Aligning mRNA Progress with Regulatory Streamlining

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Dosage Forms: Roundtable on Oral Solid Dosage Trends

Drug Solutions Podcast: 

Pharmaceutical packaging must advance to adapt to new, complex modalities

Out-of-the-Box Packaging Advancements

From Theory to Reality: Automating Process Development

Drug Digest: 

The Importance of Appropriate Supplier Oversight

Ask the Expert

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept. | Image Credit: © Dilok - stock.adobe.com

The Switzerland-based biopharmaceutical company Debiopharm Research & Manufacturing has announced a license agreement with Oncodesign Services, of Dijon, France, for the use of a technology known as AbYlink for preclinical services (1). In a press release on April 24, 2025, Debiopharm explained that AbYlink is a rapid, regio-selective bioconjugation technology designed for use in therapeutic and non-invasive diagnostic applications.

Under the terms of the agreement, Oncodesign will use the technology to prepare antibody chelator conjugates for use in preclinical studies, hoping to gain insights about the predictive effectiveness of novel treatments for molecular radiotherapy, and in particular, radioimmunotherapy for cancer treatments (1).

Debiopharm further describes AbYlink as a one-step method that results in stable conjugation at defined and invariable sites on the Fc domain of an antibody, with no impact on antigen-binding regions, enabling a seamless, reproducible conjugation of payloads to antibodies or antibody-drug conjugates (ADCs) (1).

“We have demonstrated the effectiveness of this powerful technology to rapidly and covalently conjugate any off-the-shelf antibody in a single step with an imaging agent,” Frédéric Lévy, chief scientific officer at Debiopharm, said in the press release (1). “Our strategic collaboration with Oncodesign Services allows broader access to and usage of non-invasive imaging applications and provides an innovative solution to biotech and pharma partners to integrate imagery in the development of new antibody- and ADC-based therapeutics.”

“We are pleased to integrate this cutting-edge technology into our portfolio for our clients,” said Aidan Synnott, CEO of Oncodesign Services, in the release (1). “The AbYlink technology gives the advantage of generating reproducible batches of bioconjugated antibodies and ADCs that secure specificity and efficacy of targeted radiotherapy.”

In announcing their agreement, Debiopharm and Oncodesign said a joint poster is scheduled to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25–30, 2025 in Chicago, that will illustrate a demonstration of the use of the non-invasive AbYlink technology in radioimmunotherapy, targeting animal models with human epidermal growth factor receptor 2-positive (HER2+) tumors (1).

In other radiopharmaceuticals news, Sydney, Australia-based AdvanCell 

 that it had successfully completed an oversubscribed, $112 million round of Series C financing (2). The mission of AdvanCell was originally built around targeted alpha-emitting radionuclides for cancer therapy, and, to that end, the company currently operates a 40,000-square-foot manufacturing facility. AdvanCell plans to expand manufacturing capacity even further and accelerate clinical development of its radionuclide therapy pipeline with the new funding.

As for ADCs, Christian Morello, vice-president and head of the Bioconjugates Business Unit at Lonza, highlighted some challenges 

“The technology is now at the level of maturity that enable a lot of different things,” Morello said, referencing Lonza’s acquisition of Synaffix, which presents a type of linker technology in which the developer can define how many payloads it wants to have per monoclonal antibody (3). “That is another possibility that will enable [the developer] to fine tune the benefits/risk ratio for the patient,” Morello added. “We can see [that] today for some cytotoxic compounds for oncology, for sure, but we also have radiolabeled compounds to facilitate diagnosis. [This is] also oncology treatment, but with a different approach.”

1. Debiopharm Research & Manufacturing. Debiopharm and Oncodesign Services Launch Strategic Collaboration to Propel Radiopharmaceuticals in Preclinical Research. Press Release. April 24, 2025.
2. AdvanCell. AdvanCell Successfully Completes an Oversubscribed US$112M Series C Financing. Press Release. Feb. 3, 2025.
3. Mirasol, F. Advancing ADCs to the Next Level. 

