Christopher Cole

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!

Videos

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

Digital information travels through fiber optic cables through the network and data servers behind glass panels in the server room of the data center. High speed digital lines 3d illustration | Image Credit: © flashmovie - stock.adobe.com

Cellares has announced a strategic expansion of its automated manufacturing capabilities to include gene-edited hematopoietic stem cell therapies.

 The initiative, established through a collaboration with the 

Stanford Center for Definitive and Curative Medicine

Stanford Innovative Medicines Accelerator

, moves the application of high-throughput automation beyond T cell therapies into a new cell modality. The development represents a critical step in industrializing treatments for conditions such as HIV and more than 19 rare inherited diseases. By automating manufacturing and release testing, the collaboration aims to replace labor-intensive, manual steps with a standardized platform designed to support academic innovation as it moves toward clinical development.

Why Is High-Throughput Automation Necessary for Gene-Edited Stem Cells

The transition to automated systems is intended to solve persistent manufacturing challenges related to capacity and consistency.

 Traditional methods for producing gene-edited stem cell therapies often rely on manual, lab-based processes that are difficult to scale. Matthew Porteus, MD, PhD, whose lab at the Stanford University School of Medicine developed the stem cell gene-editing approach, noted in a Cellares press release that the company’s technology in automation could remove the barrier to making therapies more cost effective and accessible.

 The current project involves establishing standardized manufacturing processes on the Cell Shuttle platform and release assays on the Cell Q platform to ensure high-throughput quality control.

This expansion into new modalities follows a 

, which Cellares announced last week and closed to scale its automated manufacturing model globally.

 This significant capital infusion serves to validate the industry's shift toward the integrated development and manufacturing organization, or IDMO. The IDMO model focuses on vertical integration across technology development and contract manufacturing to reduce costs and improve the reach of personalized medicines. Fabian Gerlinghaus, co-founder and CEO of Cellares, stated that “Gene-edited hematopoietic stem cells have the potential to address the root cause of disease for patients who today have limited or no treatment options.”

How Does the IDMO Model Facilitate Global Scaling and Reliability?

For biopharmaceutical organizations, the IDMO model offers a potential 90% reduction in required labor and facility space compared with conventional methods.

 This efficiency is achieved through a digital backbone that connects automated instruments to maintain the chain of custody and auto-generate electronic batch records. Gerlinghaus explains to 

 that the IDMO approach “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.”

 By integrating manufacturing and quality control, these platforms can achieve approximately ten times the throughput of a traditional contract development and manufacturing organization.

The move toward an automated, software-driven process allows for greater flexibility during development while maintaining strict regulatory standards.

 For instance, the Cell Q platform feeds quality control data directly into electronic records, addressing the bottleneck that typically occurs as production volumes increase. Gerlinghaus notes that “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.” This infrastructure is supported by an advanced manufacturing technology designation from FDA, which enables partners to seek expedited regulatory reviews. As the industry moves toward commercial-scale operations in 2027, the focus is increasingly on building the industrial backbone required to meet global patient demand.

Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies

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

Articles

Cellares is partnering with Stanford Medicine to automate gene-edited stem cell therapy for HIV and more than 19 rare diseases.

Cellares Scales IDMO Model for Gene-Edited Stem Cells Therapies

Concept of EMA European Medicines Agency. Drugs evaluation and quality control department | Image Credit: © wladimir1804 - stock.adobe.com

The European Medicines Agency (EMA) concluded its January 2026 meeting with the Committee for Medicinal Products for Human Use (CHMP) recommending six new medicines for marketing authorization.

 These recommendations highlight a significant shift in therapeutic landscapes, particularly in the areas of metabolic health and specialized radiopharmaceuticals.

A notable recommendation was granted for Kayshild, a semaglutide formulation from Novo Nordisk A/S, which serves as a GLP-1 receptor agonist.

 While several GLP-1s are currently authorized for weight management and diabetes, this marks the first approved for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis. This approval signalizes a broadening market for metabolic therapies, as fat accumulation in the liver causing inflammation represents a serious disease with evolving clinical needs.

The committee also issued a positive opinion for Ilumira, a radiopharmaceutical precursor developed by SHINE Europe B.V.

 From a manufacturing and labeling perspective, Ilumira requires strict adherence to specific development protocols, as the EMA stated that "Ilumira must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride."

In the realm of rare diseases, UCB Pharma received a positive opinion under exceptional circumstances for Kygevvi, intended for thymidine kinase 2 deficiency.

