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

This week's coverage discusses the M&A report, $50B+ investments, automated cell therapy, vaccine approvals, and risks from the US leaving the WHO.

PharmTech Weekly News Roundup – Week of January 26, 2026

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

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

Mirum Acquires Bluejay, Adding Brelovitug Treatment for HDV

Mirum Pharmaceuticals acquired Bluejay Therapeutics to develop brelovitug, a late-stage monoclonal antibody treatment for chronic hepatitis delta virus patients.

US Withdrawal From WHO Creates New Pharma Logistics Vulnerabilities

The United States’ withdrawal from the WHO threatens global regulatory alignment, supply chain stability, and international pharmaceutical research collaborations.

WuXi Biologics Collabs with HanchorBio on Next-Generation Fusion Protein Pipelines

WuXi Biologics and HanchorBio partnered to accelerate multi-functional fusion protein development using end-to-end CMC and GMP manufacturing services.

Halo Pharma Becomes Dedicated North American Drug Product CDMO

Halo Pharma transitioned into a standalone North American drug product CDMO, specializing in complex formulations and expanding sterile manufacturing capacity.

Repertoire Immune Medicines and Lilly Collaborate on Treatments for Autoimmune Diseases

Repertoire Immune Medicines and Eli Lilly are collaborating to develop autoimmune disease therapies using the DECODE T-cell receptor discovery platform.

Cellares Secures $257M to Scale Global Cell Therapy Manufacturing

Cellares raised $257 million to industrialize cell therapy manufacturing using automated smart factories and an integrated development manufacturing organization model.

ROSS Announces CDA-200 Dual Shaft Mixer for Processing Viscous Pharmaceuticals

ROSS launched the CDA-200 Dual Shaft Mixer to provide high-speed dispersion and agitation for processing complex, high-viscosity pharmaceutical formulations.

Vetter Announces Plan to Build Manufacturing Site in Germany with €1.5 Billion CDMO Investment

Vetter is investing €1.5 billion to expand global sterile injectable manufacturing capacity through new facilities in Germany and Illinois.

Lilly Invests $3.5B in Pennsylvania Injectable Medicine Facility

Eli Lilly is investing $3.5 billion in a Pennsylvania facility to manufacture next-generation injectable weight-loss therapies using advanced technology.

Securing Radiopharma and GLP-1 Supply Chains Through 2026 M&A

Bain’s 2026 report analyzes how pharmaceutical firms utilize M&A for vertical integration and manufacturing control to secure fragile supply.

Videos

In a 2026 industry outlook interview, Raj Puri explains balancing speed with the financial and regulatory risks of accelerated drug launches via alignment.

Navigating the Complex Risks of Accelerated Pharmaceutical Launches

Raj Puri, chief commercial officer at Argonaut Manufacturing, explores the complex balance between speed and risk in pharmaceutical product launches. Puri explains that while getting a product to market quickly is vital for patient access and commercial survival, compressed timelines introduce significant regulatory and financial hurdles. He notes that, "As a biotech or pharma company, getting product to market as quickly as possible is critical”.

One of the primary challenges discussed is the "gamble" of mass production. Puri highlights that accelerated timelines often force companies to decide whether to manufacture commercial-scale products before receiving indicative guidance from regulatory agencies. He explains, "The compressed review timeline actually forces the biotech and pharma companies into taking a bit of a gamble, and that decision really is, do you start mass production before you have indicative regulatory feedback?". This financial risk is compounded by the need to negotiate proactively with agencies for allowances, such as submitting manufacturing data on a rolling basis.

Puri also shares a personal case study involving a life-saving biologic where the Phase 3 study was discontinued early due to "overwhelming efficacy". While a positive outcome, this created a gap in patient access during the submission window and led to clinical utilization challenges. Because the study ended early, the resulting regulatory label required ICU clinicians to use unfamiliar clinical trial tools, necessitating a massive educational effort.

Finally, the interview addresses the global implications of accelerated launches. Different requirements from the FDA, EMA, and Japanese Health Authorities often force companies to prioritize one jurisdiction over others. Puri concludes that while compressed timelines are highly desirable, they necessitate robust contingency strategies and a deep, collaborative relationship with regulatory bodies to ensure alignment on all requirements.

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.

Good morning. My name is Raj Puri. I'm the Chief Commercial Officer at Argonaut manufacturing. Argonaut is a contract manufacturing company based in Carlsbad, California. We have two separate divisions within the company. One division is focused on the production of life science and diagnostic products, and then the second division is focused on aseptic filling of drug product. So again, pleasure to be here today.

As a biotech or pharma company, getting product to market as quickly as possible is critical. Both from a patient access perspective, you want to save or improve lives of many patients as possible, as quickly as possible, but also from a commercial perspective, we basically burn cash until we get to market. So, from a commercial perspective, getting there as quickly as possible is obviously desirable. It can have significant challenges, these compressed timelines, and I've gone through them, personally, myself, from a regulatory perspective, what you can often see is that you're able to negotiate proactively with the agencies allowances regarding the data required on submission. And so again, you have to work very closely with the agency to determine what allowances will be made. But for example, in your PPQ package, which is essentially the manufacturing data that's provided on your submission, you may have the opportunity to reduce the amount of data provided and provided on a rolling basis, rather than everything has to go in at once on the submission date. So again, it takes close coordination with the regulatory body to negotiate those allowances.



From a commercial risk perspective, the compressed review timeline actually forces the biotech and pharma companies into taking a bit of a gamble, and that decision really is, do you start mass production before you have indicative regulatory feedback? So typically, let's say you have a year review timeline. After six months, you probably have some guidance whether or not your clinical package is acceptable or not. You then can say, after six months, everything looks good, we're going to pull the trigger. There's some risk here. But, clinical data looks pretty good. We're going to make the decision to manufacture and have product ready for launch. When you have a compressed timeline, you can't actually make that decision. You may actually have to make a decision on actual submission before you have any indicative guidance about whether or not you're going to make product to be ready for commercial launch. So there's a significant financial risk associated with making that decision at the time of submission versus when you have some indicative guidance from the agency. Personally, early in my career, I was part of a team at one of the big pharma companies responsible for setting regulatory strategy for a lifesaving biologic. The phase three study was actually discontinued due to overwhelming efficacy, which again, was a fantastic outcome. We were very, very excited the product was saving lives, and it became not ethical now to treat patients with a placebo when we knew that the active was extremely effective.

