Feliza Mirasol is the science editor for 

Feliza Mirasol

Celltrion announced on Aug. 6, 2025 that FDA has approved its application for an expanded indication of tocilizumab-anoh (brand name Avtozma), its intravenous (IV) therapy, to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older (1). Tocilizumab-anoh is a biosimilar to Actemra (tocilizumab), the originator biologic from Genentech, a member of the Roche Group. Actemra was originally approved by FDA in January 2010 (2).

With this additional approval from FDA for the CRS indication, Celltrion’s tocilizumab-anoh IV now aligns with all indications for which Genentech’s originator tocilizumab IV is approved in the United States. Tocilizumab-anoh in IV formulation originally received FDA approval in January 2025 for treating multiple inflammatory indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus COVID-19 (3).

"We are proud that [Avtozma IV] has now achieved full indication alignment with the reference [Actemra IV]. This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS," said Thomas Nusbickel, chief commercial officer at Celltrion USA, in a company press release (1). "This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas."

CRS is a potentially life-threatening condition. It occurs when the immune system is highly activated, which leads to rapid and excessive release of cytokines into the bloodstream—a cytokine storm. During a cytokine storm, the overactivated immune system can lead to widespread inflammation and can cause damage to healthy tissue and organs throughout the body. Symptoms range from mild, flu-like symptoms to more severe complications, including low blood pressure, difficulty breathing, and multi-organ failure (4).

CRS is a recognized complication of certain T-cell-engaging (TCE) immunotherapies. Such therapies include chimeric antigen T-cell and bispecific therapies. CRS can occur from a severe infection, such as COVID-19. Multiple myeloma drugs that may cause CRS include:

idecabtagene vicleucel (brand name Abecma)

ciltacabtagene autoleucel (brand name Carvykti)

teclistamab-cqyv (brand name Tecvayli) (4).

Settlement between Celltrion and Genentech

In compliance with a patent settlement agreement between Celltrion and Genentech, the IV formulation of tocilizumab-anoh is expected to be available in the US market on Aug. 31, 2025. Celltrion holds a license to market a subcutaneous formulation in the US starting on a licensed launch date, which has not been disclosed.

Tocilizumab-anoh is a recombinant humanized monoclonal antibody that acts as an interleukin 6 receptor antagonist. FDA’s approval was based on data from a global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 (tocilizumab-anoh’s designation during pipeline development) (3) in comparison to the reference biologic, tocilizumab. The biosimilar also received approval by the European Commission in February 2025.

FDA Approves Expanded Indication for AVTOZMA (tocilizumab-anoh) Intravenous (IV) Formulation in Cytokine Release Syndrome (CRS)

. Press Release. Aug. 7, 2025.
2. FDA. Actemra Approval Letter. 

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125276

US FDA approves Celltrion's AVTOZMA (tocilizumab-anoh), a Biosimilar to ACTEMRA

. Press Release. Jan. 30, 2025.
4. International Myeloma Foundation. 

Articles

Celltrion's tocilizumab-anoh (Avtozma) has received FDA approval for an expanded indication to treat cytokine release syndrome (CRS) in patients aged two and older. This approval aligns Avtozma with all indications of Genentech's Actemra, the reference biologic. Tocilizumab-anoh, a biosimilar, was initially approved for various inflammatory conditions. CRS, a severe immune response, can result from T-cell-engaging therapies or infections like COVID-19. A patent settlement allows Celltrion to market the IV formulation in the US from August 31, 2025, with a subcutaneous version pending.

The company’s expanded label for Avtozma (tocilizumab-anoh) now includes the treatment of cytokine release syndrome, aligning the therapy with all indications for which Actemra is approved in the US.

FDA Grants Approval to Celltrion for Expanded Indication of Actemra Biosimilar to Treat CRS

Discussion with Jerry Keybl, Avantor, about latest innovations in biomanufacturing and major industry trends coming out of INTERPHEX 2025.

INTERPHEX 2025: The Search for Pragmatic Solutions to Ground Industry Innovations

Contemporary biopharmaceutical production strategies emphasize three critical drivers: scalability, flexibility, and efficiency, says Jerry Keybl, senior vice-president, Biopharma Products and Strategy, Avantor. In addition, Keybl attended INTERPHEX 2025 last April and shared some of his impressions of the energy at that show around these themes.

