Feliza Mirasol is the science editor for 

Feliza Mirasol

On Sept. 9, 2024, Sartorius announced the launch of its Vivaflow SU tangential flow filtration (TFF) cassette. The Vivaflow SU is designed to be more user-friendly and to allow for more flexibility in laboratory workflows. The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes in the range of 100 mL–1000 mL.

According to a company press release, the new all-in-one cassette reduces cost and complexity and streamlines workflows for molecule isolation in a sustainable manner. Each cassette is ready to use and has a standard laboratory pump, which enables simple set-up. The simplified set-up avoids the need for expensive systems and expensive process optimization and allows for faster and more reliable concentration and rebuffering of any molecule. The cassette also eliminates the need for cleaning and reduces contamination risk while minimizing waste, according to the press release.

“Vivaflow SU is a testament to our promise to always simplify progress,” said John Cashman, product manager for Lab Ultrafiltration at Sartorius, in the press release. “It takes the ease-of-use that our customers already value about TFF with Vivaflow and elevates the experience with improved handling and performance, while reducing waste. Our next-generation cassette eliminates the need for feed flow rate, TMP [transmembrane pressure], and permeate flux calculations, while also offering sustainability improvements that are truly impressive for a single-use consumable.”

Sustainability features of the new cassette include a new housing that uses 30.5% less plastic. It also incorporates several eco-friendly design improvements, such as locally sourced raw materials, customized tubing kits for each cassette configuration, a digital user manual, and reduced non-recyclable packaging; all these design elements contribute to a lower research footprint, the company stated in the press release.

Vivaflow SU is the-next-generation TFF cassette that replaces the previous Vivaflow 50. It is meant for research scientists who require a fast and reliable means for concentrating and rebuffering large feed volumes in molecule isolation workflows.

The launch of Vivaflow SU follows on the heels of Sartorius’ earlier launch of the Arium Mini Extend water purification system for laboratories in June 2024 (1). The Arium Mini Extend is the newest member of the Arium Mini product line. The new purification system is designed to meet the Type 1 water demands of laboratories for general, life-science, and analytical applications, according to the company in a press release. The new system is compact and offers ultrapure water purification with flexibility and convenience.

The new system comprises a flexible, ergonomic handheld dispenser, a user-friendly digital display, and the Arium Bagtank technology to significantly optimize laboratory workflows. The dispensing unit is equipped with an independent volume control function and expands the access area for ultrapure water. The new system streamlines water purification processes, especially those processes that require repeated dispensing. Meanwhile, operation and maintenance have been made simpler with intuitive menus and a 5-L Bagtank for storage of purified water. These features facilitate cleaning procedures and ensure uninterrupted laboratory workflows, the company stated in its press release.

1. Sartorius. Sartorius Launches New Arium Mini Extend with Flexible Arm for Versatile Type 1 Water Dispensing. Press Release. June 17, 2024.

Articles

Sartorius' new Vivaflow SU tangential flow filtration cassette offers better flexibility in lab workflows and is designed to be more user-friendly. 

Sartorius Introduces New TFF Cassette that Offers Streamlined Workflow in the Lab

On Sept. 6, 2024, CPHI Milan announced the finalists for the 2024 CPHI Pharma Awards. The ceremony will be held on the event’s opening evening at the CPHI Celebration. CPHI Milan will run October 8–10, 2024. 

A key feature of the CPHI Celebration, the awards ceremony spans 14 categories and celebrates excellence and innovation in the pharmaceutical industry. The 2024 awards highlight two new categories: a new "Woman of the Year" award and a new "Future Leader" award.

Editor's note: this story was edited on Sept. 18, 2024 to update the “Accelerating Innovation” award category.

The Woman of the Year award honors women leaders who inspire colleagues, champion diversity and inclusion, and advocate for industry progression. Nominees are evaluated based on leadership ability, collaboration skills, and ability to create opportunities for women while challenging the status quo. The Future Leader award recognizes rising stars who are under 35 years of age and who have at least five years of experience in pharma, biopharma, or academic institutions. The award commends those who bring fresh perspectives to the table, manage teams effectively, and introduce innovative ideas. The winners of this award are marked as the future leaders who are anticipated to shape the pharmaceutical industry with dedication and vision.

