Company: MDCXW
Filing Date: 2025-11-19
Form Type: S-1
Source: 0001062993-25-016962
Chunk: 116

Company: Medicus Pharma Ltd.
Filing Date: 2025-11-19
Form: S-1
Chunk 116
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 electron beam sterilization of the arrays. The arrays are then transported by a same-day courier service from Ebeam Services to Intertek Pharmaceutical Services ("Intertek"), who performs four functions:

1)places the majority of the arrays in stability storage;

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2)ships a designated number of arrays to Nelson Laboratories for endotoxin and bioburden testing;

3)initiates analytical and other testing of the arrays within Intertek; and

4)ships a designated number of the arrays to Clinigen on quarantine for distribution to the clinical sites when the arrays have passed quality control/quality assurance.

<div align='center'>Figure 9. Release procedures for Microneedle Arrays</div>

Figure 10 indicates the types of tests performed for release of the product.

<div align='center'>Figure 10. Certificate of Analysis qualifying the release of microneedle arrays</div>

The essential settings for the phase appropriate, GMP-validated HPLC method for identity, assay/purity, related substances, and content uniformity testing performed by Intertek are provided below.

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While Intertek is performing this testing, Nelson Laboratories is performing the following work to assess microbiological safety:

Endotoxin testing: The Bacterial Endotoxin Test, or Lumulus Amebocyte Lysate ("LAL") Test, quantifies endotoxins that are part of the cell wall of gram-negative bacteria. LAL testing is performed on samples at T0 and subsequent stability timepoints.

Sterility/bioburden: The arrays are also dissolved and the contents are cultured to determine if the sterilization eradicated all bacteria and yeasts from the samples. This test is performed on samples at T0 and subsequent stability timepoints.

All of the results of these tests and others such as moisture content and physical assessment are then collated and appended to a certificate of analysis ("COA"), which, when signed by qualified persons, allows the release of the product by Clinigen Clinical Services, who has stored the product under quarantine until they receive the signed COA authorizing release to the clinical site.

Preclinical Development of D-MNA

Preclinical Test Material

GMP-quality doxorubicin was used for all preclinical studies (murine local lymph node assay, rabbit irritation and pyrogenicity study, and Yucatan minipig local tolerance study). The nonclinical arrays were produced under non-GMP conditions;