Challenges and Opportunities in High Concentration Formulation Development and Delivery Systems for Subcutaneous Administration

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.

Speakers

Dr. Prateek Gupta, PhD, SVP & Head – Technical Development, OneSource Specialty Pharma

Dr. Prateek Gupta has over 16 years of experience in product development and manufacturing of biologics. In his current role as Senior VP – Technical Development and Scientific Services, he is accountable for delivering client development projects across biologics, drug device combination products, complex injectables and soft gelatin technology.

Prateek previously served in increasingly responsible roles in Pfizer, leading early and late-stage biosimilar assets and contributed to successful product approvals by the US FDA. He started his professional career at Genentech (Roche) in South San Francisco, where he spearheaded process development and tech transfer activities of several early stage NBE in immunology and oncology space.

Prateek has a PhD in Chemical Engineering from Cornell University and completed his undergraduate studies from IIT Delhi. He has authored numerous publications, patents and has been the recipient of several awards, including the prestigious W.H. Peterson Award from American Chemical Society.

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Loganathan Shanmugam, AVP – Device Development, OneSource Specialty Pharma

Loganathan Shanmugam has over 27 years of experience in drug delivery systems and medical devices (Class I to III), specializing in concept design, industrialization, risk assessment, design verification, process validation and quality systems for pharmaceutical drug delivery packaging.

His key contributions include co-authoring the conversion of an ophthalmic drug delivery system from a vial to a three-piece plastic dropper, earning nine design patents at Rexam (now Nemera). Extensive expertise in medical device innovation, sustenance and remediation, collaborating with BD, AMS, Cook Medical, Depuy and J&J. At Wockhardt, contributed to emergency-use autoinjectors and biosimilars, securing additional patents.

He holds an MBA in Operations Research and a degree in Plastic Engineering. Currently, he is leading the Device & Packaging Development at OneSource Specialty Pharma, overseeing combination drug delivery systems such as single-dose and multi-dose injectors, ensuring seamless integration of drug-device combination products.

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