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CSL Behring

CSL Behring is a global biopharmaceutical company specializing in the research, development, manufacture, and distribution of plasma-derived and recombinant biotherapies for patients with rare and serious diseases.^[1] As a division of CSL Limited, a biotechnology firm founded in 1916 by the Australian government as the Commonwealth Serum Laboratories to meet national health needs during wartime isolation, CSL Behring focuses on addressing unmet medical needs through three core innovation platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy.^[2] In August 2025, CSL announced a major restructuring, including workforce reductions of up to 15% and a planned spin-off of its Seqirus division by mid-2026.^[3] The company delivers its products to patients in more than 100 countries, contributing to CSL Limited's operations that employ approximately 30,000 people worldwide and generate annual revenue exceeding $15 billion USD as of fiscal year 2025.^[1]^[4] CSL Behring traces its origins to the merger of historic entities in the plasma therapeutics field, with roots in the Behringwerke founded in 1904 by Emil von Behring, the first Nobel laureate in Physiology or Medicine for his work on diphtheria antitoxin.^[5] In 2004, CSL Limited acquired Aventis Behring—formerly part of Hoechst's Behringwerke—and merged it with ZLB Bioplasma, founded in 2000 from the central laboratory of the Swiss Red Cross (established in 1949), to form ZLB Behring; the entity was renamed CSL Behring in 2007 to align with its parent company's global branding.^[6] Key historical milestones include ZLB's development of the world's first pasteurized plasma protein solution in 1954 and Behringwerke's introduction of Haemate P, the first pasteurized factor VIII concentrate for hemophilia, in 1981.^[6] Through strategic acquisitions, such as CSL's purchase of 47 plasma collection centers in 2001 to establish ZLB Plasma Services (later renamed CSL Plasma), the company has built one of the world's largest plasma collection networks to support its manufacturing.^[6] The company's therapeutic portfolio targets critical areas including hematology (e.g., treatments for hemophilia A and B), immunology (e.g., immunoglobulin therapies for primary immunodeficiencies), cardiovascular and metabolic diseases (e.g., prothrombin complex concentrates for bleeding reversal), respiratory conditions (e.g., therapies for Alpha-1 antitrypsin deficiency), and transplant-related complications.^[1] Notable products include Hizentra, the first FDA-approved 20% subcutaneous immunoglobulin in 2010 for immune deficiency treatment, and Kcentra, approved in 2013 for rapid reversal of warfarin-induced anticoagulation.^[6] CSL Behring emphasizes patient-centric innovation, collaborating with healthcare professionals and patient advocacy groups to improve access and outcomes, while maintaining rigorous quality standards in its manufacturing facilities across Australia, Europe, and North America.^[1]

Overview

Corporate Profile

CSL Behring is a biopharmaceutical subsidiary of CSL Limited, established in 2007 through the rebranding of ZLB Behring as part of CSL's global operations. Headquartered in King of Prussia, Pennsylvania, United States, CSL Behring is part of CSL Limited, which employs over 29,000 people worldwide as of June 30, 2025, and operates across more than 30 countries.^[6]^[7] The company specializes in the development and manufacturing of plasma-derived and recombinant therapies targeted at rare and serious diseases, with a primary focus on immunology, hematology, cardiovascular, and nephrology therapeutic areas. Its roots trace briefly to the Behringwerke founded in 1904 and CSL established in 1916.^[1] Guided by a mission to deliver enduring patient impact in regions of high unmet medical need, CSL Behring provides therapies to patients in more than 100 countries, emphasizing innovative biotherapeutics that address critical health challenges.^[7] For the fiscal year 2025 (ended June 30, 2025), CSL Behring generated revenue of US$11.16 billion, achieved a segment operating result of US$4.70 billion, and held segment assets valued at US$24.50 billion, underscoring its significant scale within the global biopharmaceutical sector.^[8]^[9] In alignment with broader sustainability goals, CSL Behring supports commitments to reduce absolute Scope 1 and 2 greenhouse gas emissions by 42% by FY2030 from a FY2021 baseline, including increased use of renewable energy sources, and to source 100% of paper and fiberboard for product packaging from certified sustainable forestry by FY2030.^[10]

