The world biologics market continues to rise and many new biologics have a demand for lyophilized drugs, due to the unstable nature and limited shelf life of many biopharmaceutical compounds.
Given the ever increasing costs of drug development and the increasing launch of parenteral lyophilized products, it is even more fundamental to make decisions not only about the compound, but also about the diluent. Most importantly the diluent as part of the drug package should not affect or influence the efficacy of the drug.
Choosing the optimal delivery system
There are several diluent delivery options available on the market today including vials, prefilled syringes, or dual-chamber syringes.
Traditional reconstitution requires a number of components: 2 vials (1 with the lyophilized drug and 1 with a diluent), a disposable syringe, and 2 needles. Most importantly it also requires experience and training and carries the risk of a needle stick injury to the person administering the drug.
Prefilled diluent syringes come with a number of distinct advantages. Prefilled syringes eliminate components and process steps used in traditional reconstitution, thereby reducing risks and opening up new opportunities for the product. These self-contained systems are simple and safe for patients to use – they minimize handling, decrease the potential for dosing errors, maintain a stable pH value, and even help protect against tampering.
Advantages of prefilled diluent syringes:
- Less components and fewer steps in the administration process
- Precision, single-unit dosing reduces waste of valuable API
- Less risk of dosing error and improved patient safety
- Increased user convenience and compliance
- Product differentiation from market competition
Prefilled syringes or dual-chamber diluent options can also assist in product differentiation when a drug maker is looking to expand the market for their product.
Customer specific development or established diluent program
Regardless of the choice of diluent or diluent delivery option chosen, whether to proceed with a customer specific diluent program or an established program will depend on important aspects that are critical for success like e.g. how to reduce the risk of interactions by minimizing the packaging material variation coming in contact with the diluent or a special treatment of the glass barrel. Other important aspects include packaging material preferences and the choice of an appropriate closure part to enable effective product integrity.
An established diluent program can offer significant advantages:
- Faster time-to-market: Stability data and registration documents are readily available to streamline registration
- Reduced development costs: Processes are validated, lower investment costs and planning preparations
- One-stop-shop offer: Multiple standard and customized packaging options for clinical and commercial filling
- Distinctive quality: Process technology and premium packaging enable high-quality aseptic products
Whereas customized development programs also have distinct benefits:
Flexibility in the selection of primary packaging material. Such as glass/polymer barrels, closure parts and stoppers, multiple types of tamper evident seals to protect product integrity
Availability of a broad range of filling formats. Practically unlimited selection of filling volumes
Various diluent options. Flexibility in type of the diluent such as sWFI, Sodium Chloride, NaCl etc… as well as diluent concentration
Vetter offers expertise for your valuable diluent
Whatever your needs, Vetter will work directly with your team to help you create the right diluent program for your compound. With Vetter’s established sWFI filling service you will benefit from a program that offers faster time-to-market, all-in-one simplicity and distinctive quality. If you choose a customer-specific diluent program, Vetter is a partner with the expertise and resources to support you throughout all steps of the development process and beyond.