Charter Medical

What Charter Medical does

Charter Medical, LLC is a privately held specialty manufacturer of single-use polymer-based bioprocessing and blood-management products, founded in 1991 and headquartered in Winston-Salem, North Carolina. The company operates as a wholly-owned subsidiary of Solesis, a strategic operating company focused on textile- and polymer-based healthcare solutions, alongside sister companies Polyzen (acquired by Solesis in November 2022), Secant Group, and SanaVita Medical.

Charter Medical's product portfolio spans cryopreservation bags, fluid transfer systems, cell expansion containers, filtration products, manifolds, and blood-banking disposables, with materials including polyolefins (PE, PP), PVC, TPE, EVA, and silicone. Its catalog includes branded lines such as CryoProtect Bio-Containers, Cell Freeze Cryogenic Storage Containers, Freeze-Pak Bio-Containers (with FP-FLEX tubing), EXP-Pak and CXP Cell Expansion Containers, Bio-Pak Small-Volume Bio-Containers, AccuStrain Filters, Advect Fluid Transfer Sets (FDA 510(k)-cleared and CE-marked), DEHP-free Fluid Transfer Bags, and a range of blood-management disposables (Aliquot Bag Systems, Blood Transfer Bags, Plasma Processing Bags, Platelet Sampling Sets, Neonatal Syringe Sets with 40µm and 150µm filters). Cryogenic performance is validated to -196°C for liquid-nitrogen applications. Manufacturing occurs in 16,000 square feet of ISO Class 7 and 8 cleanrooms, with an additional 1,200-square-foot Innovation Hub established in Winston-Salem's Innovation Quarter in March 2024 and expanded in 2026 via a BioNest grant.

The business model combines one-time catalog product sales (unit-based, case packs of 24–48 units) with professional services for custom design, rapid prototyping (custom manifolds in as little as six weeks), and Freezing Studies for cryogenic validation. Go-to-market is dual: direct sales by engineering and field teams for bioprocessing and cell therapy customers, and an exclusive three-distributor US network (Kentec Medical – West Coast, Med Alliance Group – Midwest, KOL Biomedical Instruments – East Coast) for blood transfusion products. Primary end markets are Cell & Gene Therapy Developers, Bioprocessing/Biopharmaceutical Manufacturers, and US Blood Banks/Transfusion Providers. The firm holds ISO 13485:2016 certification via NSAI and is FDA-registered under 21 CFR Part 820, with approximately 165 employees at the Winston-Salem location.

Name

Charter Medical

Legal name

Charter Medical, LLC

Website

https://chartermedical.com

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

51–100 employees

Short description

Charter Medical is a privately held, Solesis-owned manufacturer of single-use polymer-based bioprocessing and blood-management products, serving cell & gene therapy developers, biopharmaceutical manufacturers, and US blood banks via direct sales and an exclusive three-distributor network.

Ownership category

akta.pro rank

Product category

Single-Use Bioprocessing Medical Devices

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Cold Chain, Cryopreservation & Biologics Storage/Handling Technologies (HLAAAJAN)

akta.pro secondary industries

Sample Preparation, Storage & Cryogenics (Freezers, Cryovials, Cryostats) (HLAGAIAJ), Aseptic Processing, Fill-Finish & Sterile Manufacturing Tech (isolators, lyophilization interfaces) (HLAAAJAG), Medical & Pharmaceutical Thermoformed Packaging (IMANAHAB)

Keywords

• Single-use medical devices
• Bioprocessing consumables
• Cryopreservation containers
• Fluid transfer systems
• Blood management products

Headquarters

HQ city

Winston Salem

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Single-use Product Sales: Sale of standard single-use bioprocessing products including cryopreservation bags, fluid transfer bags, cell expansion containers, filters, manifolds, and blood management products. Products sold directly and through distribution network.
2. Custom Product Design Services: Custom single-use solution design and development services. Charter Medical engineers work with customers to develop tailored products for specific process requirements. Includes rapid prototyping, complete documentation packages, and validation support.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Charter Medical designs and manufactures specialty single-use polymer-based products used in bioprocessing, advanced therapy (cell and gene therapy) manufacturing, and blood management applications. Its portfolio includes cryopreservation bags, fluid transfer bag systems, cell expansion containers, manifold assemblies, aliquot and pooling sets, and filters validated to cryogenic temperatures as low as -196°C, produced in ISO Class 7 and 8 cleanrooms under ISO 13485 certification. The company also provides custom manifold design, freezing studies, and product customization services tailored to customer-specific bioprocessing and cell therapy workflows.