So we're very excited, but it did create some significant challenges for us on the back end. So, one of those challenges was actually a patient access issue. We discontinued study due to overwhelming efficacy, and it took us probably six to eight months to actually make a submission to the regulatory agency. You have to compile all the data, do the analysis, and then you have a review time on top of that. We did not have a scalable program in place where we continue to have availability for patients to access this product. So that was a major challenge from a patient access perspective, in that window between study discontinuation and commercial approval. And then from a clinical utilization perspective, we also had a challenge in that, because the study was discontinued early, we had a much smaller patient population than we had anticipated. What ended up happening was that the regulatory agencies then integrated into our label, the use of a clinical trial severity score.

What that meant is that you now had, commercially, you had clinicians that weren't involved in clinical trials were being asked to use a tool that they never used before. And so from a commercial perspective, we're now trying to educate the ICU doctors and nurses on how to actually assess patients effectively using this tool. And it's something they'd never done before. And so that also created a major challenge for us, again, somewhat precipitated by the compressed timeline. At the end of the day, the compressed outlines, while extremely desirable, they really do force companies to have a very robust contingency strategy developed prior to submission, and really forces them to work very closely with the regulatory agencies to make sure that they have alignment regarding requirements. It also may have the unintended effect of forcing companies to prioritize certain jurisdictions over others. Because, what the FDA may require might be quite different than what the EMA require, which may be different than what the Japanese Health Authority requires. And so now you have to say, Okay, which of these are the priority market? Because frankly, we can only really meet one. And so that's another peripheral outcome of going through a compressed review timeline.

Bain & Company have just released their Global M&A Report 2026, with a chapter dedicated to pharma that analyzes the current trends and patterns of the market to give a clear vision into how the dealmakers of the industry will conduct business in 2026.¹ The pharmaceutical sector is moving beyond a pursuit of new drug assets toward a more deliberate, capability-led strategy. Following a significant rebound in 2025, when deal values reached approximately $4.9 trillion, 80% of executives anticipate that activity will remain steady or increase.² Within the pharmaceutical and biotechnology industries specifically, strategic deal value saw a 79% jump as average deal sizes increased by over 80%.¹ Suzanne Kumar, executive vice president of Bain & Company’s global M&A and Divestitures practice, commented in a press release,² “The ingredients are in place for another robust year in M&A following last year’s near-record rebound.” The focus of these deals has transitioned from purely acquiring intellectual property (IP) to securing platforms and production capacity. As Kumar notes in a press release,² “Companies urgently need to reinvent themselves to get out ahead of the big forces of technology disruption, a post-globalization economy, and shifting profit pools. M&A will play a pivotal role in this reinvention in 2026.”

Phil Talamo, SVP of M&A and Strategic Innovation at MJH Life Sciences discusses the biggest pharma M&As from 2025. 

Phil Talamo, SVP of M&A and Strategic Innovation at MJH Life Sciences discusses the biggest pharma M&As from 2025

2025: The Biggest Year for Pharma Deals Since 2019

Do firms own end-to-end capabilities or maintain flexibility through outsourcing or partnerships?

The emergence of vertical integration as a primary objective marks a fundamental change in how industry leaders view the value chain. In specialized fields such as radio pharma, more than 80% of 2025 deals integrated manufacturing or isotope supply,¹ signaling a preference for capacity security over simple pipeline expansion. Securing scarce inputs like isotopes and managing sterile fill-finish capabilities are being viewed as strategic hedges against bottlenecks rather than just operational necessities. This transition is driven by the increasing complexity of biologics and fragile supply chains, which make direct control over production vital for maintaining speed to market.

This trend extends into the development of 

 obesity treatments. While the initial wave of investment focused on rapid market entry for injectables, the current strategy emphasizes owning next-generation delivery platforms and multi-agonist molecules alongside the necessary manufacturing capacity.¹ For 2026, the strategic advice is to look beyond the molecule itself, as value is increasingly found in delivery innovation and the ability to scale production. Decisions regarding whether to own end-to-end capabilities or rely on partners now hinge on which parts of the chain offer a competitive advantage. 

 partner at Bain & Company’s healthcare and life sciences practice, reinforces this point in an interview with 

, “The key driver of any decision between ownership and retaining the flexibility of outsourcing or partnering is the strategic importance of those products for their go-forward portfolios, the ability for ownership to drive differentiated capabilities, and market positioning against competitors – as well as the level of expected competition for the capability.” Treating supply control as a core strategic move rather than mere insurance is now a defining characteristic of market leadership.

How are acquirers balancing speed and access to differentiated science?

In the rapidly evolving landscape of antibody-drug conjugates (ADCs), identifying differentiated science is prioritized over scale. Since ADCs now account for approximately 40% of all antibody transactions,¹ the ability to secure access to unique payloads and novel linker technologies is essential for long-term scientific edge. This requires navigating a mature field where the most impactful assets are those with precise control over drug release for targeted disease indications. Leading acquirers are balancing the need for speed with the necessity of structuring flexible partnerships that allow them to access this innovation without assuming the full risk of peaking valuations.

The types of deals being struck are also evolving to focus more towards licensing deals rather than full on acquisitions. Carlebur notes, “We’ve seen a significant increase in licensing deals in particular – acquisitions themselves have remained relatively flat, while licensing deals now make up over 90% of overall deals. Although total licensing deal value has risen with the increased interest, acquirers are increasing the share of milestone-based payments in their deal structures – the average value of upfront deals versus milestone-based payments has declined to approximately 5% in 2025, compared to 10% in 2022. On balance, the type and structure of the deal enable acquirers to participate but limit over-exposure to the downside risk. This needs to be paired with detailed diligence of the science and data packages, and a willingness to assume the geopolitical risk.”