Articles

The AbYlink technology enables a seamless, reproducible conjugation of payloads to antibodies or ADCs.

Debiopharm, Oncodesign Agree to Use Non-Invasive Technology for Preclinical Research

Feliza Mirasol is the science editor for 

On April 24, 2025, CN Bio, a provider of organ-on-a-chip (OOC) systems and solutions aimed at accelerating drug discovery and development workflows, announced that it has established a strategic partnership with Pharmaron, a China-based R&D service provider for the life sciences industry, under which Pharmaron will validate CN Bio’s PhysioMimix technology across existing applications and will integrate OOC technologies into its R&D platform. Also under the deal, the partners will explore the development of new applications that address unmet needs in drug discovery and development.

In the initial phase of the collaboration, the companies will focus on validating CN Bio’s PhysioMimix technology in current applications of disease modeling, toxicity testing, and absorption, distribution, metabolism, and excretion (ADME) studies. Upon successful validation, the companies will then aim to adopt the platform in priority R&D areas while co-developing novel applications to expand the capabilities of OOC technologies.

“Pharmaron [is] the ideal partner for CN Bio as we look to accelerate the growth of our OOC solutions portfolio in new and existing application areas. By working closely together and leveraging the [expertise] of each company, we can share resources that enable us to progress new, innovative solutions from concept to global market deployment more effectively than ever before,” said Paul Brooks, PhD, CEO of CN Bio, in a company press release (1).

As a global drug R&D service platform, Pharmaron specializes in providing end-to-end services across drug discovery, preclinical, and clinical development. Through this partnership with CN Bio, Pharmaron will install PhysioMimix instruments at its global facilities to enable the joint development of cutting-edge OOC solutions to meet evolving R&D challenges.

“The developments this partnership will enable are especially important given the recent FDA announcement, outlining their plan to phase out animal testing requirement for monoclonal antibodies and other drugs with more human-relevant models. Our platform is best placed to serve current market gaps including testing for immune-mediated organ damage. Together we can expedite this key development in line with global momentum for more ethical advancements that reduce costs and improve human health,” said Tomasz Kostrzewski, PhD, chief scientific officer, CN Bio, in the release. FDA made its 

 about phasing out animal testing requirements earlier in April (2).

Over the past several years, manufacturers have been developing OOC technology, largely consisting of engineered or natural tissues grown inside microfluidic chips, which allows them to maintain tissue-specific functions, according to a 

 (3). According to the article, OOCs today encompass an array of tissue and organ functionalities, including the blood-brain-barrier, central nervous system, heart, intestine, liver, lung, kidney, muscle, and skin, which allows pharmaceutical companies to better understand the underlying pathophysiology of diseases as well as determine the effect of drugs 

 (4). Market research predicts that the global OOC market will be worth $388 million by 2028, up from $82 million in 2023, exhibiting a compound average growth of 36.4% from 2023 to 2028 (5).

“We are committed to continuous innovation that enhances the quality of our services and accelerates drug discovery and development. Organ-on-a-chip technology holds significant potential to advance translational science by improving our understanding of drugability at the preclinical stage. We are pleased to collaborate with CN Bio to explore how this technology can add meaningful value to our partners’ development programs,” said Hua Yang, PhD, chief scientific officer, Pharmaron, in the company press release (1).

CN Bio and Pharmaron Establish Long-Term Strategic Partnership to Develop OOC Technologies on a Global R&D Platform

. Press Release. April 24, 2025.
2. FDA. 

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

. Press Release. April 10, 2025.
3. Barton, C. 

 (5), 16–17, 30.
4. Leung, C. M.; de Haan, P.; Ronaldson-Bouchard, K.; et al. A Guide to the Organ-on-a-Chip. 

