Your collaborative partner for manufacturing of Single or Multiplex Assay Lyophilized beads.
Why Partner with us for Lyobeads Manufacturing
Product Diversity - We have extensive experience working with diverse assay component characteristics: light-sensitive, temperature-sensitive, and viscous reagents, as well as microparticle suspensions.
Accommodating Scale - We are equipped to efficiently handle both large and small batch sizes. We provide commercial scale beads in bulk for customer in-house assembly or complete lyobeads assembly and kitting upon request.
Demonstrated Proficiency - Our proven EVIKTM manufacturing process delivers a variety of distinct products with excellent batch-to-batch reproducibility, high yields, and complete traceability. We maintain a strict zero-tolerance policy for any form of contamination throughout production.
Global Supplier - We provide contract manufacturing services globally for customers serving laboratory testing markets across all sectors: human research and IVD, veterinary, agricultural, and environmental.
Continuous Improvement - Our expert production team constantly strives to surpass all expectations in process efficiency, and consistency.
Our Facility
Our ISO 13485:2016 certified high-tech facility features an ultra-low humidity environment for DxSphere handling and cartridge/custom device assembly. The ultra-low humidity environment ensures that all EVIKTM DxSpheres maintain their high quality and low residual moisture content.
In addition, we employ GMP (Good Manufacturing Practices) in all our processes, minimizing risks to ensure our customers' products are produced consistently and efficiently, with complete traceability. We maintain thorough procedures to prevent contamination throughout all processes.
Our Manufacturing Capabilities
Our modular production equipment structure and flexible workflow provides scalable manufacturing capacity which ranges from 1,000 to 300,000 lyobeads per day to meet the requirements of any project demand.
We reliably and accurately dispense volumes from 5-30μL, which includes active assay components plus excipients, producing lyobeads with diameters in the range of 2 to 4 mm.
Considering a Project Outside Our Standard Range?
We strive to meet our customer’s unique requirements and their associated challenges. As a result, this range may be extended by engaging our team’s expert development processes.
Our comprehensive range of analytical techniques rigorously monitors both physical characteristics and functional performance of the lyobeads. Using robust evaluation protocols, we examine every aspect of the finished products. From residual moisture assessment and detailed bead dimension analysis to mechanical properties testing and customized functional verification aligned with exact customer specifications.
Custom Assembly & Packaging
We provide EVIKTM DxSphere integration or assembly into custom devices, microfluidic or biosensor cartridges. DxSpheres can be placed into vials, tubes, or microwell plates with custom configurations.
We can work with microfluidic cartridges containing multiple beads in various precise positional arrays, sealed using foil or clear adhesive membranes. Each cartridge is packaged in a protective foil pouch containing a desiccant and features a custom label.
Recognizing that microfluidic and customized assay devices require specialized approaches, we don't offer generic solutions. Instead, our team works closely with yours to develop the most efficient manufacturing strategy tailored specifically to your requirements.
Our expert production team provides efficient solutions for small to medium levels of assembly with the flexibility and production agility required when entering emerging markets. Evik Diagnostics collaboratively partners with your team in the development of manual or semi-automated solutions to place, assemble, and package your DxSpheres into your custom device or cartridge.