumors, offering CRO services (early-phase trial feasibility, initiation, execution, regulatory submissions), CDMO services (process and assay development, cGMP manufacturing using ISO-7 cleanrooms and Miltenyi CliniMACS platforms), clinical lab diagnostics, translational analytical services, and a BioBank of matched tumor-immune cell pairs and other biospecimens from 700+ donors.

The company's core technology is the Autologous Adaptive Cell Therapy (AACT) platform, powered by its proprietary BioDICE technology, which enables point-of-care manufacturing of non-genetically modified effector cell fractions from a patient's own immune cells. Its lead therapeutic candidate is BioCytics Immune Fraction #1 (BCyIF-1), a tumor-infiltrating lymphocyte-based protocol targeting solid tumors, which completed an FDA INTERACT meeting in November 2025 and is targeted for first-in-human clinical trials in 2027. The company monetizes through quote-based contracts with biotech and pharma sponsors, with a thought-leadership-driven sales motion supported by Dr. Powderly's publication record and conference participation. BioCytics is clinically incubated by Carolina BioOncology Institute, with both organizations founded by Dr. Powderly and sharing the same facility. No external institutional funding, acquisitions, or public offering events are disclosed in the available data.

Name

BioCytics

Legal name

BioCytics, Inc.

Website

https://biocytics.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

BioCytics is a privately-held Huntersville, NC biotechnology company offering vertically integrated CRO, CDMO, clinical lab, and biobanking services to biotech and pharma sponsors developing cell therapies for solid tumors, anchored by its proprietary AACT platform and BioDICE technology.

Ownership category

akta.pro rank

Product category

Cell Therapy CDMO/CRO Services

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (62151), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Manufacturing Platforms & Automation (closed systems, bioreactors, fill-finish) (HLAAABAG)

akta.pro secondary industries

Cell Therapy Clinical Services & Treatment Centers (apheresis, administration, monitoring) (HLAAABAJ), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

Keywords

• Cell therapy manufacturing
• Contract research organization
• Contract development manufacturing
• Immuno-oncology services
• Biospecimen biobanking

Headquarters

HQ city

Huntersville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CRO Services: Contract Research Organization services providing end-to-end support for early phase cellular immunotherapy clinical trials including feasibility, initiation, execution, completion, clinical development planning, regulatory submissions, and biobanking for industry sponsors.
2. CDMO Manufacturing: Contract Development and Manufacturing services offering process development, assay development, and cGMP manufacturing for early Phase I cell and gene therapy products with point-of-care model enabling apheresis, cell processing, and patient infusion under one roof.
3. Clinical Lab Diagnostics: Clinical laboratory diagnostics including hematology, urinalysis, chemistry, and CellSearch circulating tumor cell enumeration services performed in high-complexity CLIA-certified laboratory.
4. BioBanking Services: Biobank services providing biospecimen storage and procurement including leukapheresis, PBMCs, tumor cells, matched pairs, whole blood, CTCs, and patient-derived organoids with clinical annotations for industry research use.
5. Translational Analytical Services: Translational analytical services including flow cytometry immune phenotyping, potency/cytotoxicity assays, phenotypic characterization, and biomarker analysis to support IND-enabling research.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

BioCytics provides B2B contract research, development, and manufacturing services for early-phase cellular immunotherapy programs, including CDMO (process and assay development, cGMP manufacturing), CRO (early-phase clinical trial execution), CLIA-certified laboratory diagnostics, translational analytical services, and a BioBank of matched tumor-immune cell biospecimens. The company also develops its own cell therapy pipeline, led by the BCyIF-1 candidate powered by its proprietary BioDICE point-of-care manufacturing and Autologous Adaptive Cell Therapy (AACT) platform, targeting solid tumors.

Product overview

BioCytics operates as an integrated biotechnology company offering a vertically unified platform combining multiple products and services. The core technology is BioDICE, powering their Autologous Adaptive Cell Therapy (AACT) platform for point-of-care manufacturing of non-genetically modified immune cell therapies for solid tumors. Their Human Applications Laboratory (HAL) serves as the manufacturing hub. They offer CDMO services (cGMP Manufacturing, Process and Assay Development), CRO services (Early Phase Clinical Trial Services, Clinical Trials at CBOI), Laboratory Services (Clinical Lab Diagnostics, Translational Analytical Services), and BioBank services (Biospecimen Sourcing). Their lead therapeutic candidate is BioCytics Immune Fraction #1 (BCyIF-1), currently in pre-clinical development with FDA INTERACT meeting completed for IND-enabling efforts targeting first-in-human trials in 2027.

