This investment at Novasep’s Le Mans, France site will see the firm add a green field facility offering full bio-conjugation services to antibody-drug conjugation (ADC) developers for batch sizes of up to 600g.
Increased general demand for ADC services has driven a series of investments at the site over the past few years, but this latest outlay - devoted specifically to the conjugation of ADCs – “is also being driven directly from [current] customers who are particularly interested in seeing Novasep invest in this area,” according to Novasep spokesperson Sophie Baudouin.
“The demand is indeed growing and we see that there is a need to have reliable CMOs actively participating,” she told Biopharma-Reporter.com.
“The feedback we have been increasingly hearing from ADC drug developers is that the ADC supply chain is complex. This signals a clear demand to simplify it. This is why Novasep is preparing to offer the full range of services related to the production of ADCs.”
This latest multipurpose facility will contain an R&D lab and a QC (Quality Control) lab and has been designed to be “flexible and capable of handling conjugation processes from different technology platforms which exist in the market,” and complete the site's ADC service offering, Baudouin explained.
In 2012, Novasep invested €3m to build a dedicated unit for cryogenic chemistry, HPLC chromatography and drying to support commercial scale ADC production. A further €4m was injected in May 2014 to expand its highly potent active pharmaceutical ingredient (HPAPI) capabilities on site.
“On top of this flexibility, the Novasep team has expertise in handling biological compounds as well as highly potent payloads. This team also has solid expertise in operating the different conjugation operation units (chemical reaction/Chromatography/TFF) required during the production process."
The new plant is set to be ready for testing by the second quarter 2016.