CSL Limited

Last updated

CSL Limited
Type Public
ASX:  CSL
Industry Biotechnology
Founded1916 (Federal government department), 1994 (privatised)
Headquarters Parkville, Melbourne, Victoria, Australia(Global), [1]
Key people
Paul Perreault (CEO)
Products blood plasma, vaccines, antivenom, other laboratory and medical products
RevenueIncrease2.svg USD$8.539 billion (2019) [1]
Increase2.svg USD$1.919 billion (2019) [1]
Number of employees
25,000 person (2019) [1]
Divisions
  • CSL Behring
  • Seqirus
Website www.csl.com.au

CSL Limited is a global 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. [2]

Contents

History

Origin and Penfold directorship

CSL was founded in 1916 as the Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. [3] Under the first director, William Penfold, [4] 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.

Morgan directorship

After ongoing disputes with the Commonwealth Department of Health and its director, (John) Howard Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. [5] 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. [6]

Antivenene research and production

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. [7] 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. [8]

Plasma fractionation and Wiener directorship

The operation commenced plasma fractionation in 1952. [9] 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, [10] and a new test for snakebites that would identify which snake had envenomated the victim. [11]

Other major achievements of CSL include: [12]

Privatisation

In 1994, the Commonwealth facility was privatised 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. CSL stock is part of the S&P/ASX 20 Index. [14]

Acquisition of ZLB Bioplasma AG and Aventis Behring

In 2000, CSL doubled its size through the purchase of a Swiss plasma company, the Bern-based ZLB Bioplasma AG. [15] In 2004, during a period of plasma oversupply, the company expanded again with the purchase of the German medical company Aventis Behring. [16] The company was the second Australian public company to have reached a share price of over $100 per share. [17]

Acquisition and merging of Novartis

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. [18]

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. [19]

Completed in 2018, Seqirus's Holly Spring, NC, plant was funded with $59 million from the U.S. government. [20]

Locations

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 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, USA, Liverpool, UK, and Parkville, Victoria

Vaccines

A/H1N1 2009 pandemic

CSL's vaccine for swine flu, the world's first, was approved in September 2009 for use by people over age 10. [21] The federal government ordered 21 million doses of vaccine for Australians. [22] CSL also provided vaccines for customers in Singapore and the US.

On the 28 September 2010, the Australian Therapeutic Goods Administration conducted an analysis of febrile convulsions following immunisation in children following monovalent pandemic H1N1 vaccine (Panvax/Panvax Junior, CSL)

https://www.tga.gov.au/alert/analysis-febrile-convulsions-following-immunisation-children-following-monovalent-pandemic-h1n1-vaccine-panvaxpanvax-junior-csl

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.

https://www.mja.com.au/system/files/issues/195_06_190911/kel10941_fm.pdf

COVID-19 pandemic

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. [23] [24]

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. [25]

On 23 March 2021, the Therapeutic Goods Administration 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. [26]

Divisions

CSL Limited's products can be separated by company division. Some of the key products produced by each division, have included:

Seqirus (bioCSL)

Vaccines: [27]

Antivenoms: (Australia) [28]

CSL Behring (Australia)

[29]

CSL Behring

Immunology: [30]

Coagulation/Bleeding Disorders:

Pulmonary:

Critical Care:

Wound Healing:

Product availability varies from country to country, depending on registration status.

Honours

In 2011, the company received the Minister's Award for Outstanding Equal Employment Opportunities Initiative for their Thinking Kids Children's Centre. [31]

See also

Related Research Articles

Vaccine Pathogen-derived preparation that provides acquired immunity to an infectious disease

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future. Vaccines can be prophylactic, or therapeutic.

Pentamidine

Pentamidine is an antimicrobial medication used to treat African trypanosomiasis, leishmaniasis, Balamuthia infections, babesiosis, and to prevent and treat pneumocystis pneumonia (PCP) in people with poor immune function. In African trypanosomiasis it is used for early disease before central nervous system involvement, as a second line option to suramin. It is an option for both visceral leishmaniasis and cutaneous leishmaniasis. Pentamidine can be given by injection into a vein or muscle or by inhalation.

Intramuscular injection Medical injection into a muscle

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.

This is a timeline of the development of prophylactic human vaccines. Early vaccines may be listed by the first year of development or testing, but later entries usually show the year the vaccine finished trials and became available on the market. Although vaccines exist for the diseases listed below, only smallpox has been eliminated worldwide. The other vaccine-preventable illnesses continue to cause millions of deaths each year. Currently, polio and measles are the targets of active worldwide eradication campaigns.

Antivenom Medical treatment for snakebite

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.

Antiserum is human or nonhuman blood serum containing monoclonal or polyclonal antibodies that is used to spread passive immunity to many diseases via blood donation (plasmaphoresis). 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.

Seasonal influenza vaccine brands

Seasonal influenza vaccine brands include Fluzone/Fluzone Quadrivalent and Vaxigrip/VaxigripTetra, Influvac and Optaflu.

Fresh frozen plasma

Fresh frozen plasma (FFP) is a blood product made from the liquid portion of whole blood. It is used to treat conditions in which there are low blood clotting factors or low levels of other blood proteins. It may also be used as the replacement fluid in plasma exchange. Using ABO compatible plasma, while not required, may be recommended. Use as a volume expander is not recommended. It is given by slow injection into a vein.

Sanofi Pasteur the vaccines division of Sanofi

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.

H5N1 clinical trials

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, is a medication made up of blood clotting factors II, IX, and X. Some versions also contain factor VII. It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. It may also be used in those with not enough of these factors due to other reasons such as warfarin therapy. It is given by slow injection into a vein.

