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Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

Drug Digest February 2026 

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Feliza Mirasol is the science editor for 

Technical experts are turning to sophisticated digital and analytical solutions: © tippapatt - stock.adobe.com

The modern landscape for biotherapeutics is undergoing a paradigm shift as advanced therapeutic modalities, such as cell and gene therapies, move from experimental stages to commercial availability. Unlike traditional biopharmaceuticals, these next-generation treatments require specialized manufacturing frameworks to ensure both biological quality and timely clinical availability. The complexity inherent in producing these therapies often leads to process unpredictability and operational hurdles that can significantly delay patient access to lifesaving treatments.

To address these challenges, the industry is increasingly looking toward the integration of advanced analytical tools and artificial intelligence (AI) to facilitate more robust control and enhance overall manufacturing efficiency.

 Streamlining these intricate workflows is not merely a matter of technical interest but a necessity for managing the critical timelines associated with complex biologics. By focusing on supply chain reliability and clinical delivery, stakeholders can bridge the gap between scientific innovation and patient care.

How does process unpredictability in manufacturing impact patient access to advanced therapies?

One of the most significant barriers to the success of advanced therapies is the inherent complexity in the manufacturing process, which involves a significant amount of coordination between the patient, the treatment site, and manufacturers. In addition, there is variability between different products’ manufacturing processes, which is an administrative burden for the sites to handle as well as knowing all the different processes, says Anna Catalanotto, director, Advanced Therapy Commercial Strategy, Cardinal Health.

This challenge is particularly true for autologous therapies, for which a patient’s own cells serve as the starting material.

 Manufacturing complexities in this space can create a ripple effect that touches every part of the treatment journey, Catalanotto highlights.

“The manufacturing complexities can have a significant impact to patient access to these therapies. Whether that's from the perspective of the patient cell collection, manufacturing, or patient access, the extended time to treatment for autologous cell therapies can impact patients’ ability to be treated with these therapies.”

She also emphasizes that these disruptions can have dire consequences for the individual awaiting care. Coverage and access processes that are inconsistent or delayed can lead to unpredictable patient access, which may even cause a patient to abandon their pursuit of treatment entirely, she explains.

The time to manufacture these therapies and uncertainty surrounding when a patient will be ready for administration can create logistical challenges for treatment sites and manufacturers alike, Catalanotto continues. Catalanotto notes that the very ability of a patient to receive therapy is often tied to how well the manufacturer communicates the expected journey and prepares the site for potential deviations.

“The manufacturing complexities can have a significant impact to patient access to these therapies,” Catalanotto says. “Whether that's from the perspective of the patient cell collection, manufacturing, or patient access, the extended time to treatment for autologous cell therapies can impact patients' ability to be treated with these therapies.

Because each product may follow a distinct and complex path to the patient, maintaining clear expectations regarding timelines is vital for commercial success. Beyond the logistics, the industry must recognize that solving these delivery issues is a moral and operational imperative, according to Catalanotto.

“Patient access to these cell and gene and advanced therapies is really crucial for manufacturers to solve,” she stresses.

How can process analytical technologies and AI ensure robust manufacturing control?

To combat the unpredictability in commercial strategists, technical experts are turning to sophisticated digital and analytical solutions. Process analytical technologies (PAT) and AI are no longer futuristic concepts but are currently being utilized to stabilize biomanufacturing operations, says Carrie Mason, head, PAT Center of Excellence, Lonza Integrated Biologics. She explains that these tools allow for a much more nuanced understanding of the data generated during a production run. Whereas traditional manufacturing often relied on "getting a result" and then making a reactive decision, the modern approach uses analytics tied to AI to build a library of information that supports predictive control. This shift allows manufacturers to categorize process characteristics with high precision, driving a philosophy of "right the first time" manufacturing, she notes.

“This high level of control is essential for complex molecules that do not follow the standard production rules of simpler biologics. Furthermore, the speed at which these therapies can be brought to market is directly influenced by the efficiency of these control strategies.”

The synergy between hardware tools and software intelligence is what creates processes capable of meeting strict quality standards, Mason says. “PAT and AI really work hand in hand toward developing a robust process,” she emphasizes. By augmenting PAT tools with AI, manufacturers can enhance their process control strategies to ensure that every batch meets the necessary characteristics for clinical use.

“This high level of control is essential for complex molecules that do not follow the standard production rules of simpler biologics,” Mason states. “Furthermore, the speed at which these therapies can be brought to market is directly influenced by the efficiency of these control strategies. What we are able to do with our PAT tools is augmented with advanced AI technologies in order to enhance process control strategies.”

Ultimately, she explains, the goal is to reach the clinic faster while maintaining a robust manner of production that minimizes the risk of batch failure.

Why is multidisciplinary collaboration essential for navigating the administrative burdens of advanced therapeutics?

While technical and manufacturing improvements are critical, they exist within a broader ecosystem involving payers and health care providers. Advanced therapies often carry high up-front prices, which can lead to longer review times from insurance payers who may be concerned about the lack of long-term durability data or small clinical trial sizes, Catalanotto notes.