Leadership and Governance

CSL Behring operates under the broader leadership structure of its parent company, CSL Limited, where strategic direction is provided by a team focused on advancing plasma-derived and specialty therapies globally. Paul McKenzie serves as Chief Executive Officer and Managing Director of CSL Limited, overseeing the company's overall strategy, operational performance, and long-term growth initiatives across its divisions, including CSL Behring.^[11]^[12] Key executives supporting CSL Behring's operations include Mary Oates, who was appointed Chief Operating Officer of CSL Limited in May 2025, managing enterprise-wide operations to enhance efficiency and integration. Andy Schmeltz held the role of Executive Vice President of CSL Behring until August 2025, when he was promoted to Chief Commercial Officer for CSL Limited; during his temporary caregiver's leave from September 2024 to March 2025, Joy Linton served as interim leader for the division.^[11]^[13]^[14] The Board of Directors of CSL Limited provides oversight for CSL Behring, chaired by Dr. Brian McNamee since 2018, ensuring alignment with corporate objectives in biotherapeutics. Recent board additions include Dr. Brian Daniels, elected at the 2025 Annual General Meeting in October, and Cameron Price, who joined as an independent non-executive director effective October 1, 2025, bringing expertise in pharmaceuticals and finance.^[15]^[16]^[17] CSL Limited's governance framework emphasizes ethical conduct, with policies prohibiting discrimination and promoting equal opportunities based on gender, nationality, ethnicity, disability, and other factors. The board composition reflects a commitment to diversity, with nine independent non-executive directors out of ten members as of the 2025 fiscal year, and remuneration structures linking executive pay to sustainability goals, patient outcomes, and shareholder value creation.^[18]^[19]^[20] In August 2025, CSL announced a major restructuring to enhance efficiency, including a reduction of up to 15% of its global workforce (approximately 4,500 positions), closure of 22 U.S. plasma collection centers, targeted cuts to R&D spending, and integration of medical and commercial functions between CSL Behring and CSL Vifor to realize synergies following the 2022 Vifor acquisition. This initiative aims to streamline operations and support long-term growth in biotherapeutics. CSL Limited also announced a proposal to demerge its Seqirus vaccines business into a separate ASX-listed entity by June 2026 to enable focused strategic development, though the timeline was revised in October 2025 due to volatility in U.S. vaccination rates. Under McKenzie's leadership, CSL has sustained revenue growth, reaching US$15.6 billion in fiscal year 2025, underscoring the global scale of its biotherapeutics operations.^[21]^[22]^[23]^[3]

History

Origins and Early Development

The origins of CSL Behring trace back to two pioneering entities in biotherapeutics: Behringwerke in Germany and the Commonwealth Serum Laboratories (CSL) in Australia. In 1904, Emil von Behring established Behringwerke in Marburg, Germany, as the world's first institute dedicated to serum research and production.^[24] This venture built directly on von Behring's groundbreaking work in immunology, for which he received the inaugural Nobel Prize in Physiology or Medicine in 1901 for developing the diphtheria antitoxin, a serum therapy that revolutionized treatment for infectious diseases.^[25] Behringwerke quickly became a leader in manufacturing antitoxins and vaccines, focusing on harnessing animal-derived sera to combat bacterial toxins. Meanwhile, in 1916, the Australian government founded the Commonwealth Serum Laboratories (CSL) in Melbourne to ensure domestic production of vaccines, antitoxins, and sera, reducing reliance on overseas supplies disrupted by World War I.^[26] CSL's early efforts included the development of the first commercial tiger snake antivenom in 1930, produced in collaboration with the Walter and Eliza Hall Institute, marking a milestone in addressing Australia's unique venomous threats.^[27] In the World War II era, CSL expanded its capabilities to meet urgent medical needs, initiating large-scale penicillin production in 1944 following Howard Florey's discoveries, which enabled Australia to supply this critical antibiotic to Allied forces.^[28] Post-war, CSL contributed to polio vaccine development; in 1954, CSL scientist Dr. Leslie Bazeley assisted in the U.S. clinical trials of Jonas Salk's inactivated polio vaccine and subsequently oversaw its production in Australia starting in 1956.^[29] These achievements solidified CSL's role in public health innovation. Behringwerke and CSL operated independently through much of the 20th century, with Behringwerke integrated into Hoechst AG by the mid-20th century and CSL remaining under Australian federal government control until its privatization in 1991.^[30] This period of standalone growth established their complementary expertise in plasma and biotherapy, which later converged to form the modern CSL Behring.

Mergers and Key Milestones

In 1981, Behringwerke, a predecessor entity to CSL Behring, introduced Haemate, the first high-purity factor VIII/von Willebrand factor concentrate designed for the treatment of Hemophilia A, marking a significant advancement in plasma-derived therapies.^[31] CSL Limited expanded its plasma operations in 2000 by acquiring ZLB Bioplasma from the Swiss Red Cross for $525 million, establishing ZLB Bioplasma as a key component of its biotherapeutics portfolio.^[32]^[6] This growth accelerated in 2004 when CSL acquired Aventis Behring for $925 million and merged it with ZLB Bioplasma, forming ZLB Behring and positioning the company as a global leader in plasma products.^[33]^[6] Following the integration, the entity was renamed CSL Behring in 2007 to align with CSL Limited's global branding strategy.^[6] The company's contributions to rare disease treatments earned notable recognitions, including the National Organization for Rare Disorders (NORD) Award in 2009 for the development of RiaSTAP, the Swiss Tell Award in 2009 for innovation, and the EURORDIS Company Award in 2012 for pioneering therapies in rare disorders.^[6]^[34] In 2017, CSL Behring acquired Calimmune for $91 million, gaining access to its preclinical HIV gene therapy platform based on hematopoietic stem cell technology.^[35]^[36] Building on its gene therapy efforts, CSL Behring acquired Vitaeris in 2020 for an undisclosed amount, adding the company's phase III candidate VP1 for preventing transplant rejection.^[37]^[6] A landmark expansion occurred in 2022 with the $11.7 billion acquisition of Vifor Pharma, which broadened CSL Behring's reach into iron deficiency and nephrology markets.^[38]^[39]^[6] In September 2025, CSL Behring entered a strategic collaboration with VarmX BV, including an exclusive option to acquire the company for an upfront payment of USD 117 million plus potential milestones, to develop VarmX's preclinical anticoagulant reversal agent for acute bleeding disorders.^[40]

