Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

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

PharmTech Weekly Roundup—April 17, 2026

 Weekly Roundup. I’m Susan Haigney, Lead Editor of PharmTech.

, experts discussed digital transformation through AI and real-time monitoring, strategic collaborations to solve complex logistical hurdles, and the ongoing challenge of navigating an increasingly unpredictable regulatory landscape.

Regeneron and Telix entered a $2.1 billion collaboration

 that pairs Regeneron's antibody discovery platforms and clinical oncology portfolio with Telix's radiopharmaceutical development infrastructure, manufacturing capabilities, and global supply chain.

In upcoming conference coverage, look for PharmTech editors at 

next week, where we will be interviewing industry experts on a variety of topics. In other conference news, 

CPHI Americas announced their 2026 agenda

, which centers on the critical intersections of shifting regulatory policies, AI integration in drug discovery, and strengthening global supply chain resilience. And upcoming exhibits at 

 will showcase modular, digitally transparent, and sustainable packaging solutions designed to handle increasing formulation and regulatory complexity.

In a preview of his presentation at the upcoming Excipient World in May, 

Dave Schoneker of Black Diamond Regulatory Consulting 

and a member of PharmTech’s editorial advisory board talks about the pathway for developing new excipients. The adoption of novel excipients remains slow due to intensive safety requirements and industry reluctance, yet they are increasingly vital for the successful commercialization of complex large molecules. Dave will also be providing insight on the workshop he is leading at the event.

European Frontrunners Columnist, Cheryl Barton, focuses on 

leveraging AI, multi-omics, and cell therapies to address the root causes of cardiovascular disease, driving a market projected to reach $215 billion by 2034.

In an interview with PharmTech, Andrew Chang and Steven Falcone of Novo Nordisk, 

utilizes the FDA-EU mutual recognition framework alongside a proactive internal signal-monitoring process to maintain systemic global GMP compliance across its manufacturing network and how the company is advancing a vision for a "globally interconnected digital network" that employs real-time sensor data and automated visual inspections to modernize quality management.

Whether through the adoption of real-time digital monitoring or the formation of specialized manufacturing alliances, the industry is clearly moving toward a more precision-oriented model.

Stay informed as these technologies and policies continue to reshape workflows.

Visit PharmTech.com to read more about these and other industry trends.

Videos

This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.

On April 13, 2026, the FDA granted full approval to Filspari (sparsentan) for reducing proteinuria in adults and pediatric patients aged 8 and older with focal segmental glomerulosclerosis who do not have nephrotic syndrome.

 Developed by Travere Therapeutics, sparsentan is the first and only FDA-approved medicine for FSGS, marking a regulatory milestone in a disease area that has historically relied on off-label treatment strategies.

The approval is a case study in navigating regulatory pathways for rare, heterogeneous kidney diseases.

 The label aligns with KDIGO clinical practice guidelines for managing FSGS patients, which emphasize proteinuria reduction as a primary strategy for slowing disease progression.

Nephrotic syndrome is defined by the concurrent presence of proteinuria greater than 3.5 g/24h, edema, and albumin below 3.0 g/dL.

 The approved indication specifically targets patients without this constellation of findings, a population Travere estimates at more than 30,000 individuals in the United States. Combined with sparsentan's existing indication for IgA nephropathy, the total addressable population now exceeds 100,000 patients in the U.S.

"Today marks a historic milestone for people living with FSGS, who for the first time have an FDA-approved medicine for this rare and devastating condition," said Eric Dube, PhD, president and chief executive officer, Travere Therapeutics, in a press release.

 "This approval reflects years of perseverance and our belief that those living with FSGS deserve better."

FSGS is a progressive scarring disorder of the kidney's glomeruli that can lead to kidney failure.

 In patients without nephrotic syndrome, the condition is driven largely by mechanical stress on the glomeruli and the activation of inflammatory and fibrotic pathways. The disease spans all categories of FSGS, and the lack of any previously approved therapy made this a high-unmet-need indication from a regulatory strategy perspective.

What Does the Phase III Evidence Look Like?