This hesitation manifests as an administrative burden for treatment sites, which must navigate complex health plan requirements. Treatment sites often find themselves conducting single case agreements, which are one-off negotiations for coverage and payment. Such negotiations can be time-consuming and can further delay a patient's time to treatment, Catalanotto explains. She points to this administrative friction as being a significant hurdle that requires proactive education and resources for all stakeholders.

The complexity of these therapies requires a level of collaboration that is rarely seen in traditional medicine, Catalanottoadds. She stresses that manufacturers must prepare to educate payers on evidence gaps and the specific end points used in clinical trials to ensure that the value of the therapy is understood. Similarly, treatment sites need support in managing workflows, storage requirements, and the payor authorization process.

“That upfront collaboration between manufacturers, treatment sites, and payers really is so critical to making sure that the process for getting these patients access to therapies is as smooth and as expedited as possible, and that there is a process in place to get patients access to these therapies,” Catalanotto states. “And all stakeholders involved should have all the resources and education that they need to navigate these processes that, again, are much more complex in the cell and gene therapy space compared to other therapy types.” Without this unified approach, even the most technologically advanced manufacturing process will fail to reach the patient in a timely manner, she cautions.

What role does integrated bioprocessing play in accelerating the delivery of complex molecules to the clinic?

The future of manufacturing lies in the transition away from isolated, individual steps toward a more integrated and automated model, according to Mason. Integrated bioprocessing, comprising a seamless connection of various stages of production, is viewed as the key to adapting to the needs of new modalities.

“As the industry moves toward more complex molecules, the methodologies used to produce them must also evolve to be more adaptive and faster. Advanced analytics and AI provide the necessary data to make this integration possible, allowing for a more streamlined path from the laboratory to the clinical setting,” Mason notes.

By automating these processes, manufacturers can reduce the potential for human error and decrease the time required to move between different stages of the biomanufacturing lifecycle. This evolution is being driven by the very nature of the molecules themselves, which demand more sophisticated handling than their predecessors, Mason says.

“Complex molecules and new modalities are really driving our industry to be adaptive and to drive towards a methodology that's going to get us there faster,” Mason emphasizes. The ultimate goal of this technical evolution is to reach the clinic as quickly as possible, ensuring that the innovations developed in the lab can be translated into tangible benefits for patients.

It is expected that successful delivery of advanced therapies will increasingly depends on a dual strategy that consists of the technical optimization of manufacturing through AI and PAT, and the operational optimization of the commercial ecosystem through collaboration and education. By addressing process unpredictability and administrative burdens simultaneously, the industry can create a more reliable supply chain that fulfills the promise of next-generation medicine. The integration of these disparate elements, from the cleanroom to the payer's office, may ultimately define the success of advanced therapeutic delivery moving forward.

Xie W, Pedrielli G. From discovery to production: challenges and novel methodologies for next generation biomanufacturing (version 2). 

Morrow D, Ussi A, Migliaccio G. Addressing pressing needs in the development of advanced therapies. 

Rathore AS, Sarin D. What should next-generation analytical platforms for biopharmaceutical production look like? 

de Bournonville S, Lambrechts T, Pinna T, Papantoniou I, Aerts JM. Streamlining data management & process analytics for the manufacturing of cell & gene therapies. 

Lamontagne A, Fesnak A. Limiting variability to achieve reproducibility in cell manufacturing. 

Articles

Advanced therapeutic modalities, particularly autologous cell and gene therapies, face manufacturing unpredictability that propagates across collection, production, and scheduling, extending time-to-treatment and risking patient attrition. Variability across products adds operational burden for treatment sites and amplifies the need for transparent timeline communication. Process analytical technologies paired with AI enable data-rich, predictive control strategies that support “right-first-time” manufacturing, reduce batch failure risk, and accelerate clinical delivery. Parallel administrative friction—payer reviews, evidence concerns, and single-case agreements—necessitates coordinated manufacturer–site–payer education and collaboration.

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

Addressing Manufacturing and Access Barriers in Advanced Therapeutics

Valerie Bandy brings over 25 years of distinguished experience in healthcare leadership to her current role as Vice President Pharmacy Solutions at Tecsys. With a career marked by this steadfast leadership, she has consistently excelled in driving strategic initiatives and optimizing operational efficiency. In her present capacity, Valerie collaborates closely with sales, research and development, AI and marketing teams to refine pharmacy supply chain software solutions, leveraging her extensive expertise in healthcare operations, sales strategy, supply chain, consulting, and regulatory compliance. Prior to her tenure at Tecsys, Valerie held pivotal leadership roles at prominent healthcare institutions including Director of Pharmacy at Wellstar Atlanta Medical Center, System Director of Pharmacy operations at Trinity Health, and consulting firms including Deloitte Consulting where she was a Specialist Master, and PriceWaterhouse Coopers. Throughout her career, she has spearheaded initiatives that have significantly impacted pharmaceutical procurement, cost optimization, and operational excellence, managing multi-billion-dollar budgets with adept precision. Valerie's academic credentials include a Doctor of Pharmacy, an MBA, and a Bachelor of Science in Biology, underscoring her commitment to academic excellence and professional development. Driven by her passion for healthcare leadership, Valerie actively seeks opportunities that align with organizational missions and visions, embodying a steadfast dedication to advancing healthcare delivery and patient outcomes.