Global Organ-on-Chip Market Size, Share, Trends, COVID-19 Impact and Growth Analysis Report—Segmented by Type (Heart-on-chip, Human-on-chip, Intestine-on-chip, Kidney-on-chip, Liver-on-chip and Lung-on-chip), Application and Region (North America, Europe, Asia-Pacific, Latin America, Middle East and Africa)—Industry Forecast from 2023 to 2028

Under the partnership, Pharmaron will validate and promote the application of CN Bio’s PhysioMimix technology and will integrate OOC technologies into its R&D platform.

CN Bio Forms Strategic Partnership with Pharmaron to Develop OOC Technologies 

This episode of Drug Digest will discuss where the significant bottlenecks are in the development and manufacturing of new molecules resulting from progressive technologies, such as AI and ML, and how best to approach these challenges.

Keeping Pace with Progressive Technologies in Biopharma Development

The biopharma industry is at a time where progressive technologies such as artificial intelligence, machine learning, and digitalization technologies are making a significant impact on how drug discovery, development, and manufacturing are being driven. Yet the question remains as to how the industry itself is keeping up with the fast-paced innovation churning out from these advanced technologies. This episode of 

 will examine where the significant bottlenecks are in the development and manufacturing of new molecules resulting from these progressive technologies, and how best to approach these challenges.

Kevin Dondarski, Principal, Life Sciences R&D, Deloitte Consulting

Maryland Franklin, PhD, Vice-President and Enterprise Head, Cell and Gene Therapy, Labcorp

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions

Sean Tucker, PhD, Founder and Chief Scientific Officer, Vaxart

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Developments in Small-Molecule APIs, Excipients, and Ingredients

Videos

Drug Digest: Keeping Pace with Progressive Technologies in Biopharma Development

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Switzerland-based pharmaceutical process development and API manufacturing company CARBOGEN AMCIS announced on April 22, 2025 that its facility in the Shanghai Chemical Industry Park, which is used for early-stage R&D, pilot scale production, and commercial good manufacturing practice (GMP) manufacture, has obtained its first drug manufacturing license (DML) from China’s National Medical Products Administration (NMPA) (1).

“This achievement underscores our team's commitment, disciplined execution, and the robustness of our Quality Management System, which has been rigorously aligned with both corporate and Chinese regulatory requirements,” said Simone Maggi, quality head, CARBOGEN AMCIS Shanghai site, in a company press release (1).

The Shanghai facility, which CARBOGEN AMCIS said is fully self-supporting, offers services ranging from raw materials to APIs, including high potency material handling and micronization (1). Equipment is located in four segregated units; reactor capacities range from 50 to 6300 liters. The site employs more than 140 workers.

“In addition to our core manufacturing capabilities, we’re proud that the Shanghai site is equipped to handle highly potent compounds up to category 3 and provide full GMP product release and analytical support,” said Harry Wong, country manager, CARBOGEN AMCIS Shanghai, in the press release (1). “This license is a testament to the strength of our team and demonstrates our ability to execute seamless technology transfers and align with the highest quality standards across CARBOGEN AMCIS’ global network.”

The DML from NMPA comes one month after CARBOGEN AMCIS was granted a GMP certificate, the company announced on March 24, 2025, for its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, by the French regulatory authority Agence nationale de sécurité du médicament et des produits de santé (ANSM). The certificate was achieved following a routine inspection process conducted by ANSM to gauge GMP compliance. It permits the facility to manufacture and release clinical and commercial sterile drug products; ANSM had granted the site authorization to manufacture, test, and release drug products upon its February 2023 opening, with the first clinical batch released in January 2024 (2).

“The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market,” Helen Caddy-Leach, head of Business Development, Drug Product, said in a press release at the time (2). “With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers’ drug product projects with excellence.”

In similar fashion to that inspection, CARBOGEN AMCIS said the most recent review by NMPA, which focused on GMP compliance and operational readiness, found that the Shanghai site met all regulatory expectations successfully, reflecting the strength of the facility’s quality systems (1).

