Manufacturing biologics requires customizable solutions with the flexibility to scale operations from small-scale to large-scale with replicable results. Single-use technologies in manufacturing equipment have become a mainstay. John Puglia PhD, Senior Director, R&D, Single-Use Technologies, Thermo Fisher Scientific, discusses industry trends, manufacturing challenges, and the latest production innovations.
 
Contract Pharma: What pharma/biopharma trends are having the most impact on manufacturing equipment?
 
John Puglia: Manufacturers are facing pressures to develop their products more sustainably, in addition to facing rising costs of production through inflation and supply chain issues. With this, their equipment needs to help them meet their Environmental, Social and Corporate Governance (ESG) goals by using less energy, taking up less space and creating less waste. From a biomanufacturing standpoint, manufacturers using single-use equipment like the Thermo Scientific DynaSpin Single-Use Centrifuge can reduce up to 69% of filter (plastic) waste and 74% of liquid waste.
 
Contract Pharma: What are the more significant manufacturing challenges clients look to overcome?
 
John Puglia: When it comes to biomanufacturing, customers are especially interested in products and equipment that solve their problems. It is critical to have solutions that provide a simple and consistent way to scale-up production from small-scale to large-scale without the need to change anything in the process. With single-use equipment, scaling is easy, and choosing equipment within the same family (i.e., moving from a 50L Thermo Scientific DynaDrive Single-Use Bioreactor (S.U.B) to a 5000L DynaDrive S.U.B.) means more consistent results without changing processes. Single-use equipment is significantly smaller than its stainless-steel counterparts, requiring less manufacturing space (and lower operating costs) with replicable results at any scale.
 
Contract Pharma: What are some of the latest advances in manufacturing equipment?
 
John Puglia: Thermo Fisher Scientific recently launched the Thermo Scientific DynaChrom Single-Use Chromatography System, which features many advancements in single-use manufacturing equipment. In addition to providing manufacturers with the ability to easily scale their operations, DynaChrom also provides a uniquely customizable experience with simplicity and ergonomics in mind. Thermo Fisher has built this equipment specifically to meet the needs of its customers. DynaChrom features changeable line sets to allow for run customization, while also preventing cross-contamination. The line sets are also built to withstand various chemicals thanks to the durable materials used and the inclusion of our BioTitan retention devices. It’s also column agnostic, providing additional flexibility. DynaChrom also features novel technological capabilities, including TruChrom for tracking the lifecycle of reusable columns, and InfoBatch for batch reporting to track critical milestones in every run.
 
Contract Pharma: In what areas do you see production innovation and/or new technologies being used?
 
John Puglia: Like most other areas of business, I expect to see an increase in the use of artificial intelligence. There are a tremendous number of variables in flux with biomanufacturing, especially with increased adoption of Process Analytical Technologies (PAT), and the influences of these variables are being explored to help us optimize the process. AI will be a critical part of understanding the data generated through PAT, considering all historical results and thus, providing predictive trends on the process. While a large mountain to climb, the goal is to isolate all the dependent and independent variables and track them to a resolution that is shown to be responsive to process changes, then managed in real time the results to make modifications to the process and realize its improved performance.