The approval was supported by data from the Phase III DUPLEX study, the largest interventional trial conducted to date in FSGS, enrolling 371 patients between ages 8 and 75 with biopsy-proven or genetic disease.

 The global, randomized, double-blind, active-controlled trial compared sparsentan at 800 mg against maximum labeled dose irbesartan at 300 mg, with a primary endpoint measuring the rate of change in estimated glomerular filtration rate from baseline to Week 108.

In the overall study population, patients on sparsentan experienced a 46% reduction in proteinuria from baseline to Week 108, compared to 30% for irbesartan.

In the subgroup without nephrotic syndrome, the population reflected in the new indication, sparsentan produced a 48% reduction versus 27% for irbesartan.

From a manufacturing and formulation standpoint, the compound's dual mechanism, targeting both endothelin A and angiotensin II receptors, presents the kind of pharmacological complexity that requires careful dose-titration protocols.

 The safety profile was generally consistent with irbesartan across both adult and pediatric patients. The most common adverse reactions in FSGS patients occurring in at least 5% of patients include peripheral edema, hypotension, hyperkalemia, dizziness, and anemia.

Kirk Campbell, M.D., president, National Kidney Foundation, stated in the press release,

"For decades, treatment options have been limited, often relying on off-label therapies such as long-term steroids that can carry a significant burden for patients. In the DUPLEX Study, FILSPARI delivered rapid and sustained reductions in proteinuria compared to irbesartan, with particularly meaningful effects in patients without nephrotic syndrome."

"The approval of FILSPARI as the first medication for people with FSGS is a life-changing moment for patients and families who have waited far too long," said Josh Tarnoff, chief executive officer, NephCure, in the press release.

 "This milestone reflects the strength and perseverance of an extraordinary collective and broad stakeholder community who participated in research, raised awareness and never gave up hope."

How Did the FDA Characterize Its Approval for Sparsentan?

The FDA's own characterization of the approval emphasizes that full approval, not accelerated approval, was granted on the basis of a randomized trial demonstrating significant proteinuria improvement in patients without nephrotic syndrome compared to standard of care.

Tracy Høeg, MD, PhD, acting director, the Center for Drug Evaluation and Research, stated in a press release,

 "FDA reviewers concluded that Filspari's effect on proteinuria in this FSGS subpopulation had a high likelihood of translating into clinically meaningful benefit of slowing the loss of kidney function and progression to kidney failure."

That evidentiary standard, surrogate endpoint data considered sufficient to predict clinical benefit, reflects a regulatory posture for sponsors designing pivotal trials in rare kidney diseases.

Sparsentan held orphan-drug designation as well, granted in 2015, underscoring the long development timeline common to rare disease therapeutics.

Travere Therapeutics, Inc. Travere Therapeutics Announces Full FDA Approval of FILSPARI (sparsentan), the First and Only Approved Medicine for FSGS. Press release. April 13, 2026. 

https://ir.travere.com/press-releases/news-details/2026/Travere-Therapeutics-Announces-Full-FDA-Approval-of-FILSPARI-sparsentan-the-First-and-Only-Approved-Medicine-for-FSGS/default.aspx

First Food and Drug Administration-approved treatment for patients with focal segmental glomerulosclerosis, a rare kidney condition. U.S. Food and Drug Administration. Published April 2026. 

https://www.fda.gov/drugs/drug-alerts-and-statements/first-fda-approved-treatment-patients-focal-segmental-glomerulosclerosis-rare-kidney-condition

Articles

FDA granted full approval to sparsentan for reducing proteinuria in adults and children aged ≥8 years with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome, representing the first approved therapy in this setting. The indication aligns with KDIGO’s proteinuria-centric strategy to slow progression. Approval was supported by the Phase III DUPLEX trial (n=371), where sparsentan outperformed irbesartan in sustained proteinuria reduction through Week 108, including the non-nephrotic subgroup. FDA viewed proteinuria as a surrogate reasonably likely to predict delayed kidney-function decline.

FDA grants full approval to sparsentan for FSGS, the first-ever treatment for the rare kidney disease, backed by Phase III data showing 48% proteinuria reduction.

