Table 2.

Comparison of quality metrics assessed for purified BG505 DS-SOSIP.664 material from two 50 L GLP and one 250 L cGMP bioreactor runs^*.

Attribute	50 L Run 1 (Tox Lot)	50 L Run 2	250 L cGMP Run (Phase 1)
Yield (total amount of purified trimer, g)	3.4	4.0	9.6†
Concentration	0.57 mg/mL	0.59 mg/mL	0.506 mg/mL
Purity by SEC (% Main Peak)	99.74%	99.4%	100%
Residual host cell protein	< 150 ng/mL (< 263 ppm)	< 30 ng/mL	< 30 ng/mL
Residual DNA	< 30 pg/mL	< 6.0 pg/mL	< 6 pg/mL
Endotoxin	< 8.8e-5 EU/μg	< 8.8e-5 EU/μg	< 0.0001 EU/μg
Bioburden	0 CFU/10 mL	0 CFU/10 mL	0 CFU/10 mL
PH	7.24	7.30	7.20
Appearance	Clear, colorless, no visible particles	Clear, colorless, no visible particles	Clear, colorless, no turbidity; essentially free of particulates
Protein Mass (SEC-MALS)	215 kDa	213 kDa	203 kDa
Glycan Mass (SEC-MALS)	129 kDa	128 kDa	122 kDa
PS80	< 15 ppm	< 15 ppm	< 15 ppm
TnBP	< 3 ug/mL	< 3 ug/mL	< 3 ug/mL
Melting temperature (Tm) by DSC	77.0	76.7	77.3

^*Abbreviations include SEC: Size exclusion chromatography, SEC-MALS: Size exclusion chromatography-multi angle light scattering, PS80: polysorbate 80, TnBP: Tri-n-butyl phosphate, DSC: Differential scanning calorimetry, EU: endotoxin units, CFU: colony forming units, GLP: Good laboratory practices, cGMP: current good manufacturing practices.

^†Actual output, accounting for large volume in-process sampling to suffice IND-enabling studies.