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

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Merck KGaA using AI to Reduce Cooling | Created with Canva

Through the implementation of the etaONE software platform from Etalytics, Merck KGaA’s headquarters in Darmstadt, Germany achieved a 21% reduction in electricity used for cooling within three months.¹ With the program’s ability to autonomously optimize the site’s cooling systems, Merck KGaA has demonstrated that operational costs can be significantly mitigated through the 

How Can Autonomous Software Optimize Established Cooling Systems Without Infrastructure Changes?

The ability to improve efficiency without halting operations or modifying physical assets is a significant advantage. The optimization project at the Darmstadt site focused on a cooling system that circulates more than 20 million cubic meters of chilled water annually to support the manufacturing of more than 25,000 products.¹ The optimization logic utilizes a pressure-based system model that replicates the hydraulic behavior of the cooling infrastructure. By tracking pressure levels in real time and evaluating environmental variables, the AI autonomously orchestrates the performance of chillers, cooling towers, and pump systems. The platform transitioned to full autonomous operation within two weeks of an initial test run and has continued to run without disrupting ongoing production processes.

Why is Autonomous Energy Optimization Central to Long-Term Sustainability and Operational Health?

Efficiency gains of this magnitude are critical for meeting aggressive corporate sustainability targets, such as the commitment to a 50% reduction in carbon dioxide emissions by 2030 and full climate neutrality by 2040.¹ This initiative is part of a broader collaboration funded by the German Federal Ministry for Economic Affairs and Climate Action, known as the Energy Intelligence System for smart Cooling Systems in Industrial Buildings project. As a project partner, Merck KGaA provides real-world application scenarios and system data, while Etalytics delivers digital twin models and optimization logic. Beyond immediate energy savings, the partners intend to integrate predictive maintenance use cases, beginning with automated cleaning recommendations for cooling tower filters.

The push for efficiency extends beyond energy management into the foundational hardware that makes high-level computation possible. A €500 million (US$595 million) investment in a semiconductor solutions megasite in Kaohsiung, Taiwan, addresses the surging demand for AI applications² By focusing on thin film technology, which enables materials to be deposited on an atomic level for complex chip architectures, this expansion ensures a resilient supply of materials necessary for next-generation AI chips.

“Our strategy is to stay close to customers and their technology roadmaps. This investment allows us to reinforce our position in one of the world’s most strategically important semiconductor ecosystems,” said Kai Beckmann, deputy chair of the executive board, Merck KGaA in a press release.²

How Can Semiconductor Manufacturing Techniques Enhance Pharmaceutical Production Efficiency?

This 150,000-square-meter site, integrates advanced smart manufacturing through digital twin technology to improve precision.² This digital approach supports predictive maintenance and process optimization, paralleling the needs of complex pharmaceutical lines. The facility’s lab-to-fab methodology further enables seamless collaboration between research and large-scale manufacturing.

Why Is Hardware Resilience a Strategic Priority for Life Science Innovators?

By strengthening the global semiconductor ecosystem, the company ensures that the digital tools used in drug development can evolve without supply disruptions. These investments, part of a €3 billion (US$3.57 billion) global program, demonstrate how cross-industry technological advancements are essential for maintaining a stable, high-tech supply chain. This focus on hardware resilience serves as a safeguard for the long-term technological roadmaps of the healthcare and life science sectors.

Merck KGaA. Merck Reduces Cooling Energy Use by 21% with AI Optimization from Etalytics. Press Release. Feb 11, 2026.

Merck KGaA, Darmstadt, Germany, Inaugurates Semiconductor Solutions Site in Taiwan to Support AI Growth. Press Release

Articles

Merck KGaA deployed Etalytics’ etaONE to autonomously optimize cooling at its Darmstadt headquarters, cutting electricity for cooling by 21% within three months without physical retrofits or production disruption. A pressure-based hydraulic model and real-time environmental inputs dynamically coordinate chillers, cooling towers, and pumps, reaching full autonomy in two weeks. The effort supports ambitious decarbonization targets and expands toward predictive maintenance, including automated filter-cleaning recommendations. Parallel investments in a Taiwan semiconductor megasite aim to secure AI-critical materials and strengthen hardware resilience across life-science digital roadmaps.

Merck KGaA optimized cooling by 21% at its Darmstadt site using autonomous AI, aiding sustainability without system changes.

Merck KGaA Reduced Cooling Energy by 21% Through AI Use

VP, Strategic Business Management, Hovione

Márcio Temtem, Hovione, discusses how his company integrates modular hardware and modeling software to accelerate pharmaceutical R&D and optimize manufacturing processes.

Accelerating Pharma R&D with Modular Hardware Solutions 

Márcio Temtem, vice president, Strategic Business Management, Hovione, is addressing the evolving landscape of pharmaceutical R&D by focusing on synergies between hardware and software innovation. Temtem observes that the current industry climate is defined by a permanent shift toward speed and intricacy, stating, "on the increased complexity acceleration, I think they are here to last.”

To meet these demands, Hovione has focused on hardware modularity and flexibility through strategic partnerships. Of significance is the collaboration with GEA to produce the ConsiGma® CDC Flex, an innovative technology that combines three equipment functions. This hardware allows for batch tableting alongside both low-and high-throughput continuous tableting, enabling developers to create processes at a faster pace with minimal API usage.

Additionally, Hovione is in a partnership with Microinnova, a collaboration that facilitates modular continuous flow setups. Regarding the strategy behind this, Temtem notes, "The idea is that the chemists should, from early stages of development, start thinking on the setup that will be later used in commercial manufacturing."

Beyond hardware, Temtem emphasizes the role of software and modeling in expediting the CMC section development. He highlights that Hovione has developed an arsenal of modeling tools developed to accelerate formulation screening and process development for platforms such as amorphous solid dispersions. These modeling techniques are also being applied to continuous tableting to ensure a more efficient transition from development to production. By integrating these advanced hardware solutions with sophisticated software modeling, Hovione aims to provide a more flexible and responsive framework for modern pharmaceutical manufacturing.

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.

