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@#Objective To evaluate the effects of various polysorbates(PS)on the stability of different types of monoclonal antibody(mAb)drugs.Methods Three types of monoclonal antibodies mAbA(IgG1 proantibody drug),mAbB(IgG1 mAb)and mAbC(IgG1 mAb with Fc N297A mutation)were used as model proteins,and different kinds or contents of PS were added into the mAb formulations respectively to investigate the influencing factors.The effects of PS on the stability of mAb drugs were evaluated comprehensively by detecting the changes of quality attributes,such as protein aggregates and insoluble particles.Results PS20 and PS80 showed no significant difference in inhibiting the formation of aggregates and charge variants in the three mAbs(P>0.05),while the addition of PS80 in mAbB and PS20 in mAbC significantly inhibited the increase of insoluble particles respectively(P<0.05);The content of PS20 showed a significant effect on the detection indexes of charge variants and insoluble particles in mAbC(P<0.05).Conclusion Different types of mAbs have different sensitivities to various kinds and contents of PS.Therefore,when designing the formulation of mAbs,it is necessary to select appropriate kinds and contents of PS to further improve the stability of mAb drugs.
ABSTRACT
@#AIM: To observe the clinical effect of combined anterior and posterior segment surgery in the treatment of vitreoretinal diseases with cataract and the influence on visual acuity recovery and complications after surgery. <p>METHODS: The clinical data of 94 patients(94 eyes)with vitreoretinal diseases complicated with cataract treated in the hospital during the period from January 2016 to December 2017 were collected retrospectively. Fifty of them treated by vitrectomy combined with phacoemulsification were included in Group A, and the other 44 cases treated by one-stage vitrectomy and two-stage phacoemulsification were included in Group B. The improvement rate of visual acuity, best corrected visual acuity(BCVA), changes of intraocular pressure(IOP)and incidence of complications after surgery were compared between the two groups. <p>RESULTS: There was no significant difference in the improvement rate of visual acuity between Group A and Group B(<i>P</i>>0.05). The logMAR BCVA of Group B at the last follow-up was significantly better than that of Group A(0.59±0.17 <i>vs</i> 0.78±0.28, <i>P</i><0.05), but there was no significant difference in IOP between the two groups before and after surgery(<i>P</i>>0.05). The incidence of anterior chamber inflammatory response in Group A was significantly higher than that in Group B(52% <i>vs</i> 20%, <i>P</i><0.05), but there was no significant difference between the two groups in other complications, such as transient high IOP or rubeosis iridis(<i>P</i>>0.05). <p>CONCLUSION: Both concurrent anterior and posterior segment surgery and stage surgery are safe and effective in the treatment of vitreoretinal diseases with cataract. The surgical field of the former is clearer and it is easier to operate while the latter can alleviate the anterior chamber inflammatory response, with certain advantages in improvement of postoperative visual acuity. The appropriate surgical method should be chosen according to the patient's condition.