INSIGHTS ON LIQUID DOSE MANUFACTURING

LIQUID DOSE MANUFACTURING SOLUTIONS

  • Cell and gene therapies have increased in popularity in recent years, and thanks to their ability to provide one-time treatments these therapies will play a significant role in treating some of the world's most challenging diseases. These drug products treat patients afflicted with genetic disorders and cancers by targeting the source of disease and altering its genetic makeup to eliminate its cause or symptoms. These therapies are expensive and complex and have been proven effective in numerous cases, but they present a challenge in producing them at scale and at a reasonable cost.

  • Opportunities for improving and streamlining the media fill process are interesting for aseptic filling operations. In particular, the manual visual inspection process used to inspect media vials for signs of contamination after incubation is considered to be tedious and time-consuming.

  • Used 300 sq ft BOC Edward freeze dryer, model LYOMAX 28, 316L stainless steel product contact surfaces with (13) 1170 mm wide x 1850 mm deep usable shelves, 115 mm shelf spacing, stoppering, external condenser with 300 kg ice capacity, refrigeration and vacuum skid with liquid natural gas refrigeration, model AV-LUS BOC Edward loading / unloading skid, 480 volt with controls, freeze dryer serial# MTE1930, built 2004.

  • The MicroSphere is a clean, cost-effective C.A.I for sterile compounding, that is USP <797> compliant.

  • ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.