What Sparsentan's FDA Approval Means for Rare Kidney Disease

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

In this clip from episode 1 of Manufacturing Intelligence, Richard Jaenisch of Open Biopharma discusses uses of AI for deviations and investigations in pharma.

Manufacturing Intelligence Episode 1 - Part 2: Automating Deviations with AI

According to Rick Jaenisch, senior director of Education, Outreach, and Digital Experience at OpenBiopharma, every large life sciences company is currently adopting either proprietary AI tools or enterprise versions of models like ChatGPT, Gemini, and Claude. He notes that Claude has been particularly popular because it features a model specialized for life sciences that has been utilized by the FDA. 

Jaenisch identifies the most significant use case for generative AI in the industry as the management of deviations, specifically by turning traditional paperwork into AI-fillable forms. He explains to Christopher Cole, associate editorial director at 

, that this application can save a writer anywhere from one to four hours per report, which is especially valuable since manual typing is often slowed down by multitasking and distractions. 

In more complex investigations, Jaenisch describes how AI assists teams in gathering disparate data and summarizing video transcripts to support root cause analysis. However, he warns against the rise of "work slop," which he defines as low-effort AI output that can easily be identified through pattern recognition. He points out that this "slop" creates a calculable economic loss because reviewers must spend more time on the back end fixing errors than the original writer saved. To combat this, Jaenisch argues that companies must implement training that goes beyond basic "read and understand" instructions.

Finally, regarding manufacturing, Jaenisch observes that data silos and regulations like the EU’s Annex 22—which restricts probabilistic models in GxP environments—remain significant hurdles. While AI is already established in early drug discovery, Jaenisch is looking toward a future in which "AI-native" pharma companies fully integrate these technologies into the production lifecycle.

Senior Director for Quality and Regulatory Affairs in Science, Policy, and Intelligence under Global Regulatory Affairs, Novo Nordisk

Andrew Chang and Steven Falcone, Novo Nordisk

Andrew Chang, senior director for Quality and Regulatory Affairs in Science, Policy, and Intelligence under Global Regulatory Affairs, Novo Nordisk, and Steven Falcone, head of AIR-Q, Novo Nordisk, sat down with 

 to discuss how the company is navigating GMP mutual recognition, real-time digital monitoring, and the future of pharmaceutical quality management systems.

PharmTech: What Does the FDA-EU GMP Mutual Recognition Framework Mean for Novo?

 A few years back, the FDA worked with the EU to establish GMP mutual recognition. This framework covers GMP inspections and is largely used for surveillance inspections, though it's occasionally applied to pre-license and pre-approval inspections as well.

 Because Novo Nordisk has a large global footprint, especially significant manufacturing operations in Denmark, there are quite a few European inspections that take place there that the FDA then leverages under mutual recognition conditions. It's a very practical arrangement given the scale of our operations.

How Do You Stay Ahead of Regulatory Signals Across a Global Network?

 We have a very robust signal process. That process tracks changes in regulation, changes across the industry, guidance documents, FDA 483 observations, and any other findings that occur within our own network. From there, we conduct gap assessments in collaboration with our process owners, and we also convene focus groups to evaluate whether a regulatory finding at one site might point to gaps at other sites across the network. Actions are then taken where appropriate. It's a comprehensive, proactive approach.

How Is Your Quality Management System Structured?

 One of the key cornerstones of our QMS is the concept of process owners. These are individuals and teams who take ownership of specific areas, drug product sterility, for example, and work with cross-functional groups to ensure a consistent approach across our entire manufacturing network. They're responsible for how things operate today and for setting the ambition for where we're going.

What Does Real-Time Monitoring Look Like on the Manufacturing Floor?

 Many of our drug product fill-finish sites already have automated visual inspection systems that examine every unit coming off the line. Beyond that, there's an incredible amount of sensor technology monitoring the filling operation in real-time digitally. We also have what the industry would call tag rooms — spaces with highly visible HMI screens that give teams in different locations a live view of how the process is performing. And we use closed-circuit TV as well, because with so many moving parts, that visibility is essential to our overall monitoring.

Where Is Novo Headed with Digital Manufacturing and Quality Systems?

