Mod father: Off-the-shelf facilities drawing biopharma interest

Modular facilities could prove greater than the sum of their parts with innovation increasing biopharma interest in off-the-shelf plants.

An increasing number of drug industry announcements about new plants in recent years have emphasised the “modular” nature of the project. Pfizer, for example, opted for off-shelf-tech for the facility it set up in Hangzhou, China in 2016.

The site, which won an ISPE award, makes biosimilars for the local market. Pfizer cited flexibility as a key motivation for choosing the technology.

Image: iStock/meskolo

Lonza used the same justification – and the same supplier, GE Healthcare – for its choice of modular tech for a plant it is building last year.

At the time the contractor told us, “The combination of a solid technology platform from a trusted supplier as well as a regional development authority committed to developing biomanufacturing in the region.

“It will allow us to be operational very quickly, with delivery of first batches in 2020 and gives us access to a growing biotechnology hub.”

More recently Merck & Co. announced it would use modular technology at its $300m (€268.17m) formulation laboratory, experimental (FLEx) centre in Rahway, New Jersey.

The facility, which is scheduled to open in 2021, will “speed up the process between product development and manufacturing for clinical trials” according to Merck.

The firm also said the modular facility will provide “flexibility to accommodate evolving product needs and pipelines.”

Cleanroom modules

Cost reduction is also driving interest in modular plants according to Biologics Modular, which was awarded a US patent for its cleanroom modules last week.

The firm claims the tech “can guarantee minimized capital cost and shorter production timelines” for biopharmaceutical companies that use it.

According to the patent, each preassembled module includes an ISO 8 class air filtration system including a ceiling plenum for providing clean air to the interior of the module.

But Biologics Modular is not the only firm developing off-the-shelf cleanroom technology.

Last October, G-CON and Pall agreed a deal that will see the latter’s continuous bioprocessing technology included in the former’s prefabricated “Pod” cleanroom technologies.

Again, the pitch is that the technology combination will help biopharma companies control costs and capital expenditure.