Transform Liquid Assays into Precision - Lyophilized Beads
Why Partner with Evik Diagnostics for your Lyophilized Bead Assay Development
Expertise for Your Complex Assay Requirement - Our team delivers creative solutions for your most demanding project specifications—from fast and slow lyobead dissolution profiles to enzyme stabilizing and incorporating microparticle suspensions in lyophilized beads format.
Comprehensive Development Approach – The EVIKTM process spans from reagent thermal assessment through formula optimization to process development, always with scalability in mind.
Overcoming Lyophilization Challenges - We excel through collaborating as your development partner to overcome challenges in your reagent formulas, including those with limited presence of glycerol, organic solvents, or high salt concentrations.
Collaborative Partnership - Experience a customer-centric partnership featuring transparent communication, detailed reporting, and data sharing throughout the EVIKTM process to ensure successful development of your team’s assay technology.
Our Proven Approach to Your Success
Recognizing each customer brings unique needs and challenges, our team has developed a structured process designed to achieve optimal results while honoring what makes your project special.
Explore the key stages of the EVIKTM development process below.
1. Onboarding & Scope Definition
We begin by meeting with your R&D team to establish a clear scope of work including specific goals, required activities, realistic timelines, and budget parameters. We provide a detailed proposal for Proof-of-Concept that outlines our approach to addressing your specific needs and objectives.
2. Proof of Concept
During this initial phase of development, we investigate compatibility of the customers' assay reagents with the freeze-drying process (lyophilization).
Within a short turnaround time, we offer excipient and stabilizer selection options, provide reagent mix thermal property characterization, along with reagent assessment and compatibility analysis. We design custom lyophilization cycles using proprietary EVIKTM Know-How.
Our initial experiment provides a limited quantity of EVIKTM DxSpheres for evaluating their functional performance and determining if they’re the right fit for your project. In addition, you'll receive expert guidance on optimizing reagent compatibility and ensuring top-tier bead quality.
3. Assay Development Support
As your project progresses, we can assist in optimizing your EVIKTM DxSpheres for attributes like functionality, stability, and robustness, to make sure your lyophilized beads meet your assay specification.
We provide ongoing consulting and technical support throughout your assay and platform development, along with advanced excipient strategies to enhance reagent stability and physical properties. Our services include custom dispensing, packaging, lyophilization processes, recognizing that each product requires unique lyophilization conditions depending on the components of the formulation.
Additionally, we deliver comprehensive experimental summaries with actionable recommendations to guide your development process.
4. Process Optimization
Developing optimal lyophilization cycle parameters is a key step in the development process. Once the formulation has been locked, we complete final optimization of dispensing and freeze-drying processes, along with rigorous verification of bead performance and process parameter reproducibility.
We also provide confirmation of formulation and process readiness for technology transfer and scale-up and deliver a comprehensive final R&D report with customer-specific documentation to ensure a smooth transition to the next phase.
5. Ready for Full-Scale Production?
Once your formulation is optimized and verified, our seamless Technology Transfer services will ensure your EVIKTM DxSpheres maintain their precision and performance as they move from development to commercial scale manufacturing.
Technology Transfer & Scaling Up: Why It Matters
Why do I need Technology Transfer?
Technology Transfer (Tech Transfer) is a vital step in the EVIKTM lyophilization process ensuring a successful and efficient transfer of the assay you have developed from R&D to full-scale production.
At Evik Diagnostics, we specialize in translating your assay into scalable, reproducible, high-quality manufacturing. EVIKTM Tech Transfer process ensures your assay is functional, robust, reliable, and ready for market.
What Is Tech Transfer?
Tech Transfer is the essential bridge between R&D and production. This core process is designed to turn bench-optimized formulation into a validated manufacturing process that meets quality standards, scales efficiently, and produces consistent results batch after batch.
From the Lab Bench to the Market
The perfect complement to our R&D services, our Tech Transfer expertise ensures your EVIKTM DxSpheres and other lyophilized products maintain their precision and reliability as they move from development to full-scale production.
Confidently, the EVIKTM team believes - Investing in Tech Transfer saves time, money, and ensures high quality products, to our customer’s markets.
Procurement & Logistics
We offer the service of procuring reagents, components, and other items to provide a more customer-oriented service for our customers. Procurement services are assessed on a case-by-case basis.
Tailored Packaging and Assembly for Your Unique Needs
At Evik Diagnostics, we understand the critical importance of custom packaging, placement, and assembly of lyophilized beads into devices designed specifically for your project. Whether it's microwell plates, PCR tubes, POC/PON device tubes, or microfluidic cartridges, we offer these services throughout both the lyobeads development phase and large-scale commercial production.
Additional Assay Lyophilization Formats
Evik Diagnostics Is Also Equipped to Assist with the Development of:
- Lyophilized cakes (lyo cakes) in microplates and tubes
- Lyophilized membrane pads
- Large hemispherical ‘lyo pellets’
CUSTOMER CONFIDENTIALITY: Evik Diagnostics is committed to confidentiality. It is not necessary for us to know the specific details of our customers’ formulas. It is normal practice to sign MNDAs with our customers. We respect each customer’s confidentiality: proprietary or patented technology. Furthermore, we work collaboratively with our customers and are open with our customers about how their product is processed.