“Securing the [d]rug [m]anufacturing [l]icense not only demonstrates the operational readiness of our Shanghai site but also reflects the strength of our global quality culture,” Stephan Fritschi, CEO of CARBOGEN AMCIS, said in the April 22 press release (1). “This achievement strengthens our long-term goal of becoming a trusted partner in the Chinese pharmaceutical market.”

1. CARBOGEN AMCIS. CARBOGEN AMCIS Shanghai Site Awarded Drug Manufacturing License from Chinese NMPA. Press Release. April 22, 2025.
2. CARBOGEN AMCIS. CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site. Press Release. March 24, 2025.

CARBOGEN AMCIS Shanghai Site Gets Drug Manufacturing License from China’s NMPA

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Ask the Expert: EU Data Protection

 that the agency and the Heads of Medicines Agencies (HMA) have revised their guidance on identification of commercially confidential information (CCI) and personal data used in marketing authorization applications. The revision was done as part of the agency’s commitment to transparency in the disclosure of information in response to access-to-document requests and the publication of data for authorized medicines (1).

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the impact of the revised guidelines and what manufacturers should do to secure such data.

“It was always felt that one should not have concerns when sending anything to the agencies such as the European Medicines Agency, or any agency within the European Union or the European Economic Area, because you would think that they understand what is confidential and what is not; however, this document is really a wakeup call, as the agencies only feel obliged to not disclose anything that is blindingly obvious secret, such as the manufacturing formula,” Schmitt says.

“So, this is completely different to what most companies had in the back of their mind. There are perhaps less obvious data in an application that could potentially cause enormous harm to the applicant if they were disclosed. For example, the listing of the clinical study sites and the names and contact details of the principal investigators; competitors could try and poach the patients and/or the investigators. The guidance only says that such data and information may be considered secret, but it doesn't say it is secret,” Schmitt explains.

Click the video above to watch Sue and Siegfried answer the following question:

“Our company handles a variety of personal data in our regulatory applications, and we saw that EMA has revised guidelines on the use of personal data in applications. What should we focus on when securing these data?”

1. EMA. A Common EU Approach to Data Transparency in Medicine Regulation. Press Release. Dec. 18, 2024.

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.

Boehringer Ingelheim has released data on its patient reach, sales, and investments during 2024, and is looking ahead to the company’s anticipated offerings for the rest of 2025.

In a press release on April 22, 2025, the biopharmaceutical company said the 66 million patients it reached in 2024 represented an 8% increase over 2023, with R&D investments rising to €6.2 billion (US$7.02 billion), representing 23.2% of group net sales (1).

Frank Hübler, member of the board of managing directors with responsibility for Finance, said that figure was indicative of an upward trend.

“If we look at the past five years, Boehringer Ingelheim has invested approximately €25 billion (US$28.3 billion) in R&D,” Hübler said in the release (1). “With the innovations currently in our pipeline, we will further increase investments in R&D in the years to come.”

Boehringer Ingelheim is active in both human and animal health; in 2024, its sales in the human pharma sector rose by 7% to €21.9 billion (US$24.8 billion), led by treatments for chronic kidney disease, type 2 diabetes, and heart failure (€8.4 billion, US$9.5 billion), and idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases (€3.8 billion, US$4.3 billion) (1).

The company’s human pharma pipeline includes more than 10 new Phase II and III trials over the next 12 to 18 months—to nearly the end of 2026—and R&D spending in that area in 2024 totaled €5.7 billion (US$6.46 billion), representing more than a quarter (27.6%) of Boehringer Ingelheim’s business unit’s net sales (1).

For 2025, Boehringer Ingelheim is preparing product launches that the company said will advance care for patients with idiopathic or progressive pulmonary fibrosis, along with the first orally administered targeted therapy for patients with previously treated human epidermal growth factor receptor 2 (HER2)-mutated lung cancer (1).