Simultaneously, the rise of greater China as a pharmaceutical powerhouse is forcing a rethink of global collaboration models. While US and European firms remain selective regarding outright acquisitions in the region, licensing and co-development partnerships with China have doubled since 2020.¹ This approach allows global companies to access world-class oncology pipelines while managing the risks of geopolitical fragmentation and IP exposure. These alliances provide a pathway to benefit from scientific momentum while preserving long-term control and compliance in markets outside of greater China. Furthermore, the integration of new technologies, such as AI, is being used to manage these complexities. AI adoption in M&A more than doubled in 2025,² with one in three dealmakers systematically deploying these tools to enhance intelligence and accelerate synergies during integration. This disciplined, thesis-led approach to R&D and capital allocation is essential for navigating a landscape where the bar for successful dealmaking continues to rise.

Bain & Company. M&A in Pharmaceuticals: Bigger, Bolder, and Far More Strategic. Report. Jan 27, 2026.

Global M&A poised to sustain momentum in 2026 after great rebound, finds Bain & Company

Articles

The pharmaceutical sector is shifting towards a capability-led strategy, focusing on securing platforms and production capacity rather than just acquiring intellectual property. Following a significant rebound in 2025, M&A activity is expected to remain robust, with a focus on vertical integration and securing scarce inputs. The development of GLP-1 obesity treatments and antibody-drug conjugates highlights the importance of owning delivery platforms and accessing differentiated science. Licensing deals are increasingly favored over full acquisitions, and partnerships with China are on the rise. AI adoption in M&A is enhancing deal intelligence and integration.

M&A report claims that pharma is now targeting vertical integration and manufacturing control in radiopharma, GLP-1s, and ADCs to secure the supply chain.

Los Angeles, USA - December 1, 2022 Eli Lilly only editorial Stock information on the logo of the office facade | Image Credit: © StockMarketVisuals - stock.adobe.com

Eli Lilly and Company (Lilly) has announced a $3.5 billion investment to establish a new manufacturing site in Fogelsville, Pennsylvania, specifically for injectable medicines and medical devices.

 For professionals in pharmaceutical development and production, this project represents a significant expansion of domestic capacity aimed at manufacturing next-generation weight-loss therapies, including the investigational triple hormone receptor agonist retatrutide.

 Construction for the facility is scheduled to commence in 2026, with the site projected to become operational by 2031.

Lilly’s PA Facility - Created with NotebookLM

What are the strategic drivers behind this large-scale manufacturing expansion?

This facility marks the tenth domestic manufacturing site announced by the company since 2020, reflecting a broader strategy to strengthen the supply chain for high-demand medicines.

 Industry leaders emphasize that increasing domestic production is essential for ensuring a reliable supply of essential therapies for patients. The move is part of a larger capital commitment exceeding $50 billion, which includes new developments in Alabama, North Carolina, and Indiana.

David A. Ricks, Lilly chair and CEO, noted the significance of this expansion,

 saying, "Our mission starts with patients and delivering the medicines they need. To meet increasing demand, we're expanding our U.S. manufacturing network, with Lehigh Valley adding capacity for next‑generation weight-loss medicines. We're creating high‑quality jobs and collaborating across the region—with suppliers, educators, and workforce‑development partners—to make critical medicines in the U.S. That's our commitment—to patients, to our new Pennsylvania home and to our country."

The state's leadership also underscored the importance of creating a competitive environment for life sciences. Governor Josh Shapiro stated,

 "When we announced our Economic Development Strategy here in the Lehigh Valley two years ago, we set out to win historic, life-changing deals like the one we're announcing with Lilly today. Before I took office, Pennsylvania wasn't even in the conversation for major investments like this, but thanks to our work to cut red tape, invest in site development, and expand our workforce, our Commonwealth is now competing—and winning—on a national scale. Lilly's commitment to the Lehigh Valley and to Pennsylvania will bring billions of dollars of investment and hundreds of good-paying jobs, solidifying our position as a leader in the growing life sciences industry."

How will technical innovation shape the operational capabilities of the new facility?

The selection of the Lehigh Valley site was driven by its technical manufacturing economy, existing infrastructure, and proximity to universities specializing in science, technology, engineering, and mathematics.

 The facility will utilize advanced technologies, such as AI, machine learning, integrated monitoring, and data analytics to optimize operations and maintain a reliable supply of medicine.

In regard to the vision for the site, Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations, explained,

 "Lilly Lehigh Valley—our newest injectable medicine and device manufacturing facility—will increase access to next-generation weight-loss treatments and improve the domestic supply of essential medicines for current and future patients. Our investment here is more than just building a facility—it's about building a shared future with the people and communities of the Commonwealth. Through meaningful partnerships in Pennsylvania, we're committed to fostering collaboration, driving innovation, advancing environmental stewardship, and creating lasting positive impact that extends far beyond our facility walls."

The facility is expected to create 850 high-value positions, including roles for engineers, scientists, and lab technicians, alongside approximately 2,000 construction jobs.

 Senator Dave McCormick commented on the regional impact, stating,

 "This multi-billion dollar investment in the Lehigh Valley is a powerful testament to Pennsylvania's leadership in life sciences and advanced manufacturing. In addition to producing breakthrough medicines and treatments that will improve lives nationwide, Lilly's cutting-edge facility will create thousands of high-quality jobs for working families right here in the Lehigh Valley, proving once again that Pennsylvania's skilled workforce and manufacturing heritage remain unmatched. I am grateful for the continued partnership with the Governor and his team in bringing transformational investments to Pennsylvania. This is American manufacturing at its best, and Pennsylvania is proud to lead the charge."

This investment also carries implications for the broader regional economy, with the company estimating significant secondary economic activity for every dollar invested. Senator John Fetterman stated,

 "Pennsylvania continues to be a leader in health care innovation, and I will always support companies like Lilly making major investments to advance these technologies. I am proud to support their new $3.5B manufacturing facility that will deliver hundreds of good jobs and produce critical medicine for our Commonwealth."

Finally, Congressman Ryan Mackenzie highlighted the role of the site in the national context, saying,

 "We are pleased to welcome Eli Lilly to the Lehigh Valley as part of its commitment to investing in America. Having modern, robust pharmaceutical manufacturing capabilities here in the United States is essential for both our national security and domestic economy. We are proud to see Eli Lilly making this investment here in the Lehigh Valley, where it will contribute to our prosperity and build on our historic manufacturing tradition. Because of the hard work of our local communities, the Lehigh Valley continues to be a hub for industry and investment."

