Ingenza’s inGenius™ CMC Platform Paves the Way for Biotherapeutic Success
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Ingenza’s Chemistry Manufacturing and Controls (CMC) platform, inGenius™, offers biopharmaceutical manufacturers a unique solution to streamline and accelerate the drug development process. This integrated technology suite combines Ingenza’s strain and cell line engineering expertise with a wealth of experience in upstream and downstream processing to advance any biotherapeutic candidate from discovery to commercialisation.
The CMC process is a critical component of any drug development journey, but various challenges – including biologic product complexity, batch-to-batch variability, stability issues and difficulties in technology transfer – can affect the productivity, quality and consistency of pharmaceutical manufacture. Addressing these challenges requires a multidisciplinary approach and ongoing process optimisation. Ingenza’s inGenius CMC platform is specifically designed to de-risk biopharmaceutical development and enhance the regulatory approval of final clinical products.
inGenius encompasses all the stages of bioengineering – from host and biosynthetic route selection, through genetic design, strain/cell line selection and bioprocess optimisation, to preclinical and first-in-human manufacturing – backed by a skilled team of molecular biologists, biochemists, fermentation experts and analytical chemists. The platform incorporates over 70 upstream and downstream processing parameters that are monitored and optimised for successful product development. As a result, 11 separate candidate molecules have been accelerated from discovery to toxicology testing in the last three years, and Ingenza boasts a 100 % success rate in producing customer targets, using one of 12 different biomanufacturing hosts.
Scott Baxter, Head of Downstream Processing at Ingenza, commented: “Ingenza has 20 years of successful engineering biology under its belt, with our inGenius CMC platform offering the perfect all-in-one solution for companies looking to accelerate their candidate’s journey to the clinic. The platform has been an integral part of a variety of high profile biomanufacturing programmes in recent years, including the full microbial production of a broad spectrum SARS betacoronavirus vaccine, a next generation antimicrobial peptiderecombinant haemophilia A treatmentaccelerating upcoming candidates through the drug development pathway.”