Did You Know: Drug Stability Testing & Formulation 00:00 Onset 00:11 Thermal Stability 00:23 Managing Temperature 00:25 Container Filing 01:23 Stability Testing 01:45 Formulation 02:02 Viscous Products 02:16 Complex Products From the manufacturing side it starts with the beginning of formulation conditions where we formulate and we chill the product in tanks to provide thermal stability. While we’re doing that we’re mindful of mixing to preserve the product from a sheer stress standpoint. Then during BFS filling our process optimizes as cool of conditions as possible while maintaining proper container forming if required. After filling we can employ a blast cooling step and accumulate the product as WIP or a work in progress before we package. As part of packaging we commonly use a pouch made of aluminum foil and polymer layers to aid with reducing vapor and gas transmission across the container. As well as a final step we typically overlay that pouch with nitrogen prior to sealing it. From there it’s all about cold chain. If the product needs it and the storage conditions for the end user we we commonly receive concentrated drug substance and then we dilute that with water and salts to make a final drug product form. Similarly a pharmaceutical company can send us bulk product that’s already pre-diluted in its final drug product. State either State you transfer that product into tanks you mix it you chill it and then it gets fed into the BFS for an R&D stability activity. ApiJect would execute a formulation and filling activity package it and then store it and ship it at the conditions required back to the client for their stability studies. Within our commercial manufacturing Network our formulation capabilities are near endless . As it goes for our ApiJect Technology Development Center we currently have a limited formulation equipment set on which means we can basically handle Simple Solutions. However I will say that we are able to handle almost any platform of disposable formulation technology. We can handle a wide variety of solutions suspensions and emulsions. We started getting into trouble when clients want to fill very viscous products like gels or creams but that’s not to say that we couldn’t handle some of those products. We just need to understand the client’s product specification. So challenges and formulations only really occur when you’re dealing with complex products like suspensions and emulsions. Basic Solutions are pretty simple. You add ingredients into a tank with water and you mix until they’re dissolved.