Custom Bioprocessing Systems Built Around Your Process

A custom bioprocessing system, also called a bespoke bioprocess skid or engineer-to-order (ETO) system, is a purpose-built process platform designed around your specific manufacturing requirements. Unlike off-the-shelf equipment, custom single-use bioprocessing systems are fully engineered to match your exact flow rates, pressures, hold volumes, process steps, and facility constraints. We design and build bespoke single-use systems for applications including tangential flow filtration (TFF/UF/DF), viral inactivation, inline buffer dilution, chromatography, depth filtration, and formulation for biopharmaceuticals including monoclonal antibodies, cell and gene therapies, mRNA, vaccines, and ADCs.

We design and build a comprehensive range of single-use bioprocess systems including benchtop and pilot-scale TFF skids, modular multi-unit downstream processing systems, viral inactivation feed and hold systems, inline buffer dilution and blending skids, fill-finish preparation systems, and custom chromatography automation systems. Every system is built around next-generation precision fluid control components including PIXER® single-use diaphragm pumps, VannX™ diaphragm valves, ARTēVA® pinch valves, and SoloCheck™ check valves. If your application is not listed, contact our engineering team.

Yes. Every system we build is fully automation-agnostic and integrates with your existing control infrastructure. Compatible with all major SCADA, PLC, and DCS platforms including DeltaV, Rockwell Automation (Allen-Bradley), Siemens S7/TIA Portal, AVEVA (Wonderware), and Inductive Automation Ignition. There is no proprietary software lock-in. Systems are delivered automation-ready with standard I/O mapping. If you have an existing site standard, we design to it.

Our engineer-to-order (ETO) process follows five milestones: (1) Concept Design - defining process requirements and system architecture with your team; (2) Detailed Design - full engineering package including P&IDs, 3D layouts, and Design Qualification (DQ) documentation; (3) System Build - in-house manufacturing and assembly; (4) FAT, Installation and Commissioning - including IQ and OQ protocols; (5) Ongoing Support - consumable supply, spare parts, and field service. Every phase is GMP-documented. Contact us to begin.

Lead times vary with system complexity and scope. Standard benchtop and pilot-scale systems typically deliver within 12 to 20 weeks from design sign-off. More complex modular or multi-unit production systems may require 20 to 36 weeks. Because core fluid control components are manufactured in-house, there is significantly more control over supply chain and delivery timelines than suppliers reliant on third-party procurement. Contact our team early in your planning to align lead times with your programme schedule.

Yes. Our systems support both traditional batch processing and continuous bioprocessing and process intensification (PI) strategies. Modular multi-unit systems feature reconfigurable process wall interfaces adaptable for perfusion, semi-continuous, or fully continuous downstream operations. As the industry moves toward continuous manufacturing to improve yield, reduce hold volumes, and accelerate cycle times, our systems are built to evolve with your manufacturing strategy.

We provide full qualification support across the system lifecycle, aligned with FDA 21 CFR Part 211, EU GMP Annex 15, and ICH Q7/Q10 requirements. This includes Design Qualification (DQ), Factory Acceptance Testing (FAT), Installation Qualification (IQ), and Operational Qualification (OQ). All systems are delivered with a complete GMP documentation package including material traceability, calibration certificates, and P&ID as-built drawings, ready to support your validation master plan (VMP) and regulatory submissions.

Standard equipment forces your process to adapt to fixed configurations. Our engineer-to-order approach does the opposite: every system is designed around your process goals, flow requirements, and facility footprint. Systems are powered by proprietary precision fluid control components including our PIXER® single-use diaphragm pumps, which use Polymorphic Pump Technology to deliver ultra-low shear, pulsation-free fluid transfer critical for preserving shear-sensitive biologics including viral vectors, mRNA lipid nanoparticles, and protein-based therapeutics. Combined with custom single-use assemblies and LSR overmolded connections, you get a fully integrated, single-source system.

Yes. As both system integrator and component manufacturer, we supply all single-use consumables used in your system including PIXER® pump heads, VannX™ valve diaphragms, single-use biocontainers, and custom fluid path assemblies. This single-source model simplifies procurement, guarantees compatibility, eliminates multi-vendor qualification overhead, and removes the risk of substitute components entering your validated process. We also offer consignment stock and framework supply agreements for high-volume operations.

Our systems cover a broad range of downstream processing and formulation applications: tangential flow filtration (TFF/UF/DF), viral inactivation and viral clearance, inline buffer dilution and buffer preparation, automated chromatography, depth filtration, drug substance formulation, and fill-finish preparation. Optimised for monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), cell and gene therapy products (lentiviral vectors, AAV, CAR-T), mRNA and lipid nanoparticle (LNP) formulations, recombinant proteins, vaccines, and biosimilars.

Absolutely. Our modular architecture is purpose-designed for seamless scale-up from benchtop and pilot scale through to full GMP clinical and commercial manufacturing. The same PIXER® diaphragm pump components used at development scale are available at production scale, meaning your process parameters including flow rates, shear profiles, and hold times transfer directly without re-characterisation. This materially reduces tech transfer risk, accelerates clinical timelines, and maintains product consistency across scales. Our benchtop TFF system supports working volumes from 30 mL with modular upgrade paths enabling scale-up without redesigning your process.