SCALE-UP AND TECHNICAL TRANSFER FOR LYOPHILIZED PRODUCTS

A free white paper by Baxter BioPharma Solutions

Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The process is transferred to full-scale freeze dryers that can be 10 times the size of the laboratory-scale equipment. This whitepaper from Baxter BioPharma Solutions addresses these challenges by: • Examining the different designs for lyophilizers • Discussing the in-process data collected during freeze-drying • Presenting a method of determining equipment capability and comparing data between lab-scale and full-scale equipment Considering the differences in equipment design and capability will aid in the scale-up and technical transfer of new processes from laboratory-scale to full-scale and in transfers between manufacturing sites.

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