Products and Therapies

Plasma-Derived Products

CSL Behring's plasma-derived products primarily consist of immunoglobulins, albumin, treatments for hereditary angioedema (HAE), and therapies for peri-operative bleeding, all sourced from human plasma fractionation. Immunoglobulins, such as PRIVIGEN® and HIZENTRA®, are key therapies for primary immune deficiencies, generating $6.06 billion in revenue during fiscal year 2025, reflecting their role in replacing deficient antibodies and modulating immune responses.^[21]^[9] Albumin products support critical care by maintaining oncotic pressure and volume in conditions like burns, surgery, and liver disease, contributing $1.30 billion to FY2025 revenue.^[21]^[9] HAE treatments, including HAEGARDA®, target C1 esterase inhibitor deficiency to prevent swelling attacks, with $0.76 billion in FY2025 sales.^[8]^[9] Peri-operative bleeding products, such as RiaSTAP®, provide fibrinogen replacement to control hemorrhage during surgery, accounting for $0.91 billion in revenue that year.^[8]^[9] CSL Behring sources plasma through a global network of nearly 330 collection centers, primarily in the United States and Europe, with operations in China prior to their divestment in October 2024.^[41]^[9] This network processes over 10 million liters of plasma annually following the completion of Project Aurora, a state-of-the-art fractionation facility in Broadmeadows, Australia, which enhances capacity through modular design and automation.^[9] The manufacturing process involves cold ethanol fractionation to separate plasma into protein fractions, followed by purification steps tailored to each product, such as chromatography and filtration for immunoglobulins.^[42] Safety is prioritized through multiple pathogen inactivation methods, including pasteurization at 60°C for 10 hours, solvent-detergent treatment, and nanofiltration, which collectively reduce viral risks from enveloped and non-enveloped pathogens by over 12 logs.^[42]^[43] Yield improvements are achieved via technologies like the Rika Plasma Donation System, which boosts plasma collection efficiency by up to 10%.^[9] Environmental assessments indicate high biodegradability for these biologics; four of five CSL Vifor plasma-related products were rated readily biodegradable, and many CSL Behring plasma-derived therapies, being human proteins, exhibit similar natural degradation profiles.^[9] Complementary recombinant alternatives exist for some indications, such as immunodeficiencies, but plasma-derived options remain foundational due to their broad-spectrum efficacy.^[9]

Recombinant and Gene Therapies

CSL Behring has advanced into recombinant biologics and gene therapies to address limitations of traditional plasma-derived treatments, offering engineered proteins and genetic interventions for rare diseases such as hemophilia and hereditary angioedema (HAE). These therapies emphasize precision mechanisms, including monoclonal antibodies that target specific pathways and adeno-associated virus (AAV)-based vectors that enable sustained endogenous protein production. This segment contributed significantly to CSL Behring's growth, with hemophilia revenues reaching US$1.488 billion in fiscal year 2025, reflecting the expanding adoption of innovative non-plasma options.^[9] A cornerstone of CSL Behring's gene therapy portfolio is HEMGENIX® (etranacogene dezaparvovec-drlb), the first approved one-time treatment for adults with hemophilia B, a factor IX deficiency. Delivered via AAV5 vectors, HEMGENIX introduces a modified factor IX gene into liver cells, allowing the body to produce functional clotting factor and reduce bleeding episodes without ongoing infusions. Approved by the U.S. FDA in 2022 and subsequently in the EU, UK, Canada, Switzerland, Australia, Korea, Saudi Arabia, Hong Kong, Taiwan, and Singapore by 2025, it demonstrated sustained efficacy up to four years post-infusion in clinical data, with mean factor IX activity levels stabilizing above 30% of normal. This approach contrasts with plasma-derived factor IX concentrates for overlapping indications, providing potential lifelong protection after a single administration. HEMGENIX generated substantial revenue within the hemophilia category in FY2025, underscoring its market impact.^[44]^[9] In monoclonal antibodies, CSL Behring's ANDEMBRY® (garadacimab-gxii) represents the company's first in-house developed recombinant therapy for HAE prophylaxis, targeting activated factor XIIa to inhibit the kallikrein-kinin pathway at its initiation and prevent bradykinin-mediated attacks. Administered subcutaneously once monthly, ANDEMBRY achieved over 99% median reduction in HAE attack rates in pivotal studies, enabling broad use from treatment initiation in patients aged 12 and older. It received approvals in the US (June 2025), EU (February 2025), UK and Australia (January 2025), Japan (February 2025, including a 200 mg pen device), Switzerland, and UAE, marking a novel upstream intervention in HAE management. Additionally, CSL Behring offers recombinant factor VIII products like AFSTYLA® for hemophilia A, which uses a B-domain truncated design for extended half-life and reduced immunogenicity.^[45]^[46]^[47]^[48] The recombinant and gene therapy segment overall signals CSL Behring's strategic shift toward scalable, synthetic innovations, diversifying from plasma dependency while addressing high unmet needs in rare diseases.^[9]

