ABIONYX Pharma Announces the Successful Manufacturing of the First Batch of CER-001 With Recombinant Human ApoA-I Using a New Innovative and Robust Industrial Bioprocess
10 Maio 2023 - 1:30PM
Business Wire
- Innovative industrial manufacturing based on Good
Manufacturing Practices (GMP)
- Improved yield and simplification of the biomanufacturing
process
- Raising the barrier to entry for the patented proprietary
manufacturing of CER-001, one of the most advanced
biomedicines
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, announced the successful GMP (Good
Manufacturing Practices) industrial biomanufacturing of a batch of
CER-001 using an innovative and robust method.
This success confirms the relevance of the strategy to relocate
biomanufacturing to France, which was implemented 4 years ago, not
only to contribute to the country's industrial sovereignty in
biomedicine, but also to ensure the independence of the Company's
development from external constraints. This performance also
testifies to the efforts and hard work of ABIONYX's teams who
worked to optimize the industrial process, despite raw material
inflation, a difficult context and limited financial resources.
Finally, this major manufacturing improvement simplifies the
process by making it more competitive, which increases the value of
the bioproduct and of ABIONYX Pharma, which controls the
manufacturing and intellectual property rights.
First batch of recombinant human ApoA-I CER-001 produced by
an innovative and robust industrial process
ABIONYX successfully manufactured a GMP-compliant batch of
CER-001 using a new innovative and robust industrial process.
ABIONYX thus demonstrates that the new production line constitutes
an innovative and efficient approach to access the apotherapy
market, based on the only human recombinant ApoA-I protein. All the
steps of the biomanufacturing process have been revisited, improved
and requalified in order to increase the production yield and to
serve the targeted markets such as renal diseases, sepsis or
ophthalmology.
Achievement of a major milestone in the development of the
Company's biomedicine
As a reminder, biomedicines, which are often very complex to
produce, play a crucial role in the development of new, highly
innovative treatments, as demonstrated by CER-001. Examples of
these biomedicines are interferons, coagulation factors, etc. These
are large and highly complex molecules. In contrast to the
production of "classic" drugs, a very specific know-how must be
implemented during the manufacturing of therapeutic biomolecules
due to their high potential sensitivity to changes in environmental
conditions such as temperature, the composition of the culture
medium, etc. In the case of CER-001, the natural protein ApoA-I is
the most important part of the manufacturing process and requires
this unique know-how that ABIONYX Pharma is the only company to
master to date.
The process was greatly simplified, making it more robust, with
a concomitant positive effect on its cost, enabling the filing of a
new patent in 2021 to continue to protect and extend its
intellectual property.
Performance improvement and simplification of the
biomanufacturing process
Since 2005, work on the biomanufacturing of CER-001 has crossed
all industrial barriers. Thanks to the innovative process
developed, ABIONYX ensures that the industrialization of CER-001 is
now possible for production volumes consistent with future
needs.
ABIONYX’s ApoA-I is the only recombinant protein produced from
cells and not an ApoA-I derived from purified plasma or blood. It
displays the pleiotropic, anti-inflammatory, vascular integrity
restoring and immune system modulating functional properties
described for endogenous ApoA-I. This is a unique situation
enabling ABIONYX to restore the normal level of ApoA-I to benefit
patients with deficiency. ApoA-I deficiency can be due to rare
genetic orphan diseases resulting in a severe and chronic
deficiency, can be age-related as in ophthalmologic conditions, but
can also can be due to acute severe inflammatory conditions such as
bacterial or viral sepsis, including COVID-19. The known
pleiotropic effects of natural ApoA-I enable CER-001 to address a
wide range of diseases associated with reduced ApoA-I, and its
mechanism of action is independent of endogenous levels of HDL to
be effective.
With this succesful manufacturing of the first batch, the new
manufacturing process was confirmed, advancing apotherapy programs
into larger global therapeutic trials to explore new clinical
benefits for ApoA-I replacement therapy.
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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/20230510005820/en/
NewCap Investor relations Louis-Victor Delouvrier Nicolas
Fossiez abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 94 98
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