Table 4.

R0.6C current Good Manufacturing Practices (cGMP) proposed release assays.

Attribute	Test	Analytical test method	Proposed specifications
Biochemical	Appearance	Visual Assessment USP <1790>	Clear, colorless solution free of particles
Biochemical	pH	Potentiometric pH USP <791>	7,5–8,5
Biochemical	Total Protein Concentration	SE-HPLC	≥ 0.4mg/ml
Biochemical	Endotoxin	LAL	≤ 100 EU/mg
Identity	Protein ID	Western blot	Positive identification and predominant band at expected molecular weight
Identity/Purity	R0.6C Full-length MW	SDS-PAGE	Predominant band at expected molecular weight ≥ 85%
Identity/Purity	R0.6C Full-length	SE-HPLC	≥ 85% monomer
Potency	Biological Activity	ELISA Folding	≥ 85%
Residual/Purity	Residual DNA	Quant-it	10 pg/µl to 100 ng/µl
Residual/Purity	Host cell protein	Lactococcus WB	<1% w/w
Residual/Purity	Boron/borate	ICP-AES	TBD
Safety	Pyrogen	Rabbit pyrogen testing USP <151>	USP <151>
Safety/Purity	Microbial enumeration	Bioburden USP <61>	USP <61>