Development and Validation of a Polysorbate 20 Assay in a Therapeutic Antibody Formulation by RP-HPLC and Charged Aerosol Detector (CAD)

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1 LIFE SCIENCES AR ENOUGH? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU EVALUATE PRODUCT PACKAGING? HOW DO YOU DO YOU KNOW WHAT ANALYTICAL TECHNIQUE TO USE? HOW DO YOU SIMULTANEOUSLY TEST FOR TWO BYPRODUCTS? HOW D U EVALUATE STABILITY IN HOT, HUMID ENVIRONMENTS? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU KNOW U IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU RE-OPTIM HANGES? HOW DO YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU MONITOR CHARGE VARIANTS AND DE 232/233>? HOW DO YOU KNOW WHEN TO CONDUCT E/L STUDIES? HOW DO YOU FULLY CHARACTERIZE AN ANTIBODY DRUG C RIANTS AND DEGRADATIONS? HOW DO YOU MAKE DETECT BETTER INSERT POST-TRANSLATIONAL QUESTION DEVELOPMENT HEREDECISIONS MODIFICATIONS? FASTER? HOW DO YOU RE-OPTIMIZE AN HOW DO YOU IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YO OW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU EVALUATE PRODUCT PACKAGING? HOW DO YOU IDENTIFY THE S WHAT ANALYTICAL TECHNIQUE TO USE? HOW DO YOU SIMULTANEOUSLY TEST FOR TWO BYPRODUCTS? HOW DO YOU CHARAC TABILITY IN HOT, HUMID ENVIRONMENTS? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU KNOW IF A BIOSIMI NKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU RE-OPTIMIZE AN ELISA O YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU MONITOR CHARGE VARIANTS AND DEGRADATIONS? HO WHITE PAPER Development and Validation of a Polysorbate 20 Assay in a Therapeutic Antibody Formulation Rowel Tobias, Alan Leslie, William Hanshaw, Paul Lightner, Glenn Petrie, Mike Whalon ABSTRACT The polysorbate 20 content of a therapeutic antibody formulation was quantified directly by RPHPLC and CAD without prior removal of the high concentration of antibody and excipients containing histidine and sorbitol. Isopropanol was added and thoroughly mixed with the antibody formulation at low temperature prior to analysis. The resulting solution was chromatographed on a C4 RP-HPLC and eluted with multiple gradients of methanol to allow for the complete separation of the antibody from the polysorbate 20. The other formulation excipients were eluted at the void volume of the chromatogram. The antibody was eluted at lower concentration of methanol while polysorbate 20 was highly retained and eluted at higher concentration of methanol. The fully resolved peak of polysorbate 20 in the chromatogram was quantified using a calibration curve of polysorbate 20 spiked in human IgG and detected by CAD. Method validation showed assay linearity with correlation coefficient (r) > 0.99 from 0.005% to 0.03% of polysorbate 20. Accuracy by recovery of spiked polysorbate 20 ranged from 92% to 101% at three levels bracketing the nominal concentration of 0.01% of polysorbate 20. Precision of the assay was below 5% RSD at the same three levels of spiked polysorbate 20. Specificity was evaluated in spiked placebo and formulation buffer and showed no interference in the determination of polysorbate 20. Quantitation limit of the assay was % of polysorbate 20. The current HPLC-CAD method was determined to be suitable for the quantitation of polysorbate 20 in drug formulation containing high concentration of antibody. BACKGROUND Polysorbate 20 is typically used in the formulation of antibody therapeutics for its stabilizing effect on the molecule. Most methods used to quantify polysorbate 20 in the presence of high concentration of antibody involved removal of the protein by precipitation or solid phase extraction. In the current method, polysorbate 20 was quantified by direct analysis of the antibody sample without prior removal of the protein. The poster describes the development and validation of a polysorbate assay using RPHPLC and CAD. MATERIALS AND METHODS Materials The main materials used in this project were a genetically expressed recombinant monoclonal antibody therapeutic. The antibody is in highly purified form in a drug substance and product formulations. Equipment The primary equipment used in this project was a Waters Acquity Binary UPLC equipped with a charged aerosol detector (CAD). Sample and Standard preparation For samples and blanks, the antibody or blank was diluted with sample buffer and mixed with pre-chilled isopropanol. All steps were conducted at 2 8 C. For standard, commercially-available Polysorbate 20, NF grade, was diluted with buffer and spiked with human IgG as surrogate for the antibody. The resulting solution was mixed with pre-chilled isopropanol. All steps were carried out at 2 8 C. Instrument Parameters (UPLC) Wavelength 215 nm Sample Temperature 2-8 C Flow rate Column 0.5 ml/min Column Temperature 45 ± 2 C Run Time Mobile Phase A Mobile Phase B Gradient RP-HPLC C4, 5 µm, 300 A column, 50 x 2.1mm 30 minutes Milli-Q Water Methanol 5 to 100% Methanol COPYRIGHT 2015 EAG, INC. Rev M