“As our current pipeline continues to mature and more products come closer to a potential market introduction, we have entered a pivotal phase of high investments, to bring these new innovations to patients,” said Hubertus von Baumbach, chairman of the board of managing directors, in the press release (1). “It is important that we use every opportunity to bring these new treatments to patients as fast as possible—this is our number one priority.”

®, one of Boehringer Ingelheim’s partnership efforts was spotlighted: its deal with Gubra, a Denmark-based, pre-clinical contract research organization/biotech focusing on peptide-based therapies (2). Gubra is developing four anti-obesity agents in conjunction with Boehringer Ingelheim, including two clinical programs with a long-acting neuropeptide Y receptor type 2 (NPY2R) agonist, BI 1820237—of which Boehringer Ingelheim discontinued its development in October 2024—and a triple agonist.

Another Boehringer Ingelheim partnership, with OSE Immunotherapeutics, yielded the candidates BI 765063 and BI 770371 (anti-signal-regulating protein alpha [SIRPα] monoclonal antibody on CD47/SIRPα pathway), developed for treatment of advanced solid tumors, as reported at the time of 

the announcement of a strategic partnership

 between OSE and AbbVie in February 2024 (3).

1. Boehringer Ingelheim. Boehringer Ingelheim Reaches More Patients in 2024 and Prepares New Medicine Launches. Press Release. April 22, 2025.
2. Barton, C. Next-Generation Anti-Obesity Medicines. 

AbbVie Partners with OSE Immunotherapeutics on Novel mAb for Chronic Inflammation.

Boehringer Ingelheim Previews New Product Launches Expected in 2025

The Davos Alzheimer’s Collaborative (DAC), led by the World Economic Forum and the Global CEO Initiative on Alzheimer’s Disease, announced on April 22, 2025 that it has selected the genomic sequencing company PacBio as its technology partner in the launch of a new project, the North African Dementia Registry (NADR) (1).

Other partners, according to a press release, include the Institute of Global Health and Human Ecology (I-GHHE) at The American University in Cairo (AUC), and UCL Queen Square Institute of Neurology at University College London (UCL) (1). The purpose of the project is to develop a high-quality and comprehensive multi-omics dataset that will serve to advance the research community’s understanding of Alzheimer’s disease genetics, and those of other forms of dementia, in diverse populations around the world.

Data generated by the efforts of the collaboration will be made accessible via a worldwide research platform, the Alzheimer’s Disease Data Initiative (1).

The NADR, which desires to address an underrepresentation of North African populations in dementia research, is part of DAC’s goal of investing more than $700 million to accelerate innovation in drug development and healthcare approaches to Alzheimer’s disease (2).

“This collaboration will bolster our understanding of Alzheimer’s disease in a region characterized by remarkable genetic diversity,” Vaibhav Narayan, DAC executive vice-president, said in the press release (1). “Over time, these insights will inform locally relevant prevention and intervention strategies for communities often overlooked in global research efforts.”

“Addressing the global challenge of dementia requires diverse, high-quality datasets. With PacBio’s technology and workflows, we can accelerate our understanding of the genetic architecture of populations in North Africa and uncover novel biomarkers and potential therapeutic targets,” Mie Rizig, PhD, UCL NADR lead and clinical senior research fellow in the Department of Neuromuscular Diseases at UCL Queen Square Institute of Neurology, said in the release (1).

The number of people living with dementia is forecast to as much as triple, to 139 million individuals, by the year 2050 (2). Currently, three out of four people with dementia are not only never treated for it—they aren’t diagnosed.

“With a population exceeding 110 million, Egypt serves as a unique bridge between Africa and the Middle East, offering a rich tapestry of genetic and cultural heritage,” said Mohamed Salama, AUC-NADR lead and professor at AUC’s I-GHHE, in the press release (1). “This collaboration not only promises to benefit the Egyptian population but also aims to advance our collective understanding of dementia in the region and beyond.”

