Introduction to Scale-Up and Post-Approval Changes (SUPAC)

Posted by Norm Fong

Scale-Up Blog Series, Part 2

[Editor’s note: Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. This is part 2 of an in-depth, multi-part series on product scale-up. Visit our blog page to read part 1.]


Topics: scale-up, Pilot Batch, Process Development, SUPAC, batch, Documentation, Stability Testing

Practical Considerations in Pharmaceutical Production Scale-Up

Posted by Norm Fong

Scale-Up Blog Series, Part 1 


From first-in-human and through each of the clinical trial stages and into commercialization, scale-up of formulation design is a natural part of pharmaceutical development. At each stage of process development, the batch size increases, from laboratory-scale batches that may be quite small to support preclinical and early clinical stages, to pilot batches that are used in process development, and finally to the production-scale batches needed to support commercialization.

Not surprisingly, the size, speed and power of the equipment involved in production has a significant impact on the entire process and must be matched to the batch-size requirements for production efficiency. Regardless of the size of the batch and its application — for use in clinical trials and stability testing, to service a smaller patient population with an orphan drug, or to provide for a larger population with a commercial product — the object is always the same: the finished product must be identical to the original formulation design regardless of the volume under which it is was produced.


Topics: scale-up, Pilot Batch, Validation Batch, Process Development, SUPAC, Registration Batch, Feasibility Batch