Lilly Selects Pennsylvania as Home for its Newest Injectable Medicine and Device Manufacturing Facility

What to Know about Retatrutide: An Investigational Triple Hormone Receptor Agonist

Eli Lilly and Company is investing $3.5 billion to establish a new manufacturing site in Fogelsville, Pennsylvania, focusing on injectable medicines and medical devices, including next-generation weight-loss therapies. This expansion is part of a broader strategy to enhance domestic production capabilities and ensure a reliable supply of essential therapies. The facility will leverage advanced technologies like AI and machine learning to optimize operations. It is expected to create 850 high-value jobs and significantly impact the regional economy, reinforcing Pennsylvania's leadership in life sciences and advanced manufacturing.

Eli Lilly will invest $3.5 billion in a Pennsylvania facility for injectable weight-loss medicines, creating 850 new jobs and starting by 2031.

Lilly Invests $3.5B in Pennsylvania Injectable Medicine Facility 

Vetter Germany Manufacturing Site | Created with Canva

Vetter, a long-standing contract development and manufacturing organization (CDMO), has announced a €1.5 billion investment plan to expand its global footprint, focusing on both commercial and clinical production.¹ This investment comes as the landscape for sterile injectable manufacturing is undergoing a significant shift due to rising global demand for specialized drug delivery systems. For Vetter and other firms, securing reliable capacity for vials, syringes, and cartridges is a critical factor in maintaining project timelines and ensuring market supply.

How will the expansion in Europe impact commercial supply chains?

The centerpiece of this strategic growth is the construction of a new commercial production plant in Saarlouis, Germany. Having acquired the 95-acre site in late 2024, the CDMO has submitted the building permit application for a multi-phase facility that is expected to create up to 2,000 jobs over the long term. Construction is scheduled for the second quarter of 2026, with the first phase representing a €480 million investment.¹

Senator h.c. Udo J. Vetter, chairman of the advisory board and member of the owner family, emphasized the strategic nature of this move in a Vetter press release stating,¹ "With the construction of our new production facility in Germany, we continue on our path to sustainable growth. Long-term success derives from striking the right balance between stability and expansion.”

This site, which is projected to reach operational readiness by 2031, is designed to bolster the supply of vital medicines to the global pharmaceutical market. By expanding production capacity in close proximity to its headquarters in Ravensburg, the company aims to provide more robust support for commercial filling and assembly services. Regarding the regional commitment, Senator Vetter noted in a press release,¹ “With our investments in the state of Saarland, only a five hour drive away from our headquarters in Ravensburg, we are strengthening our commitment to Germany’s economic landscape while reaffirming our engagement as a strategic partner to the global pharmaceutical market.” This project is further supported by the European Commission, which has approved up to €47 million in state aid.¹

Why is clinical development infrastructure being prioritized in the United States?

Parallel to the large-scale commercial expansion in Europe, there is a clear focus on the 

earlier stages of the drug life cycle within the US market

. Vetter recognizes that early clinical development requires specialized aseptic environments and high-quality services to ensure data integrity and patient safety.¹ To meet these requirements, construction recently began on a new clinical production site in Des Plaines, Illinois.

This facility is part of a broader initiative to support pharmaceutical and biotech companies from the initial drug product development phase through to clinical filling. For over 75 years, the organization has operated as an independent pharmaceutical service provider, and this expansion into the United States complements its existing manufacturing sites in Germany and Austria.¹ The strategic alignment of these resources allows for a smoother transition between clinical phases and eventual commercialization.

How else is Vetter looking to shape the industry in 2026?

Environmental stewardship has become a critical metric for supply chain professionals. The organization’s 2025 EcoVadis Platinum status and its Science Based Targets initiative validation for a 58.8 percent emission reduction underscore this commitment to responsible manufacturing.²

Managing director Henryk Badack noted in a Vetter press release,² “We are proud of the various steps we are taking to reduce our company’s carbon footprint. Both the validation by the SBTi and the Platinum rating from EcoVadis emphasize our strategic commitment to both people and planet and bring us one step closer to effective climate protection and to achieving overall sustainabilty goals.”

Gabriel Fischer, team lead Environment, Health & Safety, added in a press release,² “In partnership with a local partner supplying biomethane directly to our sites, we unite climate protection with regional value creation and energy security—while significantly reducing our environmental footprint. Alongside this, expanding our photovoltaic capacity and using state-of-the art technology like biomethane further demonstrates that sustainability and innovation can go hand in hand.”

Pharmaceutical Service Provider Vetter Pharma to Build New Manufacturing Site in Germany

Vetter Achieves Top Sustainability Rating and Expands Climate Goal Commitments. Press Release.

Vetter, a prominent CDMO, is investing €1.5 billion to expand its global operations, focusing on both commercial and clinical production. A new commercial plant in Saarlouis, Germany, is central to this strategy, with construction starting in 2026 and operational readiness by 2031. This expansion aims to enhance the supply of sterile injectables. In the US, Vetter is prioritizing clinical development infrastructure with a new site in Des Plaines, Illinois. The company is also committed to sustainability, achieving EcoVadis Platinum status and setting ambitious emission reduction targets.

Vetter's €1.5 billion expansion adds German commercial and Illinois clinical sites to support global sterile injectable drug supply. 

Vetter Announces Plan to Build Manufacturing Site in Germany with €1.5 Billion CDMO Investment 

In a 2026 industry outlook interview, Raj Puri discusses how the tariffs hinder US pharma investment but drive demand for geographically segregated supply chains.

Balancing Unpredictable Tariffs with Geographically Segregated Supply Chains

In this interview, Raj Puri, chief commercial officer at Argonaut Manufacturing, discusses the complex challenges and shifting strategies within the U.S. pharmaceutical supply chain. Argonaut, a contract manufacturing organization based in Carlsbad, California, operates specialized divisions for life science diagnostics and aseptic drug product filling. Puri identifies the unexpected 2025 White House tariffs on equipment and consumables as a significant disruption for mid-sized companies attempting to expand domestic infrastructure.