Some of the trends that I mentioned before, on the increased complexity acceleration, I think they are here to last, right? Our R&D continues to focus in the in the development of new hardware and new software. I think it came recently to public, very good examples of what I mean by newer hardware or the new software. On the hardware part, we have recently signed a partnership with GEA, one of the main suppliers of continuous tableting for pharma. And as part of this partnership, we have recently launched together, a new way of making tablets, a new ConsiGma® CDC Flex, which is a disruptive offer into the market. In one single press, in one single unit, you have three pieces of equipment. You have the opportunity to do batch tableting, at the same time that you have the opportunity to do, continuous batch tableting with very low throughputs or very high throughputs. So the unit has been designed with this modularity, with this flexibility, to address some of the challenges that I mentioned before on acceleration. Some of the challenges related with being able to develop processes with minimum use of API and at a much faster pace. On another example also, in the hardware, we have also recently signed a partnership with a with a company called Microinnova for the development of modular setups on continuous flow. The chemists, the idea is that the chemists should, from early stages of development, start thinking on the setup that will be later used in commercial manufacturing. And this is one of the companies that is offering these packages that allow to reach such a goal. It's not just about hardware, it's also about software, as I said before. And on the software side, we have also been exploring, for instance, new ways of doing chemistry. Miscible chemistry is a very good example of that, or new ways of expediting the CMC section development through modeling. On the modeling side, I think a very good example of that relates with the tools, with the toolbox that Hovione has developed over these years, and continuously developed to accelerate formulation screening and process development with platforms such as the ones that I mentioned before on the amorphous solids dispersions. And it's something that we are currently mimicking in other areas, such as the continuous tableting that I mentioned before.

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Accelerating Pharma R&D with Modular Hardware Solutions

Klaudia Lechowska is Business Development Specialist at 

The International Day of Women and Girls in Science is February 11.

 Klaudia Lechowska, Business Development Specialist at Mabion Biologics, provides her perspectives on the importance of encouraging girls to learn about science, technology, engineering, and mathematics (STEM) fields, and how women impact rare disease treatment innovation. She also discusses Mabion’s biosimilar to rituximab, MabionCD20, which is a monoclonal antibody granted orphan drug designation by FDA to treat membraneous nephropathy

PharmTech: Can you please give our audience a bit of background on your role and expertise

My name is Klaudia and I have been working at Mabion for four years. I started my career as a bioprocess technician in the manufacturing department, where I was responsible for cell culture operations at both small scale, such as shake flasks, and large production scale in bioreactors. This experience gave me a strong technical background and a solid understanding of bioprocessing operations. Currently, I work as a business development specialist, where I develop my negotiation skills and establish contacts with potential clients interested in our contract development and manufacturing (CDMO) services.

What are some of the benefits of STEM programs for girls in school? How do these programs translate to women building careers in the pharmaceutical industry?

I believe STEM programs play an important role in encouraging girls to explore science and technology from an early age. These programs help build confidence and show that technical fields can be interesting and accessible for everyone.

From my own experience, early exposure to technical education makes it easier to understand how scientific knowledge is used in real-life industries such as pharmaceuticals and biotechnology. STEM programs help girls develop problem-solving, teamwork, and critical thinking skills, which are essential in this industry.

My career path, from working in manufacturing to my current role in business development, shows how valuable it is to combine technical knowledge with communication and business skills. This is exactly what STEM education supports and why it creates a strong foundation for women building long-term careers in the biotech and pharma industry.

How do women working in STEM fields uniquely contribute to areas such as rare disease treatment development?

Women make up around 60% of the global pharmaceutical workforce. However, they hold only 25% of senior leadership roles and fewer than 10% of CEO positions in biopharma.

Women in STEM bring diverse perspectives that are especially valuable in rare disease research. These conditions are complex and require innovative thinking. Attention to detail, empathy, and collaboration help teams better understand unmet patient needs and create more patient-focused solutions.

Despite the leadership gap, strong female representation in the industry can help challenge stereotypes. It can also inspire the next generation of female scientists and researchers. Progress in rare diseases depends on close collaboration between science, manufacturing, and business teams. Many women lead health advocacy efforts in this field. Leaders such as Dr. Reshma Kewalramani, CEO of Vertex, and Sharon F. Terry, President and CEO of Genetic Alliance, bring valuable perspectives as mothers and caregivers. This is especially important, as 70% of rare diseases affect children.

What exciting innovations do you see on the horizon for the pharmaceutical industry?

I see many exciting innovations in the pharmaceutical industry, especially in advanced biologics and personalized medicine. These developments are making treatments more targeted and effective. The market has changed significantly in recent years. During the pandemic, many pharmaceutical companies grew rapidly due to increased demand. Today, the market is stabilizing. As a result, quality and safety are becoming top priorities in drug development. International partnerships make it possible to introduce new orphan drugs for rare diseases. Even before COVID-19, Mabion obtained orphan designation for MabionCD20, a biosimilar developed by the company. Overall, these innovations help the industry move faster, work smarter and deliver better solutions for patients.

Who are you inspired by in the pharmaceutical industry?

In addition to the leaders I mentioned earlier, I’m inspired by people in the pharmaceutical industry who combine strong scientific expertise with a deep sense of responsibility for patients. In particular, I value the scientists I have worked with who are committed to developing high-quality, safe therapies and who approach their work with curiosity, integrity and dedication.

One global figure I find especially inspiring is Katalin Karikó. Her groundbreaking work in messenger RNA technology, combined with years of perseverance in a male-dominated field, had an extraordinary impact on global health. Her dedication ultimately helped save millions of lives, and her story motivates me to break barriers and contribute to meaningful innovation in biotechnology. I believe her achievements are rightly recognized by honors such as the Nobel Prize, the Lasker–DeBakey Clinical Medical Research Award and the Paul Karrer Medal.

What are you currently working on that you are passionate about?

Currently, I work in business development, where I focus on building relationships with potential clients and exploring new collaboration opportunities. What really excites me is connecting scientific and manufacturing expertise with real business needs and helping turn innovative ideas into real projects.

