A. Proof of Concept Testing
The customer simply provides Evik with a small aliquot of the assay reagent mix and the desired bead size 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 are able to select some promising excipient compositions directly from this initial run.
B. Formula Development
Evik assists customers with optimizing the excipient selection. Excipients are an integral part of reagent formulas. We support customers with formula optimization and formula validation by quickly processing samples and returning the lyophilized beads to our customer for evaluation.
C. Formula Validation And Automated Dispensing
Evik provides customers with the necessary number of validation batches. We follow our customers’ instructions on dispensing tolerances, acceptance criteria, and specific handling requirements. 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 specifications.
Within just 1 week, Evik can provide customers with proof-of-concept prototypes and determine whether the lyophilized bead technology will work for the customer’s assay needs.