BioDuro Increases Spray Dried Drug Product Manufacturing Capacity
News Nov 10, 2016
BioDuro LLC has announced the addition of an SPX Anhydro MicraSpray 150, to its suite of established GMP spray drying capabilities that include an SPX Anhydro MicraSpray 35 and Buchi B90 Nano in its San Diego facility. This expanded capacity will support larger scale spray drying programs to 100 kg scale as BioDuro continues pursuit of its clients’ clinical success.
“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 CEO 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.”
While BioDuro currently performs clinical manufacture using its MicraSpray 35, 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.
“Expanded capacity will enable formulation and clinical trial material preparations, particularly those with solubility challenges, and enhance BioDuro’s flexibility to support client programs from preclinical to Phase 1 to 3 clinical development,” said Magdalena Mejillano, General Manager, Global CMC Solutions at BioDuro. “We take great pride in the success of our clients’ programs and look forward to continued, collaborative growth as these programs expand.”
The MicraSpray 150 will be operational at BioDuro’s San Diego location in Q1 of 2017, where the company houses its formulation development and clinical manufacturing operations. In addition to spray-dried dispersion (SDD), BioDuro offers an array of formulation enabling technologies that include hot melt extrusion (HME), complexation, drug layering, particle sizing, and granulation.
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