Formulations of Anti-lag3 antibodies and co-formulations of Anti-lag3 antibodies and Anti-pd-1 antibodies
A preparation and antibody technology, applied in the field of therapeutic antibody preparations, can solve problems such as impaired immune response, weakened T cell activation and evasion of immune surveillance
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Embodiment
[0500] Example: Long-Term Stability Studies
[0501] Anti-LAG3 antibodies (SEQ ID NO: 35 and 57, light and heavy chains) were developed as frozen drug products (storage at ≤ -70°C recommended) or refrigerated drug products (storage at 2 to 8°C recommended) , and a stability study was performed in the following examples. Formulation A: 25 mg / mL anti-LAG3 antibody (SEQ ID NO: 35 and 57, light and heavy chains); 50 mg / mL sucrose; 0.2 mg / mL polysorbate 80; 10 mM histidine buffer, pH 5.8; 70 mM L-Arginine-HCl. Thaw frozen drug product at ambient room temperature prior to infusion. The drug product was packaged in disposable sterile 2 mL Type 1 glass vials with 13-mm elastic stoppers and aluminum seals with plastic flip caps. Each vial contains a label claim for 50 mg (2.2 mL fill) at a concentration of 25 mg / mL.
[0502] Stability studies were performed according to ICH guidelines at -80°C ± 10°C (upright), accelerated storage conditions at -20°C ± 5°C (upright), and under stre...
Embodiment 2
[0503] Example 2: Particulate Matter Study
[0504] Particulate matter data for the anti-LAG3 antibody in Formulation A were collected using mHIAC, a modified version of the HIAC method in which the sample volume is smaller. The USP HIAC test method has been used to detect subvisible particulates from 2 microns to 100 microns. Under a laminar flow hood, the solution samples were allowed to come to room temperature and then gently pooled into 50 mL polypropylene tubes to obtain a combined volume of at least 6 mL in the 50 mL polypropylene tubes. The pooled samples were swirled gently and allowed to sit for 30 minutes. Prior to pooling, lyophilized samples were reconstituted with 2.2 mL of water for injection. After reconstitution, samples were allowed to rest at ambient conditions for 30 minutes prior to testing. Prior to sample analysis, the instrument was rinsed five times with 0.22 micron filtered water by inserting the sampling probe tip near the bottom of a 50 mL free-...
Embodiment 3
[0506] Example 3: Titers detected by binding ELISA
[0507] Potency Assay Anti-LAG3 activity in Formulation A was assessed by binding of anti-LAG3 to immobilized recombinant human LAG-3 (rhLAG-3). Dose response curves were generated by using serial dilutions of anti-LAG3 reference material and test samples. Determination of EC using four-parameter logistic curve fitting analysis 50 Values, i.e. the concentration of anti-LAG3 reference material and test sample that exhibited 50% of maximal binding. Relative potencies were calculated by applying parallel-line analysis of dose-response curves in SoftMax® Pro. The potency of the test samples is reported as the geometric mean potency relative to the reference material, with geometric standard deviation and 95% confidence interval.
[0508] The titer stability data of anti-LAG3 at -80°C, -20°C, 5°C, 25°C and 40°C storage conditions are shown in image 3 middle. No changes were observed in the results obtained to date and the da...
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