BioDuro currently performs clinical manufacture using its MicraSpray 35, and this new addition is directly scalable and will boost capacity to 15 kg/hr solvent evaporation with industry benchmark control and reproducibility. This processing capability is supported by downstream technologies including roller compaction by Gerteis MiniPactor, blending, and tablet compression that can support batch sizes at the 1-100 kg scale.
"With the continued rise in poorly soluble drug candidates coming out of discovery, the need to provide our clients with technologies that can overcome formulation challenges is a necessity. BioDuro has historically offered spray drying capabilities that enhance solubility of poorly soluble clinical candidates with proven 10-100 fold increases," said Cyrus K. Mirsaidi, president and chief executive officer at BioDuro. "The addition of the SPX Anhydro MicraSpray 150 will allow BioDuro to manufacture cGMP-compliant, pilot scale spray dried material with greater efficiency and reduced cycle times. We are excited to provide a more streamlined, cost-effective solution for our clients' drug development needs."
The MicraSpray 150 will be operationalat the San Diego site in 1Q17, where the company houses its formulation development and clinical manufacturing operations.