Mobius Biomedical’s scientific team brings an unprecedented holistic, applied science approach that combines essential basic sciences and engineering in efforts to change existing biopharmaceutical development processes to significantly reduce development and manufacturing costs, while increasing a target product’s probability of clinical success under the existing regulatory framework.
We are creating path-breaking process technologies to yield high quality and high purity biological therapeutics at significant cost reduction.
Novel Looking Glass
Innovative Process Technologies
The biopharmaceutical industry represents a $200 billion market globally. Though the promise of recombinant biologics is great, with the global market expected to continue to expand rapidly, biopharmaceutical manufacturing processes are not evolving in step. In fact, biopharmaceutical downstream processing has remained unchanged for decades, largely due to the need for speed to market and for ensuring regulatory compliance. That said, it is evident in the field that there is great and urgent necessity to innovate downstream processing technologies to support the evolving demands of this industry. For example, the emergence of biosimilars necessitates reduction in biopharmaceutical cost. This cost reduction has to be derived from changes to the existing manufacturing processes that enable increased yield, higher purity, higher throughput, lower capital equipment expenditure, and lower operational expenditure.
Mobius Biomedical is focused on creating innovative, process technology solutions to meet the demands of the rapidly expanding and evolving biopharmaceutical industry.
Biologics and Biosimilars
Biologics, sometimes referred to as large-molecule drugs, are protein-based therapeutics that are produced using unique cell lines, including mammalian cells, yeast, and bacteria. Unlike small-molecule drugs and generics that are manufactured via chemical synthesis, biologics undergo essential post-translational modifications when manufactured in living cells.
Biosimilars are protein-based therapeutics that are highly similar to and manifest no meaningful clinical differences in comparison with existing FDA-approved reference biologics. Biosimilar products must manifest equivalent structure-function characteristics and must maintain equivalent purity, potency and safety.
The inherent complexity and quality demands on potency and purity impose a substantial burden on commercial scale manufacturing of biosimilars and biologics, as even minor deviations in protein expression, isolation, and purification may lead to differences in the structure, reactivity, stability, and other quality aspects of the end product, causing lot-to-lot variations. Any of these differences has the potential to affect the treatment’s safety, efficacy, and shelf life, and to increase the risk of an unwanted immune response. For these reasons, the cost to reliably manufacture these biopharmaceuticals at commercial scale is generally quite high.
Mobius Biomedical will utilize novel bioprocess equipment and manufacturing process innovations to produce safe and effective, low cost biosimilars and biologics for the global market.