التفاصيل البيبلوغرافية
| العنوان: |
Use of Transient Transfection for cGMP Manufacturing of eOD-GT8 60mer, a Self-Assembling Nanoparticle Germline-Targeting HIV-1 Vaccine Candidate. |
| المؤلفون: |
Sharma, Vaneet K., Menis, Sergey, Brower, Evan T., Sayeed, Eddy, Ackland, Jim, Lombardo, Angela, Cottrell, Christopher A., Torres, Jonathan L., Hassell, Thomas, Ward, Andrew B., Tsvetnitsky, Vadim, Schief, William R. |
| المصدر: |
Pharmaceutics; Jun2024, Vol. 16 Issue 6, p742, 18p |
| مصطلحات موضوعية: |
NANOPARTICLES, CURRENT good manufacturing practices, GENE transfection, CHEMICAL purification, AMINO acid sequence, HIV, GLYCANS |
| مستخلص: |
We describe the current Good Manufacturing Practice (cGMP) production and subsequent characterization of eOD-GT8 60mer, a glycosylated self-assembling nanoparticle HIV-1 vaccine candidate and germline targeting priming immunogen. Production was carried out via transient expression in the human embryonic kidney 293 (HEK293) cell line followed by a combination of purification techniques. A large-scale cGMP (200 L) production run yielded 354 mg of the purified eOD-GT8 60mer drug product material, which was formulated at 1 mg/mL in 10% sucrose in phosphate-buffered saline (PBS) at pH 7.2. The clinical trial material was comprehensively characterized for purity, antigenicity, glycan composition, amino acid sequence, and aggregation and by several safety-related tests during cGMP lot release. A comparison of the purified products produced at the 1 L scale and 200 L cGMP scale demonstrated the consistency and robustness of the transient transfection upstream process and the downstream purification strategies. The cGMP clinical trial material was tested in a Phase 1 clinical trial (NCT03547245), is currently being stored at −80 °C, and is on a stability testing program as per regulatory guidelines. The methods described here illustrate the utility of transient transfection for cGMP production of complex products such as glycosylated self-assembling nanoparticles. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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