The shortlist for this year’s awards includes the following:

ProPharma Group/PBL for the Cell Factory Box (CF Box)

Haemopharm Healthcare s.r.l for RIGENERA, an innovative tissue regenerating technology

Akums Drugs and Pharmaceuticals for hydroxyurea oral suspension, the first room temperature-stable drug, according to CPHI’s press release

Merck/Millipore Sigma for the Benzonase Salt Tolerant endonuclease and Emprove Expert raw and starting materials chemical portfolio

AustinPx for its KinetiSol Technology, used for improving bioavailability of poorly soluble drugs

Single Use Support for the RoSS.FILL CGT, a fully automated filling and filtration system that enables automated aliquoting of small volumes at highest accuracy

Thermo Fisher Scientific for leveraging artificial intelligence (AI) to accelerate clinical trials for large pharma

Blynksolve for the Blynksolve Digital Knowledge Twin

Ministry of Industry and Mineral Resources, Kingdom of Saudi Arabia for its Pharmaceutical Industrial Strategy Acceleration Process.

Dr. Reddy’s Laboratories for its development of a drug substance process using flow chemistry and design of a continuous manufacturing plant

Teva api for the Ozonolysis in Flow, a green and safe alternative to heavy metal-catalyzed cleavage of the carbon–carbon double bond on an industrial scale

LEON and Team Consulting for the NANOme Benchtop system, used for personalized therapies

Enzymaster for (S)-4-phenyl-oxazolidinone

Lonza for the Lonza AI-Enabled Route Scouting Service.

Thermo Fisher Scientific for its efforts in revolutionizing vaccine logistics, shelf-life, and wastage with fridge-free innovation

Unistraw Corp. for the UniLayer Straw Delivery System

Lonza for Capsugel Enprotect Size 9 capsule for pre-clinical studies

Lubrizol Life Science Health (LLS Health) for Apinovex Polymers, used for enhancing oral solubility.

Axom Solution SA for its Automated Visual Inspection Station

FABRX for its Revolutionising Care for Children: Personalized 3D Printed Medicines

Teva api for its Advanced AI Optimization for API Production

RheaVita for the RheaLyo GMP-Flex continuous freeze-dryer

Catalent Cell & Gene Therapy for the UpTempo CAR-T Cell Therapy Platform Process.

Azelis Group NV, for its novel bioadhesive oral fluid gel spray

Adare Pharma Solutions for its sprinkle formulation of a drug capsule used for treating tremors and other uncontrolled body movements

Aptar Pharma and Haleon for Otrivin Nasal Mist, a first next-generation nasal congestion device transforming experience, adherence, and effectiveness

ApiJect Syestems for its Prefilled ApiJect Injector

CurTec International for CurTec Fold Pack Pails

Colorcon for EQIUS Equilibrium RH Stabilizers

WestRock for the Cere Screen Digital Display Label

Esmark Finch for the Digital Carton Workflow for pharmaceutical cartons.

TraceLink for its Multienterprise Information Network Tower(MINT)

QYOBO GmbH for a new age of supply chain visibility and resilience

HCLTech for the HCLTech Smart Material Tracking Solution

I.E. Medica Inc. for E-Z Philippine Importation.

Nordic Bioproducts Group Ltd for Pioneering Sustainable Microcrystalline Cellulose (MCC) Production, a first-of-its-kind production facility powered by patented AaltoCell technology in Lappeenranta, Finland

Rotor Print for From Rigid Packaging to Flexible Packaging

Berry Global for its Clarified PP VMS kit

PharmaBlock Sciences for Innovation for Sustainability: Pioneering Low-carbon Manufacturing with Continuous Flow Chemistry Technology

Evonik Industries AG for its PhytoSquene plant-based squalene for parenteral applications.

RTIXIO LIFESCIENCES PVT LTD for Dvarka, a regulatory driven, AI, and automation-assisted platform for emerging market access and compliance

Eidolon Learning Pvt Ltd for SEEK, an AI-driven tool for reducing human error

ProPharma Group for Prodigy, an end-to-end technology-enabled consulting platform

ASPHALION, S.L. for its Regulatory, Scientific & Safety Consulting in Life Sciences service

Esteve Quimica for the Volta Project: who said impossible?