Research and Development

Pipeline and Innovation

CSL Behring has consolidated its research and development operations around six anchor sites in the United States, the United Kingdom, Switzerland, and Australia as part of a 2025 restructuring to streamline activities in key biotech hubs and prioritize external collaborations.^[9]^[49] This focused network enhances efficiency in discovery, development, and innovation across therapeutic modalities. The company's R&D strategy centers on advanced technological platforms, including next-generation plasma fractionation for deriving therapeutic proteins, recombinant technologies enabling monoclonal antibody development, and cell and gene therapies aimed at addressing unmet needs in rare diseases.^[50] These platforms support a diversified pipeline that builds on CSL Behring's biologics expertise while exploring innovative delivery and production methods. Key innovation efforts include Project Aurora, a major expansion of plasma fractionation capabilities at the Broadmeadows campus in Australia, which achieves a ninefold increase in processing capacity to over 10 million liters of plasma annually.^[51]^[52] This initiative incorporates extensive automation and robotics, earning the 2025 ISPE Facility of the Year Award in the Pharma 4.0 category for its pioneering digital twin modeling and end-to-end manufacturing execution systems.^[53] Complementing this, in-house monoclonal antibody programs, such as ANDEMBRY® (garadacimab), demonstrate CSL Behring's recombinant expertise in targeting pathways for hereditary angioedema.^[54] Strategic R&D priorities emphasize immunology, hematology, cardiovascular and renal diseases—bolstered by the 2022 Vifor Pharma integration—and nephrology, with targeted investments in manufacturing yield optimization and Pharma 4.0-driven digital integration to enable scalable, data-informed production.^[55]^[1] These efforts underpin emerging therapies, including gene-based treatments like HEMGENIX® for hemophilia B.^[50] CSL Behring integrates sustainability into its R&D framework, committing by FY2030 to complete biodiversity impact assessments at all manufacturing sites and address any significant environmental effects, while advancing sustainable sourcing for critical materials like plasma.^[56]^[10]

Clinical Trials and Investments

In fiscal year 2025, CSL Behring allocated US$1.36 billion to research and development, supporting 59 active clinical trials spanning phases I through III across various therapeutic areas.^[9] This investment underscores the company's commitment to advancing therapies in immunology, hematology, cardiovascular and renal diseases, transplant, and vaccines.^[57] Key ongoing trials include a phase III study evaluating the expansion of RiaSTAP® for acquired fibrinogen deficiency, with the first patient dosed in October 2024.^[9] Additional efforts encompass studies for garadacimab in hereditary angioedema (HAE), such as the open-label extension of the phase 3 VANGUARD trial assessing long-term safety and efficacy, and a real-world effectiveness study (NCT07001280).^[45]^[58] For HEMGENIX®, post-approval monitoring continues through an observational long-term follow-up study (NCT06008938), with four-year data from the phase 3 HOPE-B trial confirming sustained efficacy and safety in adults with hemophilia B.^[59]^[44] These trials are distributed geographically across the United States, Europe, and the Asia-Pacific region, facilitating regulatory submissions that resulted in multiple 2025 approvals, including ANDEMBRY® (garadacimab) in the US, EU, UK, Japan, Switzerland, Australia, and UAE.^[9]^[45] Notable outcomes from prior and ongoing trials include the 2025 launches of ANDEMBRY® in the US, Japan, Germany, and Greece for HAE prophylaxis, as well as the EU standard marketing authorization for FILSPARI® in IgA nephropathy.^[9] These developments align briefly with CSL Behring's innovation in gene therapy platforms, as exemplified by HEMGENIX®.^[44]

Business Development

Acquisitions and Divestitures

In 2024, CSL Behring divested its equity interest in Wuhan Zhong Yuan Rui De Biological Products (Ruide), a plasma collection and fractionation operation in China, to Chengdu Rongsheng Pharmaceutical for US$185 million in cash proceeds.^[60] The transaction, completed on October 16, 2024, resulted in a non-material net gain of US$30 million and was classified as a non-recurring item excluded from underlying profit measures.^[9] This divestiture aligned with CSL's long-term strategy to streamline operations by reducing direct involvement in China's highly regulated plasma sector, allowing the company to redirect resources toward serving patients in core markets through alternative supply and distribution channels.^[60] The sale had no material impact on CSL's overall business in China but contributed to broader efforts to minimize exposure to complex regulatory environments.^[9] In 2025, CSL liquidated Sanifit Therapeutics, S.A., a Spanish biopharmaceutical company previously acquired through the 2022 Vifor Pharma deal to advance treatments for chronic kidney disease-associated mineral bone disorders.^[9] The liquidation, registered with the Spanish Commercial Registry on June 4, 2025, stemmed from strategic reprioritization amid evolving focus on high-unmet-need areas in immunology and hematology.^[9] This move further simplified the portfolio by exiting early-stage assets that no longer aligned with core priorities, freeing capital for investments in rare disease therapies.^[9] CSL Behring pursued no new acquisitions between 2023 and 2025, instead emphasizing integration of the prior Vifor Pharma assets to enhance manufacturing capabilities.^[9] A key milestone was the September 2024 opening of the Multicube facility in St. Gallen, Switzerland, a modular production site designed to scale output of iron deficiency therapies like Ferinject, supporting global demand through sustainable features such as heat recovery and photovoltaics.^[61] These divestitures collectively reduced operational complexity in regulated markets like China and enabled resource reallocation toward research and development in rare diseases, where CSL Behring maintains a strong emphasis.^[9] Financially, the US$185 million from the Ruide sale bolstered CSL Limited's fiscal year 2025 performance, contributing to a reported net profit after tax of US$3.0 billion for the year ended June 30, 2025.^[3]

