Table 2.
Average, SD, and range values for the five nonredundant descriptors for 79 Fvs in 77 marketed antibody-based biotherapeutics and different subsets
| Descriptors | BSA_VL: VH (Å2) | pIFv_3D | RM(µD/µH) (D) | RP | Avg_HI |
| All 79 Fvs from 77 biotherapeutics approved for human use | 797 ± 81 | 7.85 ± 1.24 | 1.09 ± 0.58 | 1.79 ± 0.51 | 0.97 ± 0.37 |
| (618 to 1,046) | (4.28 to 9.5) | (0.09 to 3.29) | (0.98 to 3.32) | (0.3 to 1.92) | |
| 43 Fvs from 42 biotherapeutics approved through 2014 | 787 ± 73 | 7.8 ± 1.4 | 1 ± 0.5 | 1.8 ± 0.5 | 1 ± 0.3 |
| (618 to 964) | (4.3 to 9.5) | (0.1 to 2.6) | (1.1 to 3.1) | (0.4 to 1.9) | |
| 36 Fvs from 35 biotherapeutics approved in 2015 and onwards | 808 ± 88 | 8 ± 0.9 | 1.1 ± 0.7 | 1.7 ± 0.5 | 1 ± 0.4 |
| (630 to 1,046) | (5.3 to 9.5) | (0.2 to 3.3) | (1 to 3.3) | (0.3 to 1.9) | |
| 28 Fvs from 27 biotherapeutics approved for subcutaneous route of administration | 798 ± 68 | 8.1 ± 0.9 | 1.1 ± 0.7 | 1.8 ± 0.5 | 1.1 ± 0.4 |
| (666 to 955) | 5.3 to 9.5 | 0.1 to 3.3 | (1.2 to 3.3) | 0.3 to 1.9 | |
| 51 Fvs from 50 biotherapeutics approved for intravenous route of administration | 792 ± 86 | 7.8 ± 1.3 | 1.1 ± 0.6 | 1.7 ± 0.5 | 0.9 ± 0.3 |
| (618 to 1,046) | (4.3 to 9.5) | (0.3 to 2.7) | (1 to 3.1) | (0.3 to 1.8) | |
| 28 Fvs from 28 approved biotherapeutics with a formulation pH < 6 | 797 ± 68 | 8 ± 0.9 | 1.1 ± 0.7 | 1.6 ± 0.5 | 0.9 ± 0.4 |
| (644 to 943) | (5.1 to 9.5) | (0.3 to 3.3) | (1 to 3) | (0.3 to 1.9) | |
| 45 Fvs from 43 approved biotherapeutics with a formulation pH ≥ 6 | 794 ± 88 | 7.8 ± 1.3 | 1.1 ± 0.6 | 1.9 ± 0.5 | 1 ± 0.4 |
| (618 to 1,046) | (4.3 to 9.5) | (0.1 to 2.6) | (1 to 3.3) | (0.3 to 1.9) | |
| 26 Fvs from 25 approved biotherapeutics with Low concentration (≤10 mg/mL) formulation | 794 ± 106 | 7.6 ± 1.7 | 1.1 ± 0.6 | 1.9 ± 0.5 | 1 ± 0.4 |
| (618 to 1,046) | (4.3 to 9.5) | (0.4 to 2.7) | (1.2 to 3.1) | (0.4 to 1.8) | |
| 27 Fvs from 27 approved biotherapeutics with high concentration (≥100 mg/mL) formulation | 797 ± 65 | 8.1 ± 0.8 | 1.1 ± 0.6 | 1.8 ± 0.4 | 1 ± 0.4 |
| (666 to 943) | (5.5 to 9.3) | (0.1 to 3.3) | (1.1 to 3) | (0.3 to 1.9) |
The routes of administration for three biotherapeutics are intradermal, intramuscular, or intravitreal. Seven biotherapeutics did not have documented pH values. When a range for pH values was provided, the midpoint of this range was used. All the datasets in this table yield similar values for the five nonredundant descriptors, and the difference among them are statistically insignificant (χ2 = 0.091 and a P value = 1.0).