Susan Haigney

Laine Mello Industry Outlook | Created with Canva

Laine Mello, director of Marketing at Ecolab for its bioprocessing business, shares her insights on the digital transformation of the pharmaceutical sector, the shift from batch to continuous processing, and the economic drivers shaping the industry’s future into 2026.

PharmTech: How is AI reshaping the drug discovery and manufacturing landscape?

 We are seeing AI fundamentally change the drug discovery timeline. Researchers are now able to design new molecules in weeks rather than months, which is an incredible shift that helps identify promising candidates with precision that wasn't possible even two years ago. This acceleration has massive implications for how quickly therapies can reach patients. On the manufacturing side, the impact is just as significant. Predictive maintenance tools are now catching equipment issues before they cause batch failures, and real-time analytics are allowing for much faster quality decisions. Digital monitoring is even making continuous processing more viable by removing the uncertainty that previously made manufacturers hesitant to move away from batch production.

What primary hurdles prevent companies from full adoption?

Adoption isn't always straightforward because regulatory frameworks are still catching up. There is an understandable need for transparency in how AI makes critical decisions, especially when patient safety is involved. Many facilities are struggling to integrate cutting-edge digital tools with legacy systems that might be 10-15 years old. We also have to address data governance and cybersecurity; these are not solved problems yet, and they cannot be afterthoughts when you are dealing with sensitive manufacturing data.

What benefits does continuous manufacturing offer over traditional methods?

It’s been a game-changer, we’ve seen facilities cut production cycles by 30%-40% while actually improving consistency. Shifting away from batch processing isn't just about increasing speed, it fundamentally changes how quality control and scale-up work. Once a facility can run continuously, it opens the door to optimizing operations in ways that simply weren’t possible before.

How is the industry responding to increasing margin pressures and the need for better process economics?

The industry is responding to margin pressure by investing heavily in next-gen therapies, such as biologics and advanced modalities that offer clinical benefits that generic competitors cannot easily replicate. This shift creates a demand for sophisticated purification solutions. For example, high-capacity chromatography resins are helping manufacturers maximize yield and recovery. These advanced resins enable intensified processing, which translates directly into cost savings and faster throughput. For biologic manufacturers dealing with complex molecules, these improvements in purification efficiency can be the difference between a commercially viable process and one that struggles economically.

What digital technology and sustainability shifts did you see in 2025?

In 2025, digital technology stopped being a "nice to have". Companies that had been piloting AI or the IoT for years suddenly found themselves racing to implement these tools across R&D and manufacturing to avoid falling behind the competition. At the same time, sustainability moved beyond simple compliance to become a genuine competitive differentiator. Companies are discovering that reducing water and energy consumption isn't just good for the planet, it improves their bottom line and makes their operations more resilient.

What will be the defining priorities for bioprocessing in 2026?

The reduction of the cost of goods will be the defining priority in 2026. Pricing pressures are intensifying, particularly for complex biologics. Manufacturers need to squeeze more productivity out of every single process step. We expect continuous and intensified bioprocessing to move from being innovative to becoming a standard practice, utilizing modular facilities and multi-column chromatography to deliver flexibility without sacrificing efficiency. We are also focused on solving technical challenges like stability and aggregation for high-concentration biologics and mRNA platforms that push the limits of current manufacturing.

How is the relationship between pharmaceutical companies and their suppliers changing?

We are seeing a shift where pharma companies are no longer looking for transactional relationships. Instead, they expect suppliers to act as strategic partners. This involves co-creating solutions, sharing technical expertise, and collaborating on process innovations. Using collaborations and acquisitions to access new technologies quickly is becoming essential for staying agile in a market where competitive advantages can erode very quickly.

