MonoBiologics was founded in 2020 and is headquartered in Waterford, Ireland, situated within what the company describes as Europe’s biopharma manufacturing corridor — the region of Ireland home to a significant concentration of global biopharmaceutical manufacturing sites. The company was established to address gaps in the single-use bioprocessing equipment market, specifically where off-the-shelf components are insufficient for the process complexity demanded by modern biopharmaceutical manufacturing, and where an engineering partner capable of delivering custom solutions from component to complete integrated system was lacking.

The company operates with fully in-house design, engineering, and manufacturing capability for its single-use product lines, including proprietary liquid silicone rubber (LSR) overmolding technology that enables custom connector and flow path fabrication. All single-use wetted components meet USP Class VI biocompatibility standards, with full traceability and regulatory documentation provided to support client validation programmes. MonoBiologics supplies clients globally, with a supply model designed to provide responsive lead times underpinned by deep inventory capability.

Its product portfolio spans three levels of complexity: individual precision components (valves, pumps), integrated single-use flow path assemblies, and fully bespoke process skids encompassing tangential flow filtration (TFF), buffer preparation, and viral inactivation systems.

Key Products and Services

Pinch Valves — ARTēVA® Series

• Manual, pneumatic, and motorised pinch valve configurations for single-use tubing applications
• Clamp-on reusable 316L stainless steel valve body with tool-free installation, visible position indicator, and IP65 ingress protection
• Motorised variant with 704-step microstepping resolution, 24V DC supply, compatible with ¼″ to 1″ ID single-use tubing

Diaphragm Valves — VannX™ and AquaSyn® Series

• VannX™ motorised single-use diaphragm valve with ±0.3 PSI flow control precision, 24V DC electric actuation, and no requirement for compressed air infrastructure
• AquaSyn® single-use diaphragm valves and sample/bleed valves for process sampling and inline fluid control
• Single-use check valves (SoloCheck) for backflow prevention, available in multiple port configurations and tubing sizes

Single-Use Pumps — PIXER® Series

• Positive displacement single-use diaphragm pump with near-pulseless, ultra-low shear flow performance
• Flow range from 0.73 mL to 240 L/min; handles fluid viscosities up to 3,000 cP; maximum operating pressure 6 bar
• Suited to applications where peristaltic pumps are insufficient, including viscous media transfer, TFF permeate pumping, and shear-sensitive biological fluids

Single-Use Flow Path Assemblies

• Fully bespoke single-use fluid path assemblies integrating pumps, valves, bags, sensors, and overmolded connectors into a single, tested, and validated assembly engineered to client process specifications
• Designed and built entirely in-house with one accountable supply partner

Single-Use Bags

• Bioprocess bags in a range of configurations, volumes, and port arrangements for fluid storage, mixing, and transfer applications within single-use workflows

LSR Overmolding — Products and Machinery

• In-house liquid silicone rubber (LSR) overmolding capability for the production of custom single-use connectors, flow paths, and tubing assemblies with integrated sealing surfaces
• LSR overmolding machinery supplied as standalone equipment: Production Pumping System (metering and mixing), Benchtop Pumping System, and LSR Moulding Press System — enabling clients to establish in-house LSR overmolding capability

Bespoke Process Systems

• Fully integrated single-use process skids engineered to client process requirements, including tangential flow filtration (TFF / TFFi) skids, buffer preparation systems, and viral inactivation systems
• Concept-to-commissioning project delivery with software-agnostic control architecture
• TFFi system for small-scale TFF operations including concentration, diafiltration, and buffer exchange

MonoBiologics occupies a well-defined manufacturing niche within the single-use bioprocessing equipment market — a segment characterised by a small number of large incumbent suppliers (Cytiva, Sartorius, Merck Millipore, Parker) and a growing demand from biopharmaceutical manufacturers for more flexible, responsive, and customisable supply alternatives. Its Irish base positions it favourably within close proximity to a dense concentration of biopharmaceutical manufacturing clients, including the Irish operations of companies such as Bristol Myers Squibb, MSD, Pfizer, AbbVie, and Regeneron. As a manufacturer with fully in-house engineering, overmolding, and assembly capability, MonoBiologics can offer a degree of customisation and single-source accountability at the flow path and system level that catalogue-only distributors cannot match. Founded in 2020 and still in its early growth phase, the company’s commercial scale and installed client base remain developing, but the breadth of its product platform — spanning valves, pumps, bags, assemblies, overmolding machinery, and complete process skids — is unusually comprehensive for a five-year-old manufacturer.