With my technical background, I enjoy acting as a bridge between science, manufacturing, and clients. Most importantly, knowing that these collaborations can lead to new therapies and improve patients’ lives is what motivates me every day. The feeling that my daily work can contribute to therapies that give patients hope is truly meaningful to me.

UN. International Day of Women and Girls in Science, 11 February. UN.org. 

https://www.un.org/en/observances/women-and-girls-in-science-day

February 11. Women and Girls in Science. 

Mabion S.A. Mabion Has Secured Approval from the FDA to Designate MabionCD20 as an Orphan Drug for the Indication of Membranous Nephropathy. Press Release. Jan. 27, 2023, 

https://www.mabion.eu/wp-content/uploads/2024/03/Mabion-has-secured-approval-from-the-FDA-to-designate-MabionCD20-as-an-orphan-drug-for-the-indication-of-membranous-nephropathy.pdf

Mabion S. A. Mabion Has Received ODD Status from the FDA for the drug MabionCD20 in the Indication of Autoimmune Hemolytic Anemia. Press Release. Feb. 8, 2023, 

https://www.mabion.eu/wp-content/uploads/2024/03/Mabion-has-received-ODD-status-from-the-FDA-for-the-drug-MabionCD20-in-the-indication-of-autoimmune-hemolytic-anemia.pdf

Dumbuya JS, Zeng C, Deng L, Li Y, Chen X, Ahmad B, Lu J. The impact of Rare Diseases on the Quality of Life in Paediatric Patients: CurrentSstatus. 

https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1531583/

Klaudia Lechowska, Business Development Specialist, 

 Thanks to years of experience in the manufacturing area, Klaudia has a strong understanding of the realities of biologics production. She is familiar with CMC challenges and understands the needs of both manufacturing and quality teams. In business relationships, Klaudia focuses on partnership and a deep understanding of client needs. Privately, she combines her passion for biotechnology with animal care and self-development.

STEM exposure early can normalize technical career pathways for girls, building confidence and foundational skills in problem-solving, teamwork, and critical thinking that translate directly to biopharma roles. A career trajectory spanning bioprocess operations to business development highlights the value of combining manufacturing fluency with commercial communication. Despite women comprising ~60% of the pharma workforce, leadership representation remains disproportionately low. Diverse perspectives, empathy, and advocacy are positioned as accelerants for rare-disease innovation, alongside stabilization-driven emphasis on quality, safety, and cross-border orphan-drug collaborations, including MabionCD20.

PharmTech spoke with Klaudia Lechowska, Business Development Specialist at Mabion Biologics CDMO, about how women working in STEM fields bring unique perspectives to the important work of rare disease treatment. 

Women in STEM: Unique Impacts in Rare Disease Development

Takeda and Iambic Collaboration | Created with Canva

A multi-year AI-powered partnership has been established by Iambic and Takeda.¹ The collaboration is designed to utilize Iambic’s suite of AI systems to advance Takeda’s small molecule programs in specific therapeutic areas, namely Oncology, Gastrointestinal, and Inflammation. Agreements such as these highlight a shift toward utilizing integrated platforms that combine digital prediction models with automated laboratory hardware to streamline the discovery process.

How Does AI Technology Impact the Speed and Risk Profile of Early-Stage Small Molecule Development?

Central to this collaboration is the use of specialized models such as Iambic’s NeuralPLexer, is designed for the prediction of protein-ligand complexes.¹ By incorporating physics principles into its architecture, the platform aims to improve data efficiency, allowing for a more thorough exploration of potential chemical structures. This capability is critical for identifying novel chemical modalities that can engage biological targets that have traditionally been difficult to address.

“Our collaboration with Takeda is a powerful opportunity to apply our AI-driven discovery and development platform, and we are excited to partner with their team to quickly advance new and better drug candidates,” said Tom Miller, PhD, co-founder and CEO of Iambic in a press release.¹ “This collaboration further validates our industry-leading technology and highlights both the breadth of our discovery capabilities and the scale at which we can operate.”

The operational model also includes an automated wet lab that supports a weekly Design-Make-Test-Analyze cycle. This rapid cadence is intended to accelerate program advancement and enable multiparameter optimization for development candidates.¹ The efficiency of these cycles is a key factor in reducing the time required to develop a defined product profile that optimizes the therapeutic window.

Why Is This Collaboration Significant for the Future of Pharmaceutical Candidate Selection?

The financial terms of the agreement, which include payments for technology access and research costs along with success-based milestones that could exceed $1.7 billion, reflect the high value placed on de-risking the development pipeline.¹By leveraging these tools, companies seek to improve the probability of success for new medicines before they enter the clinic. This approach is specifically targeted at moving programs more effectively from their start toward an Investigational New Drug (IND) application.

“We are excited to be able access Iambic’s proprietary computational platform while we work with their team to develop small molecule therapeutics with the potential to address critical unmet patient needs,”¹ stated Chris Arendt, PhD, chief scientific officer and head of Research at Takeda in a press release. “At Takeda, our focus is on accelerating the development of impactful new medicines by leveraging cutting-edge science, including the latest advances in artificial intelligence. Iambic’s small molecule platform aligns with this ambition and offers the potential to de-risk candidate selection, improve probability of success, and more quickly advance select programs from early project start to IND.”

Iambic has previously demonstrated that its platform can deliver candidates to human trials with significant speed across various target classes.¹ The presence of experienced drug developers and scientists holding a PhD on the development team suggests that 

the integration of AI and automated synthesis is becoming a standard

 for organizations aiming to address urgent patient needs through highly differentiated development candidates.

How does financial stability impact the viability of AI platforms?

Iambic announced a $100 million financing round meant to develop the firmsportfolio of Ai-develped therapeutics and technologies. “We are thrilled to have the support of many outstanding and committed investors who are partnering with Iambic to advance our mission of creating technologies to bring better medicines to patients,”² as was stated in a press release by Tom Miller, PhD. This financial backing, involving investors with a PhD or equivalent expertise in life sciences, allows for the continued development of predictive models and the progression of internal programs toward human trials.

