Company: MDCXW
Filing Date: 2025-11-19
Form Type: S-1
Source: 0001062993-25-016962
Chunk: 111

Company: Medicus Pharma Ltd.
Filing Date: 2025-11-19
Form: S-1
Chunk 111
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ution and viscosity of gels relating to accurate, consistent deposition.

Duration and speed of drying steps affecting water content and flatness of arrays.

Temperature maintained (2-8 C) within centrifuge with impact on drying time and on doxorubicin stability.

Refrigeration of arrays once fabricated.

Post-fabrication, moisture content of arrays reduced to 5%, as measured by loss on drying.

In-Process Controls: D-MNA; P-MNA

| In-Process Controls (Engineering)                          |     | Limit                                                                                                                                                                                                                                                                                               |
| Master mold fabrication via milling process                |     | CAD/CAM of all suitable material rendering required geometry for microneedles                                                                                                                                                                                                                       |
| Production molds fabricated from polydimethyl siloxane     |     | Spun in the same centrifuge to fabricate the arrays such that forces and angles used to make production mold mirror those used to fabricate the arrays. Production molds inspected after every production cycle to ensure integrity of the needle forms-Protocol P171016-1 R3 governs this process. |
| Fabrication of each fixture necessary for array production |     | Protocol P171016-1 R3 provides these parameters                                                                                                                                                                                                                                                     |

| In-Process Controls (Formulation)               
 Dissolution of all materials in gel formulation |     | Limit                                                                                                                                                                         
 Visual inspection                                                                                                                                                             |
| Viscosity of the gel                            |     | Verified by cone plate viscometer torque reading; Brookefield Viscometer DVII+ calibrated at every run                                                                        |
| pH of the gel                                   |     | A pH of between 4.5 and 5.1 is sufficiently acidic. Follow procedure for dilution of gel, use of pH probe, and calculation (Determination of the pH of SkinJect Formulations) |

| In-Process Controls (Array Fabrication) |     | Limit                                                                                                             |
| Deposition and centrifugation.          |     | Deposit approximately 0.5 ml per 2 x 5 production mold. The centrifuge is run for 30 minutes at 5,500 rpm at 15C. |
| Doxorubicin stability                   |     | Temperature maintained within centrifuge at 15C that impacts drying.                                              
 Refrigeration of arrays once fabricated at 2-8°C                                                                  |

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The flow chart, below, describes in more detail the critical steps and manufacturing parameters. A summary narrative of the process is provided on subsequent pages.

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