Whk BioSystems

What Whk BioSystems does

WHK BioSystems, LLC is a US-based contract manufacturer founded in 2012 in Clearwater, Florida, and operating as a subsidiary of the TSE Industries family of companies. The company designs and produces single-use assemblies, custom tube kits, transfer bottle assemblies, sanitary connections, and proprietary TPE and polypropylene tubing lines (W-TPE™ and ProFLo™) for the biopharmaceutical, life science, medical device, and emerging cell and gene therapy industries. Manufacturing is conducted in two ISO 13485:2016-certified Class 7 cleanrooms and is supported by a 12,000 sq ft climate-controlled warehouse.

The company's technical core is a vertically integrated stack of capabilities: medical tubing extrusion, cleanroom injection molding, overmolding (including a proprietary overmolded-connection technique that eliminates cable ties and barbed connectors), platinum-cured silicone/TPE sanitary molding, RF welding, laser cutting/engraving, design services from concept through 3D-printed prototyping, and most recently in-house UHMW sheet manufacturing via custom hydraulic presses for implantable medical device components. Inputs are formulated to meet USP Class VI, ISO 10993-5/6/10/11, FDA 21 CFR 177.1520, REACH, and RoHS standards, allowing qualification into regulated customer processes.

WHK operates a sales-led, project-based business model: revenue is generated through quote-based contract manufacturing engagements sourced via direct phone, email, contact form, and an emerging content-and-social marketing presence. Pricing is not publicly disclosed and varies by project. The company is privately held under family ownership with Robert Klingel Jr. as President and is part of TSE Industries, the Klingel family's ~60-year-old diversified manufacturing group. No outside venture capital, institutional funding, or M&A activity is disclosed, indicating an organic-growth operating posture.

Name

Whk BioSystems

Legal name

WHK BioSystems, LLC

Website

https://whkbiosystems.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

101–250 employees

Short description

WHK BioSystems is a US contract manufacturer founded in 2012 that designs and produces ISO 13485-certified, Class 7 cleanroom single-use assemblies, custom tubing kits, and proprietary tubing products for biopharmaceutical, life science, medical device, and cell and gene therapy customers, and operates as a subsidiary of TSE Industries.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Commercial and Service Industry Machinery Manufacturing (33331), Commercial and Service Industry Machinery Manufacturing (333310)

SIC

Special Industry Machinery (No Metalworking Machinery) (3550)

akta.pro primary industry

Single-Use Technologies (SUT) & Disposable Fluid Management (bags, assemblies, connectors) (HLAAAJAC)

akta.pro secondary industries

Single-Use Systems Assembly & Consumables Manufacturing (Bags/Tubing/Assemblies) (HLAGAGAH), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Single-use assemblies
• Medical device contract manufacturing
• Biopharmaceutical tubing
• Cleanroom manufacturing services
• Medical tubing extrusion

Headquarters

HQ city

Clearwater

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: WHK BioSystems generates revenue through contract manufacturing of single-use assemblies, medical device components, and custom tube kits. Services include injection molding, overmolding, tubing extrusion, device assembly, and design services. Revenue is project-based with quotes provided for each engagement.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

WHK BioSystems is a contract manufacturer of single-use technology (SUT) assemblies and medical device components for the biopharmaceutical, life science, and medical device industries. The company produces SUT assemblies, custom tube kits, transfer bottle assemblies, proprietary W-TPE™ and ProFLo™ tubing, and molded sanitary connections, supported by vertically integrated manufacturing services including injection molding, overmolding, medical tubing extrusion, device assembly, RF welding, and design services. All production occurs in ISO 13485:2016 certified Class 7 cleanroom facilities in Clearwater, Florida.

Product overview

WHK BioSystems is a contract manufacturer offering a portfolio of single-use technology products and medical device manufacturing services for the biopharmaceutical, life science, and medical industries. The core product line includes SUT Assemblies and Custom Tube Kits, Transfer Bottle Assemblies, W-TPE™ Tubing, Molded Sanitary Connections, and ProFLo™ Polypropylene Tubing. These products are supported by manufacturing services including Injection Molding & Overmolding, Design Services, Device Assembly, and Medical Tubing Extrusion. All manufacturing is conducted in ISO 13485:2016 certified Class 7 cleanroom facilities.

