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 
Publications
Published on:
August 2, 2022
Written by:
Steven Chamow, Wendy Lin, Charles Olsen
About Alira Health

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.

Related news

Publications September 21, 2023
Essential Elements of Technology Transfer
Peter Alexander, Senior Consultant, CMC, co-authored an article about technology transfer categories, essential elements, and documentation.
CDMO CMC
Publications September 20, 2023
Manufacturing Challenges of Therapeutic Antibody-Drug Conjugates
Our expert CMC team addresses the manufacturing challenges of ADCs in “Manufacturing Challenges of Therapeutic Antibody-Drug Conjugates.”
CMC Drug Development
Events July 31, 2023
World Vaccine Congress
We are pleased to announce that we will attend The World Vaccine Congress Europe, the largest and most established European meeting on vaccine R&D.
Drug Development Spain Vaccines
Publications July 11, 2023
Five Years Evolution of Chemotherapy Administration in Home Care in France
Have a look at the poster to get an overview of the dynamics in the development of chemotherapy in home care across different French regions during a five-year period.
Clinical France Outcomes Research
Events June 20, 2023
Advanced Wound Care Summit
We are pleased to announce that we will sponsor, attend, and speak at Advanced Wound Care Summit.
Clinical Clinical Trials Wound Healing
Blog April 5, 2023
Add Biologics Manufacturing Efficiency with Experiment Design
Discover how to use the DoE methodology to streamline process optimization. DoE optimization designs may be used to study three or four parameters at multiple levels to find their optima.
Biologics CMC Research and Development
Blog March 10, 2023
Add Efficiency From Development To Validation with Experiment Design, Part 1
Among many challenges in the biopharmaceutical product development cycle is the development and validation of high-yielding, reproducible processes for manufacturing products that are(...)
Biopharma CMC Research and Development
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.