Valerie Bandy, Tecsys, shares how manufacturers can build resilient supply chains, navigate drug shortages, and better support health systems.

Valerie Bandy on Building Smarter Pharma Supply Chains

In this interview, Valerie Bandy, vice president of Pharmacy Solutions, Tecsys, discusses the complex operational realities pharmaceutical manufacturers must understand when building relationships with health systems and why a proactive, strategic approach to supply chain resilience is no longer optional.

Bandy emphasizes that health systems operate within layered decision-making structures. Every new vendor relationship requires qualification, contract negotiation, and regulatory alignment. For manufacturers, understanding this complexity is critical to forming partnerships that hold up under pressure.

Drawing on real-world experience, she highlights the propofol shortage as a cautionary tale about the dangers of sole-source contracting. Health systems that had pre-established secondary vendor relationships navigated the crisis far more smoothly than those forced to scramble. As Bandy puts it, "It's really more about being intentional about the vendors that they're having relationships with and building contracts with, so that they're really being more strategic and intentional about what it is they're purchasing versus just reacting to a crisis situation."

She also calls on manufacturers to think carefully about drug allocation during shortages, urging them to prioritize health systems based on actual patient need rather than purchasing volume alone. "They have to think outside the box of their own strategy and their own marketplace and think about the patient and the health system versus just putting band-aids on the situation when they have a disruption."

Ultimately, Bandy argues that manufacturers who invest in transparency, proactive communication, and contingency planning will be far better positioned as trusted, long-term partners to the health systems and patients they serve.

Videos

Ryan Kelly is the Interim Chief Executive Officer and Senior Director of Supply Chain Security & Brand Protection at Rx-360, an international, member-driven pharmaceutical supply chain consortium focused on patient safety, quality, and supply chain integrity. In this role, he leads cross-industry initiatives spanning joint audits, supply chain security, and quality oversight, and works closely with regulators, manufacturers, suppliers, and logistics partners to strengthen risk management across global supply networks.

sat down with Ryan Kelly, interim CEO and senior director of Supply Chain Security and Brand Protection, Rx360, to explain why true supply chain visibility, smarter auditing, and quality alignment are critical to protecting patients.

Watch the 2-part video interview with Kelly:
Part 1: 

Ryan Kelly on Smarter Pharma Supply Chain Audits

Ryan Kelly's Tips for Drug Supply Chain Protection

PT: What Is the Impact of Third-Party Audits?

Kelly: The results have been significant. We have case studies where we've saved millions of dollars simply by catching issues early. There's also a compounding benefit, when third-party audits are done well, they can reduce how frequently a company needs to be audited at all. That's a win on both sides. The supplier isn't constantly hosting audit teams, and the company doing the auditing saves on cost and resources. It becomes cheaper, more efficient, and more effective for everyone involved.

The reality is you can't audit everything. It comes down to risk stratification, focusing your most intensive scrutiny on the most critical areas, and using the third-party model to provide a right-sized level of assurance for areas that are lower risk. The goal is coverage without overkill.

What Is Changing About the Intersection of Quality and Supply Chain?

Historically, quality owned the manufacturing process, batch release, process controls. Supply chain focused on execution, coordination, and moving product. Those were largely siloed functions. At Rx360, we're actively working to break down that divide, because the truth is they are inseparable. How you move product through the supply chain, maintaining temperature, visibility, and control at every stage, directly impacts quality. We have to look at GMP and GDP holistically and build quality into supply chain design from the very beginning, not add it as an afterthought.

The most effective way to drive alignment is to work backwards from the patient. If every decision ties back to ensuring the patient receives a safe and efficacious dose, quality and supply chain teams naturally find shared purpose.

What Are the Most Common Mistakes You See Organizations Making?

One big mistake I see is a false sense of supply redundancy. A company will identify a primary supplier and a secondary supplier and feel confident they're protected. But when you dig deeper, you often find that the secondary supplier is sourcing their raw materials from the same place as the primary supplier. So if there's a supply disruption at that source, there is no reliable backup in your supply chain.

That's why supply chain mapping is so essential. You need to understand every single product, its full end-to-end flow, where your inventory sits at every node, and what could go wrong at each point. That includes geographic, regional, transportation, and financial risks within your supply base. It sounds straightforward, but many organizations genuinely don't have complete visibility into where their physical product is at any given time, from raw materials and APIs all the way through to final labeling and delivery to the customer.

In order to address these gaps organizations need to digitize where they can, audit against the highest international standards regardless of where you're operating, and build quality into your workflows from the start. You simply cannot add quality at the end. The organizations that understand that are the ones that will protect both their supply chain and their patients.

Third-party auditing, when executed rigorously, can generate material cost savings by identifying issues early and can reduce redundant audit burden across suppliers and sponsors. Because comprehensive auditing is impossible, risk stratification is required to match assurance levels to criticality. Quality and supply chain can no longer operate as silos; GMP and GDP are operationally inseparable, and quality must be engineered into supply chain design rather than appended at release. Common vulnerabilities include illusory redundancy and limited end-to-end visibility, underscoring the need for mapping, digitization, and global standards.

