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Eliminate scale up by using R&D equipment for commercial production: GSK

By Natalie Morrison , 18-Oct-2012

A new QbD paradigm: keep R&D equipment when producing on commercial scale

A new QbD paradigm: keep R&D equipment when producing on commercial scale

Using the same equipment from R&D to scale up will cut costs, time and improve efficiency, according to GSK.

The firm’s senior VP of product and oncology design, Gordon Muirhead, branded the pharma industry “scientifically invalid” for the process of scale up to commercial production.

He said the common method – which simply employs a bigger version of the processing equipment used in R&D (research and development) – is flawed, because often what works in small scale does not work in large.

However by keeping the same equipment throughout the process, but using continuous production to achieve commercial scale production, Muirhead said problems caused by scale up can be wiped out.

Speaking at AAPS, he said: “Everything goes well until you have to scale up, that’s when the problems start. This is about the elimination of scale.

“In the pharma industry, when you want to make more you just put it in a bigger version of the same equipment and think it is scientifically valid. End product testing alone is insufficient. It’s only when you get to the end you find out whether your product is good enough.”

He added that scale up often means high material waste, longer manufacturing lead times and overall inefficiency that wouldn’t be tolerated in any other industry.

Of the new QbD (quality by design) concept Muirhead said: “We have been able to eliminate scale by staying at development scale.

"The big thing we did was remove inertia from the system. If you can imagine 1,000kg of material you need big machinery to produce it. In simple terms, rather than making 1,000kg at once, with this process you make 1kg 1,000 times.”

In projects so far, GSK have used the process for wet densification and blending amongst others. And though Muirhead admits it has not yet been perfected for coating, the firm is “working on it”.

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