Service Overviews Background: Pharmacokinetic (PK) studies are required for evaluating new molecular entities and is an essential prerequisite for interpreting preclinical efficacy and toxicology results. Methods: Pharmacokinetic (PK) studies involve administration of drugs through different routes and samples collection. The plasma-drug concentration at different time points can be measured by ELISA and analyzed for PK data by WinNonlin. Advantages: With AAALAC accredited animal room facilities, Sanyou Bio provides you with PK assay development and validation in various species, as well as one-stop services for the high-quality antigen/antibody production. Cases: Sanyou Bio has accumulated rich experience in PK studies, including TNFR2, CD40 and VEGF, etc. Service Contents Service Service Details Client Provides Delivery Time PK study 1. Varied routes of administration 2. Alternative species 3. PK assay development and validation 4. PK analysis Antigen/Antibody/ADC Report 8–10 weeks Anti-drug antibody detection 1. Serum collection 2. Anti-drug antibody detection Antigen/Antibody/ADC Report Antibody production 1. Plasmid construction 2. Expression and purification 3. Quality control Sequence Report Service Highlights 1. High precision PK solution Four molecular types, five animal species, six drug delivery routes and seven types of biological substrates are available for selection, and high-precision PK solutions can be customized according to molecular characteristics. 2. Standardized Laboratory Animal Facility Sanyou Bio has rented SPF/Elite level animal facility, high-quality laboratory mice and meet animal ethics requirements. 3. One-stop high-quality customized service One-stop services from the high-quality antigen/antibody to PK assay development and validation . 4. Fast and high-quality delivery We utilize effective method development, transfer, set-up, and validation techniques to identify and quantitate drug in a timely and cost-effective method. Service Features 1. Diverse molecular types Monoclonal antibody, multi-specific antibody, recombinant protein, ADC drugs, etc. 2. Complete animal species Mouserat, rabbit, dog, minipig, model animal, etc. 3. Various routes of administration Intravenous, oral, subcutaneous, abdominal, muscle, local administration, etc. 4. Comprehensive biological matrix Whole blood, plasma, serum, urine and feces, bile, cerebrospinal fluid, various tissues, etc. 5. Standardized Laboratory Animal Facility Sanyou Bio has rented SPF/Elite animal facility, high-quality laboratory mice and meet animal ethics requirements. 6. Advanced facilities and equipment Case Stastics 1. Pharmacokinetics of Monoclonal antibody Objective: To evaluate the PK characteristics of mAb A in rats. Methods: The mAb were intravenously administered to SD rats through the tail vein, and the serum concentration at different time points were measured by ELISA. Results: Fig. 1 represents the serum concentration-time curve of each rat after the administration of mAb A, The parameters fitted by WinNonlin are shown in Table 1. Conclusions: The results showed that the half-life T1/2, AUC (0-t), and Cmax of mAb molecule A are (34.14±1.67) h, (12358.76±1424.08) h·μg/mL, and (315.17±47.95) μg/mL, respectively. Fig. 1 Serum concentration-time curves of mAb A Table 1 Parameters curves of mAb A Group Animal ID T1/2 (h) Tmax (h) Cmax (μg/ml) AUC 0-t (h*μg/ml) AUC 0-∞ (h*μg/ml) Vd (ml/kg) CL (ml/h/kg) MRT0-∞(h) G1 A i.v. 1 33.56 0.5 285.69 13835.65 13853.76 161.81 1.08 122.32 2 32.84 0.5 370.50 10994.13 11004.53 201.53 1.36 141.76 3 36.02 0.5 289.31 12246.52 12257.52 182.38 1.22 107.45 mean 34.14 0.50 315.17 12358.76 12371.94 181.91 1.22 123.84 SD 1.67 0.00 47.95 1424.08 1428.06 19.86 0.14 17.21 2. Pharmacokinetics of Bispecific antibody Objectives: To evaluate the PK characteristics of bispecific antibody B in rats. Methods: The bispecific antibody molecules were intravenously administered to SD rats through the tail vein, and the serum concentration at different time points was measured by ELISA. Results: Figure 2 represents the serum concentration-time curve of each rat after the administration of B, and the parameters fitted by WinNonlin are shown in Table 2. Conclusions: The results showed that the half-life T1/2, AUC (0-t), and Cmax of bispecific antibody B are (153.11± 6.49) h, (2073.29 ± 80.01) h·μg/mL, and (35.68 ± 4.54) μg/mL, respectively. Fig. 2 serum concentration-time curves of BsAb B Table 2 parameters curves of BsAb B Group Animal ID T1/2 (h) Cmax (μg/ml) Tmax (h) AUC 0-t (h*μg/ml) AUC 0-∞ (h*μg/ml) CL (ml/h/kg) MRT0-∞ (h) G1 B i.v. 1 148.07 33.57 0.50 2165.66 2194.60 2.06 161.45 2 160.43 32.58 0.50 2028.51 2060.49 2.19 167.71 3 150.83 40.90 0.50 2025.70 2053.78 2.01 128.81 mean 153.11 35.68 0.50 2073.29 2102.96 2.09 152.66 SD 6.49 4.54 0.00 80.01 79.44 0.10 20.89