Vijay Ambati, Founder and CEO, Clearsynth

Nebu-Flow Nebuliser Platform by Acu-Flow Limited (t/a Nebu-Flow)

Galvita TIP, a new standard of oral drug delivery by Galvita AG.

Cipla Limited for Drone Powered Delivery for Critical Patient Care

Honey Farm, ICAS Employee Support; Deniz Kayadalen Brand Ambassador, Woodland Trust, Adalvo

Fox Chase Cancer Center and West Pharmaceutical Services, West Pharmaceutical Services.

Sigma Mostafa, PhD, Chief Scientific Officer, KBI Biopharma

Almuth Steinkühler, PhD, Chief Financial Officer, SCHOTT Pharma AG & Co. KGaA

Julia Tsetis, President and CEO, OFET group of pharmaceutical companies

Audrey Butler, Vice President, Global Operational Excellence, Adare Pharma Solutions

Neeti Pant, Managing Director & Co-Founder, DDReg Pharma Pvt Ltd

The 2024 CPHI Pharma Awards comprise finalists spanning 14 categories and includes awards for future leaders, women of the year, and an “at the heart of pharma” category.

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Adventitious agent testing remains critical in biomanufacturing to help ensure product purity. As such, testing protocols from monoclonal antibody (mAb) manufacturing may be transferred to gene therapy manufacturing, as the optimization of testing practices are applicable to gene therapy manufacture. 

Editor’s note: this article was published in 

For instance, in conducting tests to confirm a biological product’s safety, it is necessary to use multiple assays to ensure that various contaminants are identified. Several assays are commonly used in combination to test for adventitious agents, which is required by regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency. The two main types of assays for identifying adventitious agents are 

 assays are utilized when mammalian cell lines are used to produce biopharmaceuticals, while 

 tests to detect viruses that are not able to be grown in cell culture (1). 

Of more immediate concern is the fact that more complex modalities of biopharmaceuticals are prevalent in the industry pipeline. These complex modalities typically require more complex manufacturing processes, which means each product in development is a more significant investment of time and energy as well as patient trust. The current climate makes thorough biosafety testing procedures more crucial for biopharma developers (2).

Adventitious agents comprise a broad range of contaminants, which are unintentionally introduced into the biomanufacturing process. These agents include bacteria, fungi, viruses, mycoplasma, parasites, and mycobacteria, among others. A common way that adventitious agents enter the biomanufacturing process is via starting materials that are animal or human origin. These materials include cell substrates, bovine serum, or the cell lines themselves, or may be introduced by the manufacturing operators, such as where manual handling or processes are concerned (2).

Inadequately tested biopharma products that end up with contamination run the risk of investigation, corrective action, and downtime in manufacturing that ultimately costs the manufacturer—and developer—millions of dollars or more. Therefore, having preventative strategies and comprehensive testing in place is imperative in biologics manufacturing. Another issue to consider is that contamination can happen at any point in the process between securing the cell bank to the fill/finish stages. To mitigate contamination risk and ensure efficient workflow, it is necessary to test for adventitious agents at multiple timepoints. It is also worth it to note that testing and detecting any contamination earlier in the manufacturing workflow, rather than just relying on testing prior to final product release, can better ensure that tainted product does not reach the market and can save time, cost, and effort (2).

For virus detection, methods include traditional culture-based methods as well as electron microscopy studies, 

 molecular and antibody assays, sequencing methods such as massive parallel or next-generation sequencing, and degenerate polymerase chain reaction (PCR). Methods for detecting bacteria also include culture-based approaches and PCR but can also employ biosensor-based methods. Meanwhile, for other adventitious agents such as mycoplasma, detection can include PCR—this includes specific PCR kits, microbiological culture methods, and enzyme-linked immunosorbent assays (3).

Similarly, the adventitious agent testing requirements for viral vectors are consistent with the requirements for other modalities of biotherapeutic products, including selection of appropriate testing methods. However, a direct transfer of testing strategies used in recombinant proteins and mAbs may not necessarily be feasible or practical for viral vectors. Biological differences between viral vectors and large-molecule proteins hinder direct adoption of testing strategies (4).

