01

Manufacturing

Our team of highly skilled and knowledgeable specialists who have been working in the field of cell culture for many years are committed to providing you the best possible experience while being your partner in cell culture. We have manufacturing facilities in Germany and Australia, which makes us an ideal partner for both industrial and research organizations. We are EDQM, ISO 9001, and ISO 13485 certified with consistent and reliable production lines in order to continuously provide you with high quality products worldwide. Focusing on sterile liquid handling and dispensing, Serana has the capacity to handle your manufacturing requirements:

02

Quality Control

We regularly perform comprehensive validated quality control analysis and assays in our Quality department following the relevant regulatory guidelines (e.g., European and US Pharmacopeia). You are the most welcomed if you may contact us for any QC services and collaborations in the following fields.

03

Lyophilization

Cycle Development Cycle development begins with understanding the critical temperatures of the formulation by utilizing: + Modulated Differential Scanning Calorimetry (mDSC) + Freeze Dry Microscopy (FDM) Once we have determined the thermal properties of your formulated product, we use the following data sets: + Glass Transition Temperature (Tg) + Eutectic Temperature (Te) + Collapse Temperature (Tc) + Re-crystallization Temperature (Tcry) This is in order to develop the nominal drying conditions for the lyophilization cycle parameters.