Ryan Kelly, Rx360, shares how aligning quality, supply chain functions, and auditing deeper is key to pharmaceutical patient safety.

Q&A: Ryan Kelly on What Good Supply Chain Audits Look Like

PharmTech Weekly Roundup-May 8, 2026

This week, the industry saw a push for proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.

Whether it is navigating the complexities of genetic medicines or addressing skilled labor shortages, the industry is moving away from rigid, legacy systems toward modular, automated, and sustainable frameworks. The following stories highlight how the sector is evolving to meet modern clinical and commercial demands.

 of its Indiana manufacturing campus underscores a massive push for domestic capacity in advanced modalities, including genetic medicines and high-volume metabolic treatments for obesity.

 to learn more about IPEC-Americas’ Risk-Based Excipient Framework and the related workshop conducted at Excipient World, which was held from May 4-6 in Nashville this year. The new risk-based framework and decision-tree model from IPEC-Americas aims to streamline the development of new excipients by systematically evaluating safety, quality, and market acceptance risks.

Our coverage of INTERPHEX 2026 continued with interviews on lean and sustainable design, media and buffer strategies, robotics, and modularization.

Leslie Weaver and George Hunt of IPS talked about how integrating “

design for disassembly” and lean principles

 into capital projects allows pharmaceutical manufacturers to build more adaptable, sustainable facilities that can evolve with changing production needs rather than requiring total demolition.

 talked about how bringing media and buffer manufacturing on-site offers CDMOs a strategic way to de-risk supply chains, reduce lead times, and improve sustainability through increased productivity in cell and gene therapy production.

 explained how increasing regulatory expectations are driving the adoption of robotics in aseptic cores to minimize human intervention, thereby reducing contamination risks and improving the efficiency of environmental monitoring.

stressed that modularization and off-site fabrication are becoming essential construction strategies to mitigate the impacts of regional skilled labor shortages and enhance proactive risk management for large-scale pharmaceutical projects.

Dirk Schuster, sales director Pharma at groninger & co. GmbH

, provided his insights on how artificial intelligence is transforming the visual inspection of injectable drugs by linking complex process and image data to detect subtle deviations, particularly in sensitive, high-viscosity biologic formulations.

As this week’s news stories and interviews show, the future of the industry lies in balancing rapid innovation with robust, data-driven controls. By embracing these technological and structural shifts, manufacturers can ensure more reliable, scalable, and compliant pathways to the patient.

Be sure to join us again next week. Thank you for watching.

This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.

Lilly Invests in Indiana Manufacturing Site

A further $4.5 billion commitment to manufacturing in Lebanon, Indiana, adds to the scale of Eli Lilly’s ongoing effort to expand domestic pharmaceutical production capacity, the company announced on May 6, 2026.¹ The announcement is one of many movements from Lilly to bolster their network planning across API output, newer modality manufacturing, and future clinical-to-commercial transfer.

The new funding was disclosed as the first of three facilities at the Lebanon site, a genetic medicine plant, became operational.¹ 

David Ricks, chief executive officer, Eli Lilly, said in a press release,¹  “Lilly's legacy of firsts in Indiana continues today and the best measure of that legacy is what we do next.” He added, “From genetic medicines that could one day prevent disease at its source, to Foundayo, a pill making weight loss treatment accessible to millions, we are not just discovering the medicines of the future, we are building the world’s most advanced plants to make them.”

Why is Indiana Becoming a Focal Point for Pharmaceutical Manufacturing?

More than $21 billion of Lilly’s domestic manufacturing commitments this decade have been directed to Indiana.¹ The Lebanon complex, located in the LEAP Research and Innovation District northwest of Indianapolis, has been described by the company as a central element of its broader US production expansion. 

This investment will expand the Lebanon Advanced Therapies facility and the Lebanon API site, which is now under construction.¹ One facility is intended for therapies targeting disease at the genetic level, while the other is designed to support high-volume production of established and emerging metabolic medicines. This creates a mixed campus model spanning advanced modalities and large-scale synthetic or process chemistry operations, with implications for workforce design, quality systems, utilities, and supply chain coordination.

How Does the Lebanon Site Fit Current Demand for Obesity Medicines?

The API facility is expected to manufacture tirzepatide for Mounjaro and Zepbound, products approved in the United States for type 2 diabetes and chronic weight management, respectively.²˒³ The added Indiana funding will also allow manufacturing of Foundayo, described as a newly launched oral GLP-1 obesity treatment, as well as retatrutide, an investigational triple hormone receptor agonist.

The product mix reflects a broader industry challenge: balancing immediate commercial demand for incretin-based medicines with the need to preserve capacity for pipeline assets that may require different process configurations, material flows, or containment strategies.¹ API network design for metabolic disease products increasingly has to accommodate both current volume constraints and uncertain future shifts in formulation and route of administration.

What Does this Investment Signal for Process Development?