Product overview

Charter Medical is a provider of specialty single-use products for bioprocessing, advanced therapies, and blood management applications. The company offers a comprehensive portfolio of single-use solutions including Fluid Transfer Bag Systems, CryoProtect Bio-Containers, AccuStrain Filters, Cell Freeze Cryogenic Storage Containers, DEHP-free Fluid Transfer Bags, Freeze-Pak Bio-Containers (with and without FP-FLEX tubing), Bioprocessing Fluid Transfer Sets, Advect Fluid Transfer Sets, EXP-Pak and CXP Cell Expansion Containers, Bio-Pak Small Volume Bio-Containers, Freeze-Pak STS, and various Blood Management products (Aliquot Bag Systems, Blood Transfer Bags, Plasma Processing Bags, Plasma/Fluid Transfer Sets, Platelet Sampling Sets, Pooling Harness Sets, Neonatal Syringe Sets). The company also provides custom manifold design services and freezing studies services. Products are designed for cryopreservation applications validated to temperatures as low as -196C, bioprocessing fluid handling, and blood banking operations.

Differentiator

Problem solved

Functional benefit

Brands

• CryoProtect™ Bio-Containers: Bio-containers designed for storage, intermediate steps, final fill, and transport in bioprocessing applications with cryopreservation capabilities.
• Cell Freeze® Cryogenic Storage Containers
• Freeze-Pak™ Bio-Containers
• FP-FLEX™ Tubing
• EXP-Pak™ Cell Expansion Containers
• AccuStrain™ Filters
• DEHP-free Fluid Transfer Bags
• Advect® Fluid Transfer Sets
• Bio-Pak® Small Volume Bio-Containers
• Aliquot Bag Systems

Products and services

• Fluid Transfer Bag Systems Single-use polymer-based fluid transfer bag systems for bioprocessing applications, designed for aseptic liquid handling and transfer in regulated manufacturing workflows.
• CryoProtect Bio-Containers Single-use cryogenic bio-containers used for cryopreservation and low-temperature storage of biological samples in cell therapy and bioprocessing workflows.
• AccuStrain Filters (40µm & 150µm) Single-use strainer filters offered in 40-micron and 150-micron ratings for cell separation, debris removal, and fluid filtration in bioprocessing and cell therapy applications.
• Cell Freeze Cryogenic Storage Containers Single-use containers validated for cryogenic storage of cells, used in cell therapy and bioprocessing workflows requiring validated low-temperature preservation.
• DEHP-free Fluid Transfer Bags DEHP-free single-use fluid transfer bags for bioprocessing customers requiring formulations free of di(2-ethylhexyl) phthalate plasticizers for regulatory or patient-safety reasons.
• Freeze-Pak with FP-FLEX Cryogenic storage container incorporating FP-FLEX tubing for cell therapy and bioprocessing cryopreservation workflows.
• Bioprocessing Fluid Transfer Sets Single-use fluid transfer sets designed for bioprocessing applications, providing closed-system aseptic transfer of fluids in upstream and downstream manufacturing.
• Advect Fluid Transfer Sets Single-use Advect fluid transfer sets for aseptic fluid handling in bioprocessing and cell therapy workflows.
• Freeze-Pak Bio-Containers Single-use cryogenic bio-containers in the Freeze-Pak line for storage of biological materials at cryogenic temperatures.
• EXP-Pak Cell Expansion Containers Single-web polyolefin gas-permeable cell expansion containers in the EXP-Pak line, designed to support cell growth in cell therapy and bioprocessing applications.
• Bio-Pak Small Volume Bio-Containers Small-volume single-use bio-containers in the Bio-Pak line for low-volume bioprocessing and cell therapy applications.
• Freeze-Pak STS Freeze-Pak STS single-use cryogenic container variant within the Freeze-Pak product line for cell and gene therapy cryopreservation.
• Cell Expansion Containers (CXP) DEHP-free single-layer polyolefin cell expansion containers in the CXP line, designed for closed-system cell expansion in cell therapy manufacturing.
• Aliquot Bag Systems Single-use aliquot bag systems for aseptic subdivision of blood, plasma, and other biological fluids into measured volumes.
• Blood Transfer Bags Single-use blood transfer bags used by blood banks and transfusion services for the aseptic transfer of collected blood components.
• Plasma Processing Bags Single-use bags designed for plasma collection, processing, and storage in blood banking and plasma fractionation workflows.
• Plasma/Fluid Transfer Sets Single-use transfer sets configured for plasma and other fluid handling in blood banking and transfusion services.
• Pooling Harness Sets Single-use pooling harness sets that combine multiple blood or fluid units in blood banking workflows.
• Platelet Sampling Sets Single-use platelet sampling sets for aseptic sampling of platelet products in blood banking and transfusion services.
• Neonatal Syringe Sets with 150-micron Filter (Version F) Single-use neonatal syringe sets with an integrated 150-micron filter, Version F, for neonatal blood transfusion preparation.
• Neonatal Syringe Sets with 40-micron Filter (Version F) Single-use neonatal syringe sets with an integrated 40-micron filter, Version F, for finer neonatal blood transfusion preparation.
• Freeze-Pak Cryogenic Containers with FP-FLEX Tubing (Versions A and C) — DEHP-free DEHP-free versions A and C of the Freeze-Pak cryogenic container with integrated FP-FLEX tubing, providing plasticizer-free cryopreservation for cell therapy and bioprocessing customers.
• Single-use Manifold Design Services Custom single-use manifold design and assembly engineering services that tailor fluid pathway configurations to customer-specific bioprocessing and cell therapy processes.
• Freezing Studies Services Application engineering freezing studies service that supports customer cryopreservation process development, from biological samples through cryogenic storage.
• Customization Services Custom design and engineering services that adapt single-use products to customer-specific bioprocessing and advanced therapy manufacturing requirements.

