At AB BioTechnologies, there are several key areas where we have expertise as a service provider. The first area is in the development of injectable drug products. We can take your molecule right out of discovery and conduct all of the necessary studies to ensure that the final formulation we supply to you is stable over the shelf life of the product.
We also have a significant amount of experience with troubleshooting and correcting problematic formulations during any phase of the development process. Our expertise and equipment can develop formulations for both small and large molecules. We are experienced in developing many kinds of parenterals, including liquids, emulsions, and suspensions. Our knowledge base expands into the development and validation of analytical techniques, ensuring the potency and purity of your product are being accurately and precisely determined. Once your final formulation has been determined, we can transfer the process into a manufacturing environment.
We can conduct process compatibility studies to understand how your product will behave when it comes into contact with common manufacturing materials, including glass, stainless, steel, process tubing, filter membranes, etc. This is done to ensure that the formulation prepared, developed, and tested in the lab is the same product that comes off of the filling line.
Our area of specialty expertise is lyophilization, or freeze-drying. Not only can we develop formulations specifically for freeze-drying, but we also have the ability to conduct all the thermal characterization tools to determine glass transition temperatures, collapse temperatures, and crystalline/amorphous character. This information paired with our development scale freeze-dryer allow us to develop an optimized, custom lyophilization cycle to dry your product in the shortest possible time while meeting all required quality specifications. We have worked with many different types of companies to develop their freeze-dried products including injectable drugs, diagnostics, tissues, and foods.