The Lebanon Advanced Therapies facility will support both clinical and commercial manufacturing of therapies that act at the genetic level.¹ The work done on this site, designing and constructing for these modalities, required developing a new manufacturing process without precedent. This points to a common issue in advanced therapy manufacturing: facilities are often being built while platform assumptions, control strategies, and commercial comparability expectations are still evolving.

The third facility at the site, the Lilly Medicine Foundry, remains scheduled for completion in 2027 and is intended to combine research and development with clinical trial manufacturing.¹ That type of integration may help shorten technology transfer timelines, though the operational effectiveness of such hybrid models will depend on how flexibly they handle process changes across development stages.

The Indiana project also sits within a wider onshoring trend.¹ Lilly previously outlined four additional US manufacturing projects, including API plants in Virginia, Alabama, and Texas, and an injectables and device facility in Pennsylvania. The immediate next questions are less about investment totals than about execution: speed of qualification, labor availability, process robustness, and how quickly added capacity can be translated into reliable supply across multiple therapeutic platforms.

Eli Lilly and Company. Lilly commits additional $4.5 billion across indiana manufacturing sites. Press release. May 6, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lilly-commits-additional-45-billion-across-indiana-manufacturing

US Food and Drug Administration. Mounjaro (tirzepatide) injection prescribing information. 

US Food and Drug Administration. Zepbound (tirzepatide) injection prescribing information. 

Eli Lilly is adding $4.5 billion to its Lebanon, Indiana manufacturing buildout, bringing its decade-to-date Indiana commitments above $21 billion and reinforcing a US onshoring strategy. The first of three Lebanon facilities—a genetic medicine plant—is now operational, alongside planned expansion of advanced therapies and an API site under construction. The campus is positioned to support high-volume metabolic medicines, including tirzepatide and an oral GLP-1, while preserving flexibility for pipeline assets. Execution will hinge on qualification speed, labor, and process robustness.

Lilly expanded its Indiana manufacturing investment by $4.5 billion to support tirzepatide, oral glucagon-like peptide-1, and genetic medicines.

Lilly Invests $4.5B to Indiana Manufacturing Site

Rich Sanderson is Regional Operations Director for IPS in Pennsylvania. Rich brings extensive EPCM experience and almost three decades in construction management in the UK and US, including 25 years in US life sciences. For the past 8 years with IPS he has served as an Operations Director leading large, complex EPCM projects and teams for major clients including Merck and GSK. He is recognized for his ability to elevate team performance through Lean practices, collaboration and align stakeholders to deliver outcomes.

Richard Sanderson, IPS, discusses risk management, predictive controls, and innovation to address skilled labor shortages in pharma construction.

Richard Sanderson on Why Modularization Is Key to Pharma Construction's Future

Access Part 1 of this interview on comparisons between EPCM and more traditional construction systems.

, Richard Sanderson, Vice President in the Project Business Services Group, IPS, discusses the new era of Pharma construction, following a panel discussion on the deployment of lean, sustainable, and tech-enabled delivery platforms on large EPCM projects.

Sanderson emphasizes that proactive risk management is at the heart of IPS's approach to project delivery. "We have a very active risk management program at IPS whereby we're constantly trying to estimate and evaluate risks and identify risks and really understand what that could mean and anticipate those impacts early in the life cycle of the project so that we can discuss that with our clients,” he says, “and we can put in place appropriate mitigation strategies."

Central to this is the use of predictive controls and variance analysis, which allow for observation of troubling trends before they become costly problems and implement corrective measures in real time.

Sanderson also speaks to a broader initiative to strengthen and standardize project controls and management platforms through the newly initiated Project Business Services Group, an effort aimed at harmonizing the tools and processes used across its project portfolio.

Looking at the wider industry landscape, Sanderson acknowledges the extraordinary level of activity currently reshaping the pharmaceutical construction sector, with major companies announcing large-scale programs across the US. He points to the challenges this boom creates, particularly in regions without abundant skilled labor.

"We have to continue to innovate, and we have to continue to think about how off-site fabrication and modularization and some of those other lean project delivery tools can help with that," he says, noting that resource constraints in areas like Central Virginia. This area contains several large programs that are launching in close proximity, making creative solutions not just beneficial but essential.

Richard Sanderson of IPS discusses risk management, predictive controls, and innovation to address skilled labor shortages in pharma construction.

Dirk Schuster is sales director Pharma at groninger & co. GmbH as well as a member of the company’s management board. He is responsible for global sales activities in the pharmaceutical sector, with a strong focus on aseptic filling, containment solutions, and fill-finish technologies for complex drug products. With many years of experience in the pharmaceutical machinery industry, Schuster supports pharmaceutical and biotech manufacturers in developing scalable, regulatory-compliant production concepts. His work focuses on aligning customer requirements with long-term, robust filling solutions that address increasing product complexity, automation, and lifecycle considerations.

Automated pharmaceutical semaglutide ozempic injection pen filling line. Aseptic manufacturing of injectable drug delivery devices, insulin GLP-1 pens. weight loss drug production, medical automation | Image Credit: ©Corona Borealis -stock.adobe.com

Visual inspection of pharmaceutical products is part of quality control and quality assurance. The FDA provides guidance for the development of a risk-based approach to detecting, controlling, and preventing visual particulates in drug products, including injectables.