Strategic Partnerships and Collaborations

In September 2025, CSL Behring entered into a strategic collaboration with VarmX BV, a privately held Dutch biotechnology company, to co-develop and commercialize VMX-C001, a first-in-class investigational recombinant modified Factor X protein for reversal of Factor Xa inhibitor anticoagulation in patients with urgent surgery needs or severe bleeding. Under the agreement, CSL Behring will fully fund VarmX's global Phase 3 EquilibriX-S trial and has an option to acquire VarmX upon successful completion of the study.^[62]^[63] Following the 2022 integration of Vifor Pharma, CSL Behring has advanced nephrology-focused partnerships, including a co-promotion agreement with Travere Therapeutics for FILSPARI® (sparsentan), approved by the European Commission in 2025 for IgA nephropathy treatment across early kidney disease stages.^[64] Additionally, ongoing collaborations emphasize sustainability, with biodegradability studies on CSL Vifor iron products—such as ferric carboxymaltose—demonstrating that four out of five tested formulations are readily biodegradable, supporting environmental advancements in iron deficiency therapies.^[9] These efforts complement a prior joint drug discovery platform with Evotec for innovative nephrology therapeutics, enhancing pipeline diversity in chronic kidney disease management.^[65] CSL Behring maintains academic and regulatory ties to support rare disease initiatives, including unrestricted grants to the National Organization for Rare Disorders (NORD) for its annual Rare Disease Summit and government affairs programs, alongside participation in the EURORDIS-led RARE IMPACT consortium since 2021 to optimize patient access and advocacy in Europe.^[66] In parallel, the company has collaborated with the FDA and EMA on gene therapy regulatory pathways, contributing to approvals such as HEMGENIX® for hemophilia B in 2023, which marked the first one-time AAV5-based treatment in Europe and involved joint data submissions for accelerated patient access.^[67] These partnerships have accelerated CSL Behring's pipeline by integrating external technologies, exemplified in the development of ANDEMBRY® (garadacimab-gxii), a novel anti-FXIIa monoclonal antibody for hereditary angioedema prophylaxis approved by the FDA in June 2025, leveraging shared regulatory insights from gene therapy collaborations.^[45] They have also expanded global access to therapies in over 100 countries, aligning with internal R&D investments to address high-unmet needs.^[9] In August 2025, CSL announced plans to demerge CSL Seqirus as a standalone influenza vaccine entity by mid-2026—though delayed amid U.S. market volatility—to enable more targeted vaccine partnerships and resource allocation.^[68]^[22]

Global Operations

Headquarters and Offices

CSL Behring's global headquarters is located in King of Prussia, Pennsylvania, USA, at 1020 First Avenue, where it oversees North American operations, corporate functions, and strategic management for its biotherapeutics portfolio.^[69]^[70] This site has served as the operational headquarters since 2005 and supports key administrative roles including executive leadership and regulatory affairs.^[70] The parent company, CSL Limited, maintains its headquarters in Melbourne, Australia, at 655 Elizabeth Street, providing overarching governance and oversight for CSL Behring's activities, including coordination with the Broadmeadows site for administrative purposes.^[71]^[9] In Europe, CSL Behring operates regional offices in Bern, Switzerland (CSL Behring AG at Wankdorffstrasse 10), which functions as a hub for European management and integration of Vifor Pharma operations following its 2022 acquisition, and in St. Gallen, Switzerland, supporting Vifor-related administrative functions.^[72]^[73] Additionally, the office in Marburg, Germany (Emil-von-Behring-Straße 76), serves as a heritage site for R&D administration and regional coordination.^[74]^[73] CSL Behring has a presence in more than 30 countries through regional offices that handle sales, marketing, and regulatory affairs, with key locations including the United Kingdom (Liverpool office), Japan (Tokyo regional office), Australia (Melbourne support), and the United Arab Emirates (Dubai Science Park regional headquarters for Middle East and Africa).^[73]^[75]^[76] These offices facilitate global operations, including support for over 300 plasma collection centers worldwide.^[77] As part of CSL Limited, the company employs approximately 29,900 people globally as of June 2025, with administrative staff distributed across these sites.^[9] Following the divestiture of its Wuhan and Guangzhou operations in China on October 16, 2024, for $185 million, CSL Behring has reduced its footprint in Asia while maintaining core presence in other markets.^[9]^[78]

