This article has multiple issues. Please help improve it or discuss these issues on the talk page . (Learn how and when to remove these template messages)
|
Company type | Public |
---|---|
| |
Industry | Biotechnology |
Founded | 1916 (Federal government department), 1994 (privatised) |
Headquarters | Parkville, Melbourne, Victoria, Australia (Global), [1] |
Key people | Paul McKenzie (CEO) |
Products | blood plasma, vaccines, antivenom, other laboratory and medical products |
Revenue | US$14.8 billion (2024) [2] |
US$2.91 billion (2024) [2] | |
Number of employees | 32,000 (2024) [2] |
Divisions | |
Website | www |
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. [3] The company was established in 1916 as Commonwealth Serum Laboratories and was wholly owned by the Australian federal government until its privatisation in 1994.
CSL was founded in 1916 as Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. [4] Under the first director, William Penfold, [5] CSL commenced operation in the vacant Walter and Eliza Hall Institute building at the Royal Melbourne Hospital in 1918 before moving to its purpose-built Parkville premises in the following year.
After ongoing disputes with the Department of Health and its director-general John Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. [6] Soon after Morgan's appointment, CSL was drawn into a serious public health disaster when a batch of its diphtheria toxin-antitoxin was implicated in the deaths of twelve children in what became known as the Bundaberg tragedy of 1928. Although CSL's manufacturing processes were absolved, its labelling procedures were seen to be in error, leading to an enduring focus on the highest standards across the facility's production. [7]
In 1928, CSL also became involved in antivenene (antivenom) manufacture in conjunction with the snake venom research undertaken by Charles Kellaway at the Hall Institute. [8] This led to the successful clinical testing of antivenene against tiger snake Notechis scutatus bite in 1930 and its commercial release in 1931.
In 1934, the research on snake venoms was transferred from the Hall Institute to CSL under the direction of former snake showman and herpetologist Tom "Pambo" Eades. This represented the initiation of research at the laboratories – an outcome its directors had been seeking for over a decade. The relationship with the Hall Institute continued until World War II, particularly via joint projects on viral diseases including polio and influenza coordinated by Frank Macfarlane Burnet and Esmond "Bill" Keogh. Keogh played an important role in the establishment of penicillin production at CSL in 1944 – a critical wartime achievement. [9]
In 1952, operation commenced plasma fractionation. [10] Thereafter the range of antivenoms increased, including those against other snake species such as death adder ( Acanthophis antarcticus ) and the taipan ( Oxyuranus scutellatus ), plus spiders including the redback ( Latrodectus hasselti ) and – after much difficulty – the Sydney funnel-web ( Atrax robustus ). Much of this work, including the introduction in 1962 of a polyvalent antivenom against all of the major terrestrial Australian snakes, occurred under the direction of Saul Wiener, while from 1966 until the mid-1990s, venom research was coordinated by the eccentric but dedicated Struan Sutherland, who in 1979 released new guidelines for snakebite first aid, [11] and a new test for snakebites that would identify which snake had envenomated the victim. [12]
Other major achievements of CSL include: [13]
In 1994, the Commonwealth facility was privatised by the Keating government as CSL Ltd. and was publicly listed and traded on the Australian Securities Exchange. The company completed an initial public offering in June 1994 at A$2.30 per share (76.7c adjusted for split). CSL stock is part of the S&P/ASX 20 Index. [15]
In 2000, CSL doubled its size through the purchase of a Swiss plasma company, the Bern-based ZLB Bioplasma AG. [16] In 2004, during a period of plasma oversupply, the company expanded again with the purchase of the German medical company Aventis Behring. [17] The company was the second Australian public company to have reached a share price of over $100 per share. [18]
In October 2014, Novartis announced its intention to sell its influenza vaccine business, including its development pipeline, to CSL for $275 million. CSL merged it into its BioCSL operation. [19]
In November 2015, BioCSL rebranded the combined business with Novartis Influenza Vaccines as Seqirus [Sek-eer-us], creating the world's second-largest influenza vaccine company. [20]
In August 2017, the business announced it would acquire Calimmune and its stem cell therapy platform. [21]
Completed in 2018, Seqirus's Holly Spring, NC, the plant was funded with $59 million from the U.S. government. [22]
in June 2020, CSL announced it would exercise its right to acquire Vitaeris. [23]
In December 2021, the business announced it would acquire Swiss drugmaker, Vifor Pharma AG, for $11.7 billion. [24]
In August 2022, CSL rebranded all of its divisions to start with the CSL name. Therefore, the divisions became CSL Behring, CSL Plasma, CSL Seqirus, and CSL Vifor. [25]
The company's headquarters remain in Parkville, Victoria, an inner suburb of Melbourne, and has offices and laboratory space in Sydney.