2 esatin Parameters Environment: 60 (Hz) Enable BCD: Off BCD Polarity: Positive (+) Rate: 2.0 (Pts/Sec.) Description: Channel 1 Scale Factor: 1000 Units mv Time Period # (Minutes) Event Function (Sec) 1 8 Relay Pulse Relay Pulse 0.1 RESULTS AND DISCUSSION I. Linearity Linearity was evaluated with triplicate preparations of five (5) different concentrations within the range equivalent to about 0.005% to 0.030% of spiked polysorbate 20 in matrix. Figure 1. Linearity Plot ESA Corona Ultra CAD or CAD equivalent Nebulizer Temp: 35 C Range: 100 pa Filter: none Gain: Rate: Output Offset: 0% Table 1. Results of the Evaluation of Linearity Retention Time Area % Polysorbate 20 Net Area Polysorbate 20 levels Y-Intercept Slope Correlation Coefficient (r) Net area calculation based on sample peak area minus the matrix blank peak area mean

3 II. Accuracy by Recovery Accuracy by recovery was evaluated by spiking polysorbate 20 equivalent to about 0.005%, 0.010%, and 0.020% in matrix and determining the recovery. Table 2. Results of the Evaluation of Accuracy by Recovery Polysorbate 20 Level Area Net Area 2 % PS20 Level 1 Level 2 Level % Level (by Ratio) 3 (by Curve) 4 Mean % Level %Recovery Mean % Level %Recovery Mean %Recovery Net area calculation based on sample peak area minus the matrix blank peak area mean 3 Ratio calculation based on calibration standard ratios as per Method M Curve calculation based on linearity results obtained during validation

4 III. Precision Precision of the assay was evaluated in one day. Triplicate preparations of spiked polysorbate 20 equivalent to about 0.005%, 0.010%, and 0.020% in matrix were analyzed, and percentage RSD was evaluated at each level. In addition, one replicate with six injections for unspiked antibody drug product and placebo was evaluated. RSD was evaluated. Table 3. Results of the Precision Evaluation of Polysorbate 20 in Matrix Polysorbate 20 Level Retention Time Area 2 Net Area % Level Level Mean %RSD % Level Level Mean %RSD % Level Level Mean %RSD 3 5 Net area calculation based on sample peak area minus the matrix blank peak area mean

5 Table 4 Sample Name Retention Time Area Net Area 6 Sample Unspiked Sample Mean %RSD 5 Placebo Placebo Mean %RSD 1 6 Curve calculation based on linearity results obtained during validation IV. Specificity Specificity was evaluated in triplicate in spiked and unspiked placebo and spiked and unspiked formulation buffer. Polysorbate 20 equivalent to 0.010% was added to spiked preparations. Average Recovery was evaluated. The chromatograms for placebo and formulation buffer which both contains polysorbate 20 showed a peak corresponding to Polysorbate 20 as expected. The spiked polysorbate 20 in either placebo or formulation buffer resulted in a corresponding increase in the polysorbate 20 peak (Fig. 2 and 3).

6 Table 5. Results of the Evaluation of Specificity Sample Name Retention Time %PS20 Area Net Area 7 Placebo Sample Mean %RSD 1 %PS Spiked Placebo Sample Mean %RSD 2 %PS %Recovery 95 Formulation Buffer Sample Mean %RSD 3 %PS Spiked Formulation Bufer Sample Mean %RSD 2 %PS %Recovery 92 7 Net area calculation based on sample peak area minus the matrix blank peak area mean 8 Result calculated by ratio

7 V. LOD Determination VI. LOQ Determination The LOD of the assay was evaluated using the following formula: LOD = SD 3.3( S ) The LOQ of the assay was evaluated using the following formula: LOQ = SD 10( S ) Where SD is the standard deviation of the Y-intercepts and S is the slope of the multiple calibration curves. Table 6. Results of the Determination of LOD Replicate Mean LOD Rep I Rep II Rep III Where SD is the standard deviation of the Y-intercepts and S is the slope of the multiple calibration curves. Table 7. Results of the Determination of LOQ Replicate Mean LOQ Rep I Rep II Rep III Figure 2. Chromatograms for Specificity: Placebo and Spiked Placebo (Low Resolution, Full Analysis Time) Key: Result ID 3511 = Placebo Result ID 3523 = Spiked Placebo The sequence of chromatograms follows the order of the result IDs provided in the figure legend from top to the bottom.

8 Figure 3. Chromatograms for Specificity: Formulation Buffer and Spiked Formulation Buffer (Low Resolution, Full Analysis Time) Key: Result ID 3532 = Formulation Buffer Result ID 3541 = Spiked Formulation Buffer The sequence of chromatograms follows the order of the result IDs provided in the figure legend from top to the bottom. CONCLUSIONS The current HPLC-CAD method was validated to determine its suitability for the quantitation of polysorbate 20 in a therapeutic antibody formulation. The results of the evaluation of linearity, accuracy by recovery, precision, specificity, LOD determination, and LOQ determination met the acceptance criteria specified in the validation protocol. The current method is deemed validated and suitable for the specified intended use at EAG Laboratories.

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