Keybl emphasizes how the bioprocessing sector is experiencing significant transformation today, driven by supply chain disruptions, regionalization, and the emergence of diverse therapeutic modalities. He underscores the importance of developing future-proof bioprocessing technologies.

"Innovations today really have to be future-proof. They have to support manufacturing all the way from clinical trials to commercialization. Sometimes the challenges are different at different stages of the development, and the decisions you make early on can really impact the success as a commercialization approaches," he says.

Manufacturing flexibility is increasingly crucial, he also points out, explaining that facilities are transitioning from single-process to multi-product and multi-modality platforms. Therefore, there is a need for adaptable technologies that can accommodate diverse product requirements while maintaining operational efficiency.

Buffer management is also emerging as a crucial area for optimization, with solutions such as ready-to-use buffers and direct dispense packaging systems (solutions that Avantor offers) allowing for the reduction of labor costs and improved process efficiency.

One key takeaway from the show that made an impression on Keybl was that the bio/pharmaceutical industry is currently focused on practical innovation, balancing excitement about new modalities with a pragmatic approach to solving real-world manufacturing challenges.

Click the video above to view the full interview.

Jerry Keybl, Senior Vice-President, Biopharma Products and Strategy, Avantor

Jerry Keybl is senior vice-president of Biopharma Products and Strategy at Avantor, leading integrated product strategy and execution across traditional and novel biopharma modalities. He previously held product management, marketing, and strategy roles at MilliporeSigma, with a focus on cell and gene therapies, and served as a project leader at the Boston Consulting Group.

Videos

Jerry Keybl, senior vice-president, Biopharma Products and Strategy, Avantor, discusses innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025 held this past April.

Discussing Pragmatic Solutions to Ground Industry Innovations with Avantor

Eli Lilly and Company (Lilly) announced on July 30, 2025 results from a long-term extension (LTE) of a Phase III study (TRAILBLAZER-ALZ 2), which showed that participants treated with donanemab-azbt (brand name Kisunla) demonstrated slowing of decline (1)—a benefit that continued to grow over a span of three years, compared to an untreated external cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI) (2). Under the brand name Kisunla, donanemab-azbt was 

 for treating Alzheimer’s disease (AD) (3).

Participants in the Phase III study who began treatment at a later time still saw benefit; however, study participants who started treatment earlier significantly reduced the risk of progression to the next stage of AD compared to those who received treatment later (2). Data from the study were presented at the 2025 Alzheimer's Association International Conference (AAIC) in Toronto, Canada, which occurred on July 27–30.

"The TRAILBLAZER-ALZ 2 long-term extension reaffirms that Kisunla delivered sustained clinical benefit that continued to increase over three years and a consistent safety profile," said Mark Mintun, MD, group vice-president, Neuroscience Research & Development, Eli Lilly and Company, in a company press release (1). "Participants continued to show meaningful outcomes, reinforcing the long-term value of early intervention."

This Phase III LTE study (TRAILBLAZER-ALZ 2 LTE) was a double-blind extension of the original Phase III clinical trial (TRAILBLAZER-ALZ 2) designed to evaluate the efficacy and safety of donanemab-azbt in individuals with early symptomatic AD (2). Participants originally treated with donanemab-azbt were either continued on the same treatment or were switched to placebo, while those initially on placebo began treatment with donanemab-azbt in a blinded manner. To assess outcomes against a matched, untreated population, an external comparator group from ADNI was used.

The key preliminary results from the LTE study include:

The demonstration that the donanemab-azbt benefit continued to grow over the course of three years in study participants treated with the therapy compared to those in the matched ADNI group. The data show that donanemab-azbt reduced cognitive decline by -0.6 at 18 months and -1.2 at 36 months based on the Clinical Dementia Rating Sum of Boxes (CDR-SB). These data came from patients initially treated with the therapy in the core study compared to the ADNI group.

An earlier start of treatment with donanemab-azbt reduced the risk of disease progression to the next stage by 27% on the Clinical Dementia Rating-Global Score (CDR-G) compared to the group who had delayed initiation of treatment.

More than 75% of participants treated with donanemab-azbt achieved amyloid clearance within 76 weeks from the start of treatment.

Observed data gathered after up to 2.5 years in participants who had completed treatment showed that the reaccumulation of amyloid plaque remained slow at a rate of approximately 2.4 CL/year, which was consistent with prior observations and modeling.

