The vital second batch represents a critical step on the candidate’s pathway to regulatory approval
Abionyx Pharma, a new generation biotech company focusing on the development of innovative drugs in disease and condition areas of unmet need, has announced that it has manufactured a second batch of its ApoA-I CER-001 candidate.
This newly produced batch represents a critical step on the therapy’s pathway to regulatory approval.
The manufacturing of the drug, which includes ApoA-I, the world’s only natural recombinant, took place under good manufacturing practices (GMP) conditions using novel industrial process.
It has duly established Abionyx’s new production system, which is focused on efficiencies and innovation, enabling the company to enter the apotherapy market.
Every stage of the biomanufacturing process was designed to boost production yields, effectively enabling the company to serve its various areas of focus, notably in kidney disease, ophthalmology and sepsis.
Meanwhile, this pivotal second batch of ApoA-I CER-001 further underlines improved production and biomanufacturing processes.
Requirements of the biomanufacturing trajectory currently involve at least three successful batch completions in order to gain wider marketing approval. Biomedicines manufactured in compliance with GMP regulations typically guarantee the quality, reliability and safety of a bioproduct.
In order to obtain regulatory approval, the company must also provide data on the long-term stability of the product. This also involves undertaking stability tests on all three consecutive batches, thereby determining the product’s shelf life.
Meeting this additional criterion will allow the ApoA-I CER-001 to further comply with the regulatory requirements needed to enter the marketplace in the future.
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