 This designation is critical for biopharma organizations focusing on unmet needs, as "the CHMP adopted a positive opinion under exceptional circumstances for Kygevvi (doxecitine / doxribtimine), the first treatment for thymidine kinase 2 deficiency, a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there is no authorised treatment." The development was facilitated through the Priority Medicines scheme, which offers enhanced regulatory support for promising candidates.

Other recommendations included Supemtek, a trivalent recombinant influenza vaccine from Sanofi Winthrop Industrie, which utilizes cell culture preparation rather than traditional methods.

 Additionally, Gedeon Richter Plc. received a recommendation for Fylrevy (estetrol), which the EMA described as "a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women."

How Are Therapeutic Indications Expanding for Existing Medicines?

The January meeting also resulted in nine recommendations for extending therapeutic indications, reflecting the ongoing lifecycle management and utility expansion of authorized products.

 These extensions often require adjustments to production volumes or new delivery formats to accommodate broader patient populations.

One such expansion involves Zynyz, a retifanlimab treatment from Incyte Biosciences Distribution B.V.

The committee recommended its use for squamous cell carcinoma of the anal canal, a condition for which no specific medicines were previously authorized in the European Union (EU). Similarly, Alk-Abello A/S received a positive opinion for a new 1 mg nasal spray strength of Eurneffy, providing a non-injectable alternative for children weighing between 15 kg and 30 kg who face allergic reactions.

Following a re-examination, CHMP also recommended 

a conditional marketing authorization for Rezurock

, a Sanofi Winthrop Industrie product for chronic graft-versus-host disease.

 The regulatory guidance for this medicine is specific: "the committee concluded that this medicine is to be used when other treatment options provide limited clinical benefit, are not suitable or have been exhausted."

Regarding Mounjaro, an Eli Lilly Nederland B.V. product, the EMA reviewed an application to include the treatment of heart failure with preserved ejection fraction in adults with obesity.

 While a separate indication was not granted, the committee agreed to include the relevant study data in the product information. This decision ensures that healthcare professionals can access data on the effects of the medicine in this specific population, highlighting the importance of clinical data integration even when label expansions are not fully realized.

Why Has a Regulatory Referral Been Initiated for Data Integrity Concerns?

Maintaining market authorization is contingent upon the continuous integrity of clinical data, a principle underscored by a new referral procedure involving Tavneos.

The review was requested by the European Commission under Article 20 of Regulation (EC) No 726/2004.

According to the committee, "the committee started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the main study supporting the medicine’s marketing authorisation in the EU." This serves as a professional reminder that regulatory bodies maintain active oversight post-authorization, and any discrepancies in the underlying study data can lead to a formal re-evaluation of a medicine's status in the EU market.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 26-29 January 2026

First Treatment for Rare Thymidine Kinase 2 Deficiency

First Immunotherapy-Based Treatment Recommended for Advanced Anal Cancer

New Medicine to Treat Chronic Graft-Versus-Host Disease

EMA Starts Review of Tavneos, a Medicine for Rare Autoimmune Diseases GPA and MPA

The European Medicines Agency's January 2026 meeting resulted in recommendations for six new medicines, including Kayshild for non-cirrhotic MASH and Ilumira for radiopharmaceutical applications. UCB Pharma's Kygevvi received a positive opinion for thymidine kinase 2 deficiency under exceptional circumstances. The meeting also saw nine recommendations for extending therapeutic indications, such as Zynyz for anal canal carcinoma. A regulatory referral was initiated for Tavneos due to data integrity concerns, emphasizing the importance of maintaining clinical data integrity post-authorization.

The EMA recommends a GLP-1 for MASH, a couple rare disease medications, and a flu vaccine among six new medicine and nine extension recommendations.

Six New and Nine Indication Extension Recommendations from EMA’s CHMP

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 

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 

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.

Cellares Secures $257M to Scale Global Cell Therapy Manufacturing

With a potential US government shutdown looming, Megha Sinha, Kamet Consulting, says to treat FDA disruptions as predictable risks by protecting milestones and early readiness.

Government Shutdowns: Treating Regulatory Lapses as Predictable Operational Risks

In this part 2 of a 2-part video interview on the impacts of a US government shutdown—

set to occur January 30, 2026 if remaining bills are not passed by lawmakers

—on pharmaceutical manufacturing and development, Megha Sinha, CEO, Kamet Consulting Group, outlines a strategic framework for pharma manufacturers to navigate the operational risks and uncertainties associated with FDA shutdowns. Sinha emphasizes that while manufacturers cannot control a government shutdown, they can mitigate its impact by treating it as a predictable operational risk rather than an unpredictable crisis.