No new safety signals were observed in the study over the three-year period, which supports the established safety profile for donanemab-azbt.

Side effects include amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/with hemosiderin deposition. These are side effects within the class of amyloid targeting therapies that do not usually cause any symptoms; however, serious and life-threatening symptoms can occur. ARIA can be fatal, according to Lilly in the release.

Lilly’s Kisunla (donanemab-azbt) Showed Growing Benefit Over Three Years in Early Symptomatic Alzheimer’s Disease

. Press Release. July 30, 2025.
2. National Library of Medicine. 

A Study of Donanemab (LY3002813) in Participants with Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

, May 4, 2025 (accessed Aug. 5, 2025).
3. FDA. 

Eli Lilly's long-term extension of the Phase III TRAILBLAZER-ALZ 2 study demonstrated that donanemab-azbt (Kisunla) significantly slowed cognitive decline in Alzheimer's patients over three years. Early treatment initiation notably reduced disease progression risk compared to delayed treatment. The study, presented at the 2025 Alzheimer's Association International Conference, confirmed sustained clinical benefits and a consistent safety profile. More than 75% of participants achieved amyloid clearance within 76 weeks, with slow amyloid plaque reaccumulation. No new safety concerns were identified, although amyloid-related imaging abnormalities remain a potential risk.

Findings from a Phase III study highlight the demonstrated action of donanemab-azbt (brand name Kisunla) in slowing the decline of patients exhibiting early symptomatic Alzheimer’s disease. 

Lilly’s Kisunla Demonstrates Growing Benefit in Treating Early Alzheimer’s Disease

Roche announced on July 28, 2025 that it presented new data from its development portfolio for Alzheimer’s disease (AD) at the 2025 Alzheimer’s Association International Conference (AAIC), held in Toronto, Canada, on July 27–30. The company is conducting research on AD across both its pharmaceutical and diagnostics portfolios (1).

On the pharmaceutical portfolio front, the company’s presentations at the conference included the latest results from an ongoing Phase Ib/IIa Brainshuttle AD study, which continue to support the rapid and robust reduction of amyloid plaques, and the design of Phase III studies (TRONTIER 1 and 2) using trontinemab—an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal antibody—for early symptomatic AD. These Phase III studies are planned to start later in 2025. In addition, Roche also plans to conduct an additional Phase III trial that will investigate the use of trontinemab in preclinical AD as part of its growing programs for the disease. This additional trial will focus on individuals at risk of cognitive decline. The goal will be to potentially delay or prevent the progression of AD to the symptomatic stages.

“Alzheimer’s disease represents one of the greatest challenges in healthcare today, and tackling it requires early detection and effective therapeutics,” said 

, chief medical officer and head of Global Product Development, Roche, in a company press release (1). “Trontinemab is designed to target a key driver of Alzheimer’s disease biology more effectively in the brain.Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention. With plans for Phase III trials in both early symptomatic and preclinical Alzheimer’s disease, we are advancing science with the goal of delaying—and ultimately preventing—progression of this devastating condition.”

On the diagnostic portfolio front and using both oral and poster presentations at AAIC 2025, Roche highlighted the potential of its Elecsys pTau217 product as a reliable and accessible blood-based biomarker test, which can provide comparable results to positron emission tomography (PET) scans and cerebrospinal fluid diagnostics for rule-in and rule-out diagnosis of amyloid pathology, a hallmark of AD, across care settings. Elecsys pTau217 will be used in the planned additional Phase III studies (TRONTIER).

“Blood based testing for Alzheimer’s disease has the potential to greatly improve patient access and decrease the time to definitive disease diagnosis,” said Matt Sause, CEO of Roche Diagnostics, in the press release. “Our data show that the Elecsys pTau217 test performs comparably to PET scans but can be performed with a simple blood draw and analyzed in a routine clinical laboratory. This has the potential to transform the diagnosis of Alzheimer's and provide clear answers to caregivers, patients, and their families.”

Roche cites that up to 75% of people living with symptoms of AD globally have not been diagnosed. Meanwhile, those who have been diagnosed were said to have waited an average of 2.8 years to get the diagnosis (2). Even fewer have received any form of treatment, according to Roche in the release. The company stated in the release that “[d]iagnostics play a crucial role in addressing the global challenge of Alzheimer’s, not only to detect and identify people with the disease early, even before the first symptoms, but also to rule out those who may or may not benefit from specific treatments” (1).

Roche Presents New Insights in Alzheimer’s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC.

 Press Release. July 27, 2025.
2. Johns Hopkins Bloomberg School of Public Health. Life Expectancy Following Diagnosis of Alzheimer’s Disease Depends on Age at Diagnosis. 

https://publichealth.jhu.edu/2002/alzheimer-age

Roche has unveiled new data on Alzheimer's disease (AD) research at the 2025 Alzheimer's Association International Conference. The company is advancing its pharmaceutical and diagnostic portfolios, focusing on trontinemab, a bispecific monoclonal antibody targeting amyloid-beta, with Phase III trials planned for early symptomatic and preclinical AD. Roche's Elecsys pTau217 test, a blood-based biomarker, shows promise as a reliable alternative to PET scans for diagnosing amyloid pathology. The company emphasizes the importance of early detection and effective therapeutics in addressing the global AD challenge.

The company presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios at this year’s AAIC.

Roche Reveals New Data from Alzheimer’s Disease Research at AAIC 2025

Unidentified microbiologist is place the petri dish and tubes into incubator to incubate the culture of bacteria or fungi growth in appropriate condition, concept of microbial laboratory. | Image Credit: © Sukjai Photo – © Sukjai Photo – Stock.Adobe.com

Maintaining a sterile cleanroom environment and stringent cleanroom protocols in biopharmaceutical manufacturing are critical to ensure optimal product quality and, ultimately, patient safety. With the shift toward personalized medicines, new generation therapies, such as messenger RNA (mRNA), cell and gene therapies (CGTs), antibody-drug conjugates, and modern vaccines, are presenting sterility challenges. Therefore, it is becoming increasingly necessary for analytical technologies to advance and keep pace with the evolving, modern-day therapeutic requirements for sterile environments in cleanrooms.

As therapeutic modalities evolve, so do the challenges and methodologies associated with maintaining and verifying cleanroom sterility. Cleanroom standard operating procedures (SOPs) are the foundation to ensuring controlled, contaminant-free environments. Recent regulatory updates have prompted revisions to these procedures to align with contemporary standards and technological advancements.

For example, the International Organization for Standardization (ISO) updated the ISO 14644 series in 2015 (1), which delineates cleanroom classifications and associated protocols. In the series, ISO 14644-1 focuses on classifying air cleanliness by particle concentration, and ISO 14644-2 enumerates the requirements for testing and monitoring to ensure ongoing compliance with designated cleanliness levels. With these updates, a more rigorous approach to contamination control is emphasized, which necessitates that SOPs incorporate enhanced monitoring and maintenance strategies (1).

FDA, meanwhile, has advocated for integrating rapid and advanced detection methods into sterility testing, with the goal of expediting detection of microbial contaminants and reducing product release times without compromising safety. As a result, SOPs now often include provisions for implementing rapid microbiological methods (RMMs) alongside traditional testing techniques (2).

Sustaining sterility within cleanrooms poses multifaceted challenges, both enduring and emerging. Challenges that continue to persist include:

 Personnel remain the primary source of contamination. This is commonly attributed to inadequate gowning procedures, lapses in protocol adherence, and insufficient training—all of which can introduce particulates and microbes into the cleanroom environment (3).

Continuous surveillance of particulate and microbial levels is crucial; however, traditional monitoring methods may not provide real-time data, which potentially allows contaminants to proliferate before detection (4).

 Suboptimal cleanroom design or maintenance can lead to contamination risks. Improper airflow, inadequate filtration systems, and poorly maintained equipment are factors that can compromise sterility (5).

Meanwhile, emerging challenges posed by new therapeutic modalities, such as CGTs and mRNA-based treatments include:

 These new modalities often involve living cells or delicate nucleic acids, which are highly susceptible to environmental conditions. Therefore, maintaining appropriate temperature, humidity, and aseptic conditions is paramount.

 Production of these modalities typically involves intricate procedures, which increases the potential for contamination at multiple stages of the manufacturing process. Each step necessitates stringent controls to preserve product integrity.

 Many advanced therapies have limited shelf lives, necessitating expedited manufacturing and testing processes. Traditional sterility testing methods, which can take up to 14 days, are impractical for these products, prompting the need for rapid testing alternatives (6).

