Off-the-shelf aseptic manufacturing? Pfizer targets emerging markets in JV

10-Feb-2014 - Last updated on 10-Feb-2014 at 11:26 GMT

Looking past large fixed manufacturing capacity in Pfizer's aseptic processing project

Pfizer says its ‘off the shelf’ aseptic processing capacity is shifting the paradigm of pharma manufacturing, with emerging markets and personalised medicine driving the change.

The pharma giant has teamed up with the Jacobs' Group - a California, US-based engineering firm - to create a portable and scalable manufacturing system known as a Rapid Deployment Module (RDM).

The modular process system incorporates modular equipment, fully-automated control systems and single-use technology and - according to Pfizer’s VP of Global Technology Services Kevin Nepveux - will address the the problems of large manufacturing facilities with fixed equipment as both type of drug and geography changes the industry's focus.

He told in-Pharmatechnologist.com the RDMs will enable Pfizer “to manufacture smaller quantities closer to the patients,” and therefore “be more responsive and cost-effective.”

Smaller, more portable and adaptable manufacturing space is becoming an increasingly important capability, he added. “It is being driven by the declining volume of individual therapies - driven, to some extent, by Personalized Medicines - and the desire by Emerging Markets to have products manufactured locally.”

Jacobs' VP Chris Nagel added the “off-the-shelf technology” is “a process that can be replicated globally and offers a number of potential benefits such as reduced equipment, validation and operating costs.”

Collaboration

The project is being carried out in Pfizer and partner facilities, Nepveux said, with Pfizer’s aseptic drug product process being complemented by Jacob’s modular engineering, fabrication, and testing capabilities.

“We have prototypes deployed in some markets now that are progressing through local review processes,” he told us. “This involves a relatively small team of talented scientists working on the project.”

Financial details of the partnership were not divulged.

Portable Manufacturing

The project is not Pfizer’s first foray into portable manufacturing capacity. Last year the firm collaborated with GEA Process Engineering and G-CON to develop a flexible and adaptable oral solid dose processing platform, known as PODs.

The self-contained GMP modules were described at the time as “transformational” by GEA Sales Manager H. McCoy Knight, who told this publication the technology eliminated the need for scale-up and product transfer and thus greatly reduced time to product launch, and therefore costs.

However, the collaboration with Jacobs' “is not related to the project with GEA and G-CON,” Nepveux told us. “It involves a different technology but uses a similar approach.”

Describing both projects, he continued: “Technically nothing we are doing is brand new but it does change the paradigm of how and where pharmaceuticals can be manufactured.”