Puri highlights the financial strain these policies impose, noting that Argonaut itself was hit with a seven-figure tariff on critical equipment during the final phase of a three-year investment plan. This volatility complicates long-term planning for the industry. "The tariffs have a chilling effect on companies trying to make investments into US-based pharma manufacturing facilities is simply due to their unpredictable nature," Puri explains. However, he also observes a "positive" side effect, the tariffs have driven increased interest in U.S.-based CDMOs as firms seek proactive strategies to manage their COGS.

Beyond immediate trade policy, the Puri elaborates on the broader necessity of supply chain redundancy in the wake of COVID-19 and ongoing geopolitical shake ups. Puri notes a qualitative trend where biotech and pharmaceutical companies are no longer satisfied with simply having multiple sites under one provider. Instead, they are prioritizing geographical and economic segregation to mitigate risks. Regarding this strategic shift, Puri states: "They want completely economically and geographically segregated manufacturing sites".

Ultimately, the interview underscores a critical transition period for the industry. While tariffs present a unique hurdle that hinders domestic investment, they are simultaneously accelerating a movement toward more resilient, diversified, and U.S.-centered manufacturing models.

Good morning. My name is Raj Purdy. I'm the Chief Commercial Officer at Argonaut manufacturing. Argonaut is a contract manufacturing company based in Carlsbad, California. We have two separate divisions within the company. One division is focused on the production of life science and diagnostic products, and then the second division is focused on aseptic filling of drug product. So again, pleasure to be here today.

In my opinion, the biggest and most unwelcome surprise of 2025 was the implementation of tariffs by the White House, like many other industries, pharma industry was negatively impacted by the Tariffs applied to the acquisition of new equipment and critical consumables from non-US manufacturers. Very specifically for Argonaut, we are in the final stages of implementing a three year investment plan to build a new drug product manufacturing site in Carlsbad, California. And with all the latest and greatest equipment, unexpectedly, we got hit with a seven figure tariff on one of the key pieces of equipment, which again, for a mid-sized company, is a significant challenge.

The tariffs have a chilling effect on companies trying to make investments into US-based pharma manufacturing facilities is simply due to their unpredictable nature. On the positive side though, I would say that the Tariffs applied to pharmaceutical products not made in the US have created additional interest in US based CDMOs as a potential strategy to keep down cogs. So I get I think it's being done somewhat proactively, as we don't have a lot of details on how products made by CDMOs will be treated from a tariff perspective, but we certainly are seeing increased interest as a result.

In my opinion, the issue of tariffs geopolitical shocks and global supply disruptions underscore what we already know about the importance of having redundancy and pharmaceutical supply chains, and I think covid taught us, taught that lesson as well in 2020.

While I don't have a lot of quantitative data, qualitatively, my experience has been that biotech and pharma companies are actively looking to establish secondary commercial manufacturing sites, which are both geographically and economically segregated from their primary. So we've seen that organizations are not necessarily looking to work with the same CDMO, even if they have multiple geographical sites, because if there is an issue with that organization, they're now in a difficult position. They want completely economically and geographically segregated manufacturing sites.

 has introduced the CDA-200 Dual Shaft Mixer, designed to provide a versatile and cost-effective solution for processing formulations that require both thorough agitation and high-speed dispersive mixing, according to a company news release.¹ This mixer is powerful enough to batch viscous solutions, dispersions, suspensions, and emulsions with viscosities reaching up to 500,000 centipoise. Within the system, two independently driven agitators work together to achieve uniform mixing and dispersion in viscous, dense, and demanding applications. A 10-horsepower anchor agitator ensures the continuous movement of high-viscosity materials, while a 12-inch diameter high-speed disperser, operating between 160 and 1,600 revolutions per minute (RPM), induces the vigorous turbulent flow necessary for effective dispersion.¹

The open disc blade of the disperser, which travels at roughly 5,000 feet per minute, is designed to induce vigorous turbulent flow. This action creates a vortex that allows dry pharmaceutical ingredients to be quickly wetted upon entry into the vessel. To ensure the entire batch is processed evenly, the anchor feeds product towards the high-speed disperser blade and ensures that the mixture is constantly in motion.¹ This dual-action approach is particularly critical when obtaining a good dispersion of fillers into a mixture is critical to end product quality. The mixer is made of high-quality stainless steel type parts and features precision bearings with large bearing spans to minimize vibration and enhance the longevity of the agitation system during continuous use.

What design features address contamination risks and thermal sensitivity in large-scale manufacturing?

A significant advantage of this design is that no bearings or seals are submerged into the product zone, which means better protection against contamination. Thermal control is also managed through the CDA-200 change can design. It features a hydraulic lift that allows for the use of multiple jacketed mix cans which are constructed of stainless-steel type 304 and can be used for heating or cooling temperature-sensitive products. To further assist with temperature regulation and batch uniformity, Teflon scrapers can be installed on the anchor to remove materials from the interior vessel walls,¹ enhancing the mixer's heat transfer capabilities. These scrapers continuously remove material from the vessel walls, helping to keep them clean, improve batch uniformity, and enhance heat transfer across jacketed surfaces, particularly during cooling cycles when viscosity increases.

Manufacturers can improve final product quality by utilizing the application of a vacuum up to 29.5 inches of mercury to minimize air entrapment. This dual shaft mixer supports efficient, high-volume production, as it is capable of processing up to 200 gallons per batch. Safety protocols are also integrated into the workflow, as safety limit switches prevent operation of the mixer when the mix vessel and/or agitators are not in the mixing position.² This ensures that all motors and control panels can be customized to meet specific area classification requirements within a pharmaceutical facility. For fast transfer of the finished product, the system can be used with a discharge system for higher yield and easier cleaning.

What other innovative technologies are coming out of ROSS’s output?

For small-to mid-scale powder processing, the 

 provides a solution for high-precision manufacturing of dense materials.³ This system achieves repeatable homogeneity, which is vital for ensuring dose uniformity in pharmaceutical solids. A 2 HP intensifier bar featuring dual 6-inch chopper blades operates at up to 1,520 RPM to provide effective deagglomeration of ingredients.³ This ensures that clumps are broken down during the tumble process, resulting in a consistent powder blend. To support thermal requirements, the vessel includes a stainless-steel jacket rated for 50 pounds per square inch gauge for heating or cooling the batch. Additionally, the double cone vessel is rated for vacuum up to 29.5 inches of mercury, enabling efficient vacuum blending and drying via an integrated rotary vane vacuum pump.³

What design elements ensure compliance with high-purity cleaning and safety standards?