Articles

The pharmaceutical sector is undergoing a digital transformation, with AI significantly accelerating drug discovery and enhancing manufacturing processes. Continuous manufacturing is replacing traditional batch methods, offering improved efficiency and quality control. However, regulatory challenges and legacy systems hinder full digital adoption. Economic pressures are driving investment in advanced therapies and purification solutions. By 2025, digital technology and sustainability became crucial competitive factors. In 2026, reducing costs and enhancing bioprocessing efficiency will be priorities, with a shift towards strategic partnerships between pharmaceutical companies and suppliers to foster innovation and agility.

Laine Mello, director of Marketin, Ecolab, details how AI, continuous manufacturing, and Pharma 4.0 drive bioprocessing efficiency and cost savings.

How Digitalization Is Transforming Pharmaceutical Manufacturing Processes

Raj Puri Industry Outlook | Created with Canva

In a rapidly shifting pharmaceutical environment, the role of CDMOs has become increasingly complex. 

, oversees operation of two distinct divisions: one for life science and diagnostic products and another for aseptic drug product filling. In this interview, Puri discusses the economic, regulatory, and human factors shaping the industry's future.

PharmTech: In an industry often defined by high-tech equipment, how does a CDMO set itself apart from other firms?

 While anyone with sufficient capital can build a state-of-the-art facility, the only long-term sustainable advantage we have as a CDMO is our staff. Our executive team prioritizes getting and keeping the "right people on the bus.” As a midsize organization, we offer a dynamic environment where staff can work across various functional areas. This cross-training, where an operations professional understands the demands of Quality Assurance and vice-versa, creates an organization that truly understands the floor-level challenges of manufacturing. Our team’s intellectual curiosity drives us to adopt the latest technologies and techniques to remain on the cutting edge.

How are tariffs and massive manufacturing investments affecting the industry?

 has been the biggest and most unwelcome surprise of 2025, particularly those applied to equipment and consumables from non-US manufacturers. For Argonaut, which is completing a three-year investment plan for a new site, we were hit with a seven-figure tariff on a key piece of equipment. These costs have a chilling effect on investments because they make ROI calculations for multi-million dollar projects incredibly difficult.

We are also seeing north of $370 billion in announced investments for US manufacturing. If realized, this massive influx will likely extend construction timelines and increase costs significantly, disrupting the typical supply and demand curve. Simultaneously, if the government forces down pharmaceutical pricing, companies will be desperate to reduce their COGS. This creates an operational tightrope for CDMOs, we must find ways to lower costs while the FDA maintains its high expectations for product safety and manufacturing robustness.

How has the global climate changed how pharma companies view supply chains?

Geopolitical shocks and the lessons of COVID-19 have underscored the vital importance of redundancy. We are seeing a shift where biotech and pharma companies are looking to establish secondary manufacturing sites that are both geographically and economically segregated from their primary sites.

There is significant pressure to get products to market faster. What are the risks and rewards of compressed timelines?

Speed is critical for patient access and commercial viability. However, compressed timelines force companies to take a financial gamble, often requiring them to start mass production at the time of submission before receiving any indicative guidance from regulatory agencies.

I’ve seen cases where a Phase 3 study was discontinued early due to overwhelming efficacy. While this is a fantastic outcome for patients, it created a 6-8 month gap for data analysis and submission, leading to patient access issues before commercial approval. It also resulted in a smaller data set, leading to regulatory labels that required clinicians to use unfamiliar clinical trial severity scores. Ultimately, these compressed timelines require a robust contingency strategy and close coordination with regulatory bodies to negotiate allowances like rolling data submissions. They may even force companies to prioritize one jurisdiction, such as the FDA, over others due to differing requirements.

In the evolving pharmaceutical landscape, CDMOs face increasing complexity due to economic, regulatory, and human factors. The key differentiator for CDMOs is their workforce, emphasizing cross-functional training and intellectual curiosity. Tariffs and substantial US manufacturing investments impact ROI calculations and operational costs, challenging CDMOs to balance cost reduction with regulatory compliance. Geopolitical events and COVID-19 have highlighted the need for supply chain redundancy. Compressed timelines, while beneficial for patient access, pose financial risks and require strategic planning and regulatory coordination to manage potential data and approval challenges.

