Common themes discussed in the Advanced Manufacturing Track included the necessity of driving agile, state-of-the-art manufacturing; reluctance to embrace new technologies in the face of regulatory uncertainties; and an AI-focused future for manufacturing.
Companies are still encouraged to consider single-use technologies and continuous manufacturing operations that are flexible and can account for multiple product types, often in smaller volumes.
The following are highlights from select sessions the Scientific Programming Advisory Committee considered particularly relevant.
Smart Manufacturing
Panelists
· Bethany Silva, Industry Manager - Life Sciences, Endress+Hauser
· Scott Campbell, Director Business Development, SCHUNK
· Paul Daniel, Senior GxP Regulatory Expert, Vaisala
“Integrated factories” as key to the future of manufacturing served as a common topic during this panel discussion. Campbell described this model as “a mechanical system inside an integrated factory.” Silva envisioned the future of pharma lying in an autonomous, closed system that uses AI to limit human involvement, stating this “has to be a whole package.” Daniel reiterated support for an integrated effort, adding the need for data to be stored in the cloud.
The three panelists agreed that pharma has held back from implementing new types of manufacturing because of regulatory constraints both real and perceived. The panelists noted that FDA encourages innovation, and this constraint may be more of a communications issue than an actual regulatory constraint. In many cases, technology is moving faster than regulatory response. Recording the rationale for decisions and providing data may alleviate concerns about regulatory heavy-handedness with new technologies.
Per Campbell: “GMP, GDP, GCP—these are just good practices, i.e., the best practices to make a safe product and profit.”
Another point of discussion involved proprietary versus bespoke systems. Daniel is not a fan of customized systems and believes these should be restricted to processes that concern a competitive advantage.
AI-Powered Data
Presenter
Fabrizio Maniglio, Industry and Business Development Director, Honeywell
Maniglio opened his presentation with a sobering review of statistics. In the life sciences, only 3% of all data is used, leaving a massive amount of information unapplied and unconsidered. He referred to this as a “data swamp.”
“We all know monsters are waiting in those swamps,” he emphasized.
But AI offers solutions to this massive data challenge in three ways:
1) Ability to use unused data
2) Insights at the right time
3) Wading through the complexity of data – currently, data is often simplified, as he puts it, into a few CPPs or KPIs
With AI, insights can be turned into actions and enable proactive responses, creating a continuous improvement loop. Maniglio used the example of visual inspection. Automated visual inspection generates thousands of images. Large language models can analyze these images and identify patterns connected to quality issues. Ultimately, “we can deliver quality” by applying AI to data.
Transforming Biomanufacturing
Panelists
· Todd Pangburn, Ph.D., NA BioPharma Processing Technical Leader (R&D & TS&D), DuPont - Liveo Healthcare Solutions
· Kerry Love, Ph.D., CEO/President, Sunflower Therapeutics
· William Clark, Process Engineering Lead, Arcadis
· Chris Slevin, Lead Process Engineer, Arcadis
The panelists in this session highlighted new technologies and approaches to biopharmaceutical manufacturing.
Pangburn discussed single-use technology applications for manufacturing cell and gene therapies.
Love showcased her company’s user-friendly continuous biomanufacturing solution, which is fully automated. Her system also uses single-use technology that is more sustainable and consumes less energy than other traditional technologies. It can produce diverse product types, including cell and gene therapy products.
“Innovative products are ideal for innovative manufacturing,” she said during the Q&A. “Low volume products are good for new manufacturing approaches.”
Clark and Slevin offered insights into facilities used to produce GLP-1 products and foresee continued demand in this therapeutic. Their forecasts show that by 2030, four out of the top 10 drug products will be GLP-1 products. Growing demand means new facilities are needed to support these products, especially as they anticipate seven new GLP-1 injectables and 1-2 oral products. At present, the manufacturing infrastructure for GLP-1 products is “tapped out.”
Slevin wishes firms manufacturing GLP-1 products would bring their engineering and design firms in early to consult on processes ahead of potential demand.
Quick Fires
Accelerating Facility Development with AI and Modular Blueprints
Antonello Finucci, Director Technology Management & Process Digitalization, Exyte
Finucci addressed how large language models can be used to design facilities that “redefine time to market,” including such applications as create-your-own blueprints.
Artificial Intelligence as Enabler of Industry 4.0 and Smart Factories
Maria Batalha, Senior Consultant, Valgenesis
Batalha believes the pharma industry “is still in industry 3.0.” She sees AI as critical in moving the industry to industry 4.0. In particular, AI can help ensure validation by reducing time, eliminating human error, and generating resource efficiency. “The time to digitize is now,” she emphasized.
Highly Agile Biopharma Manufacturing Capacity
Mark Witcher, Ph.D., Biopharma Operations SME, Exyte
Of highly agile manufacturing, Witcher said “this is the facility capability I wish I’d had when I worked at Amgen, and, more importantly, in the CMO/CDMO space.” This new framework for manufacturing features facilities that adapt to processes with local operating units and rapidly supports multiple product types. He used the example of a collection rooms that offer space for different types of production instead of the typical “ballroom layout” of production lines laid out inside a large room.
Utilizing FDA Data for Regulatory Trends Within Advanced Manufacturing
George Kwiecinski, CEO, Global Key Solutions Corp.
Kwiecinski uses an AI model to identify FDA inspection trends by analyzing the CFR codes mentioned in 483 observations and Warning Letters. He used this model to identify common trends in FDA inspections, including for specific sites and firms.
Key Exhibitors
The following are key exhibitors who showcased advancement manufacturing technologies.
Common themes included greater uses of robotics and automation, sustainable materials, and single-use technologies.
CAI
The CAI booth included demos of the company’s digital twin technology that creates 3D models of manufacturing spaces and integrates AI into digital twin development.
Cytiva
During the show, Cytiva representatives offered demonstrations of the company’s SA25 aseptic filling that includes horizontal airflow simulation for smoke studies.
KROHNE
KROHNE showcased its FLEXMAG 4050 C flow meter, the first electromagnetic flowmeter with a biocompatible disposable flow tube for single-use applications.
Saint-Gobain Performance Plastics
The company showcased its new fluid transferring tubing manufactured from sustainable materials that do not require rinsing.
Sanisure
This company also showcased specialized tubing. Their CleargreenPure tubing was constructed using plant-derived materials and is designed for use in cell and gene therapy processes. Representatives demonstrated what they called the “clearest propylene container for the collection, storage, and transfer of materials during manufacturing.”
SKAN
This booth featured information about the company’s Annex 1-compliant ebeam. This system transfers presterilized tubs with ready-to-use components into high-speed isolator filling lines. Sterilization occurs upon transfer with this system.
Staubli
At a press conference, company representatives announced Staubli’s Sterimove, mobile cleanroom robot for Grade D, C, B, and A environments. The robot is constructed from FDA-compliant materials and includes features such as a magnetic touch switch on button to avoid the potential for contamination. This robot was designed for a client in the industry seeking a solution for a smaller footprint robot to automate numerous applications.
WAB
The WAB booth highlighted its TURBULA® T2G/GE Series Mixer, a 3D shaker mixer that uses a Schatz oloid shape for gentle mixing at short times.