Table 4.
Monoclonal antibodies availing lyophilization under various phases of clinical trials
| Category | Aim of the study | Condition | Intervention | Phase | Lyophilized details |
|---|---|---|---|---|---|
| Monoclonal antibody | Efficacy and Safety in Participants with Multiple Myeloma | Drug: Belantamab mafodotin frozen liquid|Drug: Belantamab mafodotin lyophilized powder | Phase 2 | Belantamab mafodotin lyophilized powder | |
| Monoclonal antibody (novel humanized anti-CD37 protein therapeutic) | Multiple-dose escalation study to determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and bendamustine and to determine a safe dosing regimen for the combination | B-cell Small Lymphocytic Lymphoma Recurrent | Drug: TRU-016 (Otlertuzumab)|Drug: Bendamustine|Drug: Rituximab | Phase 1 | Otlertuzumab (TRU-016) lyophilized solution for infusion |
| Monoclonal antibody covalently linked to the cytotoxic agent drug | safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer | Breast Cancer | Drug: Trastuzumab emtansine | Phase 2 | Trastuzumab emtansine as a single-use lyophilized formulation in a glass vial |
| Monoclonal antibody against human immunoglobulin E | To investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation. | Allergic Asthma | Drug: omalizumab at a dose of 0.016mg/kg/IU/mL|Drug: Placebo | Phase 4 | Omalizumab as lyophilized, sterile powder |
| Hydrolytic lysosomal glucocerebroside-specific enzyme | safety and effectiveness of velaglucerase alfa in patients with type 3 Gaucher disease. | Gaucher Disease, Type 3 | Biological: velaglucerase alfa | Phase 1|Phase 2 | lyophilized powder, intravenous infusion |
| Anti-interleukin-5 (IL-5) monoclonal antibody | compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug product in two different devices with the reconstituted lyophilized drug product | Asthma | Biological: Lyophilized mepolizumab|Biological: Liquid mepolizumab|Device: Prefilled autoinjector|Device: Prefilled Safety Syringe | Phase 3 | Lyophilized Drug Product |
| Anti-interleukin-5 (IL-5) monoclonal antibody | Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects with Severe Hypereosinophilic Syndrome | Hypereosinophilic Syndrome | Drug: Mepolizumab 300 mg|Drug: Placebo matching mepolizumab|Drug: Active OCS capsules (5 mg prednisolone or prednisone) |Drug: Placebo matching OCS capsules | Phase 3 | Lyophilized powder for injection |
| Humanised, agonistic IgG1 anti-OX40 monoclonal antibody | safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to participants with selected advanced or recurrent solid tumors. | Neoplasms | Drug: GSK3174998|Drug: Pembrolizumab | Phase 1 | Lyophilized powder |
| Human IgGκ monoclonal antibody | safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis. | Acute Gouty Arthritis | Drug: Canakinumab pre-filled syringe|Drug: Canakinumab lyophilized powder|Drug: Triamcinolone Acetonide|Drug: Placebo | Phase 3 | Lyophilized powder |
| Fully human immunoglobulin G1 lambda (IgG1λ) monoclonal agonistic antibody (mAb) targeting TRAIL-R1 | efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma. | Carcinoma, Hepatocellular | Drug: Mapatumumab|Drug: Placebo|Drug: Sorafenib | Phase 1|Phase 2 | lyophilized formulation |
| PEGylated anti-TNFα monoclonal antibody | safety of long-term therapy with Certolizumab Pegol | Crohn Disease | Biological: Cimzia | Phase 3 | lyophilized powder formulation |
| Monoclonal antibody against human immunoglobulin E | to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults with Mild Allergic Asthma | Allergic Asthma | Drug: omalizumab|Drug: placebo | Phase 2 | lyophilized formulation of omalizumab |