Pharmaceutical / biopharmaceutical clients of the contract manufacturing organisation (CMO) will be able to leverage BPS’s expanded Drug Master File and choose a custom-fill volume and labelling, while streamlining development work and process validation batches, eliminating capital equipment costs. This can considerably reduce time to market.
Lyophilization, known as freeze-drying, is often used to increase shelf-life and provide stability for sensitive drug candidates.
In order to be ready for injection, the lyo drug product must be reconstituted and dissolved in a solvent. In many cases, this is accomplished using a standard diluent vial, drawing the amount of solvent required into a needle, injecting the solvent into the lyo drug vial, and then withdrawing the reconstituted solution back into the needle for injection. A custom-diluent pre-filled syringe, on the other hand, offers a standardized solvent amount for reconstitution, eliminating steps and reducing the risk of error and contamination as compared with a diluent vial.
Along with improved safety and convenience for clinicians and patients, BioPharma Solutions’ diluent pre-filled syringes offer flexibility, brand enhancement, and excellent shelf-life. Diluents available include sterile water for injection (SWFI – five years expiry dating), sodium chloride (NaCl – five years expiry dating) and bacteriostatic water for injection (BWFI – three years expiry dating).
A variety of options and customization include:
- A variety of BD Hypak syringe sizes to choose from (1mL – 3mL)
- A fully customisable fill volume from 0.25mL to 3.00mL
- A variety of inspection and packaging options including a customizable label for brand enhancement, Eisai inspection, plunger rod, finger flange, cartoning, blister pack
- A new FM30 tip cap that does not contain natural rubber latex
"We are continually looking for ways to support our customers and the clients they serve, whether it is an expansion to serve their growing needs or through enhancements of our service offering," said Robert Felicelli, general manager of Baxter’s BioPharma Solutions business.
"Lyophilized drugs continue to be a growth area in the global market and for our business, while safety and convenience remain at the forefront of Baxter’s products and services. Enhancing our diluent pre-filled syringe offering to benefit our clients and ultimately the patient is yet another way we can serve their needs."