Because viral vectors are themselves viruses, standard assays may need to be modified or alternative methods used for testing them. That factor can interfere with virus detection methods during adventitious agent testing. Other complications arise if cell-based assays are used to test live-virus vaccines, replication-competent gene therapy vectors, or vectors that exhibit the cytopathic effect. The issue stems from the fact that human cell lines are primarily used to develop cell-based assays, which are susceptible to human viruses. Adenoviral products, which are lytic viruses, will, for example, infect both human and primate-derived cell lines, which would invalidate the assay. On top of that, there is always the risk that cellular toxicity may occur (4).

If adventitious agents are detected, an important step is to identify the species and the origin(s) of the contamination. It is then important to evaluate the agents’ potential to infect humans (5). Some adventitious agents still find their way into the end product despite extensive detection efforts. Examples of these occurrences include the presence of porcine circovirus 1 found in a commercial rotavirus vaccine and a novel rhabdovirus in a Spodoptera frugiperda (Sf9) cell line (6–8).

 adventitious agent testing methods are usually sufficient, but they have their limitations. For one thing, test sensitivity may not be high enough to detect certain contaminants or too-low concentrations of contaminants. Some assays require lengthy times to perform. What’s more, different testing methods inherently have different sensitivities for detecting different contaminants, and each method has its own limitations. Fortunately, these different methods can complement each other and, when combined, can offer greater understanding of detecting adventitious agents (4).

The delivery times for some adventitious virus test results can be challenging, regardless of which testing methods are used. Some assays may take several weeks to generate results. On top of that, certain biotherapeutics, such as gene therapies, have short shelf lives, so waiting on results for adventitious agent testing may come too late. This is a concern for autologous cell therapies that are dependent on gene-modified components and must be administered to the patient soon after they are produced (4).

On the positive side, detection technologies for adventitious agent testing continue to evolve, with a focus on higher sensitivity, rapid methods, and broad detection ranges. The downside is that new technologies take time to develop, and they must be thoroughly validated to demonstrate their suitability and applicability before the bio/pharma industry and regulatory bodies will accept them for implementation into the testing strategies for adventitious agent control in biomanufacturing (9).

 (accessed 10 July 2024).
2. Thermo Fisher Scientific. Improving Adventitious Agent Testing in Biologics Manufacturing. 

, 9 Feb. 2023 (accessed 10 July 2024).
3. Morris, C.; Lee, Y. S.; Yoon, S. Adventitious Agent Detection Methods in Bio-Pharmaceutical Applications with a Focus on Viruses, Bacteria, and Mycoplasma. 

, 105–114. DOI: 10.1016/j.copbio.2021.06.027
4. Challener, C. Adventitious Agent Testing for Viral Vectors. 

 (9), 40-44.
5. Klug, B.; Robertson, J. S.; Condit, R. C.; et al. Adventitious Agents and Live Viral Vectored Vaccines: Considerations for Archiving Samples of Biological Materials for Retrospective Analysis. 

 (51), 6617–6625. DOI: 10.1016/j.vaccine.2016.02.015
6. Victoria, J.G.; Wang, C.; Jones, M. S.; et al. Viral Nucleic Acids in Live-Attenuated Vaccines: Detection of Minority Variants and an Adventitious Virus. 

 (12), 6033–6040. DOI: 10.1128/JVI.02690-09
7. Dubin, G.; Toussaint, J. F.; Cassart, J. P.; et al. Investigation of a Regulatory Agency Enquiry into Potential Porcine Circovirus Type 1 Contamination of the Human Rotavirus Vaccine, Rotarix: Approach and Outcome. 

 (11), 2398–2408. DOI: 10.4161/hv.25973
8. Ma, H.; Galvin, T. A.; Glasner, D. R.; Shaheduzzaman, S.; Khan, A. S. Identification of a Novel Rhabdovirus in Spodoptera frugiperda Cell Lines. 

 (12), 6576–6585. DOI: 10.1128/JVI.00780-14
9. Playter, G. Examining Next-Gen Technology for Adventitious Agent Testing. 

®
Volume 36, No. 8
September 2024
Pages: 29–30

When referring to this article, please cite it as Mirasol, F. Meeting Adventitious Agent Testing Needs for Complex Modalities. 

