CSL Limited

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CSL Limited
TypePublic
IndustryBiotechnology
Founded1916 (Federal government department), 1994 (privatised)
HeadquartersParkville, Melbourne, Victoria, Australia(Global),[1]
Key people
Paul Perreault (CEO)
Productsblood plasma, vaccines, antivenom, other laboratory and medical products
RevenueIncrease USD$8.539 billion (2019)[1]
Increase USD$1.919 billion (2019)[1]
Number of employees
25,000 person (2019)[1]
Divisions
  • CSL Behring
  • Seqirus
Websitewww.csl.com

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.[2]

History[edit]

Origin and Penfold directorship[edit]

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[edit]

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[edit]

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[edit]

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[edit]

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[edit]

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[edit]

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, 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]

Acquisition history[edit]

CSL Limited acquisitions
  • CSL Limited (Founded 1916 as Commonwealth Serum Laboratories)
    • ZLB Bioplasma AG (Acq 2000)
    • Aventis Behring (Acq 2004)
    • Seqirus (Merged 2014)
      • BioCSL
      • Novartis Influenza Vaccines div.
    • Calimmune (Acq 2017)
    • Vitaeris (Acq 2020)
    • Vifor Pharma (Acq 2021)

Locations[edit]

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[edit]

A/H1N1 2009 pandemic[edit]

CSL's vaccine for swine flu, the world's first, was approved in September 2009 for use by people over age 10.[24] The federal government ordered 21 million doses of vaccine for Australians.[25] CSL also provided vaccines for customers in Singapore and the US.

On 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[edit]

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.[26][27]

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.[28]

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.[29]

Divisions[edit]

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

Seqirus (bioCSL)[edit]

Vaccines:[30]

  • Afluria (influenza vaccine) -- Argentina, Peru, South Africa, Spain, US[30]
    • Enzira—in various different markets[30]
    • Fluvax—in various different markets[30]
    • Nilgrip—in various different markets[30]
  • Afluria Quadrivalent (influenza vaccine) -- Australia, Canada, New Zealand, US[30]
    • Afluria Quad—in various different markets[30]
    • Afluria Tetra—in various different markets[30]
  • Agrippal (influenza vaccine) -- Argentina, Austria, Brazil, Canada, Chile, Colombia, Germany, Italy, Mexico, Spain, Thailand[30]
    • Agriflu—in various different markets[30]
    • Begripal—in various different markets[30]
    • Chiroflu—in various different markets[30]
    • Fluazur—in various different markets[30]
    • Sandovac—in various different markets[30]
  • Audenz (influenza A (H5N1) vaccine) -- US[30]
  • Fluad (influenza vaccine) -- Argentina, Austria, Australia, Brazil, Canada, Denmark, Germany, Italy, Spain, Switzerland, UK, US[30]
    • Chiromas—Spain[30]
  • Fluad Pediatric (influenza vaccine) -- Canada[30]
  • Flucelvax Quadrivalent (influenza vaccine) -- Germany, Italy, Spain, UK, US[30]
  • Q-VAX (Coxiella burnetii vaccine) -- Australia[31]
  • Rapivab (peramivir) -- Australia, US[30]

Antivenoms: (Australia)[31]

CSL Behring (Australia)[edit]

[32]

CSL Behring[edit]

Immunology:[33]

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[edit]

In 2011, the company received the Minister's Award for Outstanding Equal Employment Opportunities Initiative for their Thinking Kids Children's Centre.[34]

See also[edit]

References[edit]

  1. ^ a b c d "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. ^ "CSL Behring Acquires Biotech Company Calimmune and its Proprietary Stem Cell Gene Therapy Platform" (Press release). CSL. 6 August 2017. Retrieved 15 December 2021.
  21. ^ Willman, David (15 March 2020). "Federal vaccine development sites ill-suited to counter covid-19 epidemic". Washington Post. Retrieved 15 March 2020.
  22. ^ "CSL to Acquire Biotech Company Vitaeris" (Press release). CSL. 6 September 2020. Retrieved 15 December 2021.
  23. ^ 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.
  24. ^ "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.
  25. ^ Tran, Mark (22 July 2009). "First human trials of swine flu vaccine begin in Australia". The Guardian. ISSN 0261-3077. Retrieved 7 September 2020.
  26. ^ "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.
  27. ^ "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.
  28. ^ "Update on The University of Queensland COVID-19 vaccine" (PDF). CSL Limited.
  29. ^ "National medical regulator approves 800,000 Australian-made doses of AstraZeneca vaccine". www.abc.net.au. 23 March 2021. Retrieved 9 April 2021.
  30. ^ a b c d e f g h i j k l m n o p q r s t "Products". Seqirus. 6 December 2018. Retrieved 5 February 2020.
  31. ^ a b "Products". Seqirus. Australia. Retrieved 9 February 2020.
  32. ^ "Products". cslbehring.com.au. Retrieved 7 February 2020.
  33. ^ Global product portfolio CSL Behring, 3 November 2010
  34. ^ "CSL wins equal opportunity award for onsite childcare centre". CSL Newsroom. CSL. Retrieved 25 October 2016.

Sources[edit]

  • 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).