CSL Limited explained

CSL Limited
Type:Public
Foundation:1916 (Federal government department), 1994 (privatised)
Hq Location:Parkville, Melbourne, Victoria, Australia (Global),[1]
Key People:Paul McKenzie (CEO)
Industry:Biotechnology
Products:blood plasma, vaccines, antivenom, other laboratory and medical products
Revenue: (2024)
Net Income: (2024)[2]
Num Employees:32,000 (2024)

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.

History

Origin and Penfold directorship

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.

Morgan directorship

After ongoing disputes with the Department of Health and its director-general John Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. 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

In 1952, operation commenced plasma fractionation.[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 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.[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]

In August 2017, the business announced it would acquire Calimmune and its stem cell therapy platform.[20]

Completed in 2018, Seqirus's Holly Spring, NC, the plant was funded with $59 million from the U.S. government.[21]

in June 2020, CSL announced it would exercise its right to acquire Vitaeris.[22]

In December 2021, the business announced it would acquire Swiss drugmaker, Vifor Pharma AG, for $11.7 billion.[23]

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.[24]

Acquisition history

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 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

Vaccines

A/H1N1 2009 pandemic

See also: 2009 swine flu pandemic in Australia. CSL's vaccine for swine flu, the world's first, was approved in September 2009 for use by people over age 10.[25] The federal government ordered 21million doses of vaccine for Australians.[26] 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).[27]

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.[28]

COVID-19 pandemic

See also: COVID-19 pandemic in Australia. 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.[29] [30]

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.[31]

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.[32]

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

[33]

Antivenoms: (Australia)[34]

CSL Behring (Australia)

[35]

CSL Behring

Immunology

[36]

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.[37]