 Injectable drug products can be the typical vial and syringe products or prefilled syringe combination products. The nature of a combination product; however, creates specific challenges for visual inspection. 

spoke with Dirk Schuster, sales director Pharma at groninger & co. GmbH, to find out more about what goes into visual inspection of prefilled syringes and how artificial intelligence (AI) may be used in the process.

PharmTech: How does the viscosity of liquids complicate the filling of prefilled syringes? How does it impact traditional vial/syringe delivery?

 The viscosity of a drug substance has a direct impact on the entire filling process. While synthetically manufactured small molecules are typically low-viscosity and relatively easy to handle, modern large-molecule drugs, such as biologics, place significantly higher demands on process stability and equipment performance. Highly viscous formulations flow more slowly and are more sensitive to external influences, such as temperature, pressure, shear forces, or pump speed. Filling therefore must be fast, highly precise, and at the same time, particularly gentle to preserve product integrity.

Compared with traditional vial filling—where more robust products and larger fill volumes allow wider process windows—prefilled syringes with high-viscosity products operate within much tighter tolerances. As a result, product requirements directly affect line performance and output, making reliable equipment operation under demanding conditions a key success factor for quality, efficiency, and patient safety.

Which part of the filling processes is best suited to the addition of AI into automated filling steps?

Artificial intelligence delivers the greatest benefit where highly automated filling processes meet complex product and process requirements. This is particularly true in areas where large volumes of process, motion, and image data are generated, such as monitoring filling operations, material handling, or overall machine performance.

In our view, the value of AI lies not in replacing proven automation, but in intelligently analyzing and linking data to identify deviations, trends, or irregularities at an early stage— before they affect product quality or line efficiency. AI can also support operators by improving error detection and root-cause analysis, for example through guided, visualized, and validated format changeovers on advanced filling lines for sterile vials, prefilled syringes, or cartridges.

How do supply chain complications impact filling lines? (eg, glass and stopper materials, plastics, suspension, and other media)

Supply chain disruptions affect fill/finish processes in a fundamentally changed market environment. Historically, filling lines were designed for high volumes of robust formulations, with throughput and efficiency as the primary goals. Today, targeted therapies, biologics, and peptides—often developed as integrated drug-device combinations—are more sensitive, higher in value, and increasingly processed in prefilled syringes or

As a result, variations in glass, stoppers, or pre-sterilized components can no longer be considered in isolation; even minor deviations may significantly impact process stability. For fill/finish equipment, this means traditional compensation mechanisms reach their limits. From a machine builder’s perspective, the focus shifts to designing robust yet flexible systems that can reliably handle material variability without compromising quality or regulatory compliance.

How do aseptic/sterile manufacturing requirements impact the number of prefilled syringes that can be produced at one time?

The number of prefilled syringes produced per aseptic manufacturing run depends largely on the characteristics of the product itself. Robust, low-viscosity drug substances allow high output rates even under sterile conditions, as they tolerate wider process windows and deviations.

By contrast, sensitive peptides or biologics require particularly stable and gentle processes due to narrow tolerances, high product value, and sensitivity to mechanical or temporal stress. In such cases, it is not sterility requirements alone but product properties that limit the economically viable batch size.

For the machine builder, this means designing filling systems consistently around the product—for example through highly automated, isolator-based RTU concepts—and defining productivity through reproducible quality, process stability, and long-term controllability rather than speed alone.

Inspection of Injectable Products for Visible Particulates, Guidance for Industry.

. December 2021. Accessed April 29, 2026. https://www.fda.gov/media/154868/download

Dirk Schuster, Sales Director Pharma, groninger & co. GmbH 

Visual inspection is integral to parenteral QC/QA, and prefilled syringe combination products introduce distinct inspection and fill/finish constraints. High-viscosity, large-molecule formulations tighten process windows versus traditional vial filling because flow is slower and more sensitive to temperature, pressure, shear, and pump dynamics, necessitating fast yet gentle, highly precise dosing. AI is positioned to add value in data-rich, highly automated operations by correlating process, motion, and image data to detect deviations early and improve root-cause analysis and validated changeovers. Material variability from supply disruptions further stresses stability, shifting equipment design toward robust flexibility.

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

Using AI to Enhance Visual Inspection of Injectable Drug Products

Project Manager, Sustainability, IPS-Integrated Project Services

Corporate Lean Director, IPS-Integrated Project Services

Leslie Weaver and George Hunt, IPS, explore how design for disassembly and lean thinking are transforming the way pharmaceutical facilities are built and scaled.

Leslie Weaver and George Hunt on Scaling Lean and Sustainable Design

Access Part 1 of this interview on early sustainability and lean alignment in pharma construction.

, Leslie Weaver, sustainability project manager, IPS, and George Hunt, corporate lean director, IPS, discuss two interconnected ideas reshaping how pharmaceutical facilities are designed and built: design for disassembly and lean thinking applied to capital projects.

