Summary: Download the infographic to learn more about the latest cell-based bioassays and binding assays with an emphasis on their applications in the industry.

Summary: Patient centricity has always been at the heart of the pharmaceutical industry. With rising costs of drugs and healthcare, there has been...

Summary: In this article, Luke Deters, Director of Biologics, discusses an appropriate method for quantification and characterization of polysorbate-80 (PS-80), a commonly-used, but highly-heterogenous, surfactant...

Summary: Our regulatory team completes over 150 agency submissions each year, supporting all stages of the product lifecycle. We assign a dedicated regulatory professional to each of our clients...

Summary: OneBio™ Suite provides integrated biologics development, manufacturing and supply with a single solution from cell line development through clinical supply. OneBio Suite is designed...

Summary: The propensity of a protein to degrade under stress can vary widely among proteins and is important to understand in pharmaceutical development. A model protein, adalimumab, was tested by a limited...

Summary: This poster evaluates the degradation of a therapeutic mAb, Adalimumab, resulting from light, shear and thermal stress.  Degradation was evaluated using a combination of Sedimentation...

Summary: Typically, in early development, the quantity of protein available for studies is limited, and a dataset is required to expedite Tox- and IND-enabling stability studies. In this study, a high-throughput formulation development...

Summary: While peroxide and leachable metal-induced chemical modifications are among the most important quality attributes in bioprocess development, there is no mainstream characterization method covering all common...

Summary: At the center of analytical Quality by Design (QbD) is Design of Experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method...