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: While everyone wants a Breakthrough Therapy Designation (BTD), Fast Track or PRIME, these designations also add to the pressure of getting a drug to the clinic under tight timelines....

Summary: Pharma companies are always examining ways to increase efficiencies and reduce cost of drug development. While cost of goods sold (COGS) can be...

Summary: In this webinar, Charlotte Lukas from AstraZeneca and Amanda Henry, project management expert discussed a case study on a 30-day commercial launch plan for a product into new markets and why this approach was important for patients.

Summary: Achieve higher titers by leveraging the power of proven GPEx® Technology with a glutamine synthetase knockout CHO cell line.

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...

Summary: There are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In some cases, there is a need to identify...

Summary: Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial