Amardeep Bhalla, an executive director at Regeneron Pharmaceuticals, presented on innovations in drug product development. He began by highlighting the challenges faced in the industry, such as new routes of administration, cold chain storage, high viscosity, high dose delivery, novel excipients, new modalities, and innovations in long-acting forms. Bhalla emphasised that these challenges presented opportunities for innovation.
He discussed Regeneron's focus on biologics, particularly monoclonal antibodies (mAbs) and fusion proteins, and their exploration into gene delivery. Bhalla shared his extensive experience in biologics drug product development, mentioning his work on key programmes like Keytruda, Trumenba vaccine, and Reblozyl. He also noted Regeneron's success in developing 12 antibodies, with him contributing to at least six of them.
Bhalla elaborated on the company's platform approach, which played a crucial role during the pandemic. Regeneron expedited the development and manufacturing of REGEN-COV, a monoclonal antibody treatment for COVID-19, within 45 days from candidate selection to first-in-human manufacture. This rapid development was achieved by leveraging existing clinical programmes and platform formulations.
He also discussed high concentration formulations, highlighting the use of novel excipients and the development of suspension-based approaches to achieve concentrations beyond 400 mg/mL. Bhalla mentioned the challenges and innovative solutions for intralesional and intratumoral delivery, including the development of longer-acting formulations and non-aqueous emulsion systems.
Bhalla concluded with a look into the future, emphasising the potential of AI/ML applications in formulation and process development, as well as the exploration of microneedles and pain upon injection. He stressed the importance of continuous innovation and collaboration across various departments to address the evolving needs of drug product development.