Weaver explains the concept of design for disassembly, an approach that builds flexibility and adaptability directly into a facility from the outset, rather than locking in rigid structures that must eventually be demolished and discarded. She draws on the familiar example of modular office cubicles that can be reconfigured rather than torn out and notes that this same logic is increasingly relevant in pharmaceutical construction.

"I'd love to see us get more innovative in how we can implement the design for disassembly and keep materials in their useful life for as long as possible," Weaver says.


She acknowledges the challenge lies in the technical complexity of pharma environments, where highly specialized equipment and tightly controlled processes make flexibility harder to achieve than in conventional commercial spaces.

Hunt pivots to the question of lean thinking and how to move it beyond a one-time project exercise into an enduring partnership mindset. He argues that the real value comes not from applying lean principles to a single build, but from carrying lessons learned forward across multiple projects.

As he puts it, "We can bring what we've learned on this last one, let's bring them here and let's try and do it better and kind of improve on that."

Hunt also points out that while lean thinking is already embedded in many pharma manufacturers' production operations, what's newer is bringing that same discipline to the capital project process itself: the planning, design, and construction of the facilities where manufacturing happens.

Together, Weaver and Hunt make the case that sustainability and lean principles aren't separate agendas but complementary frameworks for building smarter, more adaptable pharma facilities and for scaling those improvements across an entire organization.

Avi has 20 years of industry experience in gene therapy, viral vectors, and vaccines. He is currently the President of SK pharmteco Cell and Gene North America managing the business unit. Previously he worked at Novartis Gene Therapies where he supported a pipeline of 15+ gene therapy products in development from preclinical to Phase III development and led the development and implementation of 4 gene therapy manufacturing processes across 4 CGMP and 3 laboratory sites. Prior to his role at SK pharmteco, Avi was the Chief Technical Officer at the Center for Breakthrough Medicines. His prior positions include Head of Technical Development at Novartis Gene Therapies, Director of Manufacturing Science & Technology at Avexis, Inc., and Product lead at Seqirus. Avi holds an MS in Biology from Adelphi University and an MBA from the University of North Carolina Kenan-Flagler Business School.

connected with Avi Nandi, president of Cell & Gene North America, SK Pharmteco, to discuss the rising needs of media and buffer manufacturing as supply chains continue to have inconsistent stability.

Watch the 2-part video interview with Nandi:
Part 1: 

Avi Nandi on How CDMOs Are Simplifying Cell & Gene Supply Chains

Avi Nandi on the Impacts of On-Site Media and Buffer Manufacturing

PT: How Do You Think About Media and Buffer Supply as a Pain Point in Bioprocessing from a CDMO Perspective?

Nandi: I look at it in three ways: lead time, consistency, and expiry. As a critical raw material for our manufacturing operations, media and buffers sit at the heart of the supply chain. On the lead time side, most of our clients in cell and gene are operating somewhere between early- and late-stage clinical development. The window from identification to use tends to be short, because clinical supply is the priority. That puts pressure on suppliers to manufacture and ship quickly, and lead time becomes a real constraint.

Once material arrives, we're then working against an expiry clock. For early-stage products especially, the timing of when a material will be used can be unpredictable, so longer shelf life is a meaningful benefit. And then there's lot-to-lot consistency. Many of these buffers and medias are highly specific to a given product, and the understanding of how variances affect the manufacturing process can still be limited. Reproducibility is critical, particularly as product scales through clinical phases and toward commercial launch.

What Are the Key Advantages and Limitations of Bringing Media and Buffer Manufacturing On-site?

There are strong pros and strong cons. On the positive side, internal control of the supply chain is a huge benefit. You're able to manufacture these materials based on immediate demand, which lowers supply chain risk, reduces cash exposure in raw material procurement, and limits the expiry exposure that comes when manufacturing schedules shift. That kind of agility is genuinely valuable.

The challenge for CDMOs specifically is that our threshold for adoption is higher, because we're supplying a much larger and more diverse client base. We need high-quality, consistent product and any variance in how media or buffer is manufactured could have downstream effects on the manufacturing process that we might not detect until late. So reproducibility and lot-to-lot consistency are non-negotiable for us. That said, I think on-site manufacturing technology is an excellent step forward, and it's ultimately where the industry needs to go to properly support clients.

How Do CDMOs Help Clients Manage Supply Chain Risk Across  Stages of Development?

Because we work with a large and diverse client base, CDMOs have a broader view of demand than an innovator focused solely on their own product. That visibility helps navigate inventory more flexibly and keep reserves where needed, though it's still a risk proposition on our side. For earlier-stage clients, speed is the priority. They need to get into the clinic as fast as possible. Those materials can also be quite product-specific, which makes it harder to absorb inventory risk. As products move toward commercial stage, though, the opportunity grows considerably. You can start building in inventory reserves, redundancy in suppliers, and more robust de-risking strategies. It really comes down to where the client is in their development journey.

How Does Sustainability Factor into Your Thinking for Cell and Gene Manufacturing?

