iBio, Inc.is developing a decoy molecule as a therapeutic against SARS-CoV-2. Recently licensed from Planet Biotechnology, the candidate is a recombinant protein made from human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment.
The COVID-19 pandemic sweeping across the globe is pushing innovation to the cutting edge throughout the biopharma industry. More rapid development of novel diagnostics, therapeutics, and vaccines is acutely needed to mitigate further spread of the virus and prevent its reoccurrence in the future. iBio is offering its FastPharming™ Contract Manufacturing Services to vaccine and therapeutic developers to address the need for speeding time-to-clinic for new antigens, antibodies, and other protein biologics using a plant-based expression system. In addition, iBio is developing its own proprietary solutions, notably IBIO-200, a virus-like particle (VLP) vaccine candidate for COVID-19 disease.
At the start of April 2020, the global number of confirmed COVID-19 cases was rapidly approaching 1.5 million; the death toll: over 80,000. And these numbers will likely have changed substantially since the publication of this article. A vaccine is urgently needed. Pharma companies are scrambling into action with vaccine candidates and early trials, but drug development will take time. Some companies, however, are taking a different approach by introducing technologies that could help with research or manufacturing. As just one example, iBio is hoping its technology can help accelerate manufacturing and scale up for a potential vaccine.
Immeasurable efforts are underway to develop treatments and vaccines to address the COVID-19 pandemic. Numerous discovery methods and technologies are currently being explored in clinical trials such as DNA and RNA-based vaccine candidates, adjuvant platform technologies, recombinant nanoparticles, and monoclonal antibodies, to name a few. As promising therapies begin to emerge, they’ll need to be rapidly scaled up for trials and potential commercialization, which is not without its challenges in a pandemic setting.
N-Glycosylation is a critical component of many protein-based therapeutics, required for appropriate stability, immunogenicity, and pharmacokinetics. In addition, it is essential for key antibody activities, including ADCC (antibody-dependent cell-mediated cytotoxicity) and CDC (complement-dependent cytotoxicity). Taken all together, glycosylation is a Critical Quality Attribute (CQA) for antibodies and other proteins.