First announcement of the successful production of a therapeutic antibody in moss (Physcomitrella patens)
London/Freiburg - Dr Sabrina Wagner (CEO, greenovation Biotech) and Dr Tarran Jones (CEO, AERES Biomedical) announced today that greenovation (Freiburg, Germany) and AERES (London, UK) had successfully completed a major milestone in the development of a new production system for the manufacture of therapeutic antibodies in moss. Using a humanised antibody (ABC-48) currently in pre-clinical development at AERES for the prevention of deep vein thrombosis, scientists at greenovation have successfully expressed the humanised antibody, which was secreted into the medium. The secreted ABC-48 antibody was shown to be correctly assembled and displayed normal binding activity to its natural ligand.
"Producing ABC-48 in a moss bioreactor offers the potential to produce this novel humanised antibody, and other therapeutic antibodies as well, far more cost effectively than more traditional manufacturing routes, significantly reducing the overall cost of goods" said Dr. Tarran Jones, CEO of AERES Biomedical. "We are very pleased to have been able to participate in this successful collaboration with greenovation to develop this important new manufacturing strategy."
"The expression of a therapeutic monoclonal antibody in moss is a major milestone again confirming that this plant can produce a wide range of complex biopharmaceuticals. Moss is the only plant that allows humanisation of its glycosylation pattern. The moss protonema grows in a simple medium consisting essentially of water and some minerals, target proteins are secreted into the medium. This makes the system safe and significantly reduces costs for cultivation and purification" said Dr. Sabrina Wagner, CEO of greenovation Biotech. "The collaboration with AERES provides us with access to a therapeutic antibody and will allow both companies to fully capitalise on our production platform."
greenovation's moss bioreactor is a major innovation in the manufacture of biopharmaceuticals including safety and cost advantages of plant-based systems and at the same time avoiding risks associated with environmental release. In cooperation with pharmaceutical companies greenovation develops the moss production strains for biopharmaceuticals.
greenovation's moss bioreactor is based on the fermentation of the moss protonema, Moss is the only known plant system which shows a high frequency of homologous recombination. This attribute allows for targeted gene insertion leading to the stable integration of foreign gene(s). Another important aspect of the moss system is that it can be manipulated to make targeted gene knockouts. Homologous recombination is used to knock out plant-specific glycosyltransferases, which allows humanisation of the glycosylation pattern. Time-to-market is comparable to traditional systems. A transient expression system is used for feasibility studies within weeks and stable production strain development takes 4 to 6 months. Cultivation in suspension allows up-scaling of the photobioreactors up to several 1000 L. Through photoautotrophic cultivation it requires a simple medium, which is safe and together with secretion of the heterologous protein greatly facilitates downstream processing.
ABC-48 is a humanised antibody which targets P-selectin, a glycoprotein found on the surface of activated platelets and vascular endothelial cells. This molecule mediates the interaction between platelets and leukocytes and plays a key role both in the development of blood clots (thrombosis) and also in the migration of leukocytes out of the blood vessels during inflammation (extravasation). Blocking the activity of P-selectin has been shown to inhibit both these processes and as such it has considerable potential to be applied in a wide range of indications in thrombosis and inflammation. Through the selective targeting of P-selectin it has been demonstrated that ABC-48 is able to inhibit the coagulation cascade in the absence of the bleeding risk normally associated with anti-coagulants. In addition, as a humanised antibody, a single dose is expected to be able to provide protection from deep vein thrombosis (DVT) for several weeks. Whilst the market for drugs aimed at preventing DVT alone is currently in excess of US$1 billion, ABC-48 also offers therapeutic potential in a number of other indications including the prevention of both reperfusion injury and neo-intimal restinosis, and as an adjunct to thrombolytic therapies. ABC-48 is currently in late pre-clinical development for the prevention of DVT following surgery and is expected to enter clinical trials in 2004/5.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
