Five-Point Checklist for Pharmaceutical Scale-Up

Posted by David Watt and Norm Fong

Scale-Up Blog Series, Part 3

[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 3 of an in-depth, multi-part series on product scale-up. Visit our blog page to read parts 1 and 2.]

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Topics: scale-up, SUPAC, Process Development, CMO Partner, excipients, Registration Batch

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.]

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

Practical Considerations in Pharmaceutical Production Scale-Up

Posted by Norm Fong

Scale-Up Blog Series, Part 1 

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook

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.

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

Part 2 — The Ins & Outs of Technology Transfer

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 2 of an in-depth, multi-part series on tech transfer. Visit our blog page to view Part 1.]

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Topics: CMO, technology transfer, process design, GMP, quality controls, scale-up