VINIF.2020.DA05 – Production of single-chain gonadotropins for fertility treatments

Principle Investigator
Assoc.Prof. Nguyen Thi Mong Diep
Host Organization
Quy Nhon University

Natural gonadotropins have been used for a long time in the treatment of infertility in humans and animals such as hFSH, hLH, hCG, eCG (PMSG), but nowadays for hygienic and ethical reasons, the use of natural gonadotropins is becoming more and more difficult to treat infertility in humans or control reproduction in animals. Major pharmaceutical companies around the world have now developed the production of recombinant wild-type hFSHs that are being used in the treatment of human infertility. However, the recombinant hFSH marketed to date are heterodimeric recombinant wild-type hFSHs with a rapid half-life, with the exception of the hFSH molecule (Corifollitropin alfa, Elonva®) which has a long half-life due to the addition of the CTP component of hCG-β at the C terminus of the b subunit of FSH.

The natural hormone PMSG (Pregnant Mare Serum Gonadotropin), is largely used in livestock farming  but has recently come under controversy because it requires constant drawing of animal blood and violates animal health regulations in many countries. Veterinary pharmaceutical companies have not yet released recombinant gonadotropins, so there are no recombinant eCGs available on the market. Therefore, it is important and very necessary now to make recombinant eCG available for the livestock market.

An important property required in the clinical use of recombinant gonadotropins is that they must have a half-life long enough to avoid daily injections and replace them with weekly injections. To achieve this goal, we intend to adjust the binding peptide sequence to provide hormones with long-lasting activity in the body and in particular easier to synthesize under in vitro conditions than Corifollitropin alfa (Elonva®).

Project objectives

Establishing and building a long-term production process of two recombinant gonadotropin hormones with biological activity such as follicle-stimulating hormone (FSH) in Vietnam:

1/ eCG for stimulation and control of reproduction in livestock

2/ hFSH used in the treatment of infertility in humans but here, the initial step is for ultrafiltration or synchronization in animals.

Principle Investigator
Assoc.Prof. Nguyen Thi Mong Diep
Host Organization
Quy Nhon University

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Expect Progress
01/11/2020
31/10/2021
Phase 1

• 01 eCG single-chain gonadotropin.
• Funding support for training 01 graduate student (year 1).
• Training 01 Master.

01/11/2022
Phase 2

• 01 single chain gonadotropin hFSH.
• Funding support for training 01 graduate student (year 2).
• Training 02 masters.
• 01 international article Q1.

21/10/2023
Phase 3

• 01 international article Q1.
• Funding support for training 01 graduate student (year 3).
• Training 01 master’s degree.
• Purified single-chain gonadotropin products eCG and hFSH.
• 01 Application for copyright registration, intellectual property of eCG and hFSH products.

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