CSL's Research and Development capabilities are focused in four areas:
Plasma Replacement Therapies are therapies replacing a natural protein that is deficient. As a leading manufacturer and developer of therapeutics derived from human plasma, CSL is committed to maintaining the highest product safety standards and to continually improving manufacturing effectiveness.
CSL registration and clinical research activities make its products available to patients worldwide and identify novel therapeutic uses for plasma proteins. CSL's research programs are focused on developing novel plasma and recombinant proteins with improved efficacy and enhanced convenience. R&D staff have extensive experience in the production and clinical development of plasma derived immunoglobulins, coagulation factors and specialty products.
CSL has extensive experience in the production and in clinical development of plasma derived coagulation factors and has launched a program to develop robust recombinant candidates.
With extensive experience in producing large scale polyclonal, plasma derived immunoglobulins, CSL is developing expertise and building facilities to support the production and testing of recombinant proteins, particularly monoclonal antibodies (MAbs) to treat cancer and inflammation. CSL has developed a portfolio of MAbs in various stages of development targeted against multiple targets.
CSL has continued to strengthen its capabilities in later stage clinical and product development of recombinant products. This has been achieved through hiring world class scientific and medical leaders for key projects, and ensuring access to R&D manufacturing capacity through relationships with contract manufacturers and investment in CSL's own facilities.
Developing our capability to take recombinant products into the clinic and ultimately to patients, construction is now complete of a new state of the art biotechnology manufacturing facility at our Broadmeadows site in Melbourne.
Vaccines & Licensing
Significant R&D activities support CSL's influenza vaccine business in providing services to production and the regulatory and clinical capability required to support registrations in international markets. We support bioCSL in providing manufacturing seed development and process development for each new influenza strain to be incorporated annually into the southern and northern hemisphere seasonal vaccines.
As the only influenza vaccine manufacturer in the southern hemisphere we also play a key role in supporting seed development for newly circulating influenza strains, antigen reagent development and vaccine supply to the global influenza vaccine network, including the WHO, regulatory authorities, testing laboratories and other companies. CSL also have significant capabilities relating to the development and supply of pandemic influenza vaccines as well as understanding the biology underlying the disease itself.
Adjuvants are used to enhance or modify the immune response to antigens in vaccines. ISCOMATRIX® adjuvant has antigen delivery as well as immunomodulatory capabilities which combine to provide enhanced and accelerated immune responses. A range of ISCOMATRIX® adjuvanted vaccines have been evaluated in clinical trials. The results of these completed and ongoing studies indicate that the ISCOMATRIX® adjuvant is generally well tolerated and increases the vaccine immune responses.
The ISCOMATRIX® adjuvant is made from saponin, cholesterol and phospholipid which, under defined conditions, form cage-like structures typically 40-50nm in diameter. In recent years the focus has been on developing an improved ISCOMATRIX® adjuvant designed to meet the ever increasing regulatory standards for components of human vaccines while maintaining strong immune responses. The result is an optimized ISCOMATRIX® adjuvant that is well defined, has minimal impurities and does not use any materials of animal origin. Additionally, improvements have been made to the method of manufacturing processes to ensure it can be reproduced on a large scale. ISCOTEC® is part of Research & Development and is responsible for overseeing the development of the ISCOMATRIX® adjuvant technology.
CSL has several license and option agreements with major vaccine manufacturers.
As part of the licensing agreements, CSL will be the worldwide supplier of the ISCOMATRIX® adjuvant. To support this large scale manufacturing capability, a manufacturing plant is located at the Kankakee, Illinois site.