Services

Quality Control Services

In-Process and Release Assay Development
Florida Biologix^® Quality Control scientists can work hand-in-hand with the client's process development scientists or our own Process Development group to determine the appropriate methodologies for assessing the in-process materials and/or final bulk and final product as well as characterizing the process itself.
Assay Qualification and Validation
Once the appropriate methodologies are developed, Florida Biologix^® Quality Control can perform assay qualification demonstrate suitability. If desired, full validation of the assay with appropriate development of standards and/or controls, to ease in transfer of the process to Phase III manufacturing may also be performed.
Specifications Development
Specifications for raw materials, in-process materials, bulk, and final product can be developed based on the collection of data from process development and production runs.
Test Record Development
The Test Record is a formal assay performance document which identifies all required materials, standards, controls, and equipment required to perform the assay. In addition, a step by step procedure for performing the assay, criteria for validity, and appropriate standard and positive control acceptance ranges are also included.
Intermediate and Product Release Testing
As part of manufacturing, Quality Control will perform appropriate testing to assess the quality, safety, and potency of your product throughout the manufacturing process. Certificates of Analysis will be provided for each batch or lot manufactured and tested.
Standard Operating Procedure Development
SOPs for operation of your own quality control laboratory can be developed and provided. Types of documents included would be sample submission, sample inventory, equipment SOPs, calibration SOPs, etc.