13.3 a ppendix c mrna-4650
certificate of analysis

VERSION NUMBER 1.0 Page 1 of 3  
  
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| CERTIFICATE OF ANALYSIS                                                            |                                                         |                                    |          |             |
|------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------|----------|-------------|
| Product Description:  mRNA-4650 Labeled Drug Product                               | Moderna Part #:  85002                                  |                                    |          |             |
| Manufacturer Name: Moderna                                                         | Container/Closure: 2R Vial, 13mm Stopper, 13mm Flip Cap |                                    |          |             |
| Manufacturer Lot #: 85002xxxyy                                                     |                                                         |                                    |          |             |
| Moderna Lot #:  85002xxxyy                                                         | Product Specification #:  SPC-0380                      |                                    |          |             |
| Date of Manufacture: DDMMMYYYY                                                     | Expiry Date: DDMMMYYYY                                  |                                    |          |             |
| Product                                                                            | Method                                                  | Specification                      | Result   | Source Data |
| Attribute                                                                          | (Test Method #/Revision #)                              |                                    |          |             |
| USP <785> Freezing                                                                 |                                                         |                                    |          |             |
| point depression                                                                   | ARN 18-                                                 |                                    |          |             |
| Osmolality                                                                         | 110 - 1510 mOsm/kg                                      |                                    |          |             |
| Moderna                                                                            | 0258-047                                                |                                    |          |             |
| SOP-0279                                                                           |                                                         |                                    |          |             |
| Dynamic Light                                                                      |                                                         |                                    |          |             |
| Scattering                                                                         | ARN 18-                                                 |                                    |          |             |
| Particle Size                                                                      | 50 - 110 nm                                             |                                    |          |             |
| Advantar                                                                           | 00258-036                                               |                                    |          |             |
| Moderna SOP-0107                                                                   |                                                         |                                    |          |             |
| Dynamic Light                                                                      | ARN 18-                                                 |                                    |          |             |
| Polydispersity                                                                     | Scattering                                              | Report results                     | 0258-036 |             |
| Moderna SOP-0107                                                                   |                                                         |                                    |          |             |
| Product                                                                            | Coulter Counter                                         |                                    |          |             |
| Related                                                                            | ARN 18-                                                 |                                    |          |             |
| Advantar                                                                           | Report Results                                          |                                    |          |             |
| Particles                                                                          | 0258-027                                                |                                    |          |             |
| Moderna SOP-0344                                                                   |                                                         |                                    |          |             |
| 0.8 - 10 µ m                                                                       |                                                         |                                    |          |             |
| In Vitro                                                                           | ARN 18-                                                 |                                    |          |             |
| Cell Free Translation                                                              | Molecular weight range                                  |                                    |          |             |
| Translation                                                                        | Moderna SOP-0489                                        | (Target ±35%)                      | 0175-040 |             |
| (Potency)                                                                          |                                                         |                                    |          |             |
| Lipid                                                                              |                                                         |                                    |          |             |
| ldentification                                                                     |                                                         |                                    |          |             |
| SM-102                                                                             | UPLC-CAD                                                | ARN 18-                            |          |             |
| Matches retention time of standard                                                 |                                                         |                                    |          |             |
| Cholesterol                                                                        | Moderna SOP-0502                                        | Matches retention time of standard | 0258-041 |             |
| DSPC                                                                               | Matches retention time of standard                      |                                    |          |             |
| PEG2000-DMG                                                                        | Matches retention time of standard                      |                                    |          |             |
| Lipid Content                                                                      |                                                         |                                    |          |             |
| SM-102                                                                             | 8.3 - 13.9 mg/mL                                        |                                    |          |             |
| UPLC-CAD                                                                           | ARN 18-                                                 |                                    |          |             |
| Cholesterol                                                                        | 3.4 - 5.8 mg/mL                                         |                                    |          |             |
| Moderna SOP-0502                                                                   | 0258-041                                                |                                    |          |             |
| DSPC                                                                               | 1.9 - 3.1 mg/mL                                         |                                    |          |             |
| PEG2000-DMG                                                                        | 0.9 - 1.5 mg/mL                                         |                                    |          |             |
| Report % area and RRT of individual                                                |                                                         |                                    |          |             |
| Lipid                                                                              | UPLC-CAD                                                | ARN 18-                            |          |             |
| impurities                                                                         |                                                         |                                    |          |             |
| Impurities                                                                         | Moderna SOP-0502                                        | 0258-041                           |          |             |
| Report % area of total impurities                                                  |                                                         |                                    |          |             |
| CONFIDENTIAL-DO NOT DISTRIBUTE OUTSIDE OF MODERNA, INC. WITHOUT WRITTEN PERMISSION |                                                         |                                    |          |             |  
VERSION NUMBER 1.0 Page 2 of 3  
  
100 Tech Drive - Norwood, MA 02062 phone 617-714-6500 - fax 617-583-1998
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| Product Description:  mRNA-4650 Labeled Drug Product   | Moderna Part #:  85002                                  |               |        |             |
|--------------------------------------------------------|---------------------------------------------------------|---------------|--------|-------------|
| Manufacturer Name: Moderna                             | Container/Closure: 2R Vial, 13mm Stopper, 13mm Flip Cap |               |        |             |
| Manufacturer Lot #: 85002xxxyy                         |                                                         |               |        |             |
| Moderna Lot #:  85002xxxyy                             | Product Specification #:  SPC-0380                      |               |        |             |
| Date of Manufacture: DDMMMYYYY                         | Expiry Date: DDMMMYYY                                   |               |        |             |
| Product                                                | Method                                                  | Specification | Result | Source Data |
| Attribute                                              | (Test Method #/Revision #)                              |               |        |             |
| Particulate                                            |                                                         |               |        |             |
| Matter                                                 | USP <788> Method 2                                      | ARN 18-       |        |             |
| ≤ 300 per container ≥ 25 µ m                           |                                                         |               |        |             |
| ≥ 25 µm                                                | Moderna SOP-0509                                        | 0258-0020     |        |             |
| ≤ 3000 per container ≥ 10 μm                           |                                                         |               |        |             |
| ≥ 10 µm                                                |                                                         |               |        |             |
| Bacterial                                              | USP <85>, EP 2.6.14                                     | ARN 18-       |        |             |
| ≤ 10 EU/mL                                             |                                                         |               |        |             |
| Endotoxins                                             | Moderna SOP-0352                                        | 0263-040      |        |             |
| USP <71>, EP 2.6.1                                     | ARN 18-                                                 |               |        |             |
| Sterility                                              | No Growth                                               |               |        |             |
| Moderna SOP-0378                                       | 0263-018                                                |               |        |             |
| BacT/Alert                                             |                                                         |               |        |             |
| Rapid Sterility                                        | No Growth                                               | N/A           |        |             |
| Moderna SOP-0508                                       |                                                         |               |        |             |
| The material meets specification:    Yes               |                                                         |               |        |             |
| Revision History:                                      |                                                         |               |        |             |
| 1.0  - Original                                        |                                                         |               |        |             |
| Department                                             | Signature                                               | Date          |        |             |
| QC/QA Review:                                          |                                                         |               |        |             |
| QA Review:                                             |                                                         |               |        |             |  
CONFIDENTIAL-DO NOT DISTRIBUTE OUTSIDE OF MODERNA, INC. WITHOUT WRITTEN PERMISSION
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