Quantifiable outcome

• MNC and CD34+ cell recoveries of 81% and 84% respectively in Cell Freeze cryogenic storage containers
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature5 records

Partnerships

Four partnerships are on record, tiered core.

• PolyzencoreTechnology or Integration · 2 November 2022Polyzen is a leading developer of polymer-based healthcare solutions acquired by Solesis (Charter Medical's parent company) in November 2022. The acquisition expanded Solesis' film and coating capabilities. Polyzen operates as a sister company to Charter Medical within the Solesis family of companies.
• Secant GroupcoreTechnology or IntegrationSecant Group is a sister company within the Solesis family of companies. Charter Medical works closely with Secant Group along with Polyzen and SanaVita Medical to provide essential products and services to life science companies through integrated research and development activities.
• SanaVita MedicalcoreTechnology or IntegrationSanaVita Medical is a sister company within the Solesis family of companies. Charter Medical collaborates with SanaVita Medical along with Polyzen and Secant Group to bring new technologies and therapies to market through integrated R&D activities.
• SolesiscoreOthersSolesis is the parent company of Charter Medical. Solesis is described as 'a leader in the custom design, development, and manufacturing of textile- and polymer-based healthcare solutions.' John Witkowski serves as President & CEO of Solesis.

Scale indicators3 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• Entegris: Entegris' life sciences division produces single-use fluid management products, including bags and transfer assemblies used in bioprocessing and cell therapy — directly comparable to Charter Medical's core portfolio.
• Saint-Gobain Life Sciences: Saint-Gobain Life Sciences produces single-use fluid transfer assemblies, bioprocessing bags, and tubing — directly comparable to Charter Medical's fluid transfer bag systems and bioprocessing transfer sets.
• Macopharma: Macopharma manufactures blood collection, processing, and storage bag systems — a direct competitor to Charter Medical's blood management product line (blood transfer bags, aliquot systems, neonatal syringe sets).
• OriGen Biomedical: OriGen Biomedical develops single-use cryopreservation and cell processing products, including cryobags validated for liquid nitrogen storage. Highly comparable to Charter Medical's Cell Freeze and CryoProtect product lines serving cell therapy manufacturers.

Broad incumbents

• Avantor: Avantor distributes and manufactures single-use bioprocessing products and fluid handling solutions, competing with Charter Medical's bioprocessing bag and transfer set portfolio in biopharma and cell therapy customers.
• Cytiva (Danaher): Cytiva offers a broad single-use portfolio including cell culture bags, transfer sets, and bioprocessing consumables, and competes head-on with Charter Medical across upstream bioprocessing and advanced therapy applications.
• Sartorius: Sartorius is a leading global supplier of single-use bioprocessing solutions (bags, filters, bioreactors, manifolds) to the biopharmaceutical industry, directly competing with Charter Medical in bioprocessing fluid handling and cell therapy manufacturing consumables.
• Corning Life Sciences: Corning supplies single-use bioprocessing vessels, cell expansion containers, and cell therapy consumables, overlapping with Charter Medical's EXP-Pak/CXP cell expansion containers and bioprocessing fluid handling products.
• Thermo Fisher Scientific: Through its BioProduction and cell therapy businesses, Thermo Fisher supplies single-use bioprocessing containers, transfer sets, and cryopreservation solutions — overlapping with Charter Medical across nearly every product category.

Emerging players

• West Pharmaceutical Services: West Pharmaceutical's injectable drug delivery and containment components serve the cell therapy and bioprocessing markets with stoppers, seals, and delivery systems — an adjacent player overlapping with Charter Medical's containment/delivery theme.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCjpN7go5jM0yem5wYvemzwA
• LinkedInlinkedin.com/company/chartermedical
• Xx.com/chartermedical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds2 records

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 Charter Medical