Christopher Cole

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.

Manufacturing Intelligence: Unpacking Digital Twin Use in Pharma Manufacturing

In this episode of Manufacturing Intelligence, Rick Jaenisch, Senior Director of Education, Outreach, and Digital Experience at Open BioPharma and Chris Cole, Associate Editorial Director at 

, offer a wide-ranging explainer on digital twins in pharmaceutical manufacturing, covering definitions, current applications, practical requirements, and future possibilities.

Jaenisch grounds the discussion in the FDA's own definition, describing a digital twin as information constructs that mirror a physical asset and are dynamically updated with real-world data, emphasizing the crucial distinction between a static virtual model and a true digital twin. "If it isn't updated with either real time or somewhat periodic updates... it's not really a digital twin,” he says. “It's a virtual model."

The conversation highlights two primary use cases: risk reduction and scale-up modeling. By running hundreds or thousands of simulations virtually, manufacturers can identify potential errors and optimize processes before committing to a physical run, effectively letting "the computer fail" cheaply and quickly. Facilities management, AR-assisted operator training, and inventory tracking via RFID are identified as active applications today.

Scaling digital twins to full manufacturing lines requires robust data unification across building management, laboratory information management systems, and inventory systems, a significant integration challenge. Jaenisch identifies AI as essential, noting that "Digital twin without AI is pretty much just a virtual model." Generative AI's ability to find the needle in a haystack makes it indispensable for anomaly detection at scale.

Looking ahead, Jaenisch sees virtual inspection—in which regulators conduct non-disruptive audits through a real-time digital twin—as a compelling frontier. He also flags a persistent human challenge: first-generation employees often resist the increased sensor and camera surveillance that digital twins require, even when the monitoring is automated rather than human-led.

Videos

Todd Vaughn and Christa Myers, CRB, discuss how Robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

Todd Vaughn and Christa Myers on What Robotics Mean for Pharma Manufacturing

rising automation in aseptic manufacturing and growing regulatory focus on sterility.

, Todd Vaughn and Christa Myers, Fellows of Aseptic and Sterile Products at CRB, speak with 

to discuss their panel discussion on the growing role of robotics and automation within the aseptic core of pharmaceutical manufacturing. Their conversation covers where the industry stands today, the opportunities automation presents, and what challenges lie ahead.

Both speakers highlight environmental monitoring, specifically, the automated handling of plates and monitors. As Myers notes, "Every time you stick your hand in a glove to change a plate, which sometimes happens every hour, sometimes happens every two hours, you have to stop your fill line, which means you have to stop production, which means you have to stop manufacturing." Automating this step, she argues, could significantly restore efficiency to fill lines and should have been done years ago.

Beyond environmental monitoring, both emphasize the value of robotics in equipment setup and component handling, citing improved repeatability and reduced reliance on human consistency. However, they are clear that automation doesn't mean fewer people; it means different people with different skills. Operators will need deeper technical knowledge, including mechanical and electronics training, while upstream areas like component prep and sterilization may actually require more staff.

Regulatory expectations are also shifting. As Todd Vaughn states, "Continuous improvement is what's expected now" and operators must be prepared to track trends and demonstrate risk mitigation when regulators come calling. Looking ahead, Vaughn describes the industry as being "right on the edge of novel use to expected use," anticipating that older lines could soon face scrutiny as fully automated systems become the new standard. Vaughn and Myers stress that the industry must also find ways to bring smaller, less-capitalized companies along for this transition, because their contributions to patients remain just as vital.

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

Stuart Tindal and David Chau discuss spectroscopic sensor selection for continuous bioprocessing and how industry collaboration drives shared innovation.

Stuart Tindall and David Chau on Sensors, Standards, and Shared Progress

Access Part 1 of this interview on automation, single-use durability challenges, and the shift to predictive control in continuous bioprocessing.

, Stuart Tindal, portfolio manager, Intensified Downstream Systems, Sartorius; and David Chau, global technical product specialist, Thermo Fisher—both Bio-Process Systems Alliance (BPSA) committee leaders—discuss spectroscopic sensor selection for continuous bioprocessing and the broader role of industry collaboration in advancing the field.

On the sensor side, Tindall argues that no single spectroscopic technique is universally superior; each occupies its own place in the toolbox depending on where it is deployed in the process. Key selection criteria include specificity, response time, ease of reference model generation, and process integration. He favors UV-visible spectrometry in downstream applications and Raman or near-infrared approaches upstream, where the complexity and noise inside a bioreactor demand particularly high specificity. Chau adds that sensor longevity and measurement drift are critical concerns in continuous processing, where instruments must perform reliably over extended periods. Both speakers point to the real frontier: combining multiple spectroscopic modalities—Raman, UV, near-infrared, capacitance, and frequency scanning—into integrated computational models that can monitor and control specific process parameters with greater precision.

The conversation then turns to BPSA's role in the industry. Both speakers describe the organization as a rare forum in which competitors set aside commercial interests to tackle shared challenges, from supply chain resilience during COVID-19 to extractables and leachables standards for single-use plastics, to updates to USP chapter 665. BPSA's technical committees — covering automation, continuous manufacturing, cell and gene therapy, and X-ray sterilization, among others — bring together component suppliers, equipment makers, CMOs, and biomanufacturers to develop industry-wide alignment. Chau captures the spirit well: when competitors share a room and a common purpose, collective innovation becomes possible.

