Issue link: https://resources.nanotempertech.com/i/1267034
8 Formulation factors As mAb are usually administered by injection, they are commonly formulated as lyophilized powders for reconstitution, or as solutions for direct injection. Various excipients are required to stabilize mAb during manufacturing, processing, fill and finish, and storage. Appropriate excipients enable development of novel therapies and robust pharmaceutical products. When deciding which excipients to add to biologic formulations, researchers must take the following factors in these general ranges into account 6 . • Buffer (type and concentration): 5-100 mM • pH range: from 4.0-8.0 • Stabilizer: e.g., cryoprotectants 1-10% • Salt concentration: 0-300 mM • Surfactant concentration: 0.01-0.1% (w/v) Types of excipients Excipients have several roles in mAb therapeutic formulations, from enhancing solubility, process, and shelf-life stability, to controlling pH and toxicity 7 . New excipients are always being considered; The International Pharmaceutical Excipients Council (IPEC)—an industry association that contributes to the development and harmonization of international excipient standards—provides guidance concerning excipients. Excipient categories to consider when developing mAb and other biologic formulations include 6 • Buffers: Acetate, Succinate, Citrate, Histidine, Phosphate, Tris • Amino acids: Arginine, Aspartic Acid, Glutamic Acid, Lysine, Proline, Glycine, Histidine, Methionine • Stabilizers and bulking agents: Lactose, Trehalose, Dextrose, Sucrose, Sorbitol, Glycerol, Albumin, Gelatin, Mannitol, Dextran • Surfactants: Tween 20, Tween 80, Pluronic F68 • Preservatives: Benzyl alcohol, m-cresol, Phenol, 2-phenoxyethanol • Chelators: Ca 2+ , Zn 2+ , EDTA • Others: Salts, Polyanions, Cyclodextrin-based excipients During the formulation development process, researchers test several conditions at various time points and temperatures to achieve the final formulation.