Plan for success
With 25 years of experience, we’ve achieved a lot that we’re proud of. Read about a couple of our recent successful projects and get in touch to find out how we can make your project the next success story.
Amediplase is a thrombolytic agent chimeric protein (a glycosylated recombinant protein constituted of parts of the Tissue Plasminogen Activator and Urokinase) and is renowned as one of the most difficult biologics to manufacture. We successfully completed the manufacture of Amediplase for Phase I/II and Phase III.
Manufacture of Amediplase for Phase I/II studies
Manufacture of Amediplase for Phase III studies
Abagovomab is an anti-idiotypic antibody that mimics the CA 125 receptor, which is over-expressed in ovarian cancer. We successfully developed this in a murine hybridoma and manufactured in a hollow fibre bioreactor.
Manufacture of Abagovomab for Phase III studies and process validation.
In 2010 Menarini Biotech began developing a biosimilars product that has entered phase I trials.
OBT & Menarini
OBT and Menarini established a strategic partnership in October 2012, covering the development and commercialization of five of OBT's proprietary antibody-based cancer therapies. Under the collaboration, Menarini Biotech contributes process development and cGMP manufacturing, for phase i, II & III clinical supply.
Currently Menarini Biotech is developing the manufacturing process and producing clinical batches of 2 antibodies:
MEN1112 Is a humanized, de-fucosylated monoclonal IgGl antibody directed against an antigen which is over expressed in blasts of Acute Myeloid leukemia. MEN1112 is currently in phase I clinical trial.
MEN 1309 is a human monoclonal antibody conjugated to a potent cytotoxic agent, maytansin derivative, against a membrane antigen which is over-expressed in many tumors such non-Hodgkin lymphoma (NHL) and solid tumors such a subtype of breast cancer.
Third party production
In 2013 Menarini Biotech began the process development and cGMP production of a Monoclonal Antibody in oncology for a non-disclosed partner.
Ketoprofene Esterase - A recombinant enzyme for the enantiomeric resolution of Ketoprofene produced in E. coli.
Many development projects including:
Monoclonal antibodies (mAbs), bi-specific mAbs, chemical immuno-conjugates, human/mouse chimeric mAbs, immuno-toxins, human apoptosis modulators, plasmid DNA vaccines produced in hybridomas, engineered CHO cells and bacteria.
Site directed mutagenesis of receptors involved in inflammation and pain for rational drug design.
Recombinant human cytokines produced in CHO cells.
We’d like your project to be our next big success story. Contact us to find out how