CSL Limited

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CSL Limited
Company type
Public
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HeadquartersParkville, Melbourne, Victoria, Australia (Global),[1]
Productsblood plasma, vaccines, antivenom, other laboratory and medical products
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Websitewww.csl.com

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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.[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]

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.[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]

Plasma fractionation and Wiener directorship

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]

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.[15]

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.[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]

Acquisition and merging of Novartis' vaccine business

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]

Acquisition history

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CSL Limited acquisitions
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  • CSL Limited (Founded 1916 as Commonwealth Serum Laboratories)
    • ZLB Behring
      • ZLB Bioplasma AG (Acq 2000)
      • Aventis Behring (Acq 2004)
      • Vifor Pharma (Acq 2021)
    • Seqirus (Merged 2014)
      • BioCSL
      • Novartis Influenza Vaccines div.
    • Calimmune (Acq 2017)
    • Vitaeris (Acq 2020)
File:CSL Global Headquarters, Parkville, Victoria, Australia.jpg
CSL's global headquarters building in Parkville, Victoria

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

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A/H1N1 2009 pandemic

Script error: No such module "Labelled list hatnote". 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]

COVID-19 pandemic

Script error: No such module "Labelled list hatnote". 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]

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:[34]

  • Afluria (influenza vaccine) -- Argentina, Peru, South Africa, Spain, US[34]
    • Enzira—in various different markets[34]
    • Fluvax—in various different markets[34]
    • Nilgrip—in various different markets[34]
  • Afluria Quadrivalent (influenza vaccine) -- Australia, Canada, New Zealand, US[34]
    • Afluria Quad—in various different markets[34]
    • Afluria Tetra—in various different markets[34]
  • Agrippal (influenza vaccine) -- Argentina, Austria, Brazil, Canada, Chile, Colombia, Germany, Italy, Mexico, Spain, Thailand[34]
    • Agriflu—in various different markets[34]
    • Begripal—in various different markets[34]
    • Chiroflu—in various different markets[34]
    • Fluazur—in various different markets[34]
    • Sandovac—in various different markets[34]
  • Audenz (influenza A (H5N1) vaccine) -- US[34]
  • Fluad (influenza vaccine) -- Argentina, Austria, Australia, Brazil, Canada, Denmark, Germany, Italy, Spain, Switzerland, UK, US[34]
    • Chiromas—Spain[34]
  • Fluad Pediatric (influenza vaccine) -- Canada[34]
  • Flucelvax Quadrivalent (influenza vaccine) -- Germany, Italy, Spain, UK, US[34]
  • Q-VAX (Coxiella burnetii vaccine) -- Australia[35]
  • Rapivab (peramivir) -- Australia, US[34]

Antivenoms: (Australia)[35]

CSL Behring (Australia)

CSL Behring

Immunology:[37]

Coagulation/Bleeding Disorders:

Pulmonary:

  • Zemaira, Respreeza freeze-dried Human Alpha1-proteinase inhibitor (A1-PI)

Critical Care:

  • AlbuRx, Alburex, Albumeon, Human Albumin Behring, Albuminar 25, human albumin solution (5%, 20% or 25% human albumin solutions)
  • Berinert P, freeze-dried human C1-esterase inhibitor (C1-INH) concentrate
  • Beriplex P/N, freeze-dried human prothrombin complex concentrate
  • Haemocomplettan P, RiaSTAP, freeze-dried human fibrinogen (factor I) concentrate
  • Kybernin P, freeze-dried human antithrombin III concentrate
  • Streptase, freeze-dried streptokinase

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.[38]

