Search results for " activity"
Article
Biopharma Outsourcing Activities Update
Most commonly outsourced activities
Results from BioPlan’s 2014 study’s preliminary data indicate that—as with the past two years—the most commonly outsourced activity is analytical testing of b…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
Article
PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Trend three: Most outsourcing remains with lower-value activities
While the range of activities being outsourced is broadening into new areas, the heaviest levels of outsourcing activity are sti…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Data from this study, however, show that f-Met species differ in terms of its disposition in the body, but have equivalent binding affinity and biological activity as compared to the GCSF and its pres…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
The importance of binding activity
Most biotherapeutics rely on specific binding activities to achieve a clinical effect. Therefore, matching the binding activities of a biosimilar candidate to th…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
During development of an early-phase purification process for an acidic Fc-fusion protein expressed in a CHO cell culture system, it was determined that the protein displayed a range of 24–100% activi…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
In turn, these data can then be used to define the structural components’ impact on the activity of the product. Furthermore, the characterization data obtained are essential for product development a…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Media design for gaining higher productivity and modulating recombinant protein product quality
Formulation of cell-culture media is an important activity under process development. Manufacturers s…