CSL Behring is headquartered in King of Prussia, USA and it has manufacturing operations and R&D laboratories in Broadmeadows, Victoria, the Swiss city of Bern, in Marburg in Germany, and Kankakee, USA.
Seqirus has its headquarters in Maidenhead and has production facilities in Holly Springs, US, Liverpool, UK, and Parkville, Victoria
Influenza (flu) |
---|
CSL's vaccine for swine flu, the world's first, was approved in September 2009 for use by people over age 10. [26] The federal government ordered 21 million doses of vaccine for Australians. [27] CSL also provided vaccines for customers in Singapore and the US.
On 28 September 2010, the Australian Therapeutic Goods Administration (TGA) conducted an analysis of febrile convulsions following immunisation in children following monovalent pandemic H1N1 vaccine (Panvax/Panvax Junior, CSL). [28]
A paper published in the Medical Journal of Australia provides a possible reason for CSL's 2010 flu vaccine causing febrile convulsions in children. The authors hypothesise that suboptimal use of the detergent called deoxycholate – used in the manufacturing process by CSL (one of the few vaccine manufacturers that use it) – to split the flu virus from its membrane may be at fault. [29]
On 7 September 2020, CSL signed agreements with the Australian government to supply the University of Queensland vaccine (V451) and to manufacture (with AstraZeneca) the Oxford University vaccine (AZD1222), which would yield nearly 85 million doses for Australians. The agreement was contingent on the future success of clinical trials of these vaccines. Most of the manufacture would occur in Melbourne, Australia. [30] [31]
On 11 December 2020, after a high percentage of the University of Queensland vaccine trial participants returned "false positive" results for HIV, it was decided that vaccine development will not proceed to Phase 2/3 trials. [32]
On 23 March 2021, the Therapeutic Goods Administration provisionally approved the first batches, numbering 832,000 doses, of the Oxford–AstraZeneca COVID-19 vaccine manufactured by CSL in its plant in Broadmeadows, Victoria. The Australian Government has contracted CSL to produce 50 million doses of the vaccine. [33]
CSL Limited's products can be separated by company division. Some of the key products produced by each division, have included:
Antivenoms: (Australia) [35]
Coagulation/Bleeding Disorders:
Wound Healing:
Product availability varies from country to country, depending on registration status.
In 2011, the company received the Minister's Award for Outstanding Equal Employment Opportunities Initiative for their Thinking Kids Children's Centre. [38]
Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have larger and more numerous blood vessels than subcutaneous tissue, leading to faster absorption than subcutaneous or intradermal injections. Medication administered via intramuscular injection is not subject to the first-pass metabolism effect which affects oral medications.
Antivenom, also known as antivenin, venom antiserum, and antivenom immunoglobulin, is a specific treatment for envenomation. It is composed of antibodies and used to treat certain venomous bites and stings. Antivenoms are recommended only if there is significant toxicity or a high risk of toxicity. The specific antivenom needed depends on the species involved. It is given by injection.
Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. The corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Synthélabo merged with Aventis and renamed to Sanofi-Aventis, which were each the product of several previous mergers. It changed its name back to Sanofi in May 2011. The company is a component of the Euro Stoxx 50 stock market index. In 2023, the company’s seat in Forbes Global 2000 was 89.
In immunology, antiserum is a blood serum containing antibodies that is used to spread passive immunity to many diseases via blood donation (plasmapheresis). For example, convalescent serum, passive antibody transfusion from a previous human survivor, used to be the only known effective treatment for ebola infection with a high success rate of 7 out of 8 patients surviving.
Rho(D) immune globulin (RhIG) is a medication used to prevent RhD isoimmunization in mothers who are RhD negative and to treat idiopathic thrombocytopenic purpura (ITP) in people who are Rh positive. It is often given both during and following pregnancy. It may also be used when RhD-negative people are given RhD-positive blood. It is given by injection into muscle or a vein. A single dose lasts 12 weeks. It is made from human blood plasma.
Imiglucerase is a medication used in the treatment of Gaucher's disease.
Sanofi Pasteur is the vaccines division of the French multinational pharmaceutical company Sanofi. Sanofi Pasteur is the largest company in the world devoted entirely to vaccines. It is one of four global producers of the yellow fever vaccine.
H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.
Prothrombin complex concentrate (PCC), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X(3-factor PCC) or, when also containing factor VII as does Kcentra, 4-factor PCC. It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. It may also be used for reversal of warfarin therapy. It is given by slow injection into a vein. Another product, activated prothrombin complex concentrate or FEIBA, may be used for acquired hemophilia.
In immunology, passive immunity is the transfer of active humoral immunity of ready-made antibodies. Passive immunity can occur naturally, when maternal antibodies are transferred to the fetus through the placenta, and it can also be induced artificially, when high levels of antibodies specific to a pathogen or toxin are transferred to non-immune persons through blood products that contain antibodies, such as in immunoglobulin therapy or antiserum therapy. Passive immunization is used when there is a high risk of infection and insufficient time for the body to develop its own immune response, or to reduce the symptoms of ongoing or immunosuppressive diseases. Passive immunization can be provided when people cannot synthesize antibodies, and when they have been exposed to a disease that they do not have immunity against.
Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.
CSL Behring is a biopharmaceutical company, manufacturing plasma-derived and recombinant therapeutic products. The company is a combination of Behringwerke, founded in 1904 in Marburg, Germany by Emil von Behring, and the Commonwealth Serum Laboratories (CSL), established in Australia in 1916 to provide vaccines to the people of Australia, as well as other companies acquired since 2004.
Diphtheria vaccine is a toxoid vaccine against diphtheria, an illness caused by Corynebacterium diphtheriae. Its use has resulted in a more than 90% decrease in number of cases globally between 1980 and 2000. The first dose is recommended at six weeks of age with two additional doses four weeks apart, after which it is about 95% effective during childhood. Three further doses are recommended during childhood. It is unclear if further doses later in life are needed.
A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.
Rabies immunoglobulin (RIG) is a medication made up of antibodies against the rabies virus. It is used to prevent rabies following exposure. It is given after the wound is cleaned with soap and water or povidone-iodine and is followed by a course of rabies vaccine. It is given by injection into the site of the wound and into a muscle. It is not needed in people who have been previously vaccinated against rabies.
Immunoglobulin therapy is the use of a mixture of antibodies to treat several health conditions. These conditions include primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain–Barré syndrome, and certain other infections when a more specific immunoglobulin is not available. Depending on the formulation it can be given by injection into muscle, a vein, or under the skin. The effects last a few weeks.
Ram Chandra was a snake showman in Australia. He was known as Australia's "taipan man" and for his work in extracting snake venom to create antivenoms.
A vaccine dose contains many ingredients very little of which is the active ingredient, the immunogen. A single dose may have merely nanograms of virus particles, or micrograms of bacterial polysaccharides. A vaccine injection, oral drops or nasal spray is mostly water. Other ingredients are added to boost the immune response, to ensure safety or help with storage, and a tiny amount of material is left-over from the manufacturing process. Very rarely, these materials can cause an allergic reaction in people who are very sensitive to them.
… this deal eclipses the A$1 billion (US$740.2 million) CSL spent in 2000 to buy ZLB Bioplasma from the Swiss Red Cross.
… Aventis says that it has agreed to sell its Aventis Behring blood products business to Australia's CSL …
CSL Biotherapies, a subsidiary of CSL Limited, Australia's leading biopharmaceutical company, can today confirm that its vaccine against the pandemic (H1N1) 2009 influenza or 'swine flu' has been approved registration for use in people aged 10 years and over.