Ease of cleaning is paramount to prevent cross-contamination. All product contact parts are polished to a 240-grit finish, and a large, hinged cover allows for sufficient access during cleaning cycles according to a ROSS press release.³ The system is built for stability with an A-profile support frame and integrated guardrails for safe operation. Material discharge is handled via a 6-inch butterfly valve with a Tri-Clamp outlet, providing a secure connection for material transfer. Operators manage all functions through a 7-inch color touch screen interface, which controls the Variable Frequency Drives (VFD) for both the blender and intensifier bar. These integrated VFD units allow for precise speed adjustments, ensuring the blender can be tailored to the specific flow characteristics of different pharmaceutical powders.³

Ross. Precise High-Speed Dispersion and Agitation with the ROSS CDA-200 Dual Shaft Mixer. Press Release. Jan 29, 2026.

Benefits of choosing a ROSS Dual Shaft Mixer

ROSS DCB-5 Double Cone Tumble Blender Achieves Superior Homogeneity in Heavy-Duty Applications

The CDA-200 Dual Shaft Mixer by Ross is engineered for efficient processing of high-viscosity formulations, featuring dual independently driven agitators for uniform mixing. It includes a 10-horsepower anchor agitator and a high-speed disperser, enhancing turbulent flow and dispersion. The design minimizes contamination risks and supports thermal control with stainless steel construction and Teflon scrapers. The mixer can process up to 200 gallons per batch, with safety features and vacuum application to improve product quality. Ross also offers the DCB-5 Double Cone Tumble Blender for precise powder processing.

The ROSS CDA-200 optimizes viscous pharmaceutical batches via independent agitation, vacuum, and thermal control.

Cellares Secures $257M | Created with Canva

The cell therapy landscape is currently undergoing a fundamental transformation from localized, manual production toward a standardized industrial model, a shift underscored by the recent announcement that Cellares has closed a $257 million Series D financing round.

 Co-led by BlackRock and Eclipse, the investment brings the total funding for the organization to $612 million. This capital infusion represents more than just financial growth; it validates a move toward a new category of service provider known as an integrated development and manufacturing organization (IDMO), according to a Cellares news release.

 The IDMO model seeks to solve the persistent challenges of capacity, cost, and consistency that have limited the reach of personalized medicines to a small fraction of the global patient population. The Cellares IDMO model is “vertically integrated across technology development, biopharmaceutical contract manufacturing, and consumables manufacturing,” says Fabian Gerlinghaus, co-founder and CEO of Cellares, in an interview with 

. “This vertical integration eliminates middle-men which helps Cellares offer the lowest cost of manufacturing in the industry - the other contributing factors being a 90% reduction in required labor and facility space.”

Can High-throughput Automation Address the Current Bottlenecks in Cell Therapy Production?

To modernize what Cellares notes as the traditional method of manufacturing cell therapies long characterized by labor-intensive, manual steps that are difficult to scale across international markets, the new funding will support a fully automated smart factory model via the continued deployment of the company’s Cell Shuttle

 The Cell Shuttle operates as an automated, end-to-end, closed system for the production of various cell therapy modalities. 

“The Cell Shuttle integrates centrifugation, magnetic cell sorting, electroporation, bioreactor-based expansion, and sterile transfer into a fully-closed, single-use, universal and programmable consumable cartridge. Different modalities run on the same universal hardware design,” saysGerlinghaus. “What changes between a CAR-T and a TCR-T program are software-controlled parameters such as timing, temperature, and cell density thresholds. We have moved the process configuration problem from hardware into software. Each Cell Shuttle processes 16 patient batches in parallel and can produce up to 2,800 patient doses per year.”

In tandem, the Cell Q platform “automates sample preparation, assay execution, and data capture, and feeds QC data directly into electronic batch records,” notes Gerlinghaus. “This removes the quality control bottleneck that typically emerges when manufacturing throughput increases but QC remains manual. Where manual cell therapy manufacturing involves writing 500 pages of quality documentation by hand on paper, Cellares is moving the industry from paper to electronic batch records and from manual generation to auto-generation.” By integrating these two technologies, an IDMO can achieve approximately ten times the throughput of a conventional contract development and manufacturing organization (CDMO) while occupying a similar physical footprint. 

This efficiency, according to Cellares, has profound implications for facility planning and human resource management within the industry.

 Where a traditional contract manufacturer might require ten facilities to reach commercial-scale capacity, the automated smart factory model requires one. Also, the staffing requirements for such a facility are reduced from thousands of trained professionals to hundreds. This reduction in labor intensity is particularly relevant given recent reports of 

rising attrition risks and eroding security within the broader bio-pharmaceutical workforce

. “Smart Factories are built around our Cell Shuttles for fully-automated manufacturing and the Cell Q systems for high-throughput quality control,” adds Gerlinghaus. “All instruments are connected by software that maintain chain of custody (COC), chain of identity (COI), and auto-generates electronic batch records. Across four sites, we can deploy 85 Cell Shuttles with room to expand, delivering roughly 10x the productivity with about 90% less labor and 90% less facility space.”

Joe Fath, Partner and Head of Growth at Eclipse, highlighted the necessity of this transition by stating,

 “For decades, cell therapy manufacturing has been constrained by artisanal, manual processes. Cellares has shown that integrated and high-throughput automation can meet regulatory standards, support commercial programs, and scale globally to unlock life-saving cell therapies for hundreds of thousands of patients worldwide.”

What Role do Regulatory Designations and Global Smart Factories Play in Scaling these Modalities?

Building a resilient supply chain for personalized medicine requires a decentralized yet standardized network of manufacturing hubs. The current expansion involves the construction of automated smart factories in South San Francisco, California; Bridgewater, New Jersey; Leiden, the Netherlands; and Kashiwa City, Japan. These sites are designed to provide an unconstrained supply of therapies for hundreds of thousands of patients annually, moving the industry closer to the goals of 

. 

“Cellares is building supply-chain resilience by owning the critical IP, vertically integrating where it matters, and designing redundancy into both sourcing and operations” notes Gerlinghaus. Wherever possible, we avoid single-source suppliers. When single sourcing is unavoidable, we qualify redundant sources across regions to ensure continuity.

