Summary: Analytical testing for biologics is evolving rapidly as new protocols become available and companies seek to expedite current methodologies.

Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke...

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...