Innovative Approaches for Preclinical Development of Biotherapeutics

Article Collection

In recent decades, biotherapeutic drugs have revolutionized modern medicine. These agents, which have been used to treat a plethora of complex diseases, have impacted the lives of millions of patients. This class of drugs largely consists of antibodies, providing a more targeted and personalized approach to medicine. With hundreds of additional entities in development, these biological agents will dramatically impact human health in the years to come.

The way that biotherapeutics interact with the body can dramatically affect their safety and efficacy. Particularly, immunogenic responses have impeded the development of some biotherapeutic candidates. It is imperative, therefore, to perform extensive preclinical research to understand the mechanism of action, the pharmacokinetics and pharmacodynamics, safety and toxicity, and dosing of biotherapeutic candidates.

Through this research article collection, researchers will be educated on important considerations and innovative techniques to enhance the preclinical development of biotherapeutic agents.

What you will learn:

  • Considerations for reducing immunogenicity by humanization of antibodies
  • Utility of biolayer interferometry in preclinical development through case studies
  • Key components of physiologically based pharmacokinetic (PBPK) models for antibody development


  • Vasudevan et al. (2017). Potency determination of inactivated H7 influenza vaccines using monoclonal antibody-based ELISA and biolayer interferometry assays.
  • Rossotti et al. (2021). Immunogenicity and humanization of single-domain antibodies.
  • Gibbs et al. (2020). Informing Development of Bispecific Antibodies Using Physiologically Based Pharmacokinetic-Pharmacodynamic Models: Current Capabilities and Future Opportunities.
  • Teal et al. (2022). Directed Evolution Enables Simultaneous Controlled Release of Multiple Therapeutic Proteins from Biopolymer-Based Hydrogels.
  • Marcion et al. (2021). Nanofitins targeting heat shock protein 110: An innovative immunotherapeutic modality in cancer.

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