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3P Bio, Zhittya Complete Process Transfer and GMP Supply for FGF-1 Candidate

3P completes transfer of the process for scaling up and performing cGMP manufacturing for clinical studies.

By: Anthony Vecchione

3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in process development and cGMP manufacturing of biologics, and Zhittya Genesis Medicine (Zhittya), a biotech company, have accomplished the process transfer and GMP supply of FGF-1 candidate. 

3P and Zhittya began their relationship in 2019 with 3P being selected as the CDMO to transfer the process for scaling up and performing cGMP manufacturing for clinical studies.

After successfully achieving transfer of the process and its first cGMP batch in 2020, Zhittya requested manufacturing of the therapeutic candidate for a new mode of administration involving nasal treatment for use in its clinical trial in Virgin Islands scheduled in 2023. According to preliminary studies conducted by Zhittya, the results for treating Parkinson’s disease using a nasal treatment are highly promising.

Zhittya chose human FGF-1 as its candidate protein. This particular growth factor is known for its ability to stimulate the growth of new blood vessels and neurons, making it an ideal therapeutic candidate for treating neurodegenerative diseases such as Parkinson’s disease.

Jack Jacobs, president, and chief science officer at Zhittya, said: “We are very pleased with the collaboration with 3P regarding the tech transfer and GMP supply of our FGF-1 candidate. We hope that this partnership will extend to the manufacturing production of our drug candidates in the future and we look forward to bringing us closer to developing effective treatments for those who need them the most.”

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