A. Proof of Concept Testing
Initially, customers send us a small aliquot of their assay reagent mix and the required bead mass or volume. We immediately formulate with upwards of five common excipients, manually dispense the customized formulation to provide 20–200 beads for each excipient, and then lyophilize the blend in a single run. Most customers succeed in selecting some promising excipient compositions directly from this initial run.
B. Formula Development
Excipients are an integral part of reagent formulas. We assist our customers with excipient selection and provide support with formula optimization and validation. We process samples quickly and return the lyophilized beads to our customers for evaluation.
C. Formula Validation And Automated Dispensing
Evik provides customers with the necessary number of validation batches. We customize our processes to allow us to strictly follow each customer’s specific instructions on handling requirements, dispensing tolerances, and acceptance criteria. Automated dispensing initiates with batches of 1000 beads.
D. Lyophilization Cycle Development Process
Evik establishes, optimizes, and validates all lyophilization cycle parameters, including lyophilization temperature, pressure, and cycle time. Cycle parameters become an integral part of each customer’s production specifications.
Within just one week, we can provide our customers with proof-of-concept prototypes and determine whether the lyophilized bead technology will work for their assay needs.