White Paper

Switching Delivery Formats: A Lifecycle Management Strategy For Sterile Injectables

Source: Thermo Fisher Scientific

Changing delivery formats for sterile injectable therapies can be a valuable strategy for effectively managing the lifecycle of a drug. Depending on the specific circumstances, switching formats can help bring a drug to market more quickly, make a drug usable in more situations, provide cost efficiencies for the supplier, and ease medication administration to patients.

For example, a growing number of suppliers of biologics are moving their products from bulk glass vials to prefilled syringes due to the ease of use and convenience syringes offer, as well as their ability to eliminate dosing errors and, thus, improve patient safety. With a prefilled syringe, medications can be delivered directly and immediately to the patient, whereas vials require multiple steps prior to injection—flipping the dust cover, cleaning the stopper surface, prepping a syringe, withdrawing the medication, and checking the dose in the syringe—all of which take extra time and introduce opportunity for error.

Several factors must be considered before switching delivery formats, however. These include technical considerations, process and cost implications, supply chain requirements, regulatory requirements, and lead times. A successful transition also requires a thorough understanding of the physicochemical properties of the molecule, the potential interactions with device components, and the impact of formulation and process variables on product stability and quality.

This report provides insight into the benefits and challenges of transferring a therapeutic compound from one injectable format to another, focusing specifically on the following:

  • The material and process information and data needed to inform decision-making
  • The technical and analytical requirements for ensuring product integrity
  • The regulatory and timeline considerations for commercializing the product
access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Outsourced Pharma? Subscribe today.

Subscribe to Outsourced Pharma X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Outsourced Pharma