 We have big ambitions to establish a globally interconnected digital network to support our manufacturing. We believe that is the future, digital monitoring across the many functions that fall under the pharmaceutical quality system, all happening in real-time. We're actively moving in that direction.

How Are You Staying on the Cutting Edge of Software Validation and AI in Manufacturing?

 This is a fast-evolving field. There is draft guidance from both the FDA and the EMA that we can reference regarding software validation, but those documents are still in draft form. That's why PDA is taking a leadership role in building a dialogue with regulatory agencies, to work through what the requirements should be for software used in manufacturing processes and quality management, and to bring some critical thinking to those questions. It's truly an industry-wide effort, and one that Novo Nordisk is actively engaged in.

Novo Nordisk is operationalizing FDA–EU GMP mutual recognition to optimize surveillance oversight across a Denmark-centered manufacturing footprint while maintaining readiness for broader inspection use cases. A structured regulatory intelligence “signal” process aggregates global regulatory change, guidance, 483s, and internal findings to drive network-wide gap assessments and corrective actions. The pharmaceutical quality system is anchored by empowered process owners who standardize practices and set forward-looking quality ambitions. Manufacturing oversight is increasingly real-time and digital, leveraging automated visual inspection, extensive sensor arrays, HMI “tag rooms,” and CCTV. Strategic focus includes globally interconnected digital quality monitoring and active industry–regulator engagement on evolving software validation and AI expectations.

Andrew Chang and Steven Falcone, Novo Nordisk, discuss GMP mutual recognition, real-time digital monitoring, and the future of pharma QMS.

Novo Nordisk Leaders on the Future of Pharma QMS

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

New Excipient Development–Part 1

The term “new excipient” can refer to different product types, according to David Schoneker, president, Black Diamond Regulatory Consulting. Excipient innovations include new chemical entities (NCEs), products designed for higher levels of use, new routes of administration, or specific new patient populations. They also encompass new grades of existing excipients, pre-mixed or co-processed materials, and slight chemical modifications. In some cases, substances are adapted from alternate industries, such as foods and cosmetics, to serve pharmaceutical functions.

Adoption of new excipients by formulators is often a slow process. The development of actual novel NCE excipients is particularly rare, primarily due to the prohibitive amountof safety data required for approval. Furthermore, the pharmaceutical industry typically exhibits a lack of acceptance for these novel materials unless they provide a solution to a problem that no other existing substance can address.

In terms of application, small-molecule drugs currently drive the majority of new excipient development due to the magnitude of potential uptake in the market, according to Schoneker. However, the commercialization of large molecules may occasionally depend on the creation of a truly novel excipient, often resulting in collaborative development between excipient manufacturers and pharmaceutical companies.

Ultimately, the push for these new products is driven the need to fulfill an unmet need within a pharmaceutical company or a desire by an excipient manufacturer to expand their market. By creating new products, these companies aim to compete more effectively with existing excipients currently on the market.

Watch the interview above to learn more about what goes into the development of a new excipient. Dave will be participating in the workshop, “Risk Based Framework for Development of New Excipient Products”, at 

 being held in Nashville from May 4-6, 2026.

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.

Peter Belden, Tjoapack, discusses how the rise of specialized medicines for smaller patient populations is necessitating more flexible, redundant packaging capacity to manage complex global distribution requirements.

Scaling for Growth: Inside Tjoapack’s US Expansion Strategy

Peter Belden, Chief Commercial Officer at Tjoapack, explains that the company’s US expansion is primarily driven by the rapid acceleration of specialized medicines and treatments for smaller, often underserved patient populations.

This shift in drug development has created a significant need for flexible, nimble outsource packaging services that can adapt to unique requirements more effectively than larger, traditional contract packagers. By targeting mid-market and emerging biopharma manufacturers, Tjoapack is positioning itself to support the entire lifecycle of these complex molecules.

The current expansion builds upon previous investments in Europe to create a redundant, two-continent platform designed for long-term growth over the next 5 to 10 years. This infrastructure allows Tjoapack to offer a wide range of capabilities, including oral solid doses, injectables, and cold chain management, as well as specialized compliance packaging. The addition of expanded automation and physical capacity ensures that the company can handle both standard scalable solutions and highly customized packaging needs.

Ultimately, these strategic investments transform Tjoapack into a global supply chain hub, providing the planning tools and resources necessary for manufacturers to reach patients in 40 to 50 countries. By offering global logistics support and coordination, Tjoapack aims to be the preferred partner for biopharma sponsors navigating the complexities of commercializing medicines in both major Western markets and emerging global territories.

Andrew Chang and Steven Falcone, Novo Nordisk share how real-time digital monitoring, smart sensors, and a globally connected manufacturing network are shaping pharma's QMS future.

Inside Novo Nordisk's Digital Quality Management Strategy

Andrew Chang, senior director for Quality and Regulatory Affairs, Novo Nordisk, and Steven Falcone, head of the AIR-Q Group, Novo Nordisk, discuss Novo Nordisk's vision for a digitally connected manufacturing network and the role of real-time monitoring in modern pharmaceutical quality management.

Falcone gives a high-level overview of Novo Nordisk's quality management system, emphasizing the central role of process owners, cross-functional teams responsible for ensuring consistency across the company's global manufacturing network. These process owners oversee critical areas such as drug product sterility and manufacturing science and technology, working to align operations and set a shared direction for continuous improvement.

Falcone describes the real-time digital monitoring infrastructure in place across Novo Nordisk's fill-finish sites. Automated visual inspection systems examine every unit coming off production lines, while dense sensor networks track filling operations as they happen. "During the filling process, there's an incredible amount of sensors that are monitoring the performance of the filling operation in real-time digitally," Falcone explains. The company also utilizes tag rooms equipped with highly visible HMI screens and closed-circuit TV to give teams across different locations live visibility into manufacturing performance.

"We have a very big ambition to establish a globally interconnected digital network to support our manufacturing,” Chang continues. This vision, which includes a standardized manufacturing network, reflects Novo Nordisk's broader belief that real-time digital monitoring represents the future of pharmaceutical quality systems.

Chang adds an industry-wide perspective, noting that PDA's AI advisory and expert working group is actively engaging with regulatory agencies to help shape software validation requirements for manufacturing and quality management systems as guidance in this fast-evolving field continues to develop.

Andrew Chang and Steven Falcone, Novo Nordisk, share how real-time digital monitoring, smart sensors, and a globally connected manufacturing network are shaping pharma's QMS future.

CPHI America’s Agenda | Image Courtesy of Informa Markets

The conference program at CPHI Americas 2026, taking place in Philadelphia from June 2–4, a

ddresses a wide range of challenges that are reshaping how drugs are developed, manufactured, and brought to market

 The event is drawing senior leaders from across the pharmaceutical supply chain, including manufacturers, biotech companies, suppliers, and service providers. This year's agenda has been structured around themes of evolving regulatory frameworks, AI in drug discovery, supply chain resilience, and the future of biologics and advanced therapies.

On the regulatory side, sessions will examine shifts in US policy and approaches to risk-based decision making.

 A session titled "FDA in Flux: Navigating the New Regulatory Landscape" will feature Molly Klote, former director of the HHS Office for Human Research Protections, alongside Highlander Health co-founder Amy Abernethy. Patrick Day, Principal Consultant, Lachman Consultants, will lead a separate session on global risk management and risk-to-value transformation, which will focus on practical framing for development and regulatory affairs teams managing cross-border portfolios.

How Will CPHI Americas Cover Biotech Funding and Supply Chain Stability?

As investment in biologics continues to accelerate, sessions will explore what that means for funding strategies and the innovation pipeline.

 Murray Aitken, executive director, IQVIA Institute, will examine the evolving biotech innovation ecosystem. A panel featuring leaders from Likarda, BioLabs, Epivax, and Morgan Stanley will discuss the financing of breakthroughs in the sector. A dedicated session on cell and gene therapy will look at how this segment of the market is developing within the U.S. context.

Supply chain resilience remains a persistent topic of concern.

 Luiz Barberini will present on Bayer's approach to procurement and external manufacturing. Mayank Nagar, Dr. Reddy's, will lead a session on the future of strategic alliances in pharma.

Digitalization and cybersecurity also feature prominently.

 A session on ransomware, social engineering, and supply chain threats, featuring Derek Booth, supervisory special agent, US Secret Service, speaks directly to the vulnerabilities that pharmaceutical organizations face as they digitize operations and rely more heavily on interconnected systems. Emily Lewis, UCB, will lead a session on embedding AI across drug discovery.

A session on market strategy will address how contract manufacturing organizations can differentiate themselves and communicate their value more effectively, with speakers from Bandwidth Solutions, LGM Pharma, and Veranova.

Sarah Griffin, event manager, CPHI Americas, noted in a press release,

"CPHI Americas brings together leaders throughout the pharmaceutical supply chain to address the challenges shaping drug development and manufacturing." She added "this year's agenda focuses on the areas having the greatest impact on the sector, including regulatory shifts, AI and biologics, providing attendees with practical insight they can apply within their organizations."

The event is part of a global portfolio spanning 11 international events across Europe, the Americas, the Middle East, and Asia.

How Does CPHI Americas Compare with Its Global Counterparts?

The CPHI portfolio extends well beyond Philadelphia, as CPHI & PMEC China, held annually in Shanghai, draws more than 110,000 attendees and more than 3,600 local and international exhibitors, making it Asia's largest pharmaceutical event.

The exhibition spans active pharmaceutical ingredients, natural extracts, machinery, laboratory instruments, packaging, biotech, and traditional Chinese medicine, a breadth that speaks to the country's dual strengths in heritage ingredients and advanced pharmaceutical development.

 The 2026 edition will feature expanded zones including traditional Chinese medicine pavilions and next-generation active pharmaceutical ingredient showcases.

As Orhan Caglayan, executive vice president of the Pharma Portfolio, Informa Markets, noted in a press release,

"The growth of CPHI & PMEC China mirrors the extraordinary pace of innovation in China, solidifying its position as the ultimate destination for sourcing, supply chain optimization, and forging strategic partnerships."

The challenges discussed in Philadelphia are inseparable from the international dynamics that events like CPHI & PMEC China bring into sharp focus. CPHI is also putting on events in Italy and India in 2026.

Informa Markets. CPHI Americas 2026 to focus on regulatory shifts, AI and biotech innovation. Press release. Philadelphia, PA; April 16, 2026. 

https://www.cphi.com/americas/agenda/events/conference-agenda/

Informa Markets. The largest pharma show in Asia makes its return to Shanghai this June 2026. Press release. March 2, 2026. 

https://www.prnewswire.com/news-releases/the-largest-pharma-show-in-asia-makes-its-return-to-shanghai-this-june-2026-302700982.html

CPHI Americas 2026 in Philadelphia convenes senior pharmaceutical supply chain stakeholders to address regulatory volatility, AI-enabled R&D, biologics investment, and supply chain resilience. Regulatory programming emphasizes US policy shifts, risk-based decision-making, and global risk-to-value approaches for cross-border portfolios. Biotech sessions span ecosystem trends, financing pathways, and cell and gene therapy maturation in the US. Operational tracks prioritize procurement/external manufacturing strategy, alliance models, and escalating cybersecurity threats amid digitalization. The broader CPHI portfolio highlights global interdependence, exemplified by Shanghai’s CPHI & PMEC China scale and expanded sourcing and innovation zones.

CPHI Americas 2026 tackles pharma's pressing challenges such as: regulatory shifts, AI in drug discovery, biologics innovation, and supply chain resilience.

Inside CPHI Americas 2026 Agenda

Interpack 2026 Preview | Image Courtesy of groninger


This year’s Interpack meeting arrives on May 7, 2026, in Düsseldorf, Germany, with some of the biggest manufacturers in the EU presenting their upcoming innovations. This year's exhibition includes a range of technology areas based around development and manufacturing operations. Modular packaging lines for parenteral and solid-dose products, automated carton handling, and precision counting equipment will be on display from the Uhlmann Group.

 Filling and closing systems for liquid pharmaceutical and consumer healthcare products, alongside digital process monitoring tools, will be presented by groninger.

 Labeling materials and application technology for pharmaceutical and hazardous goods applications, including tamper-evident and variable-data solutions, will be covered by HERMA.

What Does Increasing Complexity in Pharmaceutical Packaging Require?

For Uhlmann Group, the answer involves positioning its member companies as a coordinated portfolio rather than a set of independent equipment vendors.

"As a group, we combine technologies, expertise, and experience to provide expert consulting and pioneering, modular solutions, thereby actively driving change in the packaging ecosystem." said Prof. Dr. Matthias Niemeyer, CEO, The Uhlmann Group, in a press release.

Uhlmann Pac-Systeme's exhibit centers on two lines with direct relevance to parenteral and solid-dose packaging.

 The PTC 200 is a modular solution for packaging parenteral products in carton mono-packages; the BEC 500 combines a blister machine and cartoner in a single unit. Both are designed for flexibility across packaging materials. Visitors can explore these lines through a digital presentation, including three-dimensional visualizations and an interactive holowall display that walks through line functions and process steps.

Groninger approaches the complexity question through a different lens: the formulation itself.

 Throat sprays without preservatives, eye drops with modified viscosities, novel topical creams, each one introduces new demands on filling processes. Batch sizes are contracting, changeovers are accelerating, and hygiene requirements are stricter.

"Our customers operate in markets that have become significantly faster and more complex, while quality requirements continue to rise," says Otto Helmle, vice president sales consumer Healthcare and Cosmetics, Groninger, said in a press release.

"With flexcare, we rely on a platform concept that combines stable processes and high precision with the ability to react quickly and flexibly to new demands." The flexcare platform's modular design allows a wide range of viscosities to be processed reliably, with retrofit options intended to protect longer-term capital investment.

For labeling operations, Sven Pleier, Key Account Manager, HERMA, said in a press release,

 "Today, labels have to do far more than simply convey information. What is needed are solutions that save material and costs, can be sourced flexibly and at the same time reliably meet even demanding requirements in terms of durability, safety and variable marking."

How Are Digitalization and Material Sustainability Shaping Equipment Decisions?

On the digital side, groninger's VisionX Pink platform is designed to make machine data transparent and enable early detection of process deviations.

 Real-time data availability and process capability supports analysis, and an integrated dashcam function allows video-based fault diagnosis.

"Digitalization must never be an end in itself," Frieder Kanitz, CEO, Groninger, stated in the press release.

 "It has to support the people at the machine — through transparency, better decision-making and access to relevant knowledge."

On materials, KOCH Pac-Systeme is introducing a new folding carton module for its KMO platform that uses a horizontal cartoning process with side product insertion for fully automated handling.

 Folding cartons are gaining ground in part because of their recyclability and material efficiency, and in part because of evolving European packaging regulations. The KMO's standardized modular interfaces mean the machine can be adapted to new material requirements without full line replacement.

Goldfuss Automation’s fully automated feeder with an integrated collaborative robot retrieves pre-packaged blanks from the pallet, opens shipping cartons, and loads blanks directly into a cartoning machine's magazine.

 The system can manage the complete material flow through to the removal of empty cartons and interlayers, reducing manual handling in packaging areas where contamination control, ergonomics, or labor efficiency are concerns.

In labeling, HERMA's focus is on linerless label materials, including InNo-Liner, which requires neither silicone nor liner and has been validated in logistics applications where it reduced waste by approximately 60% and cut costs relative to conventional systems.

 The pharma-specific exhibit covers film-based labels that can be variably printed using ultraviolet lasers, creating permanent, smudge-proof, and disinfectant-resistant marks without ink or ribbons.

"What is always crucial is the interaction of material, adhesive, printing process and reliable application in the line," noted Marc Trapp, Head of Sales Industrial Labels, HERMA, in the press release.

Uhlmann Group Holding GmbH & Co. KG. Interpack 2026: One Group. One Responsibility: Uhlmann Group showcases integrated solutions for complex packaging requirements. Press release. April 8, 2026.

groninger & co. gmbh. Filling Processes in Transition: How groninger Keeps Sensitive Products Under Control. Press release. April 14, 2026. 

HERMA GmbH. HERMA label solutions at interpack 2026: Labels for growing demands. Press release. Filderstadt, Germany; April 2026.

