Table 1.
Proteomic characterization results of the bulk cellular materials (i.e., FE002-Ten primary progenitor tenocyte lysate) used for lyophilized API manufacture. The 20 most abundant proteins 1 were reported hereunder, in a decreasing order of appearance as classified by the relative detected quantities, along with the theoretical protein molecular weights and the corresponding normalized detected protein quantities. The calculated protein quantities in API unitary doses were listed for each entry. The relative protein quantity detected and normalized to the unfractionated cell lysate total protein content was expressed in pg of the specified protein per mg of the whole cell lysate total protein content. The calculated quantity of proteins in an API unitary dose (i.e., corresponding to 1.5 × 106 cell unit equivalents) was expressed in pg of the specified protein per lyophilizate vial. API, active pharmaceutical ingredient; Da, Daltons.
| Protein Abbreviated Name (Protein Full Name) |
Theoretical Protein Molecular Weight 2 (Da) |
Normalized Relative Protein Quantity in the Cell Lysate (pg/mg) | Calculated Protein Quantity in an API Unitary Dose (pg/vial) |
|---|---|---|---|
| MMP-2 (72 kDa type IV collagenase) | 72,000 | 8504 | 2412 |
| TIMP-2 (Metalloproteinase inhibitor 2) | 21,000 | 8087 | 2294 |
| sEGFR (Soluble epidermal growth factor receptor) | 110,000 | 6807 | 1931 |
| TIMP-1 (Metalloproteinase inhibitor 1) | 28,000 | 4155 | 1179 |
| sgp130 (Soluble gp130) | 100,000 | 3751 | 1064 |
| FGF-2 (Fibroblast growth factor 2) | 18,000 | 2856 | 810 |
| HGF (Hepatocyte growth factor) | 83,100 | 1859 | 527 |
| sTNFRI (Soluble tumour necrosis factor receptor type I) | 18,300 | 743 | 211 |
| MMP-13 (Collagenase 3) | 54,000 | 737 | 209 |
| IL-1Ra (Interleukin-1 receptor antagonist protein) | 17,300 | 383 | 109 |
| FST (Follistatin) | 38,000 | 308 | 87 |
| MMP-7 (Matrilysin) | 28,000 | 190 | 54 |
| FGF-1 (Fibroblast growth factor 1) | 15,500 | 155 | 44 |
| IL-23 (Interleukin-23) | 55,000 | 115 | 33 |
| ENG (Endoglin) | 64,000 | 102 | 29 |
| MDC/CCL22 (C-C motif chemokine 22) | 7800 | 75 | 21 |
| Flt-3L (Fms-related tyrosine kinase 3 ligand) | 20,000 | 73 | 21 |
| VEGF-A (Vascular endothelial growth factor A) | 27,000 | 66 | 19 |
| MCP-1 (C-C motif chemokine 2) | 8700 | 54 | 15 |
| sIL-6R (Soluble IL-6 receptor) | 42,250 | 48 | 14 |
1 Other proteins which were detected in the samples by the multiplex proteomic analyses were listed in Table S5. 2 The theoretical protein molecular weights were determined in silico based on protein structure projections.