Raj Puri, CCO, Argonaut Manufactoring, provides key insight on navigating tariffs, supply redundancy, and the risks of compressed timelines.

Navigating the Operational Tightrope in Pharmaceutical Manufacturing

Pulmonologist doctor, lungs specialist. Aesthetic handdrawn highlighted illustration of human lings. Dark grey background, studio photo and collage. | Image Credit: ©mi_viri -stock.adobe.com

 that the European Commission has approved the company’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and older in the European Union (1). Previously approved in the European Economic Areato prevent lower respiratory tract disease (LRTD) caused by RSV foradults aged 60 years and above and adults aged 50 to 59 years who are at increased risk for RSV disease, the new indication makes the vaccine available to all adults who are 18 and older.

According to GSK, RSV, a contagious virus that affects the lungs, causes an average of 158,000 adults to be hospitalized each year in the EU and an estimated 64 million people globally (1–3). RSV can have a higher risk of complications in adults, compared to children, including a higher fatality rate, especially those with chronic conditions such as asthma and chronic obstructive pulmonary disease (COPD) (1).

“This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalization, and even death, particularly for those with certain underlying health conditions,” Sanjay Gurunathan, GSK head of Vaccines and Infectious Diseases Research and Development, said in a press release (1). “GSK is proud to expand prevention options against RSV across Europe.”

The company is seeking expanded indications for Arexvy in other areas of the world including the United States and Japan.

What other GSK respiratory treatments have been approved?

On Jan. 23, 2026, GSK announced that a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium /vilanterol ‘FF/UMEC/VI’) was approved by China’s National Medical Products Administration (NMPA) (4) in 100/62.5/25mcg strength for both asthma and COPD indications and in 200/62.5/25mcg strength for asthma only.The new indication for the treatment of asthma in adults aged 18 and older makes it the first and only single inhaler triple maintenance therapy approved for COPD and asthma in China.

“Early intervention with a single inhaler triple therapy can improve clinical outcomes for suitable patients with uncontrolled asthma,” Kaivan Khavandi, Senior Vice President, Global Head, Respiratory, Immunology and Inflammation, R&D said in a press release at the time (4). “Today’s approval gives patients whose condition is not optimally managed, and therefore at increased risk of experiencing exacerbations, an important option in their care. As a company, we are committed to help change the course of disease and make clinical remission, where patients’ disease has sustained control, an ambitious but attainable treatment goal.”

FF/UMEC/VI was approved in China in 2019 for maintenance treatment of COPD and is a combination of three molecules in a single inhaler. It is taken in a single inhalation via GSK’s Ellipta dry powder inhaler once a day and contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist.

GSK. GSK’s RSV Vaccine, Arexvy, Receives European Approval for Expanded Use in All Adults 18 Years and Older. Press Release. Jan. 26, 2026. 

https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-receives-european-approval-for-expanded-use-in-all-adults-18-years-and-older/

Osei-Yeboah, R.; et al. Estimation of the Number of Respiratory Syncytial Virus–Associated Hospitalizations in Adults in the European 

National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). 

https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

GSK. Trelegy Ellipta Approved in China for Use in Adults with Uncontrolled Asthma. Press Release. Jan. 23, 2026. 

https://www.gsk.com/en-gb/media/press-releases/trelegy-ellipta-approved-in-china/

GSK's adjuvanted recombinant RSV vaccine, Arexvy, has received European Commission approval for use in adults aged 18 and older, expanding its previous indication for older adults and those at increased risk. RSV is a significant health concern, causing numerous hospitalizations and fatalities, particularly in adults with chronic conditions. GSK is also pursuing expanded indications for Arexvy globally. Additionally, GSK's Trelegy Ellipta has been approved in China for asthma and COPD, marking it as the first single inhaler triple therapy for these conditions in the region.

The European Commission has approved GSK’s adjuvanted recombinant respiratory syncytial virus vaccine, Arexvy, for use in adults aged 18 years and older. 

GSK’s RSV Vaccine Approved in Europe

In a 2026 industry outlook interview, Laine Mello, Ecolab, explains how next gen therapies, digitalization, and partnerships drive pharma agility.

Leveraging Next-Gen Therapies, Advanced Purification, and Strategic Collaborations in Pharma Production

Laine Mello, director of Marketing at Ecolab Life Sciences, discusses the strategic shifts occurring within the pharmaceutical industry in this part 3 of a 3-part interview (check out 

). With a decade of experience supporting marketing organizations like Catalent and Ecolab, Mello highlights how the industry is currently navigating significant margin pressure by pivoting toward next-generation therapies. These include biologics and advanced modalities that provide clinical benefits far beyond what generic competitors can easily replicate.

To address these changes, Mello explains that Ecolab is focusing on sophisticated purification solutions, such as high-capacity chromatography resins, which are vital for maximizing yield in the production of complex biosimilars. Mello underscores the precision required in modern manufacturing, stating "So high capacity chromatography resins, for example, are helping manufacturers maximize yield and recovery, which becomes a critical point when producing complex biosimilars or second gen molecules, where every percentage point of recovery matters economically".

Beyond chemical and physical purification, the interview touches on the operational evolution of the sector. Manufacturers are increasingly embracing digitalization and continuous processing to drive down production costs without sacrificing the quality or compliance standards expected by regulators. The overarching goal of these technological adoptions is to allow companies to respond to market fluctuations with much greater speed.

Finally, Mello emphasizes the growing role of strategic partnerships, collaborations, and acquisitions. In a fast-paced environment, these alliances allow companies to access new technologies and therapeutic areas more efficiently than building them from the ground up. Summarizing the need for this collaborative mindset, Mello remarks "It's about staying agile in a market where competitive advantages can erode quickly". This interview serves as an essential guide for understanding how bioprocessing leaders are balancing economic recovery with clinical innovation.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.



Hi, I'm Laine Mello. I am the Director of Marketing at Ecolab for its bioprocessing business. I've been in the pharmaceutical industry for around 10 years or so, supporting different marketing organizations such as Catalan and Ecolab.

The pharmaceutical industry is responding to margin pressure by investing heavily in next- gen therapy. So these include things like biologic advanced modalities and treatments that offer clinical benefits generic competitors just can't easily replicate. So from Ecolab’s perspective, this shift creates demand for more sophisticated purification solutions. So high-capacity chromatography resins, for example, are helping manufacturers maximize yield and recovery, which becomes a critical point when producing complex biosimilars or second gen molecules, where every percentage point of recovery matters economically.

Operationally, we're seeing manufacturers embrace digitalization and continuous processing to drive down cost without compromising quality. So the goal is really to respond to market changes while maintaining the compliance and quality standards regulators expect, and try to respond to those changes much, much faster.

And then, lastly, what I call out really is strategic partnerships. These are also playing a big role, or an even bigger role than before. Where companies are using collaborations and acquisitions to access new technologies and therapeutic areas quickly, rather than just building everything from scratch. It's about staying agile in a market where competitive advantages can erode quickly.

Videos

In a 2026 industry outlook interview, Laine Mello, Ecolab Life Sciences, explains how next-gen therapies, digitalization, and partnerships drive pharma agility.

In a 2026 industry outlook interview, Laine Mello, Ecolab, details how AI and Pharma 4.0 speed up discovery and production while navigating industry hurdles.

Integrating AI Discovery, Continuous Manufacturing, and Modern Regulatory Hurdles into Pharma Production

Laine Mello, director of Marketing at Ecolab Life Sciences, discusses how AI and Pharma 4.0 are fundamentally reshaping the pharmaceutical landscape in this part 2 of a 3-part interview (check out 

 and part 3). Drawing on a decade of industry experience, Mello explores the transition from traditional batch production to high-efficiency, digitally driven bioprocessing.

The most immediate impact of AI is felt in the research phase, where the timeline for designing molecules has shrunk from months to weeks. Mello emphasizes the magnitude of this shift, stating, AI “is fundamentally changing the timeline for drug discovery, which I think we're all seeing a lot of."

According to Mello, this acceleration extends to the manufacturing floor through:

• Predictive Maintenance: Tools that identify equipment issues before they result in batch failures.

• Real-Time Analytics: Digital monitoring that allows for faster quality decisions and reduces uncertainty.

• Continuous Processing: A move away from batch production that has allowed some facilities to cut production cycles by 30% to 40%.


Beyond AI, Pharma 4.0 technologies like Internet of Things, or IoT, sensors are enabling "predictive manufacturing," which catches process deviations before they become problems. Mello also highlights advancements in chromatography resins that improve purification efficiency, a critical factor for the economic viability of complex biologics. Regarding the strategic shift in production, Mello notes, "The shift from batch processing isn't just about speed, it fundamentally changes how quality control and scale up work."

Despite these advancements, Mello warns that full adoption faces hurdles. Regulatory frameworks are still evolving to address the need for transparency in AI decision making. Additionally, many manufacturers struggle to integrate cutting-edge digital tools with legacy systems that may be more than a decade old, all while managing the rising importance of cybersecurity and data governance.

I'm Laine Mello. I am the director of Marketing at Ecolab for its bioprocessing business, and I've been in the pharmaceutical industry for around 10 years or so, supporting different marketing organizations, such as Catalan and Ecolab.

Artificial intelligence is fundamentally changing the timeline for drug discovery, which I think we're all seeing a lot of. And we're watching researchers design new molecules in weeks rather than months, which is amazing to see, and it's really helping identify promising candidates with the precision that wasn't possible even two years ago. And so that acceleration has real implications for how quickly therapies can reach patients. And on the manufacturing side, the impact is equally significant. So predictive maintenance tools are catching equipment issues before they cause batch failures. Real-time analytics are enabling faster quality decisions, and even continuous processing is becoming more viableas digital monitoring removes some of that uncertainty that made manufacturers cautious about moving away from batch production. But full adoption isn't straightforward.

Regulatory frameworks are still catching up. There's an understandable need for transparency and how AI makes critical decisions, especially when safety is involved with the patient, and so many facilities are also dealing with the reality of integrating cutting edge digital tools with systems that may be 10,15 years old, and data governance and cyber security aren't solved problems yet. And they can't be afterthoughts when you're dealing with such sensitive manufacturing data, socontinuous manufacturing has been the standout innovation. We've watched facilities cut production cycles by 30% to 40% while actually improving consistency. So the shift from batch processing isn't just about speed, it fundamentally changes how quality control and scale up work. So, once you can run continuously, you start optimizing in ways that weren't even possible before.

The other thing is pharma 4.0 technologies. They're having a broad impact as well. So IoT sensors and AI analytics are enabling what's essentially predictive manufacturing, catching deviations before they even become problems, helping streamline compliance and even reducing the time between production and release. And then the other thing we're seeing too, is in bioprocessing, specifically, advanced chromatography resins are changing process economics. So that means higher capacity resins enable intensified processing, which really translate directly into cost saving and faster throughput. So, for biologic manufacturers dealing with increasingly complex molecules, these improvements in purification efficiency can be the difference between a commercially viable process and one that struggles economically.

In a 2026 industry outlook interview, Laine Mello, Ecolab Life Sciences, details how AI and Pharma 4.0 speed up discovery and production while navigating industry hurdles

Box and bottle of pills on the blue background. Pharmacy mockups for meds presentations, BADs and other kinds of pharmaceutical products. Front view. | Image Credit: ©

On Jan. 21, 2026, Sherma Ellis-Daal, event director at Pharmapack announcedthat the event would be expanding into the Asia market, located in Singapore, in November 2026 (1). The announcement came during the 2026 Pharmapack awards ceremony. 

The event is being held in Paris on January 21 and 22.

Pharmapack Asia will follow the format of the European-based event and provide stakeholders in the drug delivery and packaging markets an avenue to collaborate and showcase innovations. Exhibitions, conference sessions, and networking forums will be tailored to the Asian market and will serve a diverse audience of drug manufacturers, device developers, packaging engineers, regulators, and supply chain experts from the Asia-Pacific region.

“Singapore, renowned for its commitment to innovation and excellence, is perfectly positioned to host Pharmapack,” said Ellis-Daal in a press release (1). “By bringing the expertise, knowledge, and community of Pharmapack Europe to Singapore, we aim to strengthen our global network and establish a powerful presence in Asia. This initiative will foster collaboration and growth across the industry, creating new opportunities for all of us. The expansion of Pharmapack to Singapore, a dynamic hub for pharmaceutical innovation and excellence, underscores our commitment to empowering global healthcare with packaging solutions that enhance safety, efficiency, and sustainability.”

“Expanding Pharmapack into Asia is a strategic move that reflects the region’s growing significance in the global pharmaceutical, packaging and drug delivery industries,” Orhan Caglayan, executive vice president, Pharma at Informa Markets, which operates the event, added in the press release (1). "By bringing the event to this region, we aim to establish a dynamic platform that brings together innovators, suppliers and industry leaders to foster collaboration and drive advancements.This expansion offers exhibitors unparalleled access to emerging markets and opportunities, while attendees will gain valuable insights and solutions tailored to the unique needs of the pharma packaging and drug delivery ecosystem.”

Registration will open in early 2026. Full details will be announced in the coming months.

, sponsored by AAE B.V., were also announced during the ceremony on January 21 (2). The awards feature four categories that were open to innovators in the pharmaceutical packaging and drug delivery space. The following companies were recognized:

In the Eco-Design category, Leca Farma (Leca Graphics, Groupo Lantero) won for its Smart Safe packaging, which features a mono-material design that integrates all functions into a single piece, simplifies processes, reduces costs, and facilitates recycling.

In the Patient-Centric Design category, YPSOMED won for its prefilled autoinjector, YpsoLoop, which combines a two-step, pre-filled device with a design that advances sustainability by lowering carbon dioxide emissions through adherence to eco-design principles and by being built for circularity.

In the Delivery and Device Innovation category, Abbott Healthcare won for its SmartDose precision-engineered, metered multidose dispenser that is designed for patients with inflammatory bowel diseases.

In the Packaging Innovation category, Meadow won for its packaging system, MEADOW KAPSUL, which allows users to insert a pre-filled can into the dispenser for spill-free replacement.

For more information on the nominees and winners, visit 

Pharmapack. Pharmapack Announces Expansion to Asia with New Event in Singapore, Set for November 2026. Press Release. Jan. 21, 2026.

2026 Pharmapack Awards Winners List. Jan. 21, 2026.

Pharmapack is set to expand into the Asian market with an event in Singapore in November 2026, following the format of its European counterpart. This expansion aims to foster collaboration among stakeholders in drug delivery and packaging, offering tailored exhibitions and networking opportunities. Singapore's reputation for innovation makes it an ideal host. The 2026 Pharmapack Awards recognized companies for innovations in eco-design, patient-centric design, delivery and device innovation, and packaging innovation. Registration for the Singapore event will open in early 2026, with further details forthcoming.

At the Pharmapack Europe 2026 awards ceremony, Pharmapack announced it is expanding the event to Singapore in November 2026. This year’s award winners were also announced.