Please note: We will be conducting our annual physical inventory counts on September 28 & 29. Processing times will not be affected but shipping times may be delayed due to this. Thank you for your attention to this and we look forward to continuing to serve you.
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Case Study: Establishing nanoComposix as Second Supplier for GMP Topical Therapeutic

A customer required a second source for a topical therapeutic with a nanoparticle component. A Manufacturing Master Record (MMR) and Manufacturing Batch Records (MBRs) were provided to nanoComposix for all intermediates, and the synthesis of the nanoparticle component was replicated at nanoComposix.

Transfer to a Quality Management System

A Quality Plan was developed, the MMR and MBRs were transferred and adapted into our QMS, and engineering runs were performed using draft batch records. Additional test methods were developed and validated. New raw material suppliers were qualified. A cGMP-compliant qualification batch was produced and the material delivered to the customer.

Component Manufacturing

NanoComposix passed a customer audit for adherence to QSR/ISO 13485* for the component manufacture, and nanoComposix was approved as a second source for supply of the GMP- manufactured nanomaterial.

*Specific to 4878 Ronson Ct. Suite J and 4888 Ronson Ct. Suite B