GMP Manufacturing and IND-Enabling Studies of a Recombinant Hyperimmune Globulin Targeting SARS-CoV-2

The last two years have brought forward tremendous advances in the development of prophylactic and therapeutic approaches for the treatment of SARS-CoV-2 infections. Vaccines, monoclonal antibodies, antiviral agents, convalescent plasma, immunomodulators and other investigational therapies have either been approved or are at the investigational stage.

While serious outcomes of disease are no longer common, transmission remains high and the emergence of new variants capable of evading immunosurveillance induced by vaccination or escaping the neutralization capabilities of existing monoclonal antibodies. Thus, new medicines continue to be needed. Antibodies have been shown to be an effective treatment, and an intriguing approach is to use polyclonal (a mixture of different molecules) vs. monoclonal (a single molecule) antibodies. Indeed, the use of convalescent plasma was initiated to treat those most severely affected by infection, with the intent of delivering human polyclonal antibodies capable of neutralizing the virus.

Limitations thereof, however, are that convalescent plasma donated by vaccinated of previously infected individuals contain polyclonal antibodies against a few variants and are not effective against variants from the 8 SARS-CoV-2 clades thus far identified.   

Is it possible to create a ‘super’ mixture of antibodies reactive against all SARS-CoV-2 variants?  The answer is yes.  As described by Rena Mizrahi and her colleagues at GigaGgen, Inc., in South San Francisco, CA, it is now possible to produce such an antibody mixture using recombinant DNA technology. Titled “GMP Manufacturing and IND-Enabling Studies of a Recombinant Hyperimmune Globulin Targeting SARS-CoV-2” and published in the peer-reviewed journal Pathogens, this report by Dr. Mizrahi and her team makes for an interesting read into the development of recombinant oligoclonal antibodies against SARS-CoV-2. In addition to her colleagues at GigaGgen and collaborating institutions, Dr. Mizrahi’s team includes the following members of our team: 

  • Steven Chamow, Senior Vice President, CMC 
  • Wendy Lin, Consultant 
  • Charles Olsen, Consultant 
Published on:
August 2, 2022
Written by:
Steven Chamow, Wendy Lin, Charles Olsen
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As experienced CMC consultants, we can help you navigate the complex demands of product development and manufacture. We can provide your company with strategic advice and solutions designed to ensure success across the full product lifecycle.

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