ABIONYX Pharma Successfully Manufactures a Third Batch of Recombinant Human apoA-I CER-001 Using a New, Innovative and Robust Industrial Bioprocess
December 18 2023 - 11:00AM
Business Wire
- Complete success of industrial biomanufacturing of CER-001,
one of the most advanced biomedicines
- Preparation of biomanufacturing requiring 3 consecutive
batches for Marketing Authorization
Regulatory News:
ABIONYX Pharma, (FR0012616852 – ABNX – PEA PME
eligible), a new generation biotech company dedicated to the
discovery and development of innovative therapies based on the
world’s only natural recombinant apoA-I, announces the successful
completion of a third batch for the GMP (Good Manufacturing
Practice) industrial biomanufacturing of CER-001 using the latest
innovative and robust method.
ABIONYX successfully manufactured a third batch of CER-001 under
GMP conditions, using the new innovative and robust industrial
process. ABIONYX thus confirms that its new production line, based
on an innovative and efficient approach, is ready to bring the only
recombinant apoA-I protein to market. All stages of the
biomanufacturing process are geared to increasing production yields
and serving target markets such as kidney disease, sepsis and
ophthalmology.
Thanks to the successful production of this third batch, the new
manufacturing process has been confirmed, paving the way for
biomanufacturing, which will require the completion of 3
consecutive GMP pilot batches at the level of performance required
for the future commercial exploitation of CER-001.
ABIONYX Pharma points out that its reference shareholders
Domundi, Cyrille Tupin and Luc Demarre, have not sold any shares,
nor have all the shareholders who subscribed to the last capital
increase last October. Finally, as indicated last October at the
time of the capital increase, the Company's financial visibility is
now extended to Q1 2025, without drawing on the equity-linked
financing facility.
Next financial release: Cash position and activity update
for Q4 2023, February 29, 2024
About ABIONYX Pharma
ABIONYX Pharma is a new generation biotech company that aims to
contribute to health through innovative therapies in indications
where there is no effective or existing treatment, even the rarest
ones. Thanks to its partners in research, medicine,
biopharmaceuticals and shareholding, the company innovates on a
daily basis to propose drugs for the treatment of renal and
ophthalmological diseases, or new HDL vectors used for targeted
drug delivery.
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version on businesswire.com: https://www.businesswire.com/news/home/20231218992418/en/
NewCap Investor relations Nicolas Fossiez Louis-Victor
Delouvrier abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 00 15
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