What evidence exists for the clinical translation of these methods?

Clinical data for candidates like IAM1363, which showed activity in HER2-related cancers, provides validation for AI platforms.² Such results lead to collaborations to evaluate combinations of IAM1363 and other therapies for HER2-positive breast cancer. For professionals, these milestones suggest AI candidates can meet rigorous safety standards while addressing complex biological targets. Expanding these tools through partnerships with companies like Jazz Pharmaceuticals or Revolution Medicines allows the industry to systematically explore novel therapeutic combinations.

Iambic Announces Collaboration with Takeda to Advance AI-Driven Design of Small Molecules

Iambic Raises Over $100 Million in an Oversubscribed Round to Advance its Portfolio of AI-Discovered Therapeutics and Leading Platform Technologies

Iambic and Takeda formed a multi-year partnership applying Iambic’s AI platform to advance small-molecule programs across oncology, gastrointestinal disease, and inflammation. NeuralPLexer, a physics-informed protein–ligand complex prediction model, is positioned to improve data efficiency and expand chemical search space for historically challenging targets. An automated wet lab enabling weekly Design–Make–Test–Analyze cycles aims to accelerate lead optimization and therapeutic window refinement. Deal economics include research funding plus milestones exceeding $1.7B, underscoring emphasis on de-risking preclinical candidate selection and accelerating IND readiness.

Takeda and Iambic partner to use digital tools for discovery. NeuralPLexer helps move oncology candidates toward clinical trials.

Takeda and Iambic Partner for AI Small Molecule Discovery

Fresenius Kabi and Phlow Corp. Collaboration | Created with Canva

Fresenius Kabi and Phlow Corp. have announced a collaboration to onshore the manufacture of epinephrine injection, USP, including the production of APIs and finished doses.¹ This first-of-its-kind initiative represents a strategic response to the chronic shortages that have long impacted the availability of this essential medicine in the US. The arrangement utilizes a divided production model where Phlow Corp. produces the APIs at its advanced manufacturing campus in Virginia, while Fresenius Kabi manages the formulation and production of finished doses at its existing US facilities.

How Does This End-To-End Model Address Domestic Supply Chain Vulnerabilities?

The integration of API and finished dose manufacturing is a significant development because, while domestic production of the finished injection has existed, there has been no US-based source for the epinephrine API. To address this gap, a successful US-based validation campaign for the API was recently completed, and a Drug Master File has been filed with FDA.¹ This move aligns with a broader local-for-local strategy supported by over $1 billion in investments to modernize domestic manufacturing and logistics centers. Joel Rosenstack, president, US pharmaceuticals at Fresenius Kabi, stated in a press release,¹ “Fresenius is a committed partner in advancing America’s vision of a fully domestic, end-to-end, supply chain for essential medicines, closing a vital gap in national security.” By establishing a domestic source for both components, the collaboration aims to secure the supply of a drug indicated for critical applications, including the treatment of anaphylaxis and increasing mean arterial blood pressure during septic shock.

Why Is a Scalable Manufacturing Framework Vital for Future Pharmaceutical Security?

This collaboration is designed to be a scalable model that can be applied to other essential medicines identified by FDA and the WHO. The focus is on creating resilient supply assurance through tech-enabled processes and advanced development techniques. Eric Edwards, MD, PhD, CEO of Phlow, noted in a press release that, “Phlow is pioneering bold solutions to restore pharmaceutical sovereignty and strengthen America’s national health security”. He further commented, “For several years, we have worked alongside Fresenius Kabi to build resilient, end-to-end supply assurance for essential medicines. This expanded collaboration is focused on securing a reliable domestic supply of epinephrine, one of the most critical, life-saving drugs used across emergency and acute care settings in the United States.”¹ Pending necessary regulatory approvals, the product resulting from this domestic pipeline is expected to be available to US hospitals in 2027, potentially setting a new standard for how critical care medicines are developed and manufactured domestically.

How Else Is Fresenius Kabi Utilizing Collaborations?

Beyond the onshoring of traditional injectables, the drive for manufacturing innovation extends into the emerging field of cell and gene therapy. A strategic development agreement between Fresenius Kabi and TQ Therapeutics aims to enhance accessibility by enabling scalable and efficient manufacturing through integrated cell selection technology. Under this agreement Fresenius Kabi has the ability to develop, produce, and distribute products that are created with TQ Therapeutics’ proprietary cell selection technology.²

How Is Automated Cell Selection Streamlining Complex Manufacturing Workflows?

The integration of affinity and column-based isolation technology into automated processing systems is designed to produce high-purity cells quickly and consistently. This addresses the significant manufacturing challenges associated with process development and full commercialization. Saurabh Bhasin, head of Portfolio, Cell Therapies & contract manufacturing operations at Fresenius Kabi, noted in a press release,² “By integrating TQ Therapeutics’ novel selection technology into our Cue system, our aim is to improve manufacturing success and scalability—key steps toward supporting the advancement of cell and gene therapies.”

What Role Does Point-of-Care Processing Play in the Future of Individualized Medicine?

Advancing these technologies allows for ultra-short processes that can be performed closer to the point of care, simplifying treatment workflows. This modular approach supports the development of next-generation therapies delivered directly to the patient. “With Fresenius Kabi’s expertise in cell and gene therapy device technologies development and commercialization, and TQ Therapeutics' focus on developing ultra-short processes for clinical cell therapies from manufacturing to in vivo applications, we are creating a novel value proposition for scaling and enabling the supply of cell therapies for broader patient populations,” stated Christian Eckert, CEO of TQ Therapeutics, in a press release. Such advancements reflect a broader commitment to utilizing technological knowledge to ensure access to world-class therapies through improved clinical practice and industrial production.

