The landscape of drug product development is undergoing a significant transformation, shifting away from traditional monoclonal antibodies (MAbs) toward increasingly complex biologics and gene-based therapies. According to Amardeep S. Bhalla, Executive Director of Drug Product Development & Technology Group at Regeneron, the industry is entering an era where established platform approaches are no longer sufficient to support the diversity of emerging modalities.

While MAbs once benefited from standardized formulation strategies, newer formats—such as bispecific antibodies, antibody-tethered ligands, and RNA-based therapeutics—require tailored, “horses-for-courses” approaches. This shift is accelerating the need for customized formulation design, alongside deeper integration of process and analytical development from early stages.

Another key driver of this evolution is the rise of gene therapies, including siRNA, mRNA, and viral vector systems. These modalities depend heavily on non-platform formulation systems (which can be rigid in terms of excipient use) as well as delivery technologies such as lipid nanoparticles (LNPs) and novel lipid compositions, which introduce additional formulation and manufacturing complexity. In some cases, developers must move beyond conventional liquid formulations and increasingly consider alternatives like lyophilized or frozen formats to ensure product stability and efficacy.

Another growing trend is co-formulations and/or fixed-dose combinations (FDC) where multiple therapeutic agents—such as more than one peptide, biologic, or small molecule—are combined into a single product. While this approach offers clinical and commercial advantages, it presents significant challenges around drug formulation, compatibility, manufacturability, stability, and delivery. To address these issues, analytical development has become a critical enabler, with faster, more sophisticated methods required to keep pace with innovation timelines.

Innovation in biologics space is also extending into drug delivery systems as well. Traditional prefilled syringes and autoinjectors may be complemented—or even replaced—by injection-site and dose-dependent next-generation solutions such as high-volume injections, high concentration suspensions, micro-needles, on-body injectors, and needle-free devices. Alternate routes of administration including oral and transdermal routes are increasingly being investigated to improve patient experience.

When it comes to scaling from early development to commercialization, Bhalla notes that while challenges exist—particularly for non-traditional formulations—the industry has been successful in establishing robust pathways for scale-up. He emphasizes that the true bottleneck lies in formulation innovation, not scale-up.

Looking ahead, several key areas are expected to shape the future of drug development:

  • Continued progress in high-concentration biologics as well as mAb-base newer platforms, supported by new excipients and viscosity modifiers to enable higher dosing
  • The advancement of gene therapies, particularly AAV, siRNA and mRNA-based modalities
  • The rapid expansion of GLP-1 therapies, including multi-drug and multi-modality combinations
  • Advanced analytical systems to resolve the complexity around testing the drug in multiple formats

Ultimately, success in this evolving landscape will depend on cross-functional innovation—spanning formulation, process, and analytical development—combined with multidisciplinary expertise and a willingness to adopt unconventional approaches. As the industry pushes the boundaries of what is possible, the ability to adapt quickly and think creatively will be essential for delivering the next generation of therapies.