Manufacturing and Supply Chain

CSL Behring operates major manufacturing sites focused on plasma fractionation and biologics production. The Bern facility in Switzerland, employing over 1,800 people, specializes in developing and manufacturing plasma-derived biotherapies, including immunoglobulins, and marked its 25th anniversary in 2025.^[79]^[7] In Marburg, Germany, the largest site with 3,000 employees produces recombinant and plasma-derived therapies for bleeding disorders, bolstered by a new $470 million plasma fractionation facility opened in 2023.^[80]^[81] The Kankakee site in Illinois, the company's sole U.S. manufacturing hub comprising 20% of its global capacity, focuses on immunoglobulins and plasma-based medicines, with a recent 1.8 million square-foot expansion enhancing production for rare disease treatments.^[82]^[83] At Broadmeadows, Australia, the Project Aurora plasma fractionation facility, recognized as the 2025 ISPE Facility of the Year for Pharma 4.0, processes over 10 million liters of plasma annually, achieving a ninefold capacity increase to support immunoglobulin production.^[51]^[53] The supply chain relies on sourcing plasma from over 300 CSL Plasma donation centers, primarily in the U.S., Europe (including Germany and Hungary), and following the 2024 divestiture of its Chinese operations, emphasizes diversified North American and European collection to ensure stable raw material supply.^[41]^[84] Products undergo rigorous pathogen inactivation processes, such as pasteurization and solvent-detergent treatment, to eliminate viruses and ensure safety before global distribution.^[85] Cold chain logistics maintain product integrity during transport to over 100 countries, supported by advanced monitoring systems.^[86]^[9] Capacity expansions include the Multicube facility in St. Gallen, Switzerland, operational from 2025, which uses a modular design to scale production of active pharmaceutical ingredients for Vifor iron therapies, addressing growing demand for nephrology treatments.^[61]^[9] Project Aurora's enhancements similarly boost plasma yield efficiency, enabling higher output of critical therapies without proportional increases in resource use.^[51] Sustainability efforts integrate renewable energy across sites, with Australian manufacturing facilities matching 100% of electricity use via a seven-year agreement, and the Bern site sourcing fully renewable power to reduce emissions.^[87]^[88] These initiatives align with broader goals to lower operational carbon footprints while maintaining supply reliability.^[89] To address challenges like supply disruptions, CSL Behring employs diversified plasma sourcing and digital tracking tools for real-time visibility, mitigating risks from events such as the COVID-19 pandemic through robust monitoring of critical raw materials.^[86]^[90]