See also

Sources

Notes and References

  1. Web site: Annual Report 2019. CSL Limited. 2019.
  2. Web site: CSL Annual Report 2021/22. April 2022. 29 March 2023. CSL Limited.
  3. Web site: CSL LTD (CSL:ASX): Stock Quote & Company Profile. https://archive.today/20130118153023/http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?ticker=CSL:AU . dead . 18 January 2013 . Bloomberg Businessweek. 13 August 2012.
  4. Web site: Trove. 2020-09-22. trove.nla.gov.au.
  5. Book: Robin, A. De Q.. Penfold, William James (1875–1941). National Centre of Biography, Australian National University. Canberra.
  6. Web site: BUNDABERG TRAGEDY, Daily Examiner. 14 June 1928. 3. Trove.
  7. Hobbins. Peter G.. Winkel. Kenneth D.. 2007-12-03. The forgotten successes and sacrifices of Charles Kellaway, director of the Walter and Eliza Hall Institute, 1923–1944. The Medical Journal of Australia. en. 187. 11. 645–648. 10.5694/j.1326-5377.2007.tb01457.x. 18072902. 23444263.
  8. Keogh, Esmond Venner (Bill) (1895–1970). Australian Dictionary of Biography. 15. 2000. Lyndsay. Gardiner. Geoffrey. Serle. National Centre of Biography, Australian National University.
  9. Book: Flood. Phillip. Review of Australia's Plasma Fractionation Arrangements. Wills. Peter. Lawler. Peter. Ryan. Graeme. Rickard. Kevin A.. 2006. 1-74186-121-7.
  10. Web site: SAFER FIRST AID, Papua New Guinea Post-Courier. 18 April 1979. 11. Trove.
  11. Web site: New test for snake bites, The Canberra Times. 30 October 1979. 14. Trove.
  12. News: Blood, sweat and tears of the CSL century. Tasker. Sarah-Jane. 23 April 2016. The Australian.
  13. Web site: A global solution to reducing cervical cancer. Uniquest commercialisation stories. The University of Queensland. 29 April 2016.
  14. Web site: CSL Limited. 7 February 2020. Australian Securities Exchange.
  15. News: Dow Jones Newswires . Australia's CSL Agrees to Acquire Aventis Unit for up to $925 Million . 22 February 2021 . The Wall Street Journal . 9 December 2003 . … 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. Web site: Aventis disposes of Behring unit with $925M sale to Australia's CSL – . thepharmaletter.com . The Pharma Letter . 22 February 2021 . 15 December 2003 . … Aventis says that it has agreed to sell its Aventis Behring blood products business to Australia's CSL … . live. https://web.archive.org/web/20210923070545/https://www.thepharmaletter.com/article/aventis-disposes-of-behring-unit-with-925m-sale-to-australia-s-csl . 23 September 2021 .
  17. Web site: CSL bursts through the $100 barrier . Quest Asset Partners . 4 August 2015 . 22 February 2021 . live. https://web.archive.org/web/20160228082802/http://questap.com.au/csl-bursts-through-the-100-barrier/ . 28 February 2016 .
  18. Web site: Alex. Phillipidis. Novartis Selling Flu Vaccine Business to CSL for $275M. Genetic Engineering & Biotechnology News. 27 October 2014. 22 May 2020.
  19. http://www.csl.com.au/Seqirus.htm Sequirus
  20. CSL Behring Acquires Biotech Company Calimmune and its Proprietary Stem Cell Gene Therapy Platform . CSL . 2017-08-06 . 2021-12-15.
  21. News: Willman. David. Federal vaccine development sites ill-suited to counter covid-19 epidemic. The Washington Post. 15 March 2020. 15 March 2020.
  22. CSL to Acquire Biotech Company Vitaeris . CSL . 2020-09-06 . 2021-12-15.
  23. Web site: Australia's CSL to buy Swiss drugmaker Vifor for $11.7 bln. 2021-12-14. 2021-12-15. Nikhil. Nainan. Silke. Koltrowitz. Scott. Murdoch. Reuters.
  24. Web site: Coey . Sharon Klahr . 2022-08-26 . CSL to unite all business units, including Seqirus, under the CSL umbrella . live . https://web.archive.org/web/20220826150412/https://www.fiercepharma.com/marketing/csl-unite-all-business-unit-including-seqirus-under-one-csl-umbrella . 2022-08-26 . Fierce Pharma.
  25. Web site: Panvax H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration . https://web.archive.org/web/20090925175938/http://www.csl.com.au/s1/cs/auhq/1187378853299/news/1249870443804/prdetail.htm . CSL Limited . Melbourne, Australia . 18 September 2009 . 25 September 2009 . 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. . live .
  26. News: Tran. Mark. 2009-07-22. First human trials of swine flu vaccine begin in Australia. en-GB. The Guardian. 2020-09-07. 0261-3077.
  27. Web site: Administration . Australian Government Department of Health Therapeutic Goods . 2010-09-28 . Analysis of febrile convulsions following immunisation in children following monovalent pandemic H1N1 vaccine (Panvax/Panvax Junior, CSL) . 2022-07-25 . Therapeutic Goods Administration (TGA) . en.
  28. Adverse events associated with 2010 CSL and other inactivated influenza vaccines. 21929484. 10.5694/mja11.10941. The Medical Journal of Australia. 195. 6. 19 September 2011. 318–320. Heath A. Kelly. Danuta M. Skowronski. Gaston. De Serres. Paul V. Effler. 9389146 .
  29. Web site: 7 September 2020. CSL to manufacture and supply University of Queensland and Oxford University vaccine candidates for Australia. 2020-09-07. csl.com. en-US.
  30. Web site: 7 September 2020. Australia secures onshore manufacturing agreements for two COVID-19 vaccines Prime Minister of Australia. 2020-09-07. pm.gov.au. 7 September 2020. https://web.archive.org/web/20200907043720/https://www.pm.gov.au/media/australia-secures-onshore-manufacturing-agreements-two-covid-19-vaccines. dead.
  31. Web site: Update on The University of Queensland COVID-19 vaccine. CSL Limited. live. https://web.archive.org/web/20201211104422/https://wcsecure.weblink.com.au/pdf/CSL/02320942.pdf . 11 December 2020 .
  32. Web site: 2021-03-23. National medical regulator approves 800,000 Australian-made doses of AstraZeneca vaccine. 2021-04-09. Australian Broadcasting Corporation. en-AU.
  33. Web site: Products . Seqirus . 6 December 2018 . 5 February 2020.
  34. Web site: Products . Seqirus . Australia . 9 February 2020.
  35. Web site: Products . cslbehring.com.au . 7 February 2020 .
  36. https://web.archive.org/web/20101120162626/http://cslbehring.com/docs/555/221/Global%20Product%20Portfolio_03.11.10.pdf Global product portfolio
  37. Web site: CSL wins equal opportunity award for onsite childcare centre. CSL Newsroom. CSL. 25 October 2016.

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