Thursday, September 27, 2018 Daily Archives

Cell Culture Media: An Active Pharmaceutical Ingredient or Ancillary Material?

Cell-based therapies are used to treat diseases that require the replacement of diseased, dysfunctional, and injured cells (1). To produce these therapies, a wide range of reagents and materials such as antibodies, growth factors, and enzymes are used in their manufacturing processes. Such necessary materials are administered through a cell culture medium. Active pharmaceutical ingredients (APIs) are the main ingredients that make products therapeutic. Ancillary materials (AMs) and raw materials (RMs) are essential components used during production but are not…

Alexion refilling pipeline through potential $1.2bn Syntimmune buy

The acquisition of early-phase biotech Syntimmune is “part and parcel†to Alexion Pharmaceuticals’ plan to build up its pipeline, says the firm’s CFO. Alexion Pharmaceuticals has entered into an agreement to buy Syntimmune for an upfront payment of $400 million (€342 million), though milestone payments could see the firm shell out a further $800 million. The deal brings Alexion SYNT001, a humanized monoclonal antibody candidate that inhibits the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes. The…

Three-way collaboration looks to scalable purification for AAV

The UK’s Centre for Process Innovation (CPI) will work with CDMO Cobra Biologics and vendor GE Healthcare to reduce the cost of making adeno-associated virus (AAV) vectors. Funded by a £570,000 ($750,000) grant from Innovate UK, the three-way consortium is looking to increase the robustness and reduce costs for the manufacturing of adeno-associated virus (AAV) vectors to feed the growing gene therapy space. The collaboration will see each player contribute its expertise. GE Healthcare’s Puridify fibre-based chromatography technology platform will…