Industrial-scale manufacture of therapeutic exosomes
Coordinated purification process development service accelerates progress to clinical trials, and scale-up manufacturing.
BIA Separations has introduced its CORNERSTONE Exosome Process Development Solution, designed to help drug-developers overcome critical development bottlenecks in the preparation of exosomes for clinical use.
Introducing two proprietary new technologies central to highly pure and scalable purification, BIA Separations’ Exosome Process Development Solution represents the latest extension of its CORNERSTONE programs for the manufacture of gene therapy vectors, following the launch of its AAV program earlier this month.
Exosomes fulfil a critical role as communicators among cells, with targeting and message content depending on their surface receptors and payload. Their unique ability to deliver that payload to the right target makes them obvious candidates for an extensive range of therapeutic applications in the fields of cancer and regenerative medicine, including for neurodegenerative and cardio-pulmonary disorders.
For such clinical applications to be realised, thoroughly purified exosomes are required, with key contaminant classes such as host-cell proteins, host-cell DNA, and non-exosomal vesicles reduced to trace levels. BIA Separations’ new technology brings important new tools for this purification, whilst ensuring fast and efficient process development. The technology is easily scalable from lab to manufacturing, and is able to provide better product quality than traditional purification systems.
CORNERSTONE Exosome Development Solution is built on the capabilities of two novel technologies. Kryptonase is an integrated enzymatic treatment that reduces host-cell DNA and facilitates the removal of host-cell protein contaminants. The CIMmultus EV monolithic column is a chromatography device that eliminates non-exosomal vesicles, and concentrates exosomes in a low shear environment. The technologies are available as part of a comprehensive Process Development Service, in which BIA Separations’ experts design and optimize processes to support clinical trials and scale-up to industrial manufacturing. Translational scientists and process developers can also access both new products as a Process Development Pack for exosome research purposes.
Aleš Štrancar, CEO at BIA Separations, said: “Exosomes represent the next generation delivery strategy for nucleic acids and other therapeutics, as well as being evaluated as a platform for regenerative medicine with high hopes of bringing more therapeutic options to chronically ill patients. We are all looking forward to seeing the impact of our tools on this novel therapy space.”
Pete Gagnon, Chief Scientific Officer at BIA Separations, added: “Every new product class presents a unique new set of challenges and exosomes are no exception. Our new CORNERSTONE program embodies the decades of experience we’ve developed with the purification of viruses, DNA plasmids, mRNA, and other gene therapy products, and extends it to include exosomes. This gives our customers a head-start that will help them be first to the clinic and first to market.”
Related News
-
News Women in Pharma: Moving beyond discussions and into best practice at CPHI Milan
In this second CPHI Milan special of our monthly series, we cover the key takeaways from the Diversity & Wellbeing track held on October 10, 2024. -
News AstraZeneca invests in AI collaboration for cancer drug trials
The British-Swedish pharmaceutical giant is partnering with biotechnology firm Immunai Inc to increase the efficiency of some cancer drug trials. -
News Ozempic and Wegovy prices questioned as Novo Nordisk faces US Senate hearing
The CEO of Novo Nordisk was grilled during a US Senate committee hearing on September 24, 2024, in which the exorbitant prices of the Danish company’s blockbuster drugs Ozempic and Wegovy were called into question. -
News The BIOSECURE Act: implications for the pharma supply chain
On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin... -
News On Track at CPHI Milan: Thermo Fisher Scientific Track Sponsor interview
With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma. -
News CPHI Milan Speaker Spotlight: Pharma Manufacturing and Localisation in Africa
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Eli Lilly licenses rheumatoid arthritis manufacturing in Africa
American pharmaceutical company Eli Lilly has signed a partnership with Egyptian organisation Eva Pharma to localise manufacturing of rheumatoid arthritis treatments in Africa.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance