Plasma protein products, essential drugs for various clinical diseases, are therapeutic biological products extracted from healthy human plasma. The research and development of new plasma protein products, led by United States and European, has been widely deepened and enhanced. Therefore, accelerating the development of new plasma protein products in China is of great significance. This review summarizes the research and development of plasma protein products that have been marketed abroad but have not produced in China, as well as analyzes the difficulties and prospects of the development of plasma protein products in China.

【Objective】 To establish a method for detecting human immunoglobulin Fc function based on surface plasmon resonance technology. 【Methods】 Based on the characteristic that FcγRI can be binded to the Fc segment of IgG, the affinity constant of the sample was detected by surface plasmon resonance, and its Fc function was the KD ratio of the sample to the standard. The method was validated for specificity/specificity, precision and robustness. The method and the pharmacopoeia method were used to detect the Fc function of 30 human immunoglobulins, and the correlation and consistency of the detection results were analyzed. 【Results】 The method validation results showed that this method has strong specificity/specificity (t values were 0.15, 0.22, both P>0.05), good precision (CV value 5.37%~10.69%) and good robustness (CV value 10.06%). The detection results of this method and the pharmacopoeia method have high correlation (r=0.96, P<0.05) and high consistency (Bias-2.060, 95% Limits of Agreement-5.628~1.508). 【Conclusion】 A method for detecting human immunoglobulin Fc function based on surface plasmon resonance has been successfully established.

【Objective】 To screen the sterilizing-grade filters applicable for production of human coagulation factor Ⅷ/von Willebrand factor complex(FⅧ/VWF)and study the sterilization filtration process. 【Methods】 Four sterilizing-grade filters for FⅧ/VWF were evaluated through indicators such as filtration capacity, filtration flux, recovery rate of FⅧ activity, recovery rate of VWF activity, recovery rate of VWF antigen, recovery rate of protein and VWF molecular distribution. The sterilizing-grade filter with the best filtration performance was selected for further study. The study was designed by general full-factor design to determine the appropriate filitered protein concentration and filitered speed range through evaluating the total filtered protein amount, recovery rate of protein and filtration efficiency, and then the process operation parameters was determined. 【Results】 The filtration flux of Sartobran P, Sartopore 2 XLG, Sartopore Platinum and Sartopore 2 XLI were 1.71±0.01, 1.80±0.01, 1.34±0.01, and 1.81±0.04 L·(m²)^-1·min^-1, respectively; the recovery rates (%) of FⅧ activity were 97.09±2.82, 99.22±0.99, 96.87±1.85 and 93.76±1.21, respectively; the recovery rates (%) of VWF activity were 98.12±1.42, 99.95±1.85, 94.80±1.62 and 92.09±1.67, respectively. Between Sartopore 2 XLG and Sartobran P, the difference of filtration flux (P<0.001) was statistically significant; between Sartopore 2 XLG and Sartopore Platinum, the differences of the filtration flux (P<0.001) and VWF potency recovery rate (P<0.05) were statistically significant; between Sartopore 2 XLG and Sartopore 2 XLI, the differences of FⅧ potency recovery rate (P<0.01) and VWF potency recovery rate (P<0.01) were statistically significant. The optimal process operating space of Sartopore 2 XLG was protein concentration of 0.45-0.58 mg/mL, and filtration rate of 1.48-2.95 L·(m²)^-1·min^-1. 【Conclusion】 Sartopore 2 XLG is the most suitable filter for the production of FⅧ/VWF and the DoE test proves that it has good process operation space.

It is necessary to improve the stability of human serum albumin in response to the complex temperature, light and other conditions during the manufacture and storage. In this paper, the stabilization effect and simple stabilization mechanism of ligands on albumin were described from the perspective of ligand binding to albumin.Through review and comparison, it can be concluded that the common ligand sodium octanoate mainly plays a role in improving thermal stability, and the common ligand N-acetyl-L-tryptophan mainly plays a role in improving antioxidant activity, N-acetyl-L-methionine has better antioxidant and anti-photooxidation than N-acetyl-L-tryptophan.

【Objective】 To study the effect of different concentrations of heparin, ATⅢ or a mixture of heparin and antithrombin Ⅲ (ATⅢ) (1∶1)on the activity of human coagulation factor Ⅸ (FⅨ). 【Methods】 The heparin or heparin/ATⅢ with different concentrations were added into human coagulation Ⅸ products or human prothrombin complex (PCC) to prepare heparin or heparin/ATⅢ samples, containing 0, 0.1, 0.3, 0.5, 0.8, 1, 2 and 4 IU per unit. ATⅢ with different concentrations were added into FⅨ or PCC to prepare ATⅢ samples containing ATⅢ 0, 0.1, 0.5 and 1 IU per unit. The FⅨ activity of the samples prepared was tested by one-stage coagulation method. Then corresponding amount of protamine sulfate were added to neutralize heparin or heparin/ATⅢ to detect the FⅨ activity again. Their influence of heparin, ATⅢ and heparin/ATⅢ with different concentrations on the activity of FⅨ were analyzed. 【Results】 When the content of heparin or heparin/ATⅢ was 0, 0.1, 0.3 and 0.5 IU per unit of FⅨ, the detection results of FⅨ titer in samples were consistent. When the content of heparin or heparin/ATⅢ per unit of FⅨ was 0.8, 1, 2 and 4 IU, the detection results of FⅨ titer were all lower than those of samples without heparin. When the ATⅢ content was 0, 0.1, 0.5 and 1 IU, the FⅨ titer of the samples was consistent. 【Conclution】 When the content of heparin or heparin/ATⅢ in the product is less than or equal to 0.5 IU per IU of FⅨ, the step of protamine sulfate adding could be omitted as it has little effect on FⅨ activity. When >0.5 IU per IU of FⅨ, however, protamine sulfate adding, to neutralize heparin, is necessary before FⅨ activity testing.

Objective To explore the clinical characteristics of the distant pain associated with osteoporotic vertebral compression fracture (OVCF) and the effect of percutaneous kyphoplasty (PKP) on the distant pain. Methods Ninety-eight patients with OVCF were treated with PKP at our department from June 2013 to October 2016. They were divided into 2 groups according the their pain associated with OVCF. There were 34 patients in the distant pain group and 64 ones in the non-distant pain group. The sites of distant pain were recorded. The visual analogue scale (VAS) and Oswestry disability index (ODI) were used to assess the pain and disability severities preoperatively and postoperatively. Results The incidence of distant pain was 34.7% (34/98). The distant pain was located at the lumbosacral area in 24 cases, at the hip in 14 cases, at the iliac crest in 14 cases, at the thigh in 14 cases, and at the calf in 2 cases. The distant pain group had a significantly longer course of preoperative disease (15.3 ± 12.9 d) than the non-distant pain group (10.3 ± 7.0 d) (P <0.05). The postoperative VAS and ODI were significantly improved after surgery in both groups (P <0.05). There were no significant differences between the 2 groups in preoperative or postoperative VAS or ODI (P > 0.05). Conclusions The incidence of distant pain may be high in OVCF patients. The most common sites for distant pain are the lumbosacral area, hip, iliac crest and thigh. PKP can effectively relieve the distant pain associated with OVCF.