“We are proud to partner with DAC, AUC, and UCL on this important project to advance our understanding of the genetics of Alzheimer’s disease, and hopefully help researchers identify new diagnostic tools and therapeutic solutions,” said Neil Ward, vice-president and general manager of EMEA at PacBio, in the release (1). “Our long-read sequencing technology is uniquely suited to deliver the high-quality genomic data needed to explore the complex genetic landscape of Alzheimer’s disease. This initiative aligns with our commitment to enabling genomic discoveries that improve human health worldwide.”

At the American Society of Gene and Cell Therapy (ASGCT) conference in Baltimore, Md., in May 2024, 

® sat down with Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, about the benefits of long-read sequencing in cell and gene editing (3). That video interview can be viewed in full at 

1. Davos Alzheimer’s Collaborative. Davos Alzheimer’s Collaborative Selects PacBio as Technology Partner for Global Project to Advance Alzheimer’s Disease Research in North Africa. Press Release. April 22, 2025.
2. Comments received via email correspondence on April 22, 2025.
3. Spivey, C. 

The Benefit of Long-Read Sequencing in Gene Therapies.

The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.

PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project

Industry Outlook 2025: Mergers, Acquisitions, and Funding

According to Erik Wiklund, CEO of Circio, the bio/pharmaceutical industry has seen a trend toward fewer, but larger mergers and acquisitions. During the COVID-19 pandemic, biotechs had ample access to venture capital and public funding; however, since the pandemic, capital has dried up, as valuations have plummeted and investors have lost money. In addition, a looming patent cliff is also straining revenue expectations.

“Both of these forces can converge into larger and later-stage deals, so investors are likely to buy into later-stage de-risked programs with clinical validations, Stage II, Stage III, [with a] clear path to approval, and that's probably where the M&A deals are and will continue to happen,” Wiklund says. “Investors are looking for lower-risk assets with a clear development path closer to the clinic. Unfortunately, for a company like ours, which is building a really exciting new gene therapy technology platform, it has become difficult to fundraise in the current environment. This forces companies like Circio to prioritize asset generation, picking a track and going deep in one single area, rather than to scientifically develop the platform to its full potential which would have been the standard strategy three years ago, where Big Pharma and investors were looking for technology platforms with broad therapeutic potential.”

Click the above video to watch the interview.

Erik Wiklund, PhD, is CEO of Circio. He has deep scientific knowledge in RNA and cancer biology, and 13 years of pharma and biotech industry experience in a variety of functions including R&D, finance, and business development. Previous employment includes the radiopharmaceutical company Algeta, which was acquired by Bayer in 2014, Aker Biomarine, and management consulting experience from the Pharma & Health Care practice of McKinsey & Company. Wiklund holds a PhD in Molecular Biology from Aarhus University, Denmark, and the Garvan Institute of Medical Research, Sydney, Australia

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the future of M&A in the bio/pharmaceutical industry and the struggle small biotech companies face raising funds.

Roche announced on April 22, 2025 that it will be investing $50 billion into its United States footprint between now and 2030, a commitment that is expected to create more than 12,000 jobs—including almost 6500 in construction—and 1000 jobs at new and expanded facilities (1).

The plans that have been announced for those facilities cover eight states in the US, although a location has yet to be disclosed for a proposed 900,000-square-foot manufacturing center to support Roche’s expanding portfolio of next-generation weight loss medicines (1). Sites in California, Indiana, Kentucky, New Jersey, and Oregon will receive expanded and upgraded manufacturing capabilities for innovative medicines and diagnostics; expansion and upgrading of existing pharmaceutical and diagnostics R&D centers in Arizona, California, and Indiana will also be part of the investment.

