Core Capabilities
CSL's Research & Development programs are focused in four areas:
Plasma Replacement Therapies
Plasma Replacement Therapies are therapies replacing a natural protein which 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 our products available to patients worldwide and identify novel therapeutic uses for plasma proteins. Our research programs are focused on developing novel plasma and recombinant proteins with improved efficacy and enhanced convenience.
VaccinesCSL supports market expansion for Australian-manufactured influenza vaccines by obtaining new international registrations and by increasing key global market share.
In 2008, CSL expanded the existing influenza vaccine facility in Parkville, thereby doubling manufacturing capacity to 40 million does per season. This facility, designed to meet US regulatory requirements, enables CSL to increase distribution of both seasonal and pandemic vaccine to the US and Europe.
This increased capacity will significantly enhance CSL's ability to respond to public health emergencies, such as the Type A (H1N1) influenza outbreak.
CSL is also committed to the development of pandemic influenza vaccines. As the only southern hemisphere-based manufacturer of influenza vaccines, CSL plays a key strategic role in partnering with governments both locally and globally to develop and supply pandemic influenza vaccines.
ISCOMATRIX® Adjuvant
Adjuvants are used to enhance or modify the immune response to antigens in vaccines. The 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 safe and 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 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 manufacturing processes to ensure it can be reproduced on a large scale.
CSL has several license and option agreements with major vaccine manufacturers including Merck & Co. and Wyeth.
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 has been established at the Kankakee, Illinois site.
Therapeutic Proteins
Therapeutic proteins are used as therapy to treat patients with illnesses. They can be purified from human plasma or produced using recombinant biotechnology.
CSL has extensive experience in the production and in clinical development of plasma derived coagulation factors and has been increasing efforts to identify recombinant candidates.
With extensive experience in producing large scale polyclonal, plasma derived immunoglobulins, CSL is developing expertize 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 proprietary targets.
In July 2010 CSL announced its decision to build a large scale biotechnology facility for the manufacture of therapies based on recombinant DNA technology. The new facility will enable CSL to develop innovative products from our R&D pipeline for late stage clinical trials and ultimately patient use.
The project, supported by both the Federal and Victorian State Governments, will generate siginifcant employment opportunities and further develop Australia's biotechnology sector and medical research community. Design and construction of the new facility will commence during 2010/11.