Director, Segment Marketing, Global Biologics
May 07, 2019
Assessment of any residual solvents or other chemicals remaining after bulk preparation of the biologic will need to be accounted for in the formulation and manufacturing process. Finally, the solubility of the biologic must be assessed, to ensure that the formulation will result in high bioavailability without degrading or otherwise damaging the biologic itself. Ideal formulation conditions are then set, which may include the introduction of excipients, specific parameters that must be maintained during manufacturing and/or the presence of vacuum during certain steps.
In addition, the mechanics of administering the biologic injectable must be considered. The solution concentration will affect the dose. The route of administration may also impact choice of excipients, depending on whether the biologic is to be introduced intramuscularly, intravenously, or via subcutaneous injection. Sub-cutaneous delivery using an auto-injector or wearable device means registering as a combination product. This is a new area for many companies as they try to understand and successfully navigate the complexities of this area without negatively impacting their registration deadlines and drug approval targets.
West offers the SmartDose® platform of drug delivery devices to meet a variety of wearable, subcutaneous delivery needs. Click here to learn more about how the platform can enable delivery of your drug product. In addition, West can help you Simplify the Journey™ with our new Integrated Solutions Program. Click here to learn more about packages that include a containment and delivery system, analytical testing, regulatory support and contract manufacturing/design options .
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc., in the United States and other jurisdictions Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions