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Growth of biopharmaceuticals
Growing biopharmaceuticals industry can drive the market growth. Continuous focus on research and development of sophisticated biologic entities to target complex disease pathways has resulted in approval and launch of novel biologics. Engineered for high specificity and efficacy, these biologic drugs have transformed treatment landscapes but includes high costs of development and manufacturing challenges. Most approved biologic drugs require intravenous or subcutaneous injection, owing to their large molecular structure and sensitivity to GI conditions if orally administered.
Constant advancements are being made to produce next-generation monoclonal antibodies, fusion proteins, vaccines and gene and cell therapies. Their production involves fermentation and purification in closed sterile environments. After initial studies confirm safety and efficacy, scaling up of manufacturing becomes crucial to meet growing demands. This involves bulk sterile filling of biologic drug products into vials, prefilled syringes or cartridges from which final dosage forms are prepared for parenteral administration. Bacteriostatic water acts as a sterile solvent used widely during the steps of dissolving, diluting or reconstituting lyophilized biopharmaceutical drug powders post manufacturing.
Rising investments from large pharmaceutical companies as well as smaller biotech startups can lead to increase in number of biologic drugs in clinical pipelines and undergoing FDA/EMA review. With successful approvals, these candidate molecules will require commercial scale sterile filling into final containers from where these will be dispensed for hospital and clinical use. Expanding market landscape of sophisticated biologic therapies can boost demand for bacteriostatic water used during their preparation, handling and administration processes.
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