Downstream Processing
We at HemoSpere Bio have developed an efficient and robust down stream process.
Challenges for Purification
Octomab is a bispecific monoclonal antibody pharmaceutical. This circumstance provides additional challenges in the DSP of our Product. The removal of homodimers, mis paired subunits, oxidation-, charge- and size-related variants is essential to ensure a highly purified and homogenous product. Furthermore, the classical challenges of DSP still persist, and removal of process-related impurities (such as host-cell DNA/proteins, raw materials and leachables/extractables) is necessary for full purification.
Production lines
As Batches are N-Stage of the Batches are finalized in one week intervals our singular DSP is designed to be completed in one week. This includes Harvest, Processing and Formulation. Due to heavy use of single-use processes CIP and SIP can be reduced effectively. This way, harvest and DSP are distributed across time.
Final Product
Octomab comes as an autoinjector in the final product form. The autoinjector is an easy, fast alternative which allows safe application for anybody, no medical education needed. It comes with less discomfort for patients compared to conventional vials or syringes. The autoinjectors come in different doses depending on the patient's body weight.
We are gratefull for our partners at Gerresheimer, Germany for the partnership. Together since 2020 the autoinjector has been developed, making the treatment of Hemophilia A easy, less painfull and accessible to all patients in need.
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