During formulation development, the wide variety of formulation compositions assessed typically requires very small batch sizes (≤5 L).

While MedPharm generally recommends formal process development or process assessment, our Subject Matter Experts can leverage experience
with similar product types (e.g., creams, sprays, solutions) to select lower-risk manufacturing approaches.

As with any strategy, associated risks are clearly defined and discussed with the client prior to work commencement.

Once batch sizes exceed 50 L (UK site limit) and programs advance into later-stage clinical or registration manufacturing,
it is critical that the manufacturing process is fully understood and scalable.

To further minimize scale-up risk, MedPharm employs the same Axomatic manufacturing platforms from 10 L through 1,500 L at our US site.
This enables tight control of scale-dependent variables and greater precision when selecting final manufacturing methods.