CSL Behring (CSL654 (FIX-FP) Module 2.3 — Quality Overall Summary, Drug Product 2.3.P.3 Manufacture 2.3.P.3.1 Manufacturer(s) Table 2.3.P.3.1-1 lists the name and address of the sole entity responsible for the commercial scale manufacture of CSL654, labeling, storage, packaging, release and distribution of CSL654, Table 2,3.P,3.1-1: | Manufacture and Testing of CSL654 (DP) ‘Activity ‘Commercial Seale Process Manufacture, release, labeling and storage of CSL6S4_ | CSL Behring GmbH {in Section 32P.3.3.1) Emil-von-Behring-Strasse 76 Final labeling, packaging, QP release and distribution | D-35041 Marburg of CSL6S4 Germany, - FEI: 3003098680 Release testing of DP DUNS: 326530474 CSL Behring GmbH (CSLB) is also responsible for the manufacture of the solvent “Sterile Water for injection” (please refer to the separate Module 3.2,P for Wfl) and supply of medical devices (refer to Section 3.2.R.1) required to reconstitute and administer CSL654 to patients. This site is licensed by both the US and German authorities to manufacture and distribute sterile and non-sterile therapeutic goods for human use. 2.3.P.3.2 Batch Formula One batch of drug substance (~4.0L) is used to manufacture one or more batches of drug product (DP). Batch size varies typically between approximately 1600 and 6400 vials, depending on which presentation is manufactured. An exemplary manufacturing formula for DP Bulk Solution for each CSL654 presentation is provided in the following overview table. ‘These formulae apply to both commercial supplies and any ongoing clinical studies. ‘CSL Behring - Confidential Page 21 of 43 23.P—QOS Drug Product ~ Vers. 2.0CSL Behring (CSL654 (FIX-FP) Module 2.3 — Quality Overall Summary, Drug Product Table 2.3.P-5: Manufacturing Batch Formula for DP Bulk Solution Batches ‘Component 250 10 vial 500 1U vial Target Quantity for 3636 Target ‘Quantity for 6364 Composition * Vials Composition * Vials IX-EP 125 10m 99990010 260 [Um 3640208 1U Trisodium citrate 30mM 0.240 moles 30mM 0.420 moles Polysorbate 80 0.008% wiv 0.640 g 0.030% wiv 4200 g Mannitol 21.3 mg/m 17048 355 mgm 2708 Sucrose 8.6 mg/mL 6888 14.0 mg/mL 196.08 Wr Qs QSt08L @s QSto4L ‘Component 1000 1U vial 2000 1U vial Target ‘Quantity for 3227 Target ‘Quantity for 1614 Composition * Vials ® Composition * Vials AXP 510 1U/mL, 362069410 510 1U/mL, 3621816 1U ‘Trisodium citrate 30 mM 0.213 moles 30mM 0.213 moles Polysorbate 80 0.030% wv 2.1308 0.030% wv 2.1308 Mannitol 35.5 mg/mL 252.05 35.5 mgm, 252.08 Sucrose 14.0 mg/mL 948 14.0 mg/mL 99.48 WF Qs QSto7IL Os Qw71L The target compasition ofthe DP Bulk Solution is not the same as reconstituted CSL6SA (see Section 3.2.P.2.3.3 for explanation) © Based on a fill volume of 2.2 mL. per vial for 250 1U, 500 IU, and 1000 IU presentations and 4.4 mL per vial for the 2000 IU presentation. 2S — Quantum sats 2.3.P.3.3 Drug Product (DP) Manufacturing Drug Product (DP) Manufacturing Process Flow Diagram A high level process flow diagram for CSL654 DP is presented below in Figure 2.3.P-1 with step numbering continuing form the DS manufacturing process flow diagram. ‘CSL Behring - Confidential Page 22 of 43, 23.P—QOS Drug Product ~ Vers. 2.0