How to select the company to manufacture your antibody drug
SYNIMMUNE GmbH is a biotechnology company spin-off of the Department of Immunology of the University of Tubingen in Germany. It is developing innovative and effective mono- and bispecific anti-tumor antibodies to treat patients suffering life-threatening diseases, focusing on orphan hematopoietic malignancies.
They have performed the first clinical trial with a next-generation antibody FLYSYN, a novel Fc-optimized antibody, to treat acute myeloid leukemia (AML) in 21 adults. The results were encouraging, and they started the preparation for Clinical Phase II. AML is a deadly disease with a 5-year survival rate of 29.5%. While most AML patients achieve a complete remission with regular chemotherapy, the majority of patients relapse within several months, requiring additional chemo or stem cell transplantation. FLYSYN intends to delay or even prevent such relapse.
Back to the trials, while for phase I of the clinical trials, only 20-80 participants are needed, for Clinical Phase II, a higher number is required, 100-300 participants. And overseeing the good results and possibility of further Clinical Phase III where a number between 1000-3000 participants are necessary, an urgent need for higher production of the new drug is needed.
What are the Key factors when finding the right CDMO partner
Finding the right partner to manufacture the drug is essential for the future success of the trial. But it is not an easy task to find the “perfect match.” Here are some things to consider:
- Knowhow and infrastructure to meet manufacturing capacity needs.
- Meet FDA, EMA, and NMPA international regulatory requirements.
- Work as a partner with flexibility and collaboration.
The winner CDMO will be the one with the capacity to support the project not only now, but also in the future. Regulatory compliance is a top factor in selecting a CDMO that should treat regulatory and quality systems as a priority. Last but not least, partnership. You must look for a partner, not a provider.
On 6th September 2021, SYNIMMUNE had assigned GenScript ProBio to produce their innovative antibody FLYSYN for clinical Phase II. For SYNIMMUNE, GenScript ProBio was the partner of choice. GenScript ProBio’s GMP manufacturing center meets global regulatory requirements. Moreover, it has a comprehensive and refined technology transfer process. The complete attractive package to develop this innovative drug from SYNIMMUNE.
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