Differentiator

Problem solved

Functional benefit

Brands

• W-TPE™ Tubing: Sealable and weldable TPE tubing suitable for the biopharmaceutical industry.
• ProFLo™ Polypropylene Tubing

Products and services

• SUT Assemblies / Custom Tube Kits Single-use technology (SUT) assemblies and custom tube kits for the biopharmaceutical industry, supporting bioreactor, cell culture, and cell therapy applications with manifolds, bottle assemblies, and overmolded solutions.
• Transfer Bottle Assemblies Aseptic transfer bottle assemblies designed for efficient fluid transfer with customizable stopper configurations, container options, and accessories meeting biopharmaceutical and life science standards. Includes One Piece Centrifuge Tube Assembly in 15ml, 50ml, 250ml, and 500ml sizes with 100% fluid path integrity.
• W-TPE™ Tubing Proprietary weldable and heat-sealable thermoplastic elastomer tubing for biopharmaceutical processing, available in sizes from 0.063" ID to 1.5" ID, with flexibility from -50°F to 275°F, less permeable than silicone, REACH and RoHS compliant, certified to USP Class VI, USP 788, USP 85, USP 87, and ISO 10993 standards.
• ProFLo™ Polypropylene Tubing Sterilized, customizable polypropylene tubing manufactured for biopharma processing using FDA 21 CFR 177.1520 and USP Class VI compliant raw material, designed for critical high-purity fluid transfer applications including bioprocessing, sterile filling, and diagnostic equipment.
• Molded Sanitary Connections Molded platinum-cured silicone and TPE sanitary connections and gaskets for critical fluid transfer applications in biopharmaceutical and cell therapy industries, with all product contact surfaces tested to USP Class VI, ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-11 standards.
• MillaMed® PU Rubber Compounds MillaMed® PU Rubber Compounds brand offered through TSE Industries partnership, available to biopharmaceutical and medical device customers.
• Injection Molding & Overmolding Services Cleanroom injection molding and overmolding services for medical-grade components using TPE, LSR, PP, PC, PE, and other materials in Class 7 cleanroom facilities, with proprietary overmolding technology that eliminates cable ties and barbed connectors.
• Medical Tubing Extrusion Medical tubing extrusion services for catheter tubing, IV tubing, peristaltic pumps, and other medical devices in multiple materials including TPE, PP, TPU, PEEK, vinyl, and EVA, using REACH and RoHS compliant materials.
• Device Assembly Custom cleanroom device assembly services for biopharmaceutical, life science, and medical applications, including RF welding capabilities and 100% fluid path integrity through customized leak testing protocols for every kit built.
• Design Services Medical device design and production services from concept to full-scale manufacturing, including 3D printing, rapid prototyping, and regulatory support.

Quantifiable outcome

• 100% fluid path integrity through customized leak testing protocols for every kit built
• +1 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• TSE Industries, Inc.coreOthersParent company providing experience and resources to WHK BioSystems. TSE Industries was founded by Walt and Helen Klingel in 1962 and has nearly 60 years of manufacturing history. The partnership provides material and process knowledge for the biopharmaceutical, life science, and medical industries. WHK's name is in honor of the founders.

Scale indicators4 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Sartorius AG: Sartorius is a major bioprocess supplier of single-use bags, tubing assemblies, and fluid management for biologics manufacturing, competing in the same SUT consumables space WHK addresses, but with a much broader and globally distributed portfolio.
• Avantor: Avantor supplies bioprocess single-use solutions, fluid management components, and lab consumables to life sciences customers, with comparable end-markets to WHK across biopharma and medical devices.
• Cytiva (Danaher): Cytiva is a global leader in bioprocessing single-use technologies, offering bags, assemblies, tubing, and fluid management consumables for biopharma — directly comparable product category to WHK, but at much larger scale and global reach.
• Thermo Fisher Scientific (Bioproduction): Thermo Fisher's Bioproduction and Single-Use Technologies business supplies single-use assemblies, tubing, and bioprocess consumables to biopharma manufacturers — overlapping with WHK's SUT assemblies and custom tube kits.

Direct peers

• ILC Dover: ILC Dover (via its Life Sciences / DoverFlexoFlex-ProFlex product lines) designs and manufactures single-use flexible containment and bioprocess systems for biopharma, overlapping with WHK's custom single-use assemblies and cleanroom manufacturing.
• Foxx Life Sciences: Foxx Life Sciences manufactures single-use bioprocess containers, bottles, caps, and carboys for life sciences — closely matching WHK's bottles, caps, stoppers, carboys and flasks offerings.
• TBL Performance Plastics: TBL Performance Plastics produces custom single-use assemblies and molded plastic components for life sciences and biopharma — a smaller direct peer with similar custom SUT contract manufacturing focus.
• Entegris: Entegris manufactures fluid handling and filtration products, including single-use assemblies and bioprocessing consumables — comparable to WHK's single-use tubing assemblies and sanitary connections.
• AdvantaPure: AdvantaPure specializes in high-purity silicone and TPE tubing, single-use assemblies, and molded sanitary connections for biopharma — direct overlap with WHK's W-TPE tubing, sanitary connections, and SUT assemblies.
• Parker Hannifin (Hannifin / domnick hunter): Parker Hannifin's filtration and fluid handling division produces single-use assemblies, tubing, and bioprocess components for biopharma — directly comparable to WHK's custom tube kits, transfer bottle assemblies, and sanitary connections.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/whkbiosystems
• Facebookfacebook.com/WHKBioSystems
• LinkedInlinkedin.com/company/whk-biosystems-llc
• Instagraminstagram.com/whkbiosystems

Compliance6 records

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 Whk BioSystems