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In collaboration with the Commonwealth Serum Laboratories (CSL), the team produces Australia's first commercially available tiger snake antivenom.
[28]
CSL (Commonwealth Serum Laboratories) Collection
Tinger snake antivenom from the 1950s. In 1930, CSL and the Walter and Eliza Hall Institute developed the first antivenom for tiger snake bits. CSL continued to ...
[29]
Poliomyelitis (Polio) Epidemics in Victoria
Salk vaccine trials started in Australia in 1954; Bazeley returned to Melbourne in 1955 and manufacturing the dead-virus vaccine began. As vaccinations were ...
[30]
EXHIBIT 99.1 - SEC.gov
On August 23, 2004, Sanofi-Aventis announced that it gained indirect control over Hoechst AG, and furthermore that it would make a mandatory offer to the ...
[31]
A systematic overview of the first pasteurised VWF/FVIII medicinal ...
Haemate P is a human, plasma-derived VWF/FVIII medicinal product, which was first licensed in Germany in 1981 for the treatment of HA-associated bleeding. It ...
[32]
Capital infusion for CSL to finance US plasma acquisition
Dec 12, 2003 · ... ZLB Bioplasma, which CSL bought for A$890m in 2000. McNamee said ZLB Behring would be the world number one in plasma products market and ...
[33]
[PDF] CSL Completes Acquisition of Aventis Behring to create ZLB Behring
Apr 1, 2004 · CSL acquired Aventis Behring on March 31, 2004, combining it with ZLB Bioplasma to create ZLB Behring, headquartered in King of Prussia, USA.Missing: 2000 | Show results with:2000
[34]
News Releases | CSL
Mar 1, 2012 · CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and ...Missing: NORD 2009 Swiss
[35]
Calimmune to be purchased by CSL Behring - AZBio
Aug 28, 2017 · CSL Behring, has entered into a deal to buy Calimmune Inc. for $91 million. The deal also includes the potential for Calimmune to earn ...
[36]
CSL Ltd Annual Report 2020
... acquisition of Calimmune in 2017. The acquisition gave CSL access to the preclinical development program for an ex vivo haematopoietic stem cell gene ...
[37]
CSL Behring to Acquire Biotech Company Vitaeris
CSL Behring announced today that it has agreed to acquire Vitaeris Inc., a clinical-stage biotechnology company focused on the phase III development of ...
[38]
CSL Limited Announces Tender Offer To Acquire Vifor Pharma Ltd
Dec 14, 2021 · All-cash tender offer of US$179.25 per Vifor Pharma share, representing an aggregate equity value for Vifor Pharma of US$11.7 billion / A$16.4 billion.
[39]
Finalization of Vifor Pharma acquisition - News Releases | CSL
Aug 2, 2022 · CSL has set the settlement date of the public tender offer for Vifor for 9 August 2022. If the offer conditions that remain in effect until the ...
[40]
Global plasma collector | CSL
CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with nearly 330 plasma donation centers globally, ...
[41]
[PDF] Excellence and Innovation in Manufacturing - CSL Behring
The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain ...
[42]
Product Safety & Quality | CSL
For plasma-derived therapies, the most important safety issue is the potential for contamination with pathogens originating from the plasma used to manufacture ...Missing: inactivation | Show results with:inactivation
[43]
CSL Behring's Gene Therapy HEMGENIX® (etranacogene ...
Feb 7, 2025 · Approved in 2022 by the U.S. Food and Drug Administration (FDA), HEMGENIX is the first gene therapy for the treatment of adults with hemophilia ...
[44]
U.S. Food and Drug Administration Approves CSL's ANDEMBRY ...
Jun 16, 2025 · ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks; Once-monthly dosing ...
[45]
Andembry | European Medicines Agency (EMA)
Mar 11, 2025 · Andembry is used for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
[46]
CSL Launches ANDEMBRY® for the Prevention of Acute Attacks in ...
Apr 18, 2025 · ANDEMBRY® received manufacturing and marketing approval in Japan on February 20, 2025, for the prevention of acute attacks in hereditary ...
[47]
[PDF] ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use
Active ingredient: garadacimab-gxii. Inactive ingredients: arginine monohydrochloride, histidine, polysorbate 80, proline, water for injection. Manufactured for ...
[48]
CSL Vifor and Travere Therapeutics announce standard EU ...
Apr 29, 2025 · European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN).Missing: FDA | Show results with:FDA
[49]
CSL trims R&D team, shifts focus toward external opportunities
Jul 7, 2025 · CSL will consolidate its R&D teams around six sites located in biotech hubs as the company looks to boost external partnerships.
[50]
R&D Capabilities - CSL
R&D focuses its expertise on four strategic platforms – plasma protein technology; recombinant technology; genetic medicine; and vaccines technology.<|separator|>
[51]
CSL's Plasma Fractionation Facility Wins Pharmaceutical ...
Oct 31, 2025 · Project Aurora, the expansion project to create Facility F, took four years to build and opened in 2022. CSL expanded to meet growing patient ...
[52]
CSL Behring Project Aurora Wins 2025 ISPE FOYA Award
Oct 30, 2025 · Project Aurora not only expands CSL Behring's site capacity to nine times its previous level processing more than 10 million litres of plasma ...
[53]
2025 ISPE FOYA Category Winner for Pharma 4.0
CSL Project Aurora is a significant base fractionation expansion initiative at the Broadmeadows Campus in Victoria, Australia. The project enabled end-to-end ...
[54]
Health Canada Has Authorized CSL's ANDEMBRY® (garadacimab ...
ANDEMBRY is a monoclonal antibody designed to target activated FXII (FXIIa), a plasma protein at the top of the HAE cascade that plays a key role in attacks of ...
[55]
Product Pipeline | CSL
CSL is a global leader in developing and delivering high quality medicines that treat people with rare and serious diseases.
[56]
Water, Waste & Biodiversity - CSL
By FY2030, CSL aims to: address any significant biodiversity impacts at manufacturing sites, resulting from biodiversity impact assessments completed; and ...
[57]
CSL Impact Report 2025
In FY2025 alone we invested $1.4 billion in R&D. During this period, we ... Number of clinical trials underway in FY2025, across clinical, registration ...
[58]
Study Details | NCT07001280 | ClinicalTrials.gov - Clinical Trials
The primary aim of this study is to investigate the real-world effectiveness of garadacimab as measured by HAE attack rate before and after garadacimab ...
