Demand for biosimilar analysis drives BioOutsource to double capacity
The new Biosimilar Centre of Excellence will be located in Glasgow, UK, adjacent to BioOutsource’s existing facility and will carry out bioanalytical techniques for the characterisation of biosimilars – a necessary regulatory process to establish the similarity between the biosimilar and its reference biologic.
CEO Gerry MacKay said the company had seen sales increase four-fold in the past 18 months and therefore the new facility - which doubles current capacity for the analysis of biosimilar monoclonal antibodies - is necessary to cope with the continuous demand.
Whilst there are other contract companies who offer biosimilar testing to biologic makers and contract manufacturing organisations (CMOs), as well as some companies preferring to do these tests in-house, MacKay told Biopharma-Reporter.com BioOutsource offers the advantage of speed.
“BioOutsource has undertaken to develop off the shelf validated assays for these molecules which will reduce our customers’ time to market objectives, which is most important in developing a new molecule in this area.”
Furthermore, he continued: “We also have invested heavily in R&D programmes during the last 18 months and now have a lot of experience in this technology.”
The site, set to open in April, consists of around 40 laboratory and R&D scientists and the firm will create approximately 20 new jobs.
Monoclonal Antibody Biosimilars
Last year, Hospira’s Inflectra became the first monoclonal antibody biosimilar to be approved in Europe, and since then Biocon, Mylan and Celltrion have all seen regulatory success in Asia.
“The successful approval of monoclonal antibodies by the European regulators has most clearly shown that there is a simple pathway to achieve approval,” MacKay told us, adding “this has already encouraged more companies to become involved with this type of molecule.”
The firm offers a range of off-the-shelf assay packages to complete a comparability studies for a number of MAb biosimilars, including versions of Herceptin, Rituxan, Humira, Enbrel, Remicade and Avastin.