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 pharmaceuticals company. It is the world's largest vaccine manufacturer. It is located in the city of Pune, Maharashtra, India, and was founded by Cyrus Poonawalla in 1966. The company is a subsidiary of the holding company Poonawalla Investment and Industries.

CSL Behring

CSL Behring is a biopharmaceutical company, manufacturing plasma-derived and recombinant therapeutic products and providing them to people in more than 100 countries. Its line of therapies includes products for the treatment of bleeding disorders such as hemophilia and von Willebrand Disease; primary immune deficiencies (PIDD); hereditary angioedema; inherited respiratory disease; and neurological disorders in certain markets. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn.

Hepatitis B vaccine

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people routine immunization results in more than 95% of people being protected.

Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg.

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, also known as normal human immunoglobulin (NHIG), is the use of a mixture of antibodies (immunoglobulins) to treat a number of 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.

References

  1. 1 2 3 4 "Annual Report 2019" (PDF). CSL Limited. 2019.
  2. "CSL LTD (CSL:ASX): Stock Quote & Company Profile - Businessweek". businessweek. Archived from the original on 18 January 2013. Retrieved 13 August 2012.
  3. "Trove". trove.nla.gov.au. Retrieved 22 September 2020.
  4. Robin, A. De Q. Penfold, William James (1875–1941). Canberra: National Centre of Biography, Australian National University.
  5. Egan, Bryan, "Morgan, Frederick Grantley (1891–1969)", Australian Dictionary of Biography, Canberra: National Centre of Biography, Australian National University, retrieved 22 September 2020
  6. "BUNDABERG TRAGEDY, Daily Examiner". 14 June 1928. p. 3 via Trove.
  7. Hobbins, Peter G.; Winkel, Kenneth D. (3 December 2007). "The forgotten successes and sacrifices of Charles Kellaway, director of the Walter and Eliza Hall Institute, 1923–1944". The Medical Journal of Australia. 187 (11): 645–648. doi:10.5694/j.1326-5377.2007.tb01457.x. PMID   18072902. S2CID   23444263.
  8. Gardiner, Lyndsay; Serle, Geoffrey (2000). "Keogh, Esmond Venner (Bill) (1895–1970)". Australian Dictionary of Biography. National Centre of Biography, Australian National University. 15.
  9. Flood, Phillip; Wills, Peter; Lawler, Peter; Ryan, Graeme; Rickard, Kevin A. (2006). Review of Australia's Plasma Fractionation Arrangements (PDF). ISBN   1-74186-121-7.
  10. "SAFER FIRST AID, Papua New Guinea Post-Courier". 18 April 1979. p. 11 via Trove.
  11. "New test for snake bites, The Canberra Times". 30 October 1979. p. 14 via Trove.
  12. Tasker, Sarah-Jane (23 April 2016). "Blood, sweat and tears of the CSL century". The Australian.
  13. "A global solution to reducing cervical cancer" (PDF). Uniquest commercialisation stories. The University of Queensland. Retrieved 29 April 2016.
  14. "CSL Limited". Australian Securities Exchange . Retrieved 7 February 2020.
  15. Dow Jones Newswires (9 December 2003). "Australia's CSL Agrees to Acquire Aventis Unit for up to $925 Million". Wall Street Journal. Retrieved 22 February 2021. … this deal eclipses the A$1 billion (US$740.2 million) CSL spent in 2000 to buy ZLB Bioplasma from the Swiss Red Cross.
  16. "Aventis disposes of Behring unit with $925M sale to Australia's CSL -". www.thepharmaletter.com. The Pharma Letter. 15 December 2003. Retrieved 22 February 2021. … Aventis says that it has agreed to sell its Aventis Behring blood products business to Australia's CSL …
  17. "CSL bursts through the $100 barrier". Quest Asset Partners. 4 August 2015. Retrieved 22 February 2021.
  18. Phillipidis, Alex (27 October 2014). "Novartis Selling Flu Vaccine Business to CSL for $275M". Genetic Engineering & Biotechnology News. Retrieved 22 May 2020.
  19. Sequirus Commonwealth Serum Laboratories
  20. Willman, David (15 March 2020). "Federal vaccine development sites ill-suited to counter covid-19 epidemic". Washington Post. Retrieved 15 March 2020.
  21. "Panvax H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration". Melbourne, Australia: CSL Limited. 18 September 2009. Archived from the original on 18 September 2009. Retrieved 26 September 2009. 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.
  22. Tran, Mark (22 July 2009). "First human trials of swine flu vaccine begin in Australia". The Guardian. ISSN   0261-3077 . Retrieved 7 September 2020.
  23. "CSL to manufacture and supply University of Queensland and Oxford University vaccine candidates for Australia". www.csl.com. 7 September 2020. Retrieved 7 September 2020.
  24. "Australia secures onshore manufacturing agreements for two COVID-19 vaccines | Prime Minister of Australia". www.pm.gov.au. 7 September 2020. Retrieved 7 September 2020.
  25. "Update on The University of Queensland COVID-19 vaccine" (PDF). CSL Limited.
  26. "National medical regulator approves 800,000 Australian-made doses of AstraZeneca vaccine". www.abc.net.au. 23 March 2021. Retrieved 9 April 2021.
  27. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 "Products". Seqirus. 6 December 2018. Retrieved 5 February 2020.
  28. 1 2 "Products". Seqirus. Australia. Retrieved 9 February 2020.
  29. "Products". cslbehring.com.au. Retrieved 7 February 2020.
  30. Global product portfolio CSL Behring, 3 November 2010
  31. "CSL wins equal opportunity award for onsite childcare centre". CSL Newsroom. CSL. Retrieved 25 October 2016.

Sources