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Meeting Adventitious Agent Testing Needs for Complex Modalities

Evaluating Aseptic Processing and Manufacturing

Delving into Biopharmaceutical Development and Manufacturing

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, and Feliza Mirasol, Science Editor, Pharmaceutical Technology Group, interview experts about aseptic processing and manufacturing. During the discussion, industry experts will evaluate the importance of aseptic processing and manufacturing, highlighting the challenges impacting industry, the intricacies of the regulatory landscape, the importance of understanding nuances between products and processes, the necessity of addressing QC/QA early on, best practices to ensure aseptic sterility, and potential future trends.

Maik W. Jornitz, Founder and Principal Consultant, BioProcess Resources

Maik W. Jornitz, founder and principal consultant of BioProcess Resources, is a 35-year veteran of the industry. He is highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing-grade filtration and filter integrity testing. He has published multiple books, book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former chair of the Parenteral Drug Association (PDA) board of directors and science advisory board, and member of multiple PDA Task Forces, including the European Union Annex I response team. He is board member and senior business and strategy advisor of DIANT Pharma. As a faculty member of various training activities, including PDA Training and Research Institute, he trains members of the industry and regulatory authorities frequently. In his previous roles, he was the CEO of G-CON for 10 years, he worked 26 years for Sartorius, with his last role being the senior vice-president for Global Product and Marketing Management Bioprocess. He received his Master of Engineering in Bioengineering at the University of Applied Sciences in Hamburg, Germany, and accomplished the Program for Executive Development at IMD Business School in Lausanne, Switzerland.

Dan Strange, PhD, Chief Technology Officer, Cellular Origins

Dan Strange has been working at the intersection of engineering and biology for almost 15 years, and he is an inventor on 20 patents. After completing a PhD in regenerative medicine at the University of Cambridge, he moved to TTP where he developed complex drug delivery devices. He was instrumental in the creation of multiple technology platforms successfully licensed to large pharma in deals worth over $100 million. For the past four years, Strange has focused on cell therapy manufacturing equipment. Strange is an active member of various automation working groups and was a reviewer on the Alliance for Regenerative Medicines A-Cell report on cell therapy manufacturing.

Drug Digest is a tech talk video series with the 

® 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.

Small Molecule APIs, Excipients, and Formulation

Solid Dosage Drug Development and Manufacturing

Videos

In this episode of Drug Digest, discussion with industry experts will highlight the challenges impacting aseptic processing and manufacturing, the intricacies of the regulatory landscape, and the necessity of addressing QC/QA early on, among other critical aspects. 

Drug Digest: Evaluating Aseptic Processing and Manufacturing

Rentschler Biopharma, a biopharmaceutical contract development and manufacturing organization (CDMO), announced on Sept. 3, 2024, that it has launched an expanded service offering at Stevenage, UK, the company's advanced therapies site. With the expanded offering, Rentschler Biopharma now offers a new lentiviral vector (LVV) manufacturing toolbox for producing advanced therapy medicinal products (ATMPs), which complements the company’s existing adeno-associated virus (AAV) viral vector services.

The Stevenage site offers customized solutions for accelerating viral vector programs and includes novel, license-free toolboxes for AAVs and LVVs, according to a company press release. The company’s proprietary human embryo kidney 293 (HEK293) cell line offers additional time and cost savings for advanced therapy projects. The company’s services contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, Rentschler Biopharma stated in the press release.

“We made a strategic investment in the cell and gene therapy sector, starting with adeno-associated viral vector services, so we could offer our development and manufacturing expertise and sector experience to support innovators in this fast-developing space,” said Christiane Bardroff, chief operating officer, Rentschler Biopharma, in the press release. “We are now pleased to build on our success and augment this offering with lentiviral vectors. Our company remains dedicated to evolving our portfolio to enhance the health and quality of life for seriously ill patients around the world.”

Growing research and positive clinical results across a range of therapeutic applications has increasingly brought LVVs to the forefront in the advanced therapy space. Using LVVs for gene transfer has been applied to treat several genetic diseases, including beta-thalassemia. LVVs have also been used introduce genes to T-cells to modify them and generate immunity against cancer (1).