Cell and gene is a heavily single-use industry with high consumables, high waste, and relatively new technologies. So, when I think about sustainability, I start with productivity. We're still in early generations of these technologies, and the most impactful lever I can pull is maximizing productivity to reduce the number of manufacturing runs needed. That's different from how chemical industries approach sustainability. For on-site media and buffer manufacture specifically, it comes down to the effectiveness of manufacture and use, avoiding unnecessary resupply runs driven by expiry or inventory management issues. Improve productivity, and you improve sustainability alongside it.

Media and buffers represent a central cell and gene therapy supply-chain constraint across three dimensions: lead time, lot-to-lot consistency, and expiry-driven usability. Short clinical timelines compress ordering-to-use windows, while variable manufacturing schedules amplify shelf-life risk. Product-specific formulations heighten sensitivity to variability, making reproducibility essential through clinical scale-up and toward commercialization. On-site media/buffer manufacturing offers agility, reduced procurement cash exposure, and lower disruption from schedule shifts, but raises stringent requirements for validated consistency across diverse client portfolios.

Avi Nandi, SK Pharmteco, discusses how on-site media and buffer manufacturing can simplify supply chains and de-risk cell and gene therapy production.

Q&A: Avi Nandi on Media and Buffer Supply Chain Strategies for CDMOs

Sr. Fellow
Aseptic and Sterile Products
CRB Group

Fellow
Aseptic & Sterile Products
CRB Group

connected with Todd Vaughn, fellow, Aseptic & Sterile Products, and Christa Myers, senior fellow, Aseptic and Sterile Products, both at CRB Group, to discuss the growing role of robotics and automation in sterile pharmaceutical manufacturing and what it means for the industry's future.

Watch the 2-part video interview with Vaughn and Meyers:
Part 1: 

Robotics in the Aseptic Core: Rising Urgency, Rising Expectations

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

PT: Why Is Robotics in the Aseptic Core Such a Hot Topic?

 Robotics in aseptic manufacturing isn't new; equipment using robotics has existed for the last 10 to 15 years in this part of our industry. What's changed is the regulatory posture. Regulators are dramatically more interested in it now than they have been in the past, and they're pushing the industry to move further away from personnel manipulations associated with the process: How do we minimize human interaction all the way back from traditional fill lines, to now having greater separation between operators and the final patient?

 And it's a fantastic opportunity. One area I'm particularly excited about is environmental monitoring—the handling of plates and monitors inside the aseptic environment. That should have been the first thing we automated. We could have done it 20 years ago. Every time an operator sticks a hand in a glove to change a plate, you have to stop the fill line, which means stopping production entirely. Robotic replacement is going to drive meaningful efficiency back into the line.

What Trade-offs Does the Industry Need to Prepare for?

 The upfront work becomes significantly more challenging. When you remove personnel from the process, you have to identify every single thing that could possibly go wrong and figure out how to replicate what an engineer or operator would do across an entire batch operation. You're essentially encoding human judgment into automated systems, and that's not a small task.

 We've always been able to plan for interventions. Now we have to plan for unplanned interventions. It means thinking much deeper about your process and doing that work much earlier in the design phase. On top of that, the price tags on these fill lines are going up, and so are the lead times. Robustness has to be built in from the very beginning.

How Does this Shift Affect the Workforce?

 The operator knowledge base is likely to change significantly. In some cases, operators may actually need a greater understanding of operations than before. And the shift isn't limited to the aseptic core. We're going to need more people in component prep, parts prep, and sterile operations to facilitate cleaning and sterilization of rapid transfer ports and other components feeding into automated fill lines. There's a real workforce shift coming, and companies need to get ahead of it.

 Regulatory expectations are evolving too. The days of a site being grandfathered in are over. Continuous improvement is what's expected now. Operators and administration staff need to be tracking trends, and when regulators show up, you need to know your data and know where your highest risks are and how you're mitigating them.

Where Does the Industry Stand on the Adoption Curve?

 We're right on the edge between novel use and expected use. The first fully automated lines are coming off manufacturing floors now and will be installed at operating companies soon. That's going to drive more regulatory commentary, and as those next-generation lines follow, probably a year behind, regulatory expectations will shift again. Lines that are 10 or 15 years old could become suspect, much like what happened during the transition from restricted access barrier systems to isolators.

 One concern I have is for smaller companies. Larger organizations have the capital to push these designs forward, but smaller manufacturers are going to face real challenges keeping up. Our industry needs to figure out how to bring those companies along by finding solutions that are well-funded and accessible. Those companies are just as valuable to patients, and in many cases they're the seed that larger companies eventually acquire. We can't leave them behind.

Regulatory scrutiny is accelerating adoption of robotics in aseptic manufacturing, shifting expectations toward minimizing human interventions and increasing separation between operators and product. Automation offers major efficiency gains, particularly for environmental monitoring plate changes that currently force line stoppages. Trade-offs include higher capital costs, longer lead times, and substantially more front-end engineering to codify human judgment and manage unplanned interventions. Workforce needs will pivot toward higher technical competency and expanded sterile support roles. The sector is nearing a tipping point where automation becomes standard, challenging legacy lines and smaller manufacturers.

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

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