Interpack 2026 in Düsseldorf will spotlight EU packaging innovation spanning parenteral and solid-dose lines, liquid filling/closing, and advanced labeling. Uhlmann emphasizes an integrated group portfolio with modular parenteral cartoning and combined blister–cartoner systems, supported by digital line visualization. groninger frames complexity through sensitive formulations, smaller batches, faster changeovers, and heightened hygiene, addressed via the modular flexcare platform and VisionX Pink transparency tools. HERMA prioritizes durability, safety, variable marking, and waste reduction through linerless materials and laser-enabled, disinfectant-resistant printing.

Interpack 2026 previews filling, labeling, and packaging equipment from Uhlmann Group, groninger, and HERMA designed for pharmaceutical manufacturers.

Must-see Exhibits at Interpack 2026

Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the views or positions of Umoja Biopharma



Christopher Lewis, Umoja Biopharma, sat down with 

 to discuss how AI is reshaping quality management, workforce development, and data utilization in the pharmaceutical industry.

Check out the 2-part video Interview with Lewis:

How AI Is Transforming Biopharma Quality and Compliance

AI Tools That Drive Competency in Complex Pharma Environments

PharmTech: How Do You Think About the Risks of Implementing AI in Biopharma?

Lewis: It really comes down to risk management and balance. You have to weigh the capabilities and capacity that AI brings against the need to keep humans meaningfully involved throughout the process — not just at the end, but at every step. That means integrating human oversight from a conceptual standpoint, through qualification and validation, and all the way into day-to-day use. When you have a human in the loop at each of those stages, you end up with a balanced, risk-based approach that's appropriate for the environment we operate in.

How Do You Measure Whether AI Tools Are Delivering Value in Quality Operations?

There are a few key metrics I'd focus on. First, cycle time. How long does it take to work through an investigation? That's a meaningful indicator of whether these tools are creating real efficiency. Second, hands-on time. Is automation freeing people up, or are they spending just as many hours on these tasks as before? And third, recurrence rates. Are we seeing the same issues and deviations come back around? I'd expect those numbers to go up initially, because AI is likely to surface repeat issues that may have slipped past human reviewers. But over time, as we use that information to get to true root cause, those rates should come down. That downward trend is where you really see the value.

What Other AI Applications in Pharma Have Caught Your Attention?

A few things stand out. The first is learning and performance. Our industry has long been stuck in a model where you generate hundreds of documents and expect people to read them and absorb everything, and that's just not how people learn effectively. AI offers a way to build competency models that are tailored to the individual, the task, or the complexity of the work. In a dynamic environment where people aren't doing the same thing every day, that kind of personalized, point-of-task support is valuable.

The second is predictive analytics, using AI to continuously monitor process performance data and get ahead of problems before they become problems. And the third, is automation of repetitive tasks. We have a lot of highly skilled people in this industry spending significant time on low-complexity, repetitive work. That kind of work can breed complacency, and complacency leads to mistakes. If we can use AI to handle that, we free those people up to apply their expertise where it matters.

What Emerging AI Opportunity Excites You Most?

It’s utilizing data. Pharma has never had a problem generating data. The challenge has always been extracting it and making sense of it in a way that drives real decisions. Whether it's process monitoring, product quality, stability profiles, or risk assessment, the data is already there. What AI gives us is the ability to use it, to pull it together across systems and get meaningful, actionable insights out of it. We've put enormous time and effort into collecting this data. Now we finally have tools that can help us put it to work.

AI adoption in biopharma quality hinges on balanced, risk-based implementation with continuous human-in-the-loop oversight spanning concept, qualification/validation, and routine use. Value should be demonstrated via operational metrics: investigation cycle time, hands-on effort, and deviation recurrence trends—recognizing recurrence may rise initially as repeat issues are surfaced, then fall with true root-cause resolution. High-impact use cases include AI-enabled competency models and point-of-task performance support, predictive analytics for early signal detection, and automation of low-complexity repetitive work. The largest opportunity is converting abundant, siloed data into actionable cross-system insights for quality and risk decisions.

Christopher Lewis, Umoja Biopharma, shares how AI is reshaping pharma through smarter oversight, personalized training, and actionable data insights.

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