“From an execution standpoint, we run world-class planning and scheduling on a digital backbone that plans, schedules, monitors, and reports supply performance, with forecasting processes to anticipate demand and identify risk early. Materials and warehouse management are used to maintain targeted inventory levels, and our manufacturing and release operations are supported by integrated SAP ERP, MES, and LIMS to deliver drug product on time with audit-ready traceability.

“Logistics is treated as a core capability, with a robust vein-to-vein Chain of Identity and Chain of Custody strategy, shipping validation and courier management, and 3PL storage solutions. Our team has implemented S&OP for multiple commercial autologous cell and gene therapy companies, and we continuously optimize our ERP to sustain reliable supply.

“Finally, vertical integration of consumable cartridge manufacturing strengthens business continuity. We operate a Cellares-owned consumable cartridge manufacturing facility in Malaysia (~100,000 square feet), established as a legal entity in April 2024, with first cartridge produced in March 2025 and ISO 13485 certification targeted in 2026. In parallel, we have qualified additional third-party suppliers as backups. The result is lower manufacturing cost for partners and a more resilient, multi-region supply chain for personalized medicines.”

Regulatory confidence is another cornerstone of this industrialization effort. The automated platform has already received the FDA advanced manufacturing technology (AMT) designation, a status intended to expedite the review of regulatory submissions that utilize the platform.

 “The AMT designation allows partners manufacturing on the Cell Shuttle to reference our AMT designation in their regulatory submissions, which enables priority and expedited review,” explains Gerlinghaus. “For companies navigating CMC: engage regulators early, align on comparability strategy before you need it, and bring end-to-end manufacturing data that demonstrates control and performance. Our designation was earned through data, not promises.”

Gerlinghaus adds that while “the hardware and consumable are standardized, the software-driven process design remains fully flexible during development and optimization. Process parameters, including electroporation voltage, bioreactor perfusion rate, harvest wash concentration, and volume or timing of sampling points, are all configurable. Once the product moves into the clinic, there are still opportunities for continuous process improvement based on clinical outcomes, while maintaining the reliability, consistency, and control that come with automation.”

Andrew Farris, managing director at BlackRock, commented on the strategic importance of this development, noting, “Cellares is building the high-tech, industrial backbone required for cell therapy to scale globally. Validated and cutting-edge automation, regulatory recognition, and growing commercial demand make Cellares a category‑defining platform in a rapidly growing global market projected to reach tens of billions of dollars per year over the coming decade.”

The industry’s appetite for this automated approach is already visible in significant commercial agreements. For instance, 

Bristol Myers Squibb entered a $380 million manufacturing agreement with Cellares in 2024

 to reserve capacity within this global network.

 This trend suggests that the move toward high-tech infrastructure is no longer theoretical but a practical requirement for commercial success. As the sector looks toward the first half of 2026 for clinical manufacturing and 2027 for commercial-scale operations, the focus has shifted from scientific discovery to industrial execution.

 Gerlinghaus summarized this pivotal moment

: “The barrier to curing more patients is no longer scientific – it is industrial. With FDA validation, global commercial demand, and the capital to scale, we are building the high-tech infrastructure required to deliver cures and life-changing treatments worldwide. This financing puts Cellares on a clear, disciplined path toward becoming a public company.”

Additional support for this global initiative comes from a diverse group of investors, including Baillie Gifford, T. Rowe Price Investment Management, and the Duquesne Family Office.

 This broad financial backing reflects the growing realization that the future of cell therapy relies on a sophisticated digital architecture that 

ensures quality control through every stage of development

. By closing the gap between manufacturing and procurement, the automated IDMO model provides the pharmaceutical industry with the tools necessary to manage operational risks while 

Cellares Raises $257 Million Series D Led by BlackRock and Eclipse to Industrialize Global Cell Therapy Manufacturing with Breakthrough Automation

Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster

The cell therapy industry is transitioning from manual production to a standardized industrial model, highlighted by Cellares' $257 million Series D funding. This shift introduces the integrated development and manufacturing organization (IDMO) model, addressing capacity, cost, and consistency challenges. Cellares' automated smart factory model, featuring the Cell Shuttle and Cell Q platforms, promises tenfold throughput increases. Regulatory confidence and global smart factories are crucial for scaling. The industry is moving from scientific discovery to industrial execution, with significant commercial agreements and broad investor support underscoring this transformation.

Cellares raises $257M to scale its automated manufacturing model and validate a move toward becoming an integrated development and manufacturing organization, or IDMO.

Nerve cell with blue background attacked by red antibodies - 3D illustration of autoimmune disease | Image Source: ©peterschreiber.media -stock.adobe.com

, a biotech company that develops programmable T cell target immune medicines, announced on Jan. 29, 2026 that it is collaborating with Eli Lilly and Company to develop tolerizing therapies that restore immune homeostasis for autoimmune diseases (1). As part of the agreement, Repertoire will receive an upfront payment of $85 million with up to an additional $1.84 billion for development and commercial milestones and tiered royalties on net sales.

Collaboration activities will be led by Repertoire until a candidate is nominated. Repertoire’s T cell receptor (TCR)-epitope discovery platform, DECODE, will be used to discover and develop the tolerizing therapy candidates. Lilly will then lead clinical development, manufacturing, regulatory affairs, and commercialization of the therapy.

“This collaboration further expands Repertoire’s partnered pipeline of tolerizing therapies and affords us the opportunity to translate the unique discoveries produced by our DECODE platform into potentially paradigm shifting new medicines for autoimmune patients by addressing the root cause of the immune dysregulation and resetting their immune system to a healthier state,” Torben Straight Nissen, PhD, chairman and CEO of Repertoire and executive partner at Flagship Pioneering, said in a press release (1). “Lilly’s established leadership in immunology and commitment to advancing novel, potentially transformative medicines to patients with clear unmet needs give us great hope for the impact our innovation can have in the hands of such an exceptional partner.”

Repertoire was founded in 2019 by Flagship Pioneering. The company’s DECODE platform reveals the entire immune synapse to provide understanding of the interactions between TCRs and their cognate antigenic epitopes. The company translates these discoveries into T cell-targeted therapies for the treatment of cancer and autoimmune diseases.

