Search results for " methods"
Article
Biosimilar Quality Requirements
Effective Analytical Methods
High-resolution mass spectrometry (HR–MS) is the go-to method for primary structural analysis and characterization of complex protein molecules, particularly following…
Article
Witnessing Major Growth in Next-Generation Antibodies
For next-generation products, delivery methods that give the best therapeutic effects, safety profiles, and convenience for the patient, the latter becoming increasingly important, should be the goal,…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Testing should be conducted at the most meaningful process steps using appropriate samples, sample volumes, and suitable testing methods.
• Limitations of the existing testing methods us…
Article
Lessons Learned Accelerate Vaccine Development
Early bioprocessing challenges
The diversity of viruses that cause diseases, the number of different vaccine products, and the variety of vaccine production methods all contribute to the complexit…
Article
Use of Multivariate Data Analysis in Bioprocessing
COadReS and ACO are variable selection methods that are used to enhance the predictive ability of the chemometric model by removing unnecessary spectral information. In yet another application, resear…
Article
Single-Domain Antibodies for Brain Targeting
Stanimirovic, Methods Mol Med, 89, 435-49 (2003).
43. A.S. Haqqani et al., Mol Pharm, 10 (5) 1542-56 (2013).
44. A. Muruganandam et al., FASEB J, 16 (2) 240-242 (2001).
45. A. Abulrob and …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
For process validation Stage 1 process characterization studies, analytical methods for measuring CQAs may not yet be fully validated, but still, must be scientifically sound.
The level of accur…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Analytical methods should thus be chosen or developed to compare critical quality attributes (CQAs) between the biosimilar and the reference product. “This involves assessing the physicochemical prope…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Harmonization between vendor test methods and raw material data management will enable the real-time release of buffer stocks and reduce the risk of noncompliance. Reduced in-house testing will also a…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Novel techniques including Raman spectroscopy and other advanced monitoring methods have the potential to reduce the reliance on discrete sampling points for off-line analytics such as titer measureme…