In this free webinar, learn about developing high-concentration, low-viscosity formulations and selecting the right delivery device for drugs. Attendees will gain insight into what goes in the development of drug delivery devices. The featured speakers will discuss how to accelerate development of drug products.
TORONTO, April 28, 2025 /PRNewswire-PRWeb/ -- Biopharmaceutical companies are increasingly adopting a patient-centric approach in product lifecycle management.
This shift is driven by the need to improve patient experiences and outcomes, which in turn can lead to better compliance and differentiation from competitors. One significant trend in this area is the transition from intravenous (IV) infusion to subcutaneous (SC) administration using injection devices. This change can have a profound impact on patient focus and compliance as SC administration is generally more convenient and less invasive than IV infusion.
Over the last few decades, the number of approved monoclonal antibody (mAb) products has risen significantly, with 41 percent of them administered via SC injection between 2015 and 2023. This trend highlights the growing importance of SC administration in the biopharmaceutical industry.
However, the transition to SC administration is not without its challenges. One of the main issues is the restricted dosing volume of conventional SC injections, which is typically less than 2 mL. This limitation is particularly problematic for mAbs-related products, which often require high dosing levels, sometimes exceeding 100 mg per dose.
To address this issue, there is a strong need for the development of highly concentrated antibody formulations and advanced injection devices. These devices must be capable of delivering high-concentration, low-viscosity formulations efficiently and comfortably. Advances in the understanding of SC delivery and SC drug delivery technologies, including innovative injection devices, have helped to overcome the perceived "volume limitation" for SC administration. Nevertheless, there remains a significant driver for developing low-viscosity, high-concentration stable formulations that can facilitate small volume delivery.
These advanced formulations and devices are crucial for several reasons. First, they allow for accelerated product development for first-in-human (FIH) clinical trials, which can speed up the overall development timeline. Second, they can seamlessly integrate with the final delivery strategy for commercial settings, reducing the burden of chemistry, manufacturing and controls (CMC) related activities. By addressing these challenges with both innovative formulations and devices, biopharmaceutical companies can enhance patient-centricity in their product lifecycle management, ultimately leading to better patient outcomes and competitive advantages in the market.
Register for this webinar to gain insights into how the opportunities in high concentration formulation development for subcutaneous administration and its impact on patient care in biopharmaceuticals.
Join experts from OneSource Specialty Pharma, Dr. Prateek Gupta, PhD, SVP & Head – Technical Development; and Loganathan Shanmugam, AVP – Device Development, for the live webinar on Wednesday, May 21, 2025, at 11am EDT (5pm CEST/EU-Central).
For more information, or to register for this event, visit Challenges and Opportunities in High Concentration Formulation Development and Delivery Systems for Subcutaneous Administration.
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