This successful filing enhances Horizon’s market opportunity by demonstrating that the cells and recombinant adeno-associated virus (rAAV) engineering technology used in their generation have been assessed as safe from a regulatory perspective for the manufacture of biotherapeutics for use in humans.
Industry adoption of Horizon’s CHO K1 GS knockout cell line has provided the Group with a strong source of repeatable revenue that has accelerated in recent months, with over 20 full commercial licenses in place and a strong pipeline of new licenses pending. These licenses have been secured as a result of Horizon’s unrivalled combination of high performance, transparent cell line history, and disruptive licensing terms. Now, as an important part of a successful IND filing by a licensee, Horizon’s Bioproduction cell line has been proven as a high-value platform upon which regulatory submissions can be based.
Horizon licenses its CHO K1 cell line broadly across the industry including to pharmaceutical, biotechnology, and biosimilar companies, as well as to Contract Manufacturing Organizations (CMO). By adopting this approach, Horizon intends to demonstrate its global leadership, empowering organizations of all sizes by providing access to the best biotherapeutic manufacturing technology available, driving efficiencies so that they, and ultimately patients, benefit.
Richard Vellacott, Interim CEO and CFO, Horizon Discovery, commented: "Next-generation biotherapeutics require next-generation manufacturing platforms. We are pleased that our highly specialized gene-edited cell line for bioproduction is not only being widely adopted by customers of all sizes but has now also been validated as a highly effective platform for regulatory submissions. Today’s announcement enables Horizon to access a wider customer base and represents a significant milestone in our goal of harnessing the power of the cell to empower customers across the life sciences.”
Glossary:
- Bioproduction: A type of manufacturing that utilizes biological systems, including specialized cells, to produce commercially important biomaterials and biomolecules for use in medicines
- Biotherapeutic: A therapeutic material produced using biological means, for example an antibody
- Contract manufacturing organization (CMO): a company that serves the pharmaceutical industry on a contract basis to provide services from drug development through drug manufacturing
- Investigational New Drug (IND): The first step in the drug review process by the U.S. Food and Drug Administration
- Knockout (KO): A cell line in which one or more of the genes in a cell is made inoperative
- rAAV: A gene editing technology, exclusive to Horizon for non-therapeutic applications, which allows cells to be edited with extreme precision and virtually no risk of unforeseen errors
About Horizon’s Bioproduction platform:
Biological therapeutics made up eight of the top ten best selling drugs of 2016, and feature extensively in developmental pipelines. Historically, access to bioproduction cell lines for the manufacture of these therapeutics has been cost prohibitive and is often restricted in ways that prevent their further optimization by customers. This stifles innovation and means that drugs are not always getting to market due to the inability to generate bioproduction cell lines that meet the needs of commercial release.
Horizon is using its expertise in gene engineering to improve biological therapeutics manufacturing. As well as developing cell lines for the manufacture of a range of current and next-generation biological therapeutics, Horizon encourages customer innovation by allowing access to its state-of-the-art bioproduction cell line platform under flexible and affordable licensing terms that allow the further modification of cells.