Harnessing ceramic hydroxyapatite as an effective polishing strategy to remove product- and process-related impurities in bispecific antibody purification

Bioresources and Bioprocessing

Table 1 Product purity (%), HCP and HCDNA contents in loads, and product pools of Molecules A, B, and C after Protein A, CEX, CHT-P, and CHT-NaCl chromatography

Molecule	Protein samples	Purity (%)			HCP (ppm)	HCDNA (ppm)
Molecule	Protein samples	HMW	Main	LMW		HCDNA (ppm)
A	HCCF	21.32	35.39	43.29	1,012,636	100,223
	Post Protein A	4.73	93.55	1.72	5839	39
	Post CEX	3.23	95.74	1.03	301	0.008
	Post CHT-P	1.82	96.49	1.68	378	N.D
	Post CHT-NaCl	0.53	97.49	1.98	73	N.D
	Post CHT-NaCl (optimized-PLW)	0.47	98.49	1.04	62	0.009
B	HCCF	30.98	34.18	34.84	391,286	51,832
	Post Protein A	4.10	91.69	4.22	4578	17
	Post CEX	2.85	94.81	2.34	43	0.006
	Post CHT-P	0.88	96.08	3.04	155	N.D
	Post CHT-NaCl	0.28	96.46	3.26	34	N.D
	Post CHT-NaCl (optimized-PLW)	0.15	97.36	2.50	12	N.D
C	HCCF	25.16	30.97	43.87	380,062	108,858
	Post Protein A	2.28	91.47	6.25	1304	7
	Post CEX	2.04	92.90	5.05	243	0.026
	Post CHT-P	0.39	97.70	1.91	70	N.D
	Post CHT-NaCl	0.33	95.36	4.31	35	0.012