Challenges And Solutions In Biologics Finished Product Manufacturing

Development of biologic therapies can present a number of unique challenges for formulation scientists and process engineers.  Unlike many small molecule products, most biologics require a parenteral route of administration.  Formulators therefore must develop a suitable means to deliver the product via injection which entails addressing a variety of potentially complex challenges related to the unique properties of the biologic substance being delivered.  Issues such as the stability of the biologic material in a solution state must be considered along with the overall practicality of a formulation in terms of manufacturing, storage, transport, and administration. 

While it may be possible to develop a formulation that meets the desired finished product characteristics using laboratory techniques, it is imperative that each formulation is carefully evaluated to confirm it is practical for industrial-scale manufacture.