Cell and gene facilities will get smaller according to an expert, who says automation and the vogue for in-house manufacturing will drive the change.
Traditional biopharmaceutical manufacturing has relied on processes or platforms that can be used to make a range of products.
For example, CHO-based expression systems are used to make many of the best-selling therapeutic proteins. While the specific processes differ for each product, the technologies and methods are common.
Smaller footprints in the future? Image: iStock/Marina Lohrbach
The platform approach has influenced facility design. Most modern biomanufacturing plants are set up to multiple products – particular in the contract manufacturing organization (CMO) and contract development and manufacturing organization (CDMO) space.
Cell and gene CDMOs
In the emerging cell and gene therapy industries the multi-product facility model is much less common.
In part this is due to developers’ reluctance to hand over production according to Alan Bream, a bioprocess specialist at CRB Consulting Engineers.
“Firms are opting to bring that production in-house for supply chain certainty, control of their intellectual property and manufacturing flexibility. “
Bream also says capacity constraints are a factor, explaining “It’s well known that there’s a shortage of viral vector manufacturing as more companies enter the gene therapy arena and, in some cases, CMO’s might be limited.â€
A closed shop
The vogue for in-house manufacturing is likely to further influence facility design according to Bream.
“In the future, I see companies continuing to drive to closed systems as well as automated and robotic manufacturing platforms. For manufacturing processed that require open manipulations isolator technology will a key approach to ensure aseptic operations.â€
The advantage for cell and gene therapy firms is that the approach will reduce required floor space, thereby allowing facilities to become smaller.
“With closed systems in place, HVAC can de-classified which leads to lower operating costs, smaller facilities by removing airlocks and simplified gowning,†he said.