Fresenius Kabi and Phlow Corp. Announce First-Ever, End-to-End, U.S. Manufacturing Collaboration for Epinephrine Injection, USP

Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement

Fresenius Kabi and Phlow Corp. are advancing a fully domestic epinephrine injection supply chain by pairing US-based API production with US-based finished-dose manufacturing to mitigate chronic shortages and national security vulnerabilities. A completed API validation campaign and FDA Drug Master File submission support regulatory readiness, with hospital availability targeted for 2027. The framework is positioned as scalable for other essential medicines using advanced, tech-enabled manufacturing. Separately, Fresenius Kabi’s agreement with TQ Therapeutics integrates automated cell selection to improve scalability, purity, and point-of-care feasibility for cell therapies.

Fresenius Kabi and Phlow partner to onshore US epinephrine production, securing the domestic supply chain for essential medicines.

Fresenius Kabi and Phlow Corp. Enter First US End-to-End Manufacturing Collaboration

FDA granted priority review for the supplemental Biologics License Application (sBLA) for marstacimab, marketed as HYMPAVZI.¹ This medicine is intended for the 

treatment of patients with hemophilia A or B

, and the application seeks to expand the current indication to include patients aged 6 and older with inhibitors, as well as pediatric patients aged 6 to 11 without inhibitors. This review comes as the landscape of hemophilia treatment is shifting toward non-factor prophylactic options that simplify administration and address biological resistance.

Marstacimab is notable as the first anti-tissue factor pathway inhibitor (TFPI) approved in the United States and the 

. Unlike traditional factor replacement therapies that replace missing factor VIII or factor IX, marstacimab targets the Kunitz 2 domain of TFPI.¹ This mechanism is intended to re-establish the balance between bleeding and clot formation. The product's use of a pre-filled, once-weekly subcutaneous auto-injector pen is a critical design element, as it eliminates the need for the routine treatment-related lab monitoring and complex preparation often associated with intravenous infusions.

How Do Recent Clinical Trial Outcomes Address the Challenges of Pediatric Patients?

The clinical evidence supporting these expanded indications stems from the BASIS and BASIS KIDS Phase 3 trials. These studies address populations with a high degree of unmet medical need, particularly those who have developed inhibitors, referring to antibodies that neutralize factor replacement therapies and render them ineffective. Michael Vincent, MD, PhD, chief inflammation & immunology officer at Pfizer, emphasized the importance of these developments in a press release:¹ “There is a significant medical need for younger patients with hemophilia and for those who have developed inhibitors, which neutralize factor replacement therapies and render them ineffective.” He further noted, “Based on the findings in the BASIS clinical trial program and if approved, we believe HYMPAVZI has the potential to become a transformative option for these patients that have limited or burdensome treatment options today. We look forward to progressing discussions with regulators to make this medicine available for patients.”

Repeated bleeding episodes in children can lead to permanent joint damage due to the vulnerability of growing cartilage and bone. Guy Young, MD, director of the Hemostasis and Thrombosis Center at Children's Hospital, Los Angeles, explained the necessity of preventative care for this demographic,¹ “for children living with hemophilia A or B between ages 6 and 11, treatment approaches that prevent bleeds are particularly important to protect growing joints.” He added that “HYMPAVZI would address a critical unmet medical need for these patients and those with inhibitors if approved, particularly patients ages 6 to 11 with hemophilia B who do not have non-factor treatment options available today.”¹

The BASIS trial evaluated the efficacy and safety of marstacimab by measuring the treated annualized bleeding rate over a 12-month active treatment period. In the BASIS KIDS study, 68 patients aged 6-11 were treated with a regimen consisting of a 150 mg loading dose followed by 75 mg once weekly.¹ These trials are essential to understanding the safety profile of anti-TFPI therapies, which may include risks such as thromboembolic events or allergic reactions. Beyond the United States, the use of marstacimab for patients 12 years and older with inhibitors is also under review by the EMA. This global regulatory activity underscores the industry's drive to provide stable, subcutaneous alternatives for more than 800,000 people living with hemophilia worldwide.

How Are Other Pfizer Biologics Progressing?

Beyond advancements in hematology, the pharmaceutical industry is witnessing a parallel evolution in long-acting metabolic therapies. Topline results from the Phase 2b VESPER-3 

 receptor agonist PF-08653944 demonstrated that switching from weekly titration to monthly maintenance dosing achieved significant weight loss, reaching 12.3% at 28 weeks.²

Why Does the Transition to Monthly Maintenance Dosing Matter for Metabolic Therapy?

A four-fold reduction in dosing frequency addresses significant barriers to patient adherence and simplifies supply logistics. Jim List, MD, PhD, stated in a press release,² “These topline results from the Phase 2b VESPER-3 study reinforce the potential of PF’3944 as a monthly treatment with competitive efficacy.” Dr. List noted that PF-08653944 serves as a key anchor in addressing critical care gaps.

How Does the Expansion of Long-Acting Injectable Pipelines Influence Development Strategies?

Advancing 10 Phase 3 trials in 2026 highlights a strategic push to address the global obesity epidemic and its associated comorbidities.² This shift toward monthly subcutaneous options within 

 agonist class reflects a developmental priority to provide less burdensome treatment alternatives for chronic metabolic conditions.

FDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need

Pfizer’s Ultra-Long-Acting Injectable GLP-1 RA Shows Robust and Continued Weight Loss with Monthly Dosing in Phase 2b Trial. Press Release

FDA priority review is underway for marstacimab (HYMPAVZI) sBLA to extend use to patients ≥6 years with inhibitors and children 6–11 without inhibitors, reflecting momentum toward non-factor prophylaxis. As the first approved anti-TFPI therapy in the US/EU, marstacimab targets TFPI’s Kunitz 2 domain and is delivered via once-weekly subcutaneous auto-injector, reducing infusion burden and monitoring. Phase 3 BASIS/BASIS KIDS data support pediatric relevance amid inhibitor-driven resistance and joint-protective prophylaxis needs. Pfizer also reported Phase 2b monthly GLP-1 RA maintenance dosing with 12.3% weight loss.

FDA granted priority review for Pfizer’s Marstacimab, a weekly subcutaneous anti-TFPI to treat pediatric and inhibitor hemophilia.

