Search results for " analytics"
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
Biosimilars to Drive Modern Manufacturing Approaches
…s are being asked to switch from a life-sustaining medicine that is working well, requires extensive analytics and testing under FDA’s “totality of evidence” framework. FDA’s regulation of biosimilar…
Article
Digitalization: The Route to Biopharma 4.0
It is propelled by transformative trends such as the proliferation of data and connectivity, advancements in analytics, human–machine collaboration, and enhancements in robotics. Biopharmaceutical man…
Article
Optimizing your Cell Culture Process to Improve Productivity
Cell Culture Process
In this video, Mary Szorik and Alicia Elwood at Cytiva, discuss the rationale for cell culture and analytical testing as well as the types of tests that can lead …
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Biