How industry collaboration drives single-use technology standardization for fast and reliable implementation

Manufacturing processes for gene therapy products are generally low yielding compared to production processes for other biologics.

As the number of biotherapeutic candidates in development is increasing, the requirements of analytical tools to understand the molecules better early in the process are rising, simultaneously. To understand product quality attributes (PQAs) fully, identification, localization, and relative quantification are key. Mass spectrometry (MS) plays an important role with peptide mapping being the gold standard to assess post-translational modifications (PTM). However, traditionally used collision-induced dissociation (CID) has a number of limitations in PTM identification and localization. Here, the novel fragmentation technique electron activated dissociation (EAD) was employed for peptide mapping of a multispecific monoclonal antibody (mAb) as well as IgG1 and IgG4 mAb samples.

Join this 60-minute KnipBio webinar, to learn examples of engineering solutions based on biotechnology that will help the sustainable expansion of this field. Aquaculture, or the farming of fish, shrimp and seaweeds, is expected to continue its dramatic growth in the coming decades. One of the central issues for the continued growth of aquaculture will be the supply of high quality ingredients.

Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, the requirements for real-time measurement and the testing of cell-containing products cannot be met with most of these methods.