FDA Grants Priority Review For Pfizer’s Marstacimab for Hemophilia A or B

A look at a cross-industry shift toward integrated automation, domestic resilience, and a critical focus on the human talent pipeline.

PharmTech Weekly Roundup - February 6, 2026

video feature, I highlight the week’s industry news in an easy-to-consume format. New roundups  drop every Friday, so be sure to come back each week.

Fabian Gerlinghaus of Cellares explained to us 

how their integrated development and manufacturing organization, or IDMO, model can reduce labor and facility requirements for cell therapies by 90%.

ACG’s Shirwal, India site, the first packaging facility in the World Economic Forum’s Global Lighthouse Network

, where digital twins and AI have slashed defects by 71%.

that Pharma 5.0 is integrating digital systems for real-time quality adjustments to limit resource use. He noted that harmonizing global standards is essential to reducing the industry's total environmental footprint.

Walid Kamoun and Alex Philippidis discussed in Episode 32 of Behind The Headlines 

how AI has moved from "FOMO" to practical ROI, exemplified by the $1 billion NVIDIA-Eli Lilly co-innovation lab.

, Daniel Delubac of iOrganBio told us that strategic outsourcing allows sponsors to link together the best technologies, reducing the risk of clinical failure.

Collaboration is also driving cardiovascular R&D. This week, 

BMS and J&J introduced the "Change the Target. Change What’s Possible"

 initiative, which focuses on preventing blood clots while preserving healthy clotting.

Regulatory pathways are becoming more collaborative and localized. On Sunday, 

to encourage domestic onshoring by providing regulatory predictability for US-based sites.

supplemental Biologics License Application, or sBLA, for AstraZeneca’s Datroway was granted priority review

 for the first-line treatment of metastatic triple negative breast cancer. The sBLA is being reviewed under Project Orbis, an international framework that allows for the concurrent submission and review of oncology medicines among participating global partners.

In Europe, the CHMP recommended Kayshild for MASH and 

six new and nine indication extension recommendations

Finally, in recognition of the International Day of Women and Girls in Science on February 11, we spoke with several women leaders in the industry. E

 told us that while interest in STEM is rising, women hold only 20% to 30% of pharma STEM roles, citing a "confidence paradox" that requires early, hands-on mentorship to fix. 

, emphasized a "servant leadership" style as she advances a novel DNA-based immunotherapy for ovarian cancer. Similarly, 

noted that visibility in leadership is crucial for inspiring the next generation of women in pharmaceutical manufacturing.

From automated "Lighthouse" factories to the economics of rare diseases, the theme this week is clear: innovation requires not just new science, but the structural and human frameworks to support it.

Come back next Friday for another PharmTech Weekly Roundup!

This week, we look at a cross-industry shift toward integrated automation, domestic resilience, and a critical focus on the human talent pipeline.

Mike Schaefers is chief commercial officer at Simtra BioPharma Solutions.

 are critical components of therapeutic innovation that require significant investments of time, money, and intellectual capital. Speeding the delivery of new therapeutics to market and, ultimately, to patients demands novel approaches that reduce drug and process development complexity, minimize failures, and ensure that every step in the long road from bench to bedside is executed with precision. Achieving precision along a continuum that requires expertise across multiple disciplines, including biology, chemistry, formulation development, manufacturing process development, and clinical and regulatory science, is challenging, especially for small- and mid-size biopharmaceutical companies that may have personnel and infrastructure limitations.

Rather than building capacity internally, these companies can partner with contract development manufacturing organizations (CDMOs) and other external vendors to access critical knowledge, experience, and infrastructure.

Selecting a CDMO is a complex decision. While “one-stop shops” minimize the number of relationships that need to be managed, they may not have leading expertise in every step of the continuum. This lack of comprehensive expertise may be especially true with increasingly complex drug molecules, such as antibody-drug conjugates (ADCs). Alternatively, working with multiple vendors, each with expertise in a particular aspect of drug development, can be difficult to manage and creates opportunities for missteps if the hand-off from one vendor to the next is not done seamlessly.

 that have established their own partnerships with other leaders can be the balance point between these two less than optimal options. Such partnerships allow integration of processes that ensure seamless progression from one end of the continuum to the other. Here, the author discuss the role of CDMO expert networks in streamlining high-quality drug development and reducing drug development timelines and costs.

What is the role of CDMOs across key steps in the drug development continuum? 

Opting to work with multiple specialist CDMOs rather than a single, one-stop shop can provide companies with essential and relevant expertise at each step in the development process. For example, a company seeking CDMO support for development of a novel ADC could work with one CDMO that has expertise in bioconjugation (linking the antibody to the therapeutic payload) and another CDMO that has deep experience in filling and lyophilizing biologic therapies. These are distinct skill sets, and optimizing both is essential for attaining the CQAs (safety, potency, stability) needed for clinical and commercial success.

CDMOs have extensive experience that can be leveraged to streamline development, reduce the time and cost of development, and avoid errors/missteps that can lead to costly delays in the future. Given the frequency and scale at which they perform key steps in the development process, CDMOs can provide unique insights and expertise in areas such as drug formulation for injectable medicines, lyophilization cycle development and optimization, analytical methods and process development, and packaging selection to achieve critical quality attributes (CQAs).

Such capabilities may be especially valuable for emerging/small biopharma companies that lack the time and/or financial resources to build these capabilities internally. These capabilities can also provide value to larger biopharma companies that may need external support for a small number of molecules, especially more complex molecules, such as ADCs, or other modalities with which they have less experience or interest in building internal capabilities.

For example, a larger biopharma company with established expertise in small molecule oncology drug development that is expanding into biologic oncology therapy may be able to move more quickly and cost-effectively by working with a CDMO, which would mitigate the need to hire additional personnel or invest in physical infrastructure. Regardless of a company’s size or development stage, an experienced CDMO can be an important resource when developing ADCs and other high-potency molecules requiring specialized handling protocols and infrastructure that bigger companies may not want to invest in internally.