Objective To evaluate surgical treatment of chronic tibial osteomyelitis of Cierny-Mader type Ⅳ with Ilizarov technique and lesion osteotomy. Methods From January 2010 to May 2016, 39 patients with chronic tibial osteomyelitis of Cierny-Mader type Ⅳ were treated at our center. They were 33 males and 6 females, 8 to 54 years of age (average, 33.8 years). After debridement and lesion osteotomy, the tibia was fixated with Ilizarov external fixator. Bone was transported to the bone defect after corticotomy was performed on the proximal and/or distal tibial metaphyses simultaneously. Bifocal corticotomy was per-formed in 11 cases, proximal corticotomy in 21 cases, and distal corticotomy in 7 cases. The transport began 3 to 5 days after operation at a speed of 0.5 to 1.0 mm/d initially. The speed was lowered according to the bone healing and pain. Radiographic examination was done every 2 weeks to observe transporting deviation and osteogenesis in the transporting area. The transporting was adjusted whenever any abnormality was observed. The bone transporting lasted for 50 to 130 days (average, 62.4 days). Results The patients were fol-lowed up for 11 to 49 months (average, 21 months). All the soft tissue wounds healed uneventfully and there was no relapse of osteomyelitis. The bone defects in the 32 cases were reconstructed primarily. Nonunion of fracture ends happened in 5 cases and nonunion of the bone lengthening zone in 2 cases. The 7 cases of nonunion were healed after secondary bone grafting. Malalignment happened in 5 cases, 4 of which responded to timely adjustment of the external fixation and one of which had to receive secondary bone grafting after failure in adjustment of the external fixation. Ankle joint dysfunction occurred in 7 cases, 5 of which re-sponded to functional exercise and 2 of which accepted joint dysfunction because they refused surgery after unsatisfactory functional exercise. Pin tract infection of different severities occurred in 9 cases, one of which was treated by replacement of the K-wires under local anesthesia and the other 8 of which responded to rein-forced dressing change. Conclusions Chronic tibial osteomyelitis of Cierny-Mader typeⅣcan be treated by Ilizarov technique and lesion osteotomy. However, the Ilizarov technique should be improved because of the risks of multiple complications which can be reduced significantly by strengthening postoperative instruction, nursing, and regular follow-up.

【Objective】 To explore the factors that affect the coordinated development of blood banks and apheresis plasma collection banks (hereinafter referred to as plasma banks), and explore feasible measures for the coordinated development of blood banks and plasma banks. 【Methods】 The blood information management system and blood source information management system were used to retrieve related data of blood and plasma donation from 9 cities in Shandong province from 2017 to 2021. The number of blood donors and plasma donors and the intersection of them were analyzed. The data analysis was performed using chi-square test, and a questionnaire survey was conducted to investigate the policies and information status, as well as expectations for coordinated development for blood and plasma donation. 【Results】 From 2017 to 2021, the total number of blood donors in 9 cities was higher than that of plasma donors, both have been increasing year by year, and the increase in plasma donors was significantly higher than that of blood donors (131.78% vs 23.90%, P<0.05). The intersection proportion of blood and plasma donors had increased from 0.45% in 2017 to 1.04% in 2021, with an increase of 131.11%. Among the administrative regions where the participating blood and plasma banks located, 94.2% have not released relevant policy to promote the coordinated development of blood and plasma donation. The majority (63%) expected blood banks and plasma banks to be set at a distance more than 50 km apart. The top four functional requirements for the interconnection between blood banks and plasma banks management information system were blood test results (94.61%), ID number (87.54%), blood and plasma donation records (85.51%) and health consultation/examination results (82.15%). The top four elements of coordinated development between blood and plasma banks were policy support (96.25%), information networking (92.36%), top-level design (87.44%) and cultural construction (86.58%). 【Conclusion】 The number of donors who donate both blood(mainly whole blood) and plasma has been increasing year by year, which deserves our close attention. To achieve the coordinated development of blood donation and plasma donation, policy support is the most crucial and fundamental means. Establishment of a standard system and the share of blood and plasma donation information is necessary for blood informatization construction. It was critical to promote the coordinated development of blood and plasma donation and ensure blood safety with improving legislation, formulating policies for coordinated development, strengthening top-level design, standardizing the publicity of blood and plasma donation and establishing the idea that blood and plasma donation are equally honorable.