See also

References

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  1. ^ Page Module:Citation/CS1/styles.css has no content."Annual Report 2019" (PDF). CSL Limited. 2019.
  2. ^ a b c Page Module:Citation/CS1/styles.css has no content."CSL Annual Report 2021/22". CSL Limited. April 2022. Retrieved 29 March 2023.
  3. ^ Page Module:Citation/CS1/styles.css has no content."CSL LTD (CSL:ASX): Stock Quote & Company Profile". Bloomberg Businessweek. Retrieved 13 August 2012.{{cite web}}: CS1 maint: deprecated archival service (link)
  4. ^ Page Module:Citation/CS1/styles.css has no content."Trove". trove.nla.gov.au. Retrieved 22 September 2020.
  5. ^ Page Module:Citation/CS1/styles.css has no content.Robin, A. De Q. Penfold, William James (1875–1941). Canberra: National Centre of Biography, Australian National University.
  6. ^ Page Module:Citation/CS1/styles.css has no content.Egan, Bryan, "Morgan, Frederick Grantley (1891–1969)", Australian Dictionary of Biography, Canberra: National Centre of Biography, Australian National University, retrieved 22 September 2020
  7. ^ Page Module:Citation/CS1/styles.css has no content."BUNDABERG TRAGEDY, Daily Examiner". 14 June 1928. p. 3 – via Trove.
  8. ^ Page Module:Citation/CS1/styles.css has no content.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.
  9. ^ Page Module:Citation/CS1/styles.css has no content.Gardiner, Lyndsay; Serle, Geoffrey (2000). "Keogh, Esmond Venner (Bill) (1895–1970)". Australian Dictionary of Biography. 15. National Centre of Biography, Australian National University.
  10. ^ Page Module:Citation/CS1/styles.css has no content.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.
  11. ^ Page Module:Citation/CS1/styles.css has no content."SAFER FIRST AID, Papua New Guinea Post-Courier". 18 April 1979. p. 11 – via Trove.
  12. ^ Page Module:Citation/CS1/styles.css has no content."New test for snake bites, The Canberra Times". 30 October 1979. p. 14 – via Trove.
  13. ^ Page Module:Citation/CS1/styles.css has no content.Tasker, Sarah-Jane (23 April 2016). "Blood, sweat and tears of the CSL century". The Australian.
  14. ^ Page Module:Citation/CS1/styles.css has no content."A global solution to reducing cervical cancer" (PDF). Uniquest commercialisation stories. The University of Queensland. Retrieved 29 April 2016.
  15. ^ Page Module:Citation/CS1/styles.css has no content."CSL Limited". Australian Securities Exchange. Retrieved 7 February 2020.
  16. ^ Page Module:Citation/CS1/styles.css has no content.Dow Jones Newswires (9 December 2003). "Australia's CSL Agrees to Acquire Aventis Unit for up to $925 Million". The 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.
  17. ^ Page Module:Citation/CS1/styles.css has no content."Aventis disposes of Behring unit with $925M sale to Australia's CSL –". thepharmaletter.com. The Pharma Letter. 15 December 2003. Archived from the original on 23 September 2021. Retrieved 22 February 2021. … Aventis says that it has agreed to sell its Aventis Behring blood products business to Australia's CSL …
  18. ^ Page Module:Citation/CS1/styles.css has no content."CSL bursts through the $100 barrier". Quest Asset Partners. 4 August 2015. Archived from the original on 28 February 2016. Retrieved 22 February 2021.
  19. ^ Page Module:Citation/CS1/styles.css has no content.Phillipidis, Alex (27 October 2014). "Novartis Selling Flu Vaccine Business to CSL for $275M". Genetic Engineering & Biotechnology News. Retrieved 22 May 2020.
  20. ^ Sequirus Commonwealth Serum Laboratories
  21. ^ Page Module:Citation/CS1/styles.css has no content."CSL Behring Acquires Biotech Company Calimmune and its Proprietary Stem Cell Gene Therapy Platform" (Press release). CSL. 6 August 2017. Retrieved 15 December 2021.
  22. ^ Page Module:Citation/CS1/styles.css has no content.Willman, David (15 March 2020). "Federal vaccine development sites ill-suited to counter covid-19 epidemic". The Washington Post. Retrieved 15 March 2020.