What other companies are collaborating with Flagship Pioneering and Repertoire?

In December 2025, Flagship Pioneering announced a research program in collaboration with Pfizer, in which Repertoire will identify and optimize TCR bispecifics for metastatic prostate cancer (2). Flagship’s in-house drug discovery and development unit, Pioneering Medicines, is leading the partnership with Pfizer and will drive the exploration process to discover potential drug development programs.

“Repertoire’s DECODE platform uniquely maps the entire immune synapse, presenting enormous uncharted potential to discover new antigens capable of activating the immune system to fight cancer, and when coupled with Repertoire’s immune medicine engineering technologies and capabilities, places us in a strong position to generate targeted medicines to engage them,” Nissen said in a press release at the time (2). “Guided by Pfizer’s drug development expertise in oncology, we will apply our platform to uncover new potential T-cell targeted medicines.”

“This research program with Repertoire demonstrates both the continued momentum in our strategic alliance with Pfizer and the breadth of novel modalities our Flagship companies offer as a supply chain of potential therapeutic innovation,” said Paul Biondi, Flagship Pioneering managing partner, in the press release (2). “We have now collaborated on eight programs across multiple modalities and five therapeutic areas in our shared commitment with Pfizer to co-create a pipeline of novel candidates that have a potential to become differentiated medicines with greater precision, speed, and scale for the patients who need them most.”

TCR bispecifics are a potential immunotherapy that may be able to overcome barriers associated with disease progression. The research program aims to identify and develop an early optimized TCR bispecific that can control the disease reduce toxicity, according to the company.

Repertoire Immune Medicines. Repertoire Immune Medicines Announces Strategic Collaboration with Lilly to Develop Tolerizing Therapies for Autoimmune Diseases. Press Release. Jan. 29, 2026.

Flagship Pioneering. Flagship Pioneering and Repertoire Immune Medicines Announce Agreement to Identify T Cell-Targeted Immune Medicines for Prostate Cancer Under Strategic Partnership with Pfizer. Press Release. Dec. 22, 2025.

Repertoire Immune Medicines has partnered with Eli Lilly to develop tolerizing therapies for autoimmune diseases, leveraging Repertoire's DECODE platform for T cell receptor-epitope discovery. The collaboration involves an upfront payment of $85 million to Repertoire, with potential additional payments up to $1.84 billion. Repertoire will lead initial discovery efforts, while Lilly will handle clinical development and commercialization. Additionally, Repertoire is collaborating with Pfizer to identify TCR bispecifics for metastatic prostate cancer, highlighting the potential of their DECODE platform in both autoimmune and oncology applications.

Repertoire’s T cell receptor-epitope discovery platform will be used to develop tolerizing therapy development candidates with Eli Lilly and Company.  

Halo Pharma in North America | Created with Canva

Halo Pharma has emerged as a standalone drug product contract development and manufacturing organization (CDMO) based out of North America.¹ The news comes as a result of SK Capital Partners entering into a definitive agreement to divest the active pharmaceutical ingredient (API) related assets of the Noramco Group to Siegfried, based in Zofingen, Switzerland. This change allows the organization, which was originally acquired from Cambrex in 2023, to serve as a dedicated platform for drug product services across its sites in Whippany, New Jersey, and Mirabel, Quebec.

How will the transition to a standalone drug product CDMO impact development partnerships?

The restructuring of the organization into a standalone drug product CDMO is intended to provide a more concentrated focus on drug product services in the North American market. This narrowed scope often results in more streamlined technical support throughout the product lifecycle, from initial formulation to commercial manufacturing. The divestiture of the API business enables the remaining leadership to concentrate resources on complex drug product requirements and technical expertise. Discussing this strategic shift, Lee Karras, Normaco Group CEO, noted in a press release,¹ “Anytime you can focus on doing one thing really well, success is inevitable.” He further stated, “I look forward to working with the Halo teams more directly at both sites. We already have significant interest from established pharma companies looking to sign up in advance for sterile CDMO services.”

By operating independently, the organization aims to refine its scientific expertise in tech transfer and scale-up/validation. Current operations provide both non-GMP and cGMP services,¹ which are critical for maintaining compliance across different stages of clinical and commercial production. The organization continues to manage a variety of dosage forms, including oral solids, semi-solids, and oral liquids. Its facilities maintain registrations to handle products within the CI–CV Drug Enforcement Administration designations, a necessary capability for partners working with controlled substances.

What infrastructure investments are being made to address complex manufacturing needs?

As part of its growth strategy as a standalone CDMO, the organization is expanding its portfolio to include more complex manufacturing services, specifically focusing on sterile fill/finish capabilities.¹ This expansion is supported by recent investments in sterile product development, including dedicated analytical testing and formulation services. For manufacturing professionals, the introduction of a state-of-the-art Groninger UFVN FlexFill filling line and a Skan isolator, expected to be operational in the second half of 2026, represents a significant increase in available sterile capacity.

The technical specifications of this new equipment are designed for versatility in pharmaceutical manufacturing. The line is configured to fill a range of formats, including vials (2-30 mL), syringes (0.5-10 mL), and various sizes of cartridges using ready-to-use formats.¹ This move into sterile manufacturing, alongside existing capabilities in liquids and solids, allows the CDMO to support clients from the development phase through to commercialization. This shift reflects a broader industry trend where a CDMO must provide highly specialized and integrated capabilities to remain a viable partner for modern drug pipelines.

What other developments are being pushed at Halo Pharma?

Halo Pharma has transitioned into a standalone drug product CDMO, focusing on drug product services in North America. This shift follows SK Capital Partners' divestiture of Noramco Group's API assets to Siegfried. The organization aims to enhance its scientific expertise and expand its manufacturing capabilities, including sterile fill/finish services. Infrastructure investments, such as the Groninger UFVN FlexFill line and Gerteis Macro-Pactor, are being made to address complex manufacturing needs. These developments are expected to streamline operations, improve scale-up efficiency, and support compliance with regulatory standards.

Halo Pharma becomes a standalone drug product CDMO after the sale of Noramco’s API assets, adding sterile services by H2 2026.

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