[59]
Study Details | NCT06008938 | ClinicalTrials.gov - Clinical Trials
This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in ...
[60]
https://investors.csl.com/pdf/10545bfd-5f5d-4af4-ac54-a45b11ee9c2e/CSL-announces-sale-of-Ruide-operations.pdf
[61]
Meeting the Global Demand for Iron-Based Therapies - CSL
Aug 20, 2024 · A new CSL Vifor manufacturing facility in St. Gallen, Switzerland, has a modular design that can be expanded – cube by cube – to meet future ...
[62]
CSL announces rise in full year net profit - Aug 18, 2025
Aug 18, 2025 · "Financial Year 2026 group revenue growth is anticipated to be approximately 4-5% over Financial Year 2025 at constant currency. "In CSL Behring ...
[63]
NautaDutilh advised VarmX on strategic collaboration and option ...
Sep 22, 2025 · Under the terms of the strategic collaboration agreement, CSL will fully fund VarmX's global Phase 3 EquilibriX-S trial evaluating VMX-C001 in ...
[64]
CSL Vifor and Travere Therapeutics Recognize Updated KDIGO ...
Sep 26, 2025 · CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize ...
[65]
News Releases from CSL Vifor
Vifor Pharma and Evotec to create a jointly-owned drug discovery and development platform for innovative nephrology therapeutics Collaboration brings together ...
[66]
Leading the Way on Serious & Rare Diseases - CSL Behring
We are a leader in the development and introduction of innovative therapies that can treat rare and serious diseases.Missing: small molecules
[67]
First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved ...
Feb 20, 2023 · HEMGENIX is an adeno-associated virus five (AAV5)-based gene therapy given as a one-time treatment for moderately severe to severe hemophilia B patients.Missing: NORD FDA
[68]
CSL announces rise in full year net profit - Aug 18, 2025
Aug 18, 2025 · "Financial Year 2026 group revenue growth is anticipated to be approximately 4-5% over Financial Year 2025 at constant currency. "In CSL Behring ...
[69]
Contact - CSL
CSL, Global Headquarters 655 Elizabeth Street Melbourne VIC 3000 Australia, phone: +61 3 9389 1911. CSL Behring, 1020 First Avenue PO Box 61501
[70]
https://dced.pa.gov/paproudblog/pennsylvania-biotech-combating-rare-diseases-worldwide/
[71]
Contact - CSL
CSL, Global Headquarters 655 Elizabeth Street Melbourne VIC 3000 Australia, phone: +61 3 9389 1911. CSL Behring, 1020 First Avenue PO Box 61501
[72]
CSL Group Legal Entities - Melbourne
Company Entities ; CSL Behring AG. Wankdorfstrase 10, 3014. Bern, Switzerland ; CSL Behring ApS. Lyngby Hovedgade 10 C · Lyngby, 2800, Denmark ; CSL Behring Asia ...
[73]
Worldwide Locations - CSL
CSL Behring, Regional Sales Offices · Argentina · Australia · Austria · Belgium/Luxemburg · Brazil · Canada · Chile · China.Missing: employees | Show results with:employees
[74]
Contact us - CSL Behring
CSL Behring's address is Emil-von-Behring-Straße 76, D-35041 Marburg. For medical questions, call +49 6190 75-84810 or email medwiss@cslbehring.com. For ...
[75]
CSL Behring United Kingdom
Welcome to CSL Behring UK. Delivering on our promise to serve people with rare and serious diseases across the United Kingdom and Ireland. Learn More About Our ...
[76]
MEA Contacts - CSL Behring Middle East and Africa
Middle East & Africa Head Office. CSL Behring UAE CSL Behring MEA FZ-LLC Office No. 903 – Floor No. 9. Building HQ Complex – North Tower Dubai Science Park ...
[77]
CSL Plasma and Terumo Blood and Cell Technologies Announce ...
Rika devices are installed in more than 300 CSL Plasma centers to increase plasma supply for patients. ... – 18 September 2025 – CSL Plasma ...
[78]
CSL announces sale of Wuhan plasma collection and fractionation ...
September 5, 2024 Latest News. CSL Limited (ASX:CSL) has announced the sale of its Wuhan Zhong Yuan Rui De Biologicals Products (Ruide) plasma collection ...
[79]
CSL Behring AG in Bern
In the heart of Switzerland's capital. More than 1,800 employees at the Bern facility develop and manufacture innovative biotherapies derived from human plasma.Missing: offices St. Gallen
[80]
Our Locations | CSL Behring Germany
In Deutschland ist CSL Behring hauptsächlich an zwei Standorten in Hessen vertreten: Marburg und Hattersheim.
[81]
CSL's $470 Million Plasma Fractionation Facility Opens in Marburg ...
Mar 24, 2023 · This week in Marburg, Germany, CSL celebrated the opening of a new plasma fractionation facility, a $470 million project that took five years to construct.
[82]
CSL Behring - Illinois Economic Development Corporation
CSL Behring, which began as Armour Pharmaceuticals, has 30,000 employees worldwide, including plants in Australia, Germany and Switzerland. CSL had $12.3 ...A Global Biotherapeutics... · News Stories · Advanced Manufacturing Finds...
[83]
CSL Behring Announces 1.8 Million SF Kankakee Site Expansion
CSL Behring, an Australia-based global biotherapeutics firm, plans to expand its operations center in Kankakee, Illinois.
[84]
[PDF] SALE OF RUIDE OPERATIONS - CSL
Aug 30, 2024 · The transaction is expected to close by the end of calendar year 2024, subject to regulatory approval by relevant government authorities. In ...
[85]
Global Pathogen Safety - CSL Behring
The department develops and evaluates state-of-the-art process steps that remove or inactivate viruses and other pathogens.Missing: cold chain
[86]
Responsible & Resilient Supply Chain - CSL
CSL is focused on driving a responsible global mindset and creating an end-to-end operation that is scalable, from plasma collection through to delivery.
[87]
CSL Makes a Match to Support Renewable Energy
In a new seven-year agreement with energy supplier AGL, CSL will match 100% of the electricity used by its Australian manufacturing sites with renewable energy ...
[88]
CSL announces carbon emissions reduction targets - PR Newswire
Aug 16, 2022 · CSL facilities in Liverpool, United Kingdom, and Bern, Switzerland, currently source renewable energy. CSL's new R&D complexes in Marburg ...
[89]
Energy | CSL
CSL commits to reduce absolute Scope 1 and 2 greenhouse gas emissions by 42% by FY2030 (from a FY2021 base year)¹. CSL commits that 73.1% of CSL's suppliers by ...
[90]
CSL Outlook Revised To Stable Fr | S&P Global Ratings
May 30, 2024 · It illustrated this during the pandemic by overcoming significant supply-chain disruptions and associated challenges. Although the group has ...