  23. ^ Page Module:Citation/CS1/styles.css has no content."CSL to Acquire Biotech Company Vitaeris" (Press release). CSL. 6 September 2020. Retrieved 15 December 2021.
  24. ^ Page Module:Citation/CS1/styles.css has no content.Nainan, Nikhil; Koltrowitz, Silke; Murdoch, Scott (14 December 2021). "Australia's CSL to buy Swiss drugmaker Vifor for $11.7 bln". Reuters. Retrieved 15 December 2021.
  25. ^ Page Module:Citation/CS1/styles.css has no content.Coey, Sharon Klahr (26 August 2022). "CSL to unite all business units, including Seqirus, under the CSL umbrella". Fierce Pharma. Archived from the original on 26 August 2022.
  26. ^ Page Module:Citation/CS1/styles.css has no content."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 25 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.
  27. ^ Page Module:Citation/CS1/styles.css has no content.Tran, Mark (22 July 2009). "First human trials of swine flu vaccine begin in Australia". The Guardian. ISSN 0261-3077. Retrieved 7 September 2020.
  28. ^ Page Module:Citation/CS1/styles.css has no content.Administration, Australian Government Department of Health Therapeutic Goods (28 September 2010). "Analysis of febrile convulsions following immunisation in children following monovalent pandemic H1N1 vaccine (Panvax/Panvax Junior, CSL)". Therapeutic Goods Administration (TGA). Retrieved 25 July 2022.
  29. ^ Page Module:Citation/CS1/styles.css has no content.Kelly, Heath A; Skowronski, Danuta M; De Serres, Gaston; Effler, Paul V (19 September 2011). "Adverse events associated with 2010 CSL and other inactivated influenza vaccines". The Medical Journal of Australia. 195 (6): 318–320. doi:10.5694/mja11.10941. PMID 21929484. S2CID 9389146.
  30. ^ Page Module:Citation/CS1/styles.css has no content."CSL to manufacture and supply University of Queensland and Oxford University vaccine candidates for Australia". csl.com. 7 September 2020. Retrieved 7 September 2020.
  31. ^ Page Module:Citation/CS1/styles.css has no content."Australia secures onshore manufacturing agreements for two COVID-19 vaccines | Prime Minister of Australia". pm.gov.au. 7 September 2020. Archived from the original on 7 September 2020. Retrieved 7 September 2020.
  32. ^ Page Module:Citation/CS1/styles.css has no content."Update on The University of Queensland COVID-19 vaccine" (PDF). CSL Limited. Archived (PDF) from the original on 11 December 2020.
  33. ^ Page Module:Citation/CS1/styles.css has no content."National medical regulator approves 800,000 Australian-made doses of AstraZeneca vaccine". Australian Broadcasting Corporation. 23 March 2021. Retrieved 9 April 2021.
  34. ^ a b c d e f g h i j k l m n o p q r s t Page Module:Citation/CS1/styles.css has no content."Products". Seqirus. 6 December 2018. Retrieved 5 February 2020.
  35. ^ a b Page Module:Citation/CS1/styles.css has no content."Products". Seqirus. Australia. Retrieved 9 February 2020.
  36. ^ Page Module:Citation/CS1/styles.css has no content."Products". cslbehring.com.au. Retrieved 7 February 2020.
  37. ^ Global product portfolio CSL Behring, 3 November 2010
  38. ^ Page Module:Citation/CS1/styles.css has no content."CSL wins equal opportunity award for onsite childcare centre". CSL Newsroom. CSL. Retrieved 25 October 2016.

Sources

  • AH Brogan, Committed to Saving Lives: a History of the Commonwealth Serum Laboratories (Melbourne: Hyland House, 1990).
  • Dando McCredie, The Fight Against Disease and CSL's Seventy Year Contribution (Richmond: Dando McCredie, c.1986).
  • FG Morgan, 'The Commonwealth Serum Laboratories and their work', Collected Proceedings of the Society of Chemical Industry of Victoria, XXXV (1935), 1015–31.
  • WJ Penfold, 'The Commonwealth Serum Laboratories', Medical Journal of Australia, 1 (14 April 1923), 396–400.
  • Struan K Sutherland, A Venomous Life: the Autobiography of Professor Struan Sutherland (Melbourne: Hyland House, 1998).

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