Adeno-associated viruses (AAVs) are the leading viral vector for in-vivo gene therapy, and their use is expected to grow rapidly in the next decade. While AAVs are promising tools for treating many genetic diseases, vectors are vulnerable to adsorpti...
Polysorbate 20 (PS20) is commonly used as an excipient in therapeutic protein formulations. However, over the course of a therapeutic protein product's shelf life, minute amounts of co-purified host-cell lipases may cause slow hydrolysis of PS20, rel...
Capturing subvisible particles using flow imaging microscopy is useful for evaluating protein aggregates that may induce immunogenicity. Automated labeling is desirable to distinguish harmless components such as silicone oil (SO) from subvisible part...
Subvisible particle count is a biotherapeutics stability indicator widely used by pharmaceutical industries. A variety of stresses that biotherapeutics are exposed to during development can impact particle morphology. By classifying particle morpholo...
Lipid nanoparticles (LNPs) are a subset of pharmaceutical nanoparticulate formulations designed to encapsulate, stabilize, and deliver nucleic acid cargoes in vivo. Applications for LNPs include new interventions for genetic disorders, novel classes ...
Cell-based medicinal products (CBMPs) are a growing class of therapeutics that promise new treatments for complex and rare diseases. Given the inherent complexity of the whole human cells comprising CBMPs, there is a need for robust and fast analytic...
Subvisible particles may be encountered throughout the processing of therapeutic protein formulations. Flow imaging microscopy (FIM) and backgrounded membrane imaging (BMI) are techniques commonly used to record digital images of these particles, whi...
There remains a substantial need for a comprehensive assessment of various natural language processing (NLP) algorithms in longitudinal pharmacokinetic/pharmacodynamic (PK/PD) modeling despite recent advances in machine learning in the space of quant...
Pharmacokinetics (PK) is the result of a complex interplay between compound properties and physiology, and a detailed characterization of a molecule's PK during preclinical research is key to understanding the relationship between applied dose, expos...
Monoclonal antibodies (mAbs) can be damaged during the aseptic compounding process, with aggregation being the most prevalent form of degradation. Protein aggregates represent one of several risk factors for undesired immunogenicity of mAbs, which ca...