Lyophilization

I. Proof of Concept

-Clients send us samples of their reagents with bead size requirements.

-We formulate with excipients based on reagent chemistry.

-Proof of concept batches are separated into 3-4 runs to assess consistency and most favorable lyophilization conditions.

II. Formula Development

-Select formula that best fits the need of client.

-Modify formula if necessary.

III. Lyophilization Recipe Development

-Develop unique recipe for client for optimal bead formulation.

IV. Regulatory

-We are ISO13485.

-We will develop internal design files for client to outline parameters for optimal bead formulation and maintain lot to lot consistency.

V. Production

-Final formulation will transfer to production for manufacturing.

-Strict QC guidelines are maintained.

VI. Custom Packaging

-We can package based on client needs.