TABLE 4.

Quality control summary of antigen expression

Lot	Strain	Bulk lysate					Clones
		Qualitative expression resulta	Quantitative expressionb				Qualitative expressionc		Quantitative expressiond
			Avg	SD	CoV (%)	Result	Correct/total	Result	Avg	SD	CoV (%)	Result
036	SL521	NAe				NA		NA				NA
039	SL524	Pass	0.80	0.05	0.06	Pass	0/15	Fail	NA	NA	NA	Fail
040	SL525	Pass	0.49	0.03	0.07	Pass	15/15	Pass	2.40	0.60	25	Pass
062	SL547	Pass	1.38	0.65	0.47	Pass	15/15	Pass	2.77	0.73	26	Pass

^aQualitative expression of antigen was detected by Western blotting. A passing lot contained detectable antigen in three out of three vials examined.

^bDensitometry was used to quantify expression of antigen. A passing lot contained >25% protein levels of the parental transformant.

^cThe accession lot material was filtered and plated for single rBCGD colonies. Colonies were picked and grown in liquid culture for Western blot analysis of qualitative antigen expression. A passing lot displayed antigen expression in 15 of 15 clones examined.

^dDensitometry was used to quantify the expression of antigen in 15 rBCGD clones. A passing lot achieved <50% covariance (CoV).

^eNA, not applicable.