Search results for " novel molecules"

Article Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations. By Cynthia A. Challener Cell-culture and fermentation are high-…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics. By Robert Karlsson Abstract Biotherapeutic antibodies are still the larg…

Article Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …

Article Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success. By Cynthia A. Challener Next-generation antibodies are designed to be more specific and are ofte…

Article Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…

Article Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs New platform technologies, advanced modeling tools, and addressing patient needs are important developments. By Cynthia A. Challener …

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment. A critical quality attribute (CQA) has been defined as “a physical, chemical, …

Article A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape New ligands are being developed to meet the separation and purification needs of next-gen biologics. By Cynthia A. Challener …

Article ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects. By Feliza…

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