On the other end of contamination prevention is verification of sterility, which is also a critical step to ensuring a product’s safety and efficacy. Verification requires analytical testing methods, including membrane filtration, direct inoculation, and automated culture systems.

In membrane filtration, product is passed through a filter that captures potential contaminants. The filter is then incubated in growth media to detect microbial presence (7). Direct inoculation is applied to products that cannot undergo filtration. In this method, product is directly inoculated into culture media, incubated, and microbial growth is monitored over a specified period of time (8). Meanwhile, automated culture systems were developed to enhance efficiency and reliability. In these systems, product is continuously monitored for microbial growth. This method offers advantages in sensitivity and reduced hands-on time compared to manual methods (9).

The evolving regulatory requirements over the years as well as the increasing biopharmaceutical complexity and growing demand for aseptic processing have prompted significant advancements in cleanroom technologies and analytical testing methods. These innovations have been driven by the need for faster, more accurate contamination detection, improved environmental monitoring, and greater flexibility in biomanufacturing. Innovations include rapid microbiological methods (RMMs), next-generation sequencing (NGS), real-time environmental monitoring, and the use of digitalization and artificial intelligence (AI) in cleanroom analytics.

The adoption of RMMs has been prompted by the lengthy time it takes for traditional sterility testing methods. For example, membrane filtration and direct inoculation can take up to 14 days to get results. RMMs utilize technologies such as nucleic acid amplification (e.g., polymerase chain reaction-based assays), flow cytometry, and adenosine triphosphate bioluminescence to detect microbial contaminants in real-time or within hours rather than days (4). Advanced therapies such as CGTs and mRNA-based therapeutics require faster contamination detection than traditional methods and have been the real drivers behind accelerating the implementation of RMMs.

NGS, meanwhile, has emerged as an important tool for microbial identification in cleanrooms as it enables the detection and characterization of diverse microbial populations, unlike conventional culture-based methods. NGS also enables the detection of previously unculturable organisms. This technology enhances contamination tracing and root-cause investigations and can lead to more effective contamination control strategies (10).

Real-time environmental monitoring has been enabled with the development of advanced sensors. The ability to monitor particles and microbes in real time is changing the way contamination control is handled in the cleanroom. For example, technologies such as laser-induced fluorescence sensors allow for immediate airborne microbial detection without the need for culture-based methods. Systems such as those are often integrated into continuous environmental monitoring platforms and provide instant alerts to deviations in cleanroom conditions (2).

Finally, AI-driven analytics, combined with machine learning algorithms, are being deployed to analyze environmental monitoring data, detect contamination patterns, and predict contamination risks before they occur. Having this predictive approach enables proactive decision-making and reduces the risk of contamination events, which in turn minimizes production shutdowns (11).

Cleanrooms and Associated Controlled Environments Standards

 (2015).
2. Thermo Fisher Scientific. Rapid Sterility Testing: Overcoming Challenges in Cell Therapy Production. 

Cleanroom Technology: Fundamentals of Design, Testing and Operation

; Wiley, 2010.
4. Agalloco, J.; Akers, J. 

Advanced Aseptic Processing and Biopharmaceutical Manufacturing

Cleanroom Microbiology for the Non-Microbiologist

; CRC Press, 2019.
6. Jallow, J. Rapid Sterility Testing for Cell and Gene Therapy Treatments. 

 (Rockville, Md., 2023).
8. PDA. Sterility Testing of Pharmaceutical Products. 

 (2019).
9. Khuu, H. M; Stock, F.; McGann, M.; et al. Comparison of Automated Culture Systems With a CFR/USP-Compliant Method for Sterility Testing of Cell-Therapy Products. 

 (3), 183–195. DOI: 10.1080/14653240410005997
10. Xiao, Y.; Zhang, L.; Yang, B.; et al. Application of Next Generation Sequencing Technology on Contamination Monitoring in Microbiology Laboratory. 

 (1), 25–31. DOI: 10.1016/j.bsheal.2019.02.003
11. Bradshaw, N. Using AI and Machine Learning in Cleanroom Contamination Control. 

®
Vol. 49, No. 4
May 2025
Pages: 28–29

When referring to this article, please cite it as Mirasol, F. Evolving Cleanroom Procedures and Sterility Challenges. 

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Evolving Cleanroom Procedures and Sterility Challenges

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.