Abstract: The invention provides a mass-spectroscopic approach for assessing and determining the in vivo comparability of a candidate biologic molecule to a reference biologic molecule. The results can be presented in the form of an in vivo comparability profile, which can serve as a development tool, e.g., as a guide or target for the development of biologies, biosimilars, or gene therapy-based drugs. The invention further provides an approach using an in vivo comparability profile for measuring the similarity of two biologies, for example, a biosimilar and a reference approved biologic or manufacturing lots of the same biologic to confirm acceptable release criteria for a particular manufacturing lot.

Abstract: The invention provides methods for determining a set of critical features that serves as a “map” of attributes critical for maintaining the structure and function of a biologic. The map can serve as a development tool, e.g., as a guide or target during the development of expression, purification, and formulation protocols, a quality assurance tool during manufacturing, or as a definitive identifier of the specific biologic. The map can also serve as the definition of the biologic thereby providing a means by which a given product may be reliably characterized as a biosimilar of another biologic product.

Abstract: This invention relates to optical imaging probes and the use of such probes for diagnosing and monitoring disease, and disease treatment. The optical imaging probes of the current invention can be used to identify and characterize normal and diseased tissues with regards to altered metabolic activity.

Abstract: Chromophore probes that are capable of being taken up by, retained by or bound to a biocompatible molecule to form an imaging construct are provided. Various activation strategies of the resulting imaging construct are also provided.

Abstract: The invention features biocompatible fluorescent nanoparticle and their use in in vivo imaging methods.