SPPS Tips for Success: Optimizing Synthesis of SARS-CoV-2 Epitopes for GMP Manufacture
Therapeutic peptides have many advantages, including high activity, broad chemical and biological diversity, and low toxicity. These and the relative ease and low cost of peptide manufacture compared to protein-based biologicals has meant that therapeutic peptides are now being used to treat a range of conditions, including metabolic diseases, cancer, cardiovascular, and infectious diseases.
The speed and flexibility of peptide synthesis is a major advantage when handling rapidly evolving conditions, such as neoantigen peptide-based vaccines for the individualized immunotherapy of certain forms of cancer. The dynamics of neoantigen presentation by the tumor cells demands high peptide purity and yield, and also the ability to quickly synthesize many peptides in parallel for timely treatment. Such performance will be invaluable in fighting COVID-19.
This session in the “SPPS Tips for Success” webinar series will focus on the synthesis of 24 SARS-CoV-2 peptides with therapeutic potential which represents a real-world example of synthetic challenges brought by a diverse range of sequences (based on published work by Grifoni and colleagues (1)). Other applications covered in this presentation include the synthesis of GLP-1 receptor agonists as an important treatment for type 2 diabetes, and the synthesis of neoantigen peptides for metastatic melanoma cell therapy development (2). In addition to application data, here we also discuss features of peptides synthesizers that are critical for cGMP and regulatory compliance when manufacturing peptide products for clinical use. Which hardware options are important? What software features should be included, such as designing for 21CFR Part 11 compliance? And what needs to be included in an IQ/OQ package for a peptide synthesizer instrument.
(1) Grifoni, A. et al. Cell Host & Microbe 27, 671–680 April 8, 2020
(2) Lu, Y et al. Clin Cancer Res. 2014 July 1; 20(13)
LEARNING OBJECTIVES:
- Understand how peptide-based epitopes and therapeutics are synthesized for COVID-19 and Neoantigen applications, as well as GLP-1 agonists therapeutics for type-2 diabetes treatments.
- Learn how to optimize peptide syntheses through reagent and condition screening.
- Understand which factors are important for the manufacture of clinical peptides under cGMP conditions.
Speaker:
Dr. Cyf Ramos-Colon, Senior Scientist,
Gyros Protein Technologies