Opportunities and challenges in building a CDMO network

While this approach can tailor CDMO resources to the specific needs of a particular therapeutic molecule, it also can present its own challenges. These include the need to manage multiple vendors and ensure a smooth and timely hand-off from one vendor to the next. This approach becomes increasingly complex with the engagement of additional specialist CDMOs, and the benefits gained by accessing specific competencies may be negated by the time and energy needed to manage the network.

Working with multiple CDMOs can create procurement/management challenges, especially for smaller biopharma companies with limited resources to support these functions. The hand-off from one CDMO to another may be complicated by logistical challenges (shipping, receiving, documentation, etc.). Lack of coordination/integration between CDMOs also may lead to duplication of work due to poor communication or as the result of difference in processes/methods for a particular work stream between the organizations.

Why leverage existing relationships among CDMOs?

Selecting CDMOs that already have effective relationships with each other can help to minimize some of these challenges and reduce burdens on the drug development partner. When done well, CDMO alliances have the potential to create a seamless user experience. Whether building a bespoke CDMO network or accessing resources through an existing alliance between CDMOs, it is critical that all players share the belief that reducing the cost, time, and complexity of developing and manufacturing biopharma products is essential for delivering medicines to patients.

The CDMO industry has the expertise, resources, and capacity to play a critical role in transforming decades-old approaches that fail to maximize value for patients, drug innovators, and health systems. Creating a new paradigm that brings optimized expertise to each step of the development and manufacturing continuum requires inter-vendor partnerships and networks that provide a seamless user experience and time and cost savings compared with traditional approaches.

With more innovation happening in emerging and small biopharma companies, there is a growing need for CDMOs that have expertise in supporting novel, complex molecule development (ADCs, bi-specific or tri-specific antibodies, etc.). As biopharma companies consider how best to access the knowledge and infrastructure needed for timely and cost-effective development of potentially transformative therapies, they should consider not only the capabilities of a potential CDMO partner but also the relationships that the CDMO has with other vendors.

CDMOs should evaluate the areas in which they provide differentiated capabilities and consider partnering with other CDMOs that provide complementary (but largely non-overlapping) expertise. Establishing these types of partnerships requires identifying areas of potential overlap and defining at the outset which organization is responsible for each part of the service offering chain. Protecting key trade secrets is also critical for eliminating the risk that today’s partner doesn’t become tomorrow's competitor and ensuring that these collaborations provide long-term value to each CDMO

The growing need for new types of expertise and capabilities that comes with the rise of novel treatment modalities (i.e., additional antibody-based therapies, gene and cell therapies, and DNA and RNA editing therapies) is a powerful driver for CDMO specialization. DNA and RNA editing approaches require expertise in nucleotide chemistries; ADCs require lyophilization expertise and the infrastructure for handling high-potency payloads; and there is a growing need for capabilities in developing and formulating therapies with novel viral and non-viral delivery systems. Specialist CDMOs that work together to provide end-to-end expert support for these innovative modalities can create value for themselves, their drug development partners, and, ultimately, the patients that should always be at the center of the drug development process.

Case study: Simtra and MilliporeSigma ADC partnership

A recent partnership between Simtra BioPharma Solutions and MilliporeSigma provides an example of how integrating specialized capabilities in ADC drug substance manufacturing and bioconjugation and ADC fill/finish provides the developer with a seamless user experience that can streamline drug development. Established in June 2025, the partnership combines MilliporeSigma’s bioconjugation expertise and Simtra’s fill/finish capabilities, especially with respect to lyophilization formulation development (1).

ADC manufacturing is complex because it requires combining a monoclonal antibody (mAb), a cytotoxic payload, and a linker, each of which has its own production challenges. The targeted result is a single therapeutic molecule that is safe, potent, effective, and stable. Specialized infrastructure is needed when working with cytotoxic molecules, before, during, and after bioconjugation to the mAb. Additionally, approximately 90% of commercially available ADCs are formulated as lyophilized powders for reconstitution to optimize ADC stability and extend product half-life (2). In the absence of a one-size-fits-all process, optimizing ADC development requires expertise in antibody biology, bioconjugation chemistry, payload handling, and lyophilization formulation. The processes put in place for the development of each ADC must also be scalable to meet late-stage clinical and commercial needs.

The purpose of the MilliporeSigma–Simtra partnership is to provide a turnkey offering for biopharma companies seeking seamless access to expertise in ADC and bioconjugation, linker/payload manufacturing, drug product formulation development, and fill/finish capabilities. Designated project managers at each company work closely together with each other to ensure smooth transfers and expedited timelines. This work is done through the development and use of detailed plans for each joint project outlining agreed-upon processes, timelines, documentation, and transfer protocols. With this approach, Simtra can immediately begin work on drug substance materials received from MilliporeSigma. Ongoing communication between the teams also provides an effective mechanism for addressing questions or challenges collaboratively and in a timely manner.

The business rationale for this partnership was grounded in the recognition that working together could allow each company to capture a larger share of the expanding ADC pipeline. With more than 200 ADCs currently in clinical development (3), and about another 250 in discovery/pre-clinical development stages (4), the need for ADC bioconjugation and formulation process development expertise is rapidly growing. MilliporeSigma has extensive expertise in bioconjugation while Simtra has differentiated capabilities with respect to ADC lyophilization, formulation development, analytical process development, and package selection. Working collaboratively opens new doors for each company while providing drug development partners with a seamless user experience that gives them access to industry-leading expertise for key steps in the ADC development continuum. This partnership is just one example of how CDMOs can gain more through collaboration when each side provides complementary services rather than competing against each other. For development partners, the ability to access the expertise they need in a seamless fashion allows the partnership to provide greater value than the sum of its parts.

Decades-old drug development and manufacturing process development approaches are not optimized for modern-day biopharma products, and there is an evolving and expanding market demand for specialized expertise that can support the development of novel therapeutic modalities. CDMOs have a critical role to play in establishing new paradigms that reduce development time and costs and ensure timely and sustainable delivery of cutting-edge therapeutics to patients in need.To capitalize on this opportunity, CDMOs must identify organizations with complementary services and build new models that expand access to optimized expertise at every step in the process.Working together, CDMOs can create the continuum of expertise that customers need and patients deserve.