“The new lentiviral vector manufacturing toolbox highlights our commitment to providing cutting-edge solutions that enable our clients to advance their viral vector programs from pre-clinical and clinical development to market. By integrating lentiviral vector process development and manufacturing to our services, we are better serving the market by meeting the growing needs of the evolving and vibrant global advanced therapies sector,” said Robert Panting, general manager, ATMP, Rentschler Biopharma, in the press release.

Manufacturing LVVs has traditionally been difficult because 

, which are more delicate and sensitive than non-enveloped viruses. LVVs are therefore more sensitive to temperature, pH, shear, etc. (2).

Because of their sensitivity, purification approaches for LVVs are typically gentler, often applying one single-step chromatography and one concentration/buffer exchange step; however, final sterile filtration is still a challenge and may impact titer and yield. Designing a manufacturing process must therefore consider how to mitigate yield loss all along the way (2).

1. Ghosh, S.; Brown, A. M.; Jenkins, C.; Campbell, K. Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges. 

 (1), 7–18.
2. Mirasol, F. Comparing Viral Vectors for Gene Therapy Delivery. 

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

Rentschler Biopharma Offers New Toolbox for LV Manufacturing

AstraZeneca’s Imfinzi (durvalumab), a human monoclonal antibody (mAb), was approved by FDA earlier this month in combination with chemotherapy for treating adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. Following this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery, according to an Aug. 16, 2024 company press release.

Also in August 2024, Imfiniza and Lynparza (olaparib) were approved throughout the 

 (EU) for treating certain patients with primary advanced or recurrent endometrial cancer (1). With this EU approval, Imfinzi plus chemotherapy can be used as first-line treatment, followed by treatment with Imfiniza and Lynparza (olaparib). In addition, Imfinzi, may be used to treat patients with mismatch repair proficient disease. A regimen using Imfinzi plus chemotherapy, followed by Imfinzi alone, can also be used for treating patients with mismatch repair deficient (dMMR) (1).

FDA’s latest approval was based on positive results from a pivotal Phase III trial (AEGEAN), which showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death before and after surgery in patients treated with Imfinzi in combination with chemotherapy versus chemotherapy alone. These results were published in 

“This approval brings an important new treatment option that should become a backbone combination approach for patients with resectable non-small cell lung cancer, who have historically faced high rates of recurrence even after chemotherapy and surgery. When added both before and after surgery, durvalumab delivered a significant and meaningful improvement in outcomes in this curative-intent setting,” said John V. Heymach, MD, PhD, professor and chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, in the AstraZeneca press release.

Imfinzi was shown to be well tolerated, AstraZeneca stated in the press release. Furthermore, no new safety signals were observed in the neoadjuvant and adjuvant settings. Adding Imfinzi to neoadjuvant chemotherapy showed consistency with the known profile for this combination and did not compromise patients' ability to complete surgery, compared to chemotherapy alone.

“Today’s approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease. We remain committed to bringing novel approaches [such as] AEGEAN to early lung cancer settings where cure is the goal of treatment,” said Dave Fredrickson, executive vice-president, Oncology Business Unit, AstraZeneca, in the press release.

In addition to the United States, Imfinzi is approved in the United Kingdom, Switzerland, and Taiwan (China) for this indication, also based on the Phase III (AEGEAN) results. Furthermore, the company has regulatory applications under review in the EU, China, and several other countries in this indication.

Further to its application in the treatment of lung cancers, Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) for treating locally advanced or metastatic biliary tract cancer and in combination with AstraZeneca’s Imjudo (tremelimumab), a mAb that blocks the activity of cytotoxic T-lymphocyte-associated protein 4 to aid in activating T-cells, for treating unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved in Japan and the EU as a monotherapy for unresectable HCC as well as in the US in combination with chemotherapy (carboplatin plus paclitaxel), followed by Imfinzi monotherapy, for treating primary advanced or recurrent endometrial cancer that is dMMR.

1. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
2. Heymach, J. V.; Harpole, D.; Mitsudomi, T.; et al. Perioperative Durvalumab for Resectable Non–Small-Cell Lung Cancer. 

 (18),1672–1684. DOI: 10.1056/NEJMoa2304875

Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.