About

About Sartorius Xpress Biologics Sartorius Xpress Biologics (SXB) is a biotech company proposing contract services for the production of recombinant proteins, antibody fragments and plasmid DNA for preclinical and clinical applications specific to the therapeutic, vaccine and diagnostic markets (human & veterinary). Both, the production scale (from 100 mg up to 40 g) and the quality of the biologics (R&D, GLP and GMP grade material) proposed by Sartorius Xpress Biologics are adapted for in vitro and in vivo pre-clinical and clinical validation of the biologics (proof-of-concept, early safety, potency, efficacy, Tox…). Moreover, Xpress Biologics processes are free of charge in terms of license or royalty fees and take into account the industrial (scale-up) and regulatory requirements for the manufacturing of GMP grade material. The services proposed by Sartorius Xpress Biologics are based on 4 technological platforms: - molecular biology for the design of microbial expression systems (E. coli & P. pastoris), - fermentation development with 5L fermenters for production yield optimization and scale-up development and production with 50L fermenter, - downstream process development including extraction, clarification, liquid chromatography, tangential flow filtration…, - quality control (HPLC, spectrophotometry…). The company offers the following services: - project development, experimental design, risk analysis, consultancy, - design and construction of expression systems, - development of fermentation and purification methods, - development of analytical tools, - process scale-up study, - production of biologics (from 100 mg up to 40 g), - process scale-up study. Sartorius Xpress Biologics has extensive experience in the production of plasmid DNA (pDNA) and proposes custom manufacturing of Discovery Grade (DG), Research Grade (RG), High-Quality (HQ), and GMP grade pDNA. The DG grade manufacturing service is based on the production of up to 100 mg of purified pDNA using an optimized shake-flask production combined with an advanced small-scale purification process leading to highly purified pDNA with low endotoxin content (<10 EU/mg of pDNA). The RG, HQ and GMP grade manufacturing services are based on the use of Sartorius Xpress Biologics large-scale pDNA fermentation process combined with a unique pDNA downstream process based on a single chromatographic step for the purification of highly purified supercoiled pDNA with an endotoxin content generally below 1 EU/mg of pDNA. The manufacturing of linearized pDNA is also offered. Different fermentation processes have been developed to produce different types of plasmid backbones such as large backbones with or without duplicated sequences, LTR/ITR containing backbones to produce LV and AAV, mRNA plasmid containing the polyA tail, and low copy number large DNA vaccine backbones that may be prone to recombination events and unstable or toxic for E. coli. The production yields range from 300 mg/L for very challenging plasmids to over 1 g/L for standard plasmids. Sartorius Xpress Biologics has developed a proprietary cell lysis and DNA extraction process allowing the use of a single chromatographic step to purify supercoiled pDNA reaching all the quality attributes as recommended by the regulatory authorities, FDA and EMA. This process has been shown to be applicable to any type of pDNA if the fermentation pDNA productivity is higher than 200 mg/L. Sartorius Xpress Biologics pDNA manufacturing platform is based on the following 4 technological platforms: - Molecular biology: for the production of different types of cell banks including Glycerol Cell Bank (GCB), Research Cell Bank (RCB), and GMP Master and Working Cell Banks (MCB/WCB), which are required to manufacture RG, HQ, and GMP grade pDNA respectively. - Fermentation (USP): including 8x 5L fermenters for the manufacturing of RG pDNA batches, 2x 15L and 1x 50L fermenters for the manufacturing of HQ grade batches and 1x 15L and 1x 50L fermenters for the manufacturing of GMP grade batches. The implementation of a 100 L GMP fermentation suite is also planned for 2026 to produce GMP grade batches up to 40 g. - Purification (DSP): including different Akta purification systems adapted to the different fermentation scales and ultra/diafiltration systems based on membrane and hollow fibers technologies to purify and formulate the pDNA. - Quality controls: including all In Process (IPC) and product (QC) analytical methods required for the production of RG, HQ and GMP grade materials.