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.
Founded in 1916 the Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. Under the first director, William Penfold, CSL commenced operation in the vacant Walter and Eliza Hall Institute building at the Melbourne Hospital in 1918, before moving to its purpose-built Parkville premises in the following year. 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. 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. 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. 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, 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.
The operation commenced plasma fractionation in 1952. 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.
Other major achievements of CSL include:
early production of insulin for treatment of Australian diabetics (1923)
development of a tetanus vaccine (1938)
development of a combined vaccine for diphtheria, tetanus and whooping cough (1953)
rapid adoption and production of a polio vaccine (1956)
development of a multi-purpose animal vaccine covering pulpy kidney (enterotoxemia), tetanus, black disease, malignant oedema and blackleg (1961)
production of Rhesus (D) immunoglobulin to prevent haemolytic disease in newborns due to Rh factor incompatibility (1966–67)
pioneering heat treatment to protect blood and plasma products from infection with HIV (1983)
collaboration on development of the world's first human papillomavirus vaccine, Gardasil, building on the pioneering work by Professor Ian Frazer (1994-2005).
In 1994, the Commonwealth facility was privatised as CSL Ltd. In 2000 CSL doubled its size through the purchase of a Swiss plasma company, the Bern-based ZLB Bioplasma AG. In 2004, during a period of plasma oversupply, the company expanded again with the purchase of the German medical company Aventis Behring. The company was the 2nd Australian public company to have reached a share price of over $100 per share.
In 2011, the company received the Minister's Award for Outstanding Equal Employment Opportunities Initiative for their Thinking Kids Children's Centre.
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. 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.
The company's headquarters remain in Parkville, Victoria, an inner suburb of Melbourne. CSL Behring is headquartered in King of Prussia, USA and has manufacturing operations 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
CSL is a public company and its stock is traded on the Australian Securities Exchange under the stock code CSL. 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 50 Index.
Vaccine for A/H1N1 2009 Pandemic
CSL's vaccine for Swine Flu was approved in September 2009 for use in Australia by people aged 10 and over. The federal government ordered 21 million doses of vaccine for 2009 A/H1N1 of which eight million were manufactured by CSL. The Australian government intended to use the CSL Vaccine in one of the largest national vaccine programs in the country's history.
CSL Limited's products can be separated by company division. Some of the key products produced by each division, have included:
Vaccines:
ADT (acellular diphtheria/tetanus vaccine)
Afluria (influenza vaccine)
Afluria Quad (influenza vaccine)
Agrippal (influenza vaccine)
Comvax (Haemophilus influenzae type B/hepatitis B vaccine)
Fluad {influenza vaccine)
Flucelvax (influenza vaccine)
Flucelvax Quad (influenza vaccine)
Fluvax (influenza vaccine)
Fluverin (influenza vaccine)
Gardasil (a human papilloma virus vaccine which gained TGA approval in June 2006)
H-B Vax II (hepatitis B vaccine)
Liquid PedVaxHIB (Haemophilus influenzae type B vaccine)
M-M-R II (MMR vaccine)
Menjugate (meningococcus group C vaccine)
Meruvax II (rubella vaccine)
Panvax (H5N1 influenza vaccine)
Panvax H1N1 (2009 A/H1N1 influenza vaccine)
Plague vaccine (Yersinia pestis vaccine)
Pneumovax 23 (pneumococcus vaccine)
Q-VAX (Coxiella burnetii vaccine)
Tet-Tox (tetanus vaccine)
Vaqta (hepatitis A vaccine)
Varivax (varicella zoster vaccine)
Antivenoms:
Black snake
Box jellyfish
Brown snake
Death adder
Funnel web spider
Polyvalent snake antivenom
Redback spider
Sea snake
Stonefish
Taipan
Tick
Tiger snake
Pharmaceuticals:
Angiomax (bivalirudin) – licensed from The Medicines Company
Austrapen (ampicillin)
BenPen (benzylpenicillin)
Burinex (bumetanide) – licensed from LEO Pharma
Daivobet (calcipotriol/betamethasone) – licensed from LEO Pharma
Daivonex (calcipotriol) – licensed from LEO Pharma
EpiPen (epinephrine autoinjector) – licensed from Dey Laboratories
Flomaxtra (tamsulosin) – licensed from Astellas Pharma
Flopen (flucloxacillin)
Fucidin (fusidic acid) – licensed from LEO Pharma
Minijet system – preparations include: epinephrine, atropine, calcium chloride, furosemide, glucose, lidocaine, naloxone, sodium bicarbonate
Modavigil (modafinil) – licensed from Cephalon
Solaraze (diclofenac sodium in hyaluronic acid – licensed from Almirall
Tramal (tramadol) – licensed from Grünenthal
Vaniqa (eflornithine) – licensed from Almirall
Albumex (serum albumin)
Biostate (Factor VIII)
Carimune, which is immunoglobulin for intravenous administration (IGIV)
CMV Immunoglobulin-VF (cytomegalovirus immunoglobulin)
Helixate, which is recombinant Antihemophilic Factor, a blood-clotting factor for the treatment of haemophilia
Hepatitis B immunoglobulin
human immunoglobulin – Intragam P, Normal, Rh(D) Immunoglobulin-VF, Sandoglobulin,
MonoFIX-VF (Factor IX)
Prothrombinex-HT (prothrombin complex)
Rhophylac (Rh(D) immunoglobulin G)
Tetanus Immunoglobulin-VF
Thrombotrol-VF (antithrombin III)
Vivaglobin, sub-cutaneous human immune globulin indicated for the treatment of primary immunodeficiency. This product gained FDA approval in January 2006.
Von Willebrand factor
Zoster Immunoglobulin-VF (varicella zoster immunoglobulin)
Immunology:
Beriglobin P, human hepatitis A immunoglobulin, liquid 16% solution for intramuscular injection
Berirab P, human rabies immunoglobulin, liquid 16% solution for intramuscular injection
Carimune NF, Sandoglobulin, Sanglopor human normal immunoglobulin, freeze-dried formulations for intravenous administration
Cytogam, human cytomegalovirus immunoglobulin. Liquid immunoglobulin containing a standardized amount of antibody to cytomegalovirus.
Hepatitis B Immunoglobulin P Behring, human hepatitis B immunoglobulin, liquid 16% solution for intramuscular injection
Hizentra,Human normal immunoglobulin. Liquid 20% immunoglobulin solution, ready-to-use for subcutaneous administration
Privigen, human polyvalent immunoglobulin, liquid 10% solution for intravenous injection
Rhesogamma P, human anti-D immunoglobulin. Prefilled syringes of highly purified anti-Rhesus factor D IgG for intravenous administration and intramuscular injection.
Rhophylac human anti-D immunoglobulin. Prefilled syringes of highly purified anti-Rhesus factor D IgG for intravenous administration and intramuscular injection.
Sandoglobulin NF Liquid, Redimune, Redimune NF Liquid, human normal immunoglobulin, liquid 12% solution for intravenous administration
Tetagam P, human tetanus immunoglobulin, liquid 16% solution for intramuscular injection
Varicellon P, human varicella immunoglobulin, liquid 16% solution for intramuscular injection
Vivaglobin, human normal immunoglobulin, liquid 16% solution for subcutaneous administration
Coagulation/Bleeding Disorders:
Beriate, freeze-dried human coagulation factor VIII concentrate
Berinin P, freeze-dried human coagulation factor IX concentrate
Factor X P Behring, a freeze-dried human coagulation factor IX and factor X concentrate
Fibrogammin P, Cluvot and Corifact, freeze-dried human coagulation factor XIII concentrate
Helixate FS and Helixate NexGen, freeze-dried recombinant coagulation factor VIII
Humate-P and Haemate P, freeze-dried human coagulation factor VIII: C and von Willebrand factor concentrate
Monoclate P, a freeze-dried monoclonal antibody purified human coagulation factor VIII concentrate
Mononine, a freeze-dried human coagulation factor IX that has been purified using monoclonal antibodies
Stimate, a synthetic desmopressin acetate nasal spray
Octostim, a synthetic desmopressin acetate nasal spray
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:
Beriplast P Combi-Set, fibrin sealant kit, freeze-dried fibrin sealant for topical application
Fibrogammin P, freeze-dried human coagulation factor XIII concentrate
TachoComb, fibrin sealant fleece-type, fleece-type collagen preparations coated with fibrin glue components
Product availability varies from country to country, depending on registration status.