Simtra BioPharma Solutions and MilliporeSigma Announce Strategic Alliance for Antibody Drug Conjugates Drug Substance andDrug Product Manufacturing Services

Wen, L.; Zhang, Y.; Sun, C.; et al. Fundamental Properties and Principal Areas of Focus in Antibody-Drug Conjugates Formulation Development. 

Colombo, R.; Tarantino, P.; Rich, J. R.; et al. The Journey of Antibody-Drug Conjugates: Lessons Learned from 40 Years of Development. 

Antibody Drug Conjugate Market Industry Trends and Global Forecasts to 2035, by Target Disease Indication, Therapeutic Area, Linker, Payload, Target Antigens and Key Geographical Regions

Drug and process development demands cross-disciplinary precision that smaller and mid-size biopharma often cannot resource internally. CDMOs can compress timelines and reduce downstream failures via formulation, lyophilization, analytical, process, and packaging expertise, particularly for complex modalities such as ADCs and other high-potency products. However, single “one-stop” providers may lack best-in-class depth, while multi-vendor models increase hand-off and governance risk. CDMO alliances with complementary, non-overlapping strengths can create an end-to-end, seamless operating model with clearer accountability and improved execution.

Integrated CDMO networks streamline complex drug development across advanced modalities like ADCs. 

How CDMO Alliances Can Provide End-to-End Service that Reduces Drug Development Time and Costs

Marcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing.

Hovione’s Strategy for Complexity, Speed, and Regional Supply Chains

The landscape of small molecule manufacturing is rapidly evolving, according to Marcio Temtem, vice president, Strategic Business Development, Hovione, who provides an expert look into how his firm is evolving their approach as the industry changes. With 17 years of experience at Hovione, a family-owned CDMO with a 66-year legacy, Temtem identifies three pivotal trends currently shaping the industry: increased complexity, accelerated development speed, and the regionalization of supply chains.

Temtem observes that small molecules have grown significantly in size and complexity, often requiring multiple chemical steps and high-potency handling. This shift necessitates a specialized "toolbox" to overcome modern bioavailability challenges. Highlighting Hovione's technical approach to these hurdles, Temtem states, "We use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability.” This platform represents a core area in which Hovione maintains global leadership, utilizing innovative tools to scale processes efficiently while minimizing the use of APIs.

Temtem also mentions the increased influence of AI in drug discovery and deployment, which requires CDMOs to bridge the gap from grams to tons at a much faster pace than in previous years. He further addresses the trend of regionalization, noting the rise of countries such as the US and China prioritizing regional supply chain strategies. He explains that Hovione is uniquely positioned to navigate these new challenges with supply chains through its FDA-inspected sites across three continents.

Central to Hovione’s competitive advantage is their integrated manufacturing offer, which combines drug substance and drug product expertise at a single location. Temtem emphasizes the value of this model, stating, “The company… has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop.” To support this integration, the company continues to pioneer advanced manufacturing avenues, including continuous flow for drug substances and continuous tableting for drug products.

I’m Marcio Temtem. I'm currently vice president for strategic business management at Hovione. I've been in the company for 17 years. Hovione is a CDMO for pharmathat has been in the business for 66 years. Still a family-owned business that supports small molecule synthesis, production of drug product intermediates, and drug product, for pharma clients. First, and my answer will focus on the small molecule side, and I will try to cover three big trends. One of the trends that we see today is the increased complexity. Small molecules, they are not so small anymore. These days, they have come to a size and to a complexity, that require multiple chemical steps and that very often require high potency. They also require, on the formulation side of things, not just on the chemistry, but on the formulation side of things they also require a new toolbox. A new toolbox to address some of the challenges related with bioavailability. In our case at Hovione, we use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability. One other trend that we see happening as we speak relates with acceleration speed. I think it reach a different definition in 2025. There's a need to develop new molecules, new candidates at a faster pace. AI, it's booming all over the place, in the deployment of new molecules. And with this, new way of synthesizing molecules also comes complexity, bridging to what I said before. But it also requires companies like Hovione to develop the CMC section, to develop the process that will take the program from grams to tons at a much faster pace. So that's the second trend. The third trend is that there is an increased concern with the regionalization of the supply chains. You see a big trend in US for US, China for China. In our case, we look at this as an opportunity. Hovione has sites in three continents. In Asia, China, Macau, in Europe, Portugal, and Ireland, and the US. And we believe that, all these sites, they are FDA-inspected, I could say. And we believe that this is also an opportunity for Hovione to continue serving as it has been doing so far, all these markets. I would like to highlight two of our platforms. One of the platforms, I already touched before, that relates with the addressing solubility, bioavailability challenges through the making of amorphous solid dispersions. This is an area where Hovione has, today, the global leadership. And not just over 2025, but over the last years, we have been developing a number of tools, that allow to scale up the process, to develop the formulation with minimum use of API, and with a high probability of success. This is one element where innovation has played an important role to us in 2025. One other aspect to it is that the company, Hovione, has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop. And when I say at the same shop, at the same site, which is something very, very unique in the CDMO environment. And in order to do so, we have also been developing new ways of manufacturing. I can tell you that, for instance, in the drug substance space, we have been exploring new avenues, such as, continuous flow, or on the drug product manufacturing, we have been exploring new ways of manufacturing, such as continuous targeting, in order to accelerate, in order to address some of these needs that clients today, bring to our shop.

Women in STEM: Early Phase Drug Development

Dr. Maria de Miguel, MD, PhD, MBA, an oncologist and Director, Clinical Research for 

, offers her perspective on the evolving landscape of early phase oncology drug development. With a decade of experience spanning phase 1 clinical trials, her expertise covers a broad spectrum of novel therapies, including immunotherapies, antibody drug conjugates (ADCs), and targeted therapies.

Oncologist Dr. Maria de Miguel, MD, PhD, MBA, Director, Clinical Research for START Rioja, spoke with PharmTech about the importance of STEM education in early phase drug development.

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