Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, is expanding its cell and gene therapies (CGT) process and analytical development laboratories at its locations in Houston (U.S.) and Geleen (NL).
 
The expansions further strengthen Lonza’s global process development service offering by adding capabilities and capacity to its existing laboratories. Alongside its rapidly growing team of CGT process development experts, the expansions support the company’s ability to meet the increasing global demand for cell and gene therapies process development expertise.
 
In Houston, the expansion includes 15,000 ft² of new laboratory suites, including viral vector-based process development and analytical development laboratories. Lonza’s Geleen facility will add over 4,500 ft² of laboratory space. The new laboratories are expected to be operational by the end of 2022. These expansions come in addition to Lonza’s recent acquisition of exosome development services laboratories in Siena, Italy, further expanding Lonza’s CGT process development footprint across the globe. 
 
The increased service capabilities and capacity will facilitate multiple early- and late-stage CGT development services, complementing the existing CGT offering of development services for autologous cell therapies, allogeneic cell therapies, viral vector-based gene therapies, and exosome applications. Lonza’s range of services and a strong focus on quality, enabled by its New Product Introduction (NPI) and Product Lifecycle process, set customers up for success in cGMP manufacturing.
 
For the CGT market to continue to expand in size and scope, it is becoming critical to address specific challenges related to the manufacturing of the products and the respective quality requirements. To achieve this, process and analytical development activities need to be performed in phase-appropriate approaches to de-risk the manufacturing and successfully commercialize cell and gene therapies.
 
To meet global demand for these services, the investment has enabled the operations of several new laboratories covering both process and analytical development. In addition, the expansions enable Lonza to drive its Chemistry, Manufacturing, and Control (CMC) activities, which are increasingly acknowledged as key success factors for the commercialization of Cell and Gene products.

Comments from Leadership

Behnam Ahmadian Baghbaderani, executive director, Global Process Development, Cell & Gene Technologies, Lonza, commented, “We expect this newly added capacity to provide Lonza’s CGT Development Services asset with extensive room to grow and serve the growing needs of our customers. It will enable our existing team to build on their track record of more than 150 Cell & Gene process development projects delivered to customers. With the expansion, Lonza Cell & Gene Technologies will offer various early- and late-phase development services in one of the largest process development laboratories in the field.”
 
Alberto Santagostino, SVP, head of Cell & Gene Technologies, Lonza, added, “The foundation of cell and gene therapies is a process. As the field matures, drug developers are now electing to spend more time and effort building a robust, reliable process early to avoid high-risk gaps in manufacturing. This has seen demand for our process development expertise and capabilities increase consistently. To continue supporting these drug developers, we are investing in internal growth to strengthen our teams and capabilities. This will support our systematic approach, both to reliably produce commercial cell and gene therapies and to bring them to market for our customers.”