CSL Recombinant Proteins Production Plant, Parkville, Australia

The CSL Parkville facility has undergone several phases of expansion since 1997 when it was first opened. The production facilities have been expanded three times.

The most recent phase of construction was in 2001 to 2002 when a major expansion of the company's influenza vaccine production facility was completed. This resulted in a doubling of the previous production capacity in line with the new demand for the CSL vaccine products for the home market and the international market (demand occurs at different times).

The new capacity was developed to supply the influenza vaccine requirements of the northern hemisphere winter. The company has already signed a major contract to supply influenza vaccine (FLUVAX) to northern hemisphere countries. The influenza vaccine is the company’s main revenue source and by optimising production capacity to supply both northern and southern hemisphere winter requirements the plant is in full production all year around.

With the advent of H5N1 avian flu (bird flu) in Asia and worldwide, vaccines are in even greater demand and the company aims to capitalise on their production capacity.

In late 2005 CSL signed a contract with Merck & Co to supply Iscomatrix adjuvant for Merck's pipeline of investigational vaccine products. Iscomatrix adjuvant is a phospholipid-cholesterol formulation containing a purified saponin from the Quillaj saponaria tree. The adjuvant is used to enhance immune stimulation when vaccines are administered. These kinds of adjuvant are a CSL speciality with all of its experience in producing and marketing its own vaccines.

PILOT SCALE GOOD MANUFACTURING PRACTICE COMPLIANT FACILITY

CSL completed a A$10.8 million upgrade of their insulin production facility in Parkville in 1999. The upgrade was carried out to provide a pilot scale GMP (Good Manufacturing Practice) compliant facility for the production of experimental and clinical scale biopharmaceuticals. The contractor responsible for the design, construction, procurement and management of the project was Hooker Cockram.

The project, instigated in 1998, was completed in under a year and has a floor space of 980m². The upgraded facility included new Class 100 cleanrooms, interlocked pass-throughs, extensive fume hood facilities, a new Water for Injection (WFI) production plant, autoclaves and a programmable logic control automation system. Hooker Cockram undertook most of the validation and commissioning requirements including the development of new protocols and computer validation.

BIOTECH PLANT EXPANSION

In 1999 CSL opened a new A$14 million (US$8.3 million) biotech plant in Parkville, Victoria. The plant manufactures a variety of products including vaccines against a variety of organisms including Helicobactor pylori, which is implicated as a cause of peptic ulcers and stomach cancers and also recombinant proteins and monoclonal antibodies.

The new plant is contained within a three-storey building, half of which is owned by CSL. CSL develops, manufactures, markets and distributes pharmaceutical products for humans and also animals (presumably this could cause some problems with the difference in validation and regulatory procedures between human and veterinary products). One of the company’s most successful products on the veterinary side is a vaccine for Q-fever, a major problem in Australia for cattle farmers.

The facility has enabled the production of large quantities of recombinant proteins under stringent standards for research and commercial markets. Through the new capacity, the plant is more than capable of producing products such as genetically engineered vaccines and other biologicals on a contract basis for evaluation in clinical studies and is able to produce quantities of materials for large-scale clinical studies in many countries.

This facility allows CSL to have independence so that clinical trial drugs do not have to be manufactured overseas and can be kept in-house. CSL is also using the facility to research into the fermentation of various genetically engineered bacteria (E. coli and of mammalian origin) and yeasts to produce biologically active proteins (monoclonal antibodies and other therapeutic compounds) to expand its product range.

CSL RESEARCH AND DEVELOPMENT

CSL has the distinction that it has been able to fully fund all of its research projects to date. It is the largest investor in pharmaceutical research and development in Australia and is supported by the federal government whose schemes include a 125% tax deduction for research and development (formerly 150%) and the Factor (f) scheme, which compensates pharmaceutical companies for selling drugs in Australia at less than world market prices if they undertake R&D locally.

These subsidies have allowed a structured and focused push of home-grown science into commercialisation for Australia. CSL is the country’s largest and most successful biotech company.

COMPANY HISTORY AND MANUFACTURING CONTRACTS

The company was formerly the Commonwealth Serum Laboratories Commission (hence the name CSL), established in 1916 as part of the quarantine division of the Commonwealth Department of Trade and Customs. It moved to the Department of Health in 1921. The commission became a corporate body under the Commonwealth Serum Laboratories Act 1961.

CSL was incorporated in 1991, and in 1992 the company signed an agreement with Merck Sharp & Dohme (Australia) Pty Ltd and Merck & Co Inc to develop combination vaccines for children in Australia, New Zealand and the Asia-Pacific region.

In 1993 CSL entered a ten-year agreement with the Commonwealth to manufacture and supply a range of plasma-derived products for Australia. It went on to sign a ten-year agreement with the Australian Red Cross to distribute fractionised plasma products and acquired a majority interest in Iscotec AB, a Swedish company with global rights to commercialise a vaccine response enhancer. It also acquired the assets and business of JRH Biosciences Inc, a US cell culture manufacturer and marketer, and was appointed exclusive Australian distributor for the products of Ortho Diagnostic Systems Inc (USA).

In 1995 a licensing agreement was signed with Merck & Co for development and global marketing of a new Human Papillomavirus Vaccine (HPV), in collaboration with UniQuest (University of Old). A further licensing agreement was then made for Avonex, a treatment for multiple sclerosis in Australia and NZ.

COMPANY HISTORY AND MANUFACTURING CONTRACTS

The company was formerly the Commonwealth Serum Laboratories Commission, established in 1916 as part of the quarantine division of the Commonwealth Department of Trade and Customs. It moved to the Department of Health in 1921. The commission became a body corporate under the Commonwealth Serum Laboratories Act 1961.

CSL was incorporated in 1991, and in 1992 the company signed an agreement with Merck Sharp & Dohme (Australia) Pty Ltd and Merck & Co Inc to develop combination vaccines for children in Australia, New Zealand and the Asia-Pacific region.

In 1993 CSL entered a ten-year agreement with the Commonwealth to manufacture and supply a range of plasma-derived products for Australia. It went on to sign a ten-year agreement with the Australian Red Cross to distribute fractionised plasma products and acquired a majority interest in Iscotec AB, a Swedish company with global rights to commercialise a vaccine response enhancer. It also acquired the assets and business of JRH Biosciences Inc, a US cell culture manufacturer and marketer, and was appointed exclusive Australian distributor for the products of Ortho Diagnostic Systems Inc (USA).

In 1995 a licensing agreement was signed with Merck & Co for development and global marketing of a new human papillomavirus vaccine (HPV), in collaboration with UniQuest (University of Old). A further licensing agreement was then made for Avonex, a treatment for multiple sclerosis in Australia and NZ.