A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS With Confidence

By Jean-Sebastien Steffen, Ph.D., Group Lead, Combination Products and Primary Packaging, Lonza

Prefilled syringes (PFSs) offer significant advantages for both manufacturers and patients of biotherapeutics. For manufacturers, PFSs provide flexibility in accommodating different drug viscosities, volumes, and administration routes, enhancing their delivery options. Additionally, by eliminating the need for overfilling vials, PFSs contribute to reduced waste of medication, leading to cost savings and improved environmental sustainability.

For patients, PFSs offer several benefits. Precise pre-filled volumes ensure accurate dosing, reducing the risk of errors, and filled in controlled environments, PFSs minimize the risk of contamination during administration compared to self-filling from vials. Furthermore, PFSs offer convenience by enabling self-administration at home, eliminating the need for hospital visits or lengthy IV infusions. This not only improves convenience but also potentially increases medication adherence and promotes safer and more consistent patient care by facilitating compliance with regulatory standards and guidelines for drug administration.

Download the full article to explore how Lonza has developed a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection. Review technical considerations and case studies for how a partnership may help to overcome some of the challenges associated with selecting the optimum biotherapeutic presentation and PFS combination.