The MANCO consortium is developing monoclonal antibodies against 2019-nCoV. CR2O is a partner within this consortium and responsible for the clinical operations. For pre-clinical and clinical Phase I study we require a GMP manufacturing company for the production of monoclonal antibodies (IMP) using transient and stable CHO expression systems.

The procurement includes the following:

• vector construction will be outsourced to a third-party laboratory (CHO cells should be provided);

• selected clone will be transferred directly to 10 L scale bioreactor systems via standard fed-batch and purification process with process recoveries of 20-40 %;

• performance of two 10 L bioreactor runs;

• purification at the end of culture or moment of harvest (clarification, UF/DF, two or three chromatography steps (anion exchange, cation exchange, Size exclusion), low pH treatment, virus filtration and a final filtration step;

• QC testing for the purpose of process monitoring (IPC) and GMP release (mAb quantification by Prot A analysis, SDS-PAGE (reduced and non-reduced), Host Cell DNA quantification by qPCR, Host Cell Protein quantification by ELISA, Isoelectric point confirmation (Isoelectric Focusing), Charge variant distribution by HP-CEX, Glycan mapping, pH, Osmolality (buffers used), Sterility, Mycoplasma, Endotoxin);

• scale-up the process to 50 L scale in GMP (no engineering run will be performed);

• prepare required GMP documentation (process description, Bill of Materials (BOM), Bill of Equipment (BOE), Bill of Testing (BOT) and the Drug substance (USP and DSP) batch production records (MPRs));

• Master Cell Bank (MCB) at > 1 x 106 cell/vials (testing to be performed, like sterility, mycoplasma and cell recovery after thawing);

• QC testing (described above);

• certificate of analysis will be prepared and QP will perform the batch disposition;

• Max. 200 vials drug product and max. 100 vials of the MCB;

• each process step will be documented in a study plan and report.