Stuart Tindal and David Chau on Sensors, Standards, and Shared Progress

At INTERPHEX 2026, Mel Radford, Bethany Silva, and Jason Pennington explore data trust, cybersecurity, organizational barriers, and KPI-driven thinking in smart pharma manufacturing adoption.

Why Loving Your Problem Is the Key to Smarter Pharma Process Optimization

Watch Part 1 of this interview on how smart sensors, connectivity, and advanced analytics are enabling predictive, insight-driven pharmaceutical manufacturing.

, Jason Pennington and Bethany Silva of Endress+Hauser and Mel Radford of Rockwell Automation discuss the barriers to smart instrumentation adoption and how manufacturers can measure meaningful progress in process optimization.

The panel opens by framing data trust as foundational. Manufacturers need data not only for reporting but to engineer new processes and procedures, and that data must be consistent, traceable, and audit-ready to satisfy regulators. The speakers emphasize that regulators are increasingly supportive of innovation and transparency, but companies must be able to clearly explain the "why" behind their data and decisions. Bringing offline or asynchronous analytical measurements into alignment with time-synchronized process data within a unified namespace is essential to achieving that standard.

On barriers to adoption, the trio identifies several. Financial constraints prevent some facilities from fully re-instrumenting and revalidating. Cybersecurity is a growing concern, as new field devices increasingly come with built-in IP addresses, requiring deliberate network segmentation and cyber resilience strategies as IT and OT environments converge. People and organizational priorities present perhaps the most persistent challenge, as internal quality teams can be more demanding than regulators and companies can struggle to prioritize among competing initiatives. The panel's advice is to engage quality stakeholders early, not at the end of a project.

For measuring success, the speakers point to throughput gains and manufacturing footprint reduction as the clearest KPIs. A real-world digital twin deployment across an entire drug product line serves as a compelling example, with one customer now rolling out the approach across all production lines after seeing measurable yield improvements. The panel closes with a reframe: rather than chasing solutions, start by deeply understanding the problem and defining how success will be measured.

At INTERPHEX 2026, Bryan Poltilove highlights a new technology as a promising point-of-use media manufacturing approach with major sustainability and logistical benefits.

Point-of-Use Media Manufacturing Could Cut Bioprocessing's Carbon Footprint by Two Thirds

Watch Part 1 of this interview on how the industry is shifting!

, Bryan Poltilove, strategic advisor and independent board director focused on bioprocessing and advanced therapy manufacturing, discusses 

technology and its potential to transform how cell culture media is produced and distributed.

Poltilove describes the core innovation as a point-of-use media manufacturing approach that stores dry powder components on site, requiring only the addition of water to produce media on demand. This model delivers what he characterizes as a compelling combination: the ease and flexibility of liquid media paired with the logistical and cost advantages of powder. The reduction in shipping requirements and on-site storage footprint, driven by the fundamental differences in volume and weight between powder and liquid formats, represents a significant operational shift for bioprocessing facilities.

From a sustainability standpoint, Poltilove points to figures suggesting roughly a two-thirds reduction in carbon footprint when comparing point-of-use distributed manufacturing of cell culture products to traditional centralized manufacturing models. He frames this within a broader concept of total environmental impact of ownership, encompassing everything from sourcing through production to disposal, a lens he sees increasingly reflected in industry best practices around green sustainability.

On the technology's current status, Poltilove notes that Krakatoa is only just launching commercially, though a prototype system has already been deployed across academic and industrial laboratories on multiple continents, demonstrating strong reproducibility, consistency, and reliability. He expresses confidence that scaling the technology to full bioprocessing environments will follow the same proven trajectory, with meaningful real-world impact expected in the coming months.

At INTERPHEX 2026, Bryan Poltilove highlights a novel technology as a promising point-of-use media manufacturing approach with major sustainability and logistical benefits.

At INTERPHEX 2026, George Kwiecinski examines FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

George Kwiecinski on Why Now Is the Time to Reassess Your GMP Audit Strategy

, George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, discusses FDA GMP inspections and the evolving compliance landscape for both domestic and foreign manufacturers.

Kwiecinski opens by emphasizing inspection coverage as a foundational concern, specifically whether organizations have the right tools, technology, and documentation practices to properly assess and select their suppliers. With recent quality management system regulation changes expanding the FDA's ability to scrutinize internal audit documentation for medical devices, supplier oversight has become a particularly hot-button issue. He argues that improved technology stacks make this an ideal moment for companies to reassess and reprioritize their audit workflows.

On the broader compliance risk landscape, Kwiecinski expects the core FDA citation categories—quality unit deficiencies, drug efficacy and safety standards, and vendor enforcement—to remain stable, but he highlights an AI citation appearing in an FDA warning letter. A company had used AI to generate regulatory documentation, drawing formal scrutiny. He sees this as a signal of things to come, urging companies to examine how their organizations are managing AI-related risks.

Kwiecinski backs this up with data from a white paper his firm recently published, tracking the FDA's use of AI as a keyword across regulatory correspondences over the past three to four years. The findings indicate that AI mentions are growing in frequency, now spanning five regulatory correspondences and more than twenty FDA guidance documents. His guidance to industry is to adopt AI tools if they demonstrably save cost or drive profit, but approach the risk-based framework governing AI-assisted decisions with care, as that is precisely where FDA scrutiny is heading.

Christopher Cole

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