“We signed the first MOU [Memorandum of Understanding] with Samsung BioLogics in 2014 that encompasses a long-term supply agreement in which we would provide raw materials to Samsung for its biopharmaceutical manufacturing,” Yong Kim, head of Process Solutions, Korea, for the Life Science business of Merck KGaA told this publication.
That agreement place MilliporeSigma as the preferred supplier for filters, chromatography resins and process chemicals for the contract development and manufacturing organisation (CDMO), but after building “a strong and stable supply of raw materials” a second MOU takes the alliance “to the next level,” Kim said.
Kim added the deal was beyond a simple supply agreement between vendor and end-user, but rather a strategic alliance with MilliporeSigma supporting Samsung BioLogics and its customers.
“We are not just a supplier to Samsung, we will be supporting their CDMO business where we will provide the technical expertise and knowledge to Samsung to develop the biologics process for its small biotech customers,” he said.
“Under these two MoUs, we will specifically support Samsung in cell line, cell culture media and single-use systems.”
However, the MoU is non-binding and Samsung is free to work with other companies.
Clinical production
When Samsung BioLogics opens its third biomanufacturing plant at its site in Songdo, South Korea – expected later this year – the CDMO will offer customers 360,000L of commercial stainless steel bioreactor capacity.
But Kim said this partnership was not focused on the commercial scale offered in Songdo, but smaller-scale manufacturing and process development.
“Small biotech companies need greater flexibility in the production of clinical materials. A bioreactor of up to 2,000L will suit this purpose,” he told us.
“The benefits of adopting single-use systems in the production of biologics include avoiding the need for cleaning and allowing faster and more flexible manufacturing.”