Additionally in Indiana, there are plans to build a new manufacturing facility for continuous glucose monitoring. A state-of-the-art gene therapy manufacturing facility will be built in Pennsylvania, and a new R&D center is planned in Massachusetts, where Roche said cutting-edge artificial intelligence (AI) research would be conducted, with the facility serving as a hub for the company’s new R&D efforts in the cardiovascular, renal, and metabolism spaces (1).

“Roche is a Swiss company with a strong heritage in more than 130 countries globally. Today’s announced investments underscore our long-standing commitment to research, development, and manufacturing in the US,” Thomas Schinecker, Roche Group CEO, said in the press release (1). “We are proud of our 110-year legacy in the United States which has been a key driver for jobs, innovation, and the creation of intellectual property in the US, across both our Pharmaceutical and Diagnostics divisions. Our investments of $50 billion over the next five years will lay the foundation for our next era of innovation and growth, benefiting patients in the US and around the world.”

Roche said that when the new and expanded manufacturing capacity all comes online, the company will be exporting more medicines from the US than it imports; its diagnostics division already has an export surplus from the US, according to the press release (1). That may be especially relevant given the uncertainty surrounding tariffs being imposed by the US, and reciprocation from other countries, which were 

 at INTERPHEX 2025 in New York City from April 1–3.

“We have seen a few companies that are our customers that are reaching out to look at automated manufacturing stateside, where they had [previously] been producing the parts overseas,” Peter Sarvey, head of sales at Automation NTH, told 

® at the conference (2). “So I think that’s the end result, and the end goal, I’d have to imagine, is to bring that manufacturing back [to the US].”

Some of Roche’s other activity thus far in 2025 was covered 

 series. In that discussion, industry experts included Roche’s unveiling of a new class of next-generation sequencing with its novel sequencing by expansion technology, as part of a larger conversation about new genomics tools (3,4).

Prior to the announcement of the $50 billion investment, Roche’s US footprint included more than 25,000 company employees at 15 R&D centers and 13 manufacturing sites (1).

1. Roche. Roche to Invest USD 50 Billion in Pharmaceuticals and Diagnostics in the United States over the Next Five Years. Press Release. April 22, 2025.
2. Lavery, P. 

Tariff Pause Reinforces Uncertainty Among Biopharma Professionals.

Behind the Headlines Episode 12–Cell and Gene Therapies, New Genomics Tools, and Recent Partnerships.

, March 5, 2025.
4. Roche. Roche Unveils a New Class of Next-Generation Sequencing with its Novel Sequencing by Expansion Technology. Press Release. Feb. 19, 2025.

The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.

Roche to Invest $50 Billion in US Pharmaceuticals and Diagnostics

Industry Outlook 2025: The Impact of Politics on Pharma

The political landscape is evolving and unpredictable at the moment, according to Edwin Stone, CEO of Cellular Origins, and the development of an inward focus by the United States might have a negative impact on the development and manufacturing of emerging treatments. Collaboration when tackling complex biology to treat complex diseases is necessary between the US, Europe, and beyond, says Stone.

“For a long time, I've always been hopeful and optimistic, and frankly, my confidence is a little shaken now that Asia, and particularly China, can be bought into the fold,” Stone says. “There's an awful lot going on in advanced therapies in China that we do not see in Europe or the US, and similarly, vice versa. Unfortunately, it looks like in the immediate term, we may see a backing off on that. Now, what we don't know is how much narrative transfers into reality there. And there is some suggestions, I think, that perhaps actually the reality will be a bit more tempered, some saber rattling and some strong signals early on to get some positioning. And hopefully, actually what we're seeing is a level of pragmatism come into that, because I really am a great believer that for the sort of problems we attack on now, if we work together, we'll have a chance to actually move these things forward and move these things forward a lot quicker. And let's remember this is for the benefits of patients and for people. It is not just about profits.”

Click the video above to watch the full interview.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the impact of the changing political landscape on the pharmaceutical industry.

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