Watch Part 1 of this interview on how a government shutdown causes FDA inspection bottlenecks and backlogs

Sinha identifies that the most vulnerable stages during a shutdown are those dependent on new starts and scheduling capacity. This includes new fee-bearing submissions, with the FDA likely unable to accept new fees during a lapse, as well as any milestones dependent on physical inspections, such as pre-approval inspections or major manufacturing site changes.

While critical health and safety functions often continue using carryover user fee funding, the resulting system becomes less predictable. Sinha highlights a critical takeaway for the industry: "The big lesson from recent funding lapses is that the uncertainty cost is often higher than the shutdown itself."

To maintain stability, Sinha recommends four specific planning actions:

• Protect Milestones: Pull forward any fee-triggering filings that can be reasonably completed before a high-risk window.

• Early Inspection Readiness: Close out critical CAPAs and ensure data integrity early so the company can take advantage of the first available inspection slots once operations resume.

• Two-Scenario Planning: Create a "base case" versus a "shutdown case" timeline for all milestones to prevent supply chain whiplash from late changes.

• Operational Buffers: Build inventory for high-critical products and diversify the supply chain so the US does not become a single point of failure.

As the industry looks toward 2026, Sinha advises companies to develop formal shutdown playbooks with clear decision rights. While digital submissions and mature quality systems have made the industry more prepared than it was a decade ago, the throughput of physical inspections remains a primary exposure point. Sinha concludes that success depends on proactive management: "The winners are really the team that will treat this like any other operational risk: Plan early, protect the milestones, and communicate clearly."

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.



So, you hedge like it's weather, right? We can't control the shutdown. But you can really plan around it. I would really do four things to plan around it.

So, one is protect your milestones. So, if companies are able to pull forward any fee-triggering filings or actions, that can be reasonably completed before the high-risk window, do that, because if FDA can't accept fee-bearing submissions during the lapse, that's a hard stop.

To go inspection-ready earlier than it feels comfortable. So, close out critical CAPAs, lock your validation evidence, ensure data integrity, so if inspections restart with limited slots, manufacturers are able to take advantage of that first available window.

Third, really build a two-scenario plan. I really like a simple base case versus a shutdown case timeline for any submission acceptance, inspections, and approval milestones so your supply chain isn't really whiplashed by late changes.

And then, you know, create operational buffers, that's the fourth one. Where you can build inventory buffers for high-critical products. I think a lot of manufacturers have already done this, but really derisking sole source constraint and really sequencing global work that US doesn't become a single point of failure. Really, the point is not to overreact, but it's to really avoid being forced into heroics, because we didn't plan for a predictable risk.

Yeah, so most vulnerable stages are really the ones that depend on new start and scheduling capacity. So most vulnerable are the new fee-bearing submissions that need to be accepted and the clock has to start because FDA has signaled that it may be unable to accept new fees during a lapse. Anything that is inspection-dependent, so again, pre-approval inspections, major manufacturing site changes, and some high-impact supplements, because inspection slots are a throughput bottleneck, even in normal times. So, that will absolutely be impacted. And then administrative, so, meeting scheduling, follow-ups, and coordinated cross-center communication. So, these are really the most vulnerable.

And the least impacted will be the critical health and safety functions. That will continue to be supported by the carryover user fee funding. So, certain reviews can continue for at least a period of time even if the broader government operation is constrained. So, it is not really a universal slowdown, it's going to be targeted.

And the agency's really going to focus its effort on the high-critical items. So, the big lesson from recent funding lapses is that the uncertainty cost is often higher than the shutdown itself. We have seen that FDA can continue to position and process a portion of it's work using the carryover user fee funding, but the system becomes less predictable.

So, can they accept new fee-bearing submissions or not? What's the pace of the routine operations? And the result is really this backlog after reopening, and companies lose time, not only during the lapse, but also the revamp.

So, for 2026, companies should be doing three things. So, having the shutdown playbooks, with clear triggers, decision rights, and two scenario timelines. So what's the base case versus if there is a shutdown that happens? How are you going to plan around it?

Earlier inspection readiness: really having that single source of truth documentation so that they can move fast when the capacity actually returns with the agency. And your supply and portfolio product prioritization, so really deciding upfront which products and changes get resources if the timelines actually compresses.

How prepared is the industry? I think better than a decade ago, because we have digital submissions, we have stronger quality systems, and really more a mature scenario planning cadence within manufacturers.

But, we're still exposed to where dependency is physical inspections and the agency throughput. So, the winners are really the team that will treat this like any other operational risk: Plan early, protect the milestones, and communicate clearly.