Ingenza’s inGenius™ CMC Platform Paves the Way for Biotherapeutic Success
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 peptide for treating a wide range of topical infections, and the world’s most affordable recombinant haemophilia A treatment. The success of these projects has laid the foundations for a bright future in the bioengineering space, and we have high expectations of inGenius accelerating upcoming candidates through the drug development pathway.”
For more information, visit www.ingenza.com.
About Ingenza
Ingenza engineers biological systems to make everything from therapeutics to enzymes and consumer products, addressing challenges in human health and the global environment. Ingenza’s understanding of nature, combined with its engineering biology toolbox, allows the company to accelerate customer journeys through key milestones to commercial success. Its scientific and commercial activities are led by a management team with over 60 years’ experience in applied bioscience and the development and commercialisation of bio-based products. In addition to engaging in strategic partnerships to tailor its bioprocess services for clients, the company also licenses its proprietary bioprocess technologies.
Emily Armiger-Welch
kdm communications limited
01480 405333
pressreleases@kdm-communications.com
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