Differentiator

Problem solved

Functional benefit

Products and services

• BioDICE BioDICE is BioCytics' proprietary technology platform that enables point-of-care manufacturing of autologous cell therapy products, powering the company's applications of living cells for personalized medicine and underpinning the AACT process.
• CDMO Contract Development and Manufacturing Services Contract Development and Manufacturing Organization services including cGMP manufacturing in ISO-7 cleanrooms using closed-system devices such as Miltenyi CliniMACS Plus and Prodigy and G-Rex for T cell therapy, plus process and assay development for IND-enabling activities in pre-clinical and early Phase I Cell and Gene Therapy products. Targeted at biotech and pharma sponsors developing cellular immunotherapies.
• CRO Early Phase Clinical Trial Services Contract Research Organization services for early phase cellular immunotherapy clinical trials, including feasibility, initiation, execution, and completion, clinical development planning, trial documentation, medical writing, regulatory submissions (FDA, IRB, IBC), pre-IND/IND consultations, and e-clinical data solutions. Specialized in Immuno-Oncology and Cell & Gene therapies for biotech and pharma sponsors.
• Laboratory Services (Clinical Lab Diagnostics and Translational Analytical) Professional laboratory services combining a CLIA-certified, COLA-accredited high-complexity clinical diagnostic laboratory (hematology, urinalysis, chemistry, CellSearch CTC enumeration) with RUO translational analytical services including flow cytometry, immunofluorescence, live cell imaging, cytotoxicity assays, and biomarker analysis to assess identity, purity, safety, and potency of pre-clinical biological products.
• BioBank Biospecimen Sourcing and Storage Professional biospecimen storage and procurement services under the IRB-approved BioCytics 0001 clinical trial, offering leukapheresis, PBMCs, tumor cells, tumor matched pairs, whole blood, CTCs, patient-derived tumor organoids, patient-derived tumor spheroids, and other biospecimens with clinical annotations for industry sponsors and academic research use.
• Human Applications Laboratory (HAL) BioCytics' dedicated Human Applications Laboratory facility staffed by PhDs, MDs, biomedical engineers, certified clinical research coordinators, cell processing technicians, and flow specialists, providing quality and informatics-driven services from patient consent through biospecimen procurement, storage, and GxP capabilities, and supporting the CDMO and CRO service offerings.
• Autologous Adaptive Cell Therapy (AACT) Pipeline BioCytics' portfolio of nonclinical cell therapy programs leveraging the intrinsic specificity of autologous immune cells, with manufacturing at the point of care and the lead candidate BioCytics Immune Fraction #1 (BCyIF-1) targeting first-in-human clinical trials in 2027.

Quantifiable outcome

• 140+ Phase I clinical studies initiated since founding
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• UNC CharlottecoreStrategic or Co-development Partner · 20 July 2026BioCytics is collaborating with UNC Charlotte (specifically Dr. Richard White III, Associate Professor) and Carolina BioOncology Institute on a project to study 'dark genome' of cancer cells. The dark genome refers to approximately 98% of the human genome that does not directly code for proteins. Goal is to identify viral and immune sequences involved in cancer progression and immune response to cancer. Dr. Renaud Warin, BioCytics Chief Scientific Officer, is leading the collaboration from BioCytics side.
• Carolina BioOncology Institute (CBOI)coreStrategic or Co-development PartnerCarolina BioOncology Institute is a co-located, clinically-incubated company that provides Phase I clinical trial facility for BioCytics. CBOI serves as the Southeast regional referral hub for metastatic cancer patients' access to Phase I clinical research trials. Both companies were founded by Dr. John Powderly in 2005 and share the Huntersville, NC facility. CBOI is an independent community-based cancer research clinic.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Lonza: Global CDMO leader with a large cell and gene therapy manufacturing services business. Comparable because it serves the same biotech sponsors seeking cGMP cell therapy manufacturing, though it operates at far greater scale and breadth than BioCytics.
• Catalent: Large diversified CDMO with a cell therapy services franchise (formerly Paragon). Comparable as a competing provider of early-phase cell therapy process development and cGMP manufacturing to biotech sponsors.
• WuXi Advanced Therapies: Cell and gene therapy CDMO arm of WuXi AppTec providing process development and cGMP manufacturing. Comparable as a scaled competitor in the early-phase cell therapy contract manufacturing market.
• Charles River Laboratories: Large CRO/CDMO with discovery, preclinical, and cell therapy manufacturing capabilities. Comparable as a competing early-phase sponsor services partner, especially in IND-enabling assay development and translational analytics.

Direct peers

• Iovance Biotherapeutics: Leader in autologous tumor-infiltrating lymphocyte (TIL) therapy for solid tumors, including the FDA-approved Amtagvi. Highly comparable because BioCytics' AACT platform and BCyIF-1 candidate also leverage autologous immune effector cells for solid tumor indications.
• Andelyn Biosciences: Specialty CDMO focused on cell and gene therapy cGMP manufacturing and process development. Comparable as a competing early-phase cell therapy CDMO offering process/assay development and cleanroom-based manufacturing to biotech sponsors.
• Akron Bio: Cell and gene therapy CDMO specializing in cGMP ancillary materials, process development, and contract manufacturing. Directly comparable to BioCytics' CDMO offerings around early-phase cell therapy manufacturing services.
• Precision for Medicine: CRO/CDMO with biorepository, cell banking, and translational lab services supporting cell therapy developers. Comparable to BioCytics' combined CRO/CDMO plus annotated biobank service offering.

Emerging players

• Adaptimmune: Clinical-stage cell therapy company developing engineered TCR-T cell therapies for solid tumors. Comparable to BioCytics' AACT efforts in targeting solid tumors with autologous immune cells, though Adaptimmune uses genetic engineering.
• Cellares: Cell therapy manufacturing automation company developing closed-system platforms for autologous cell therapy production. Comparable to BioCytics' BioDICE point-of-care manufacturing concept and cleanroom-based cell processing capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biocytics-inc.
• Facebookfacebook.com/biocytics

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds1 record

Investors1 record

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 BioCytics