CSL Limited is an Australianmultinational specialtybiotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas includeblood 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 asCommonwealth 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 vacantWalter and Eliza Hall Institute building at theRoyal Melbourne Hospital in 1918 before moving to its purpose-built Parkville premises in the following year.
After ongoing disputes with theDepartment of Health and its director-generalJohn 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 itsdiphtheria toxin-antitoxin was implicated in the deaths of twelve children in what became known as theBundaberg 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 inantivenene (antivenom) manufacture in conjunction with the snake venom research undertaken byCharles Kellaway at the Hall Institute.[8] This led to the successful clinical testing of antivenene against tiger snakeNotechis 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 includingpolio andinfluenza coordinated byFrank Macfarlane Burnet and Esmond "Bill" Keogh. Keogh played an important role in the establishment ofpenicillin 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 ofSaul Wiener, while from 1966 until the mid-1990s, venom research was coordinated by the eccentric but dedicatedStruan 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]
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 asSeqirus [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]
CSL's vaccine forswine flu, the world's first, was approved in September 2009 for use by people over age 10.[26] The federal government ordered 21million doses of vaccine for Australians.[27]CSL also provided vaccines for customers in Singapore and the US.
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 calleddeoxycholate – 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 (withAstraZeneca) theOxford 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]
Vivaglobin, sub-cutaneous human immune globulin indicated for the treatment ofprimary immunodeficiency. This product gained FDA approval in January 2006.
In 2011, the company received the Minister's Award for Outstanding Equal Employment Opportunities Initiative for their Thinking Kids Children's Centre.[38]
^Egan, Bryan,"Morgan, Frederick Grantley (1891–1969)",Australian Dictionary of Biography, Canberra: National Centre of Biography, Australian National University, retrieved22 September 2020
^"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. Retrieved26 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.
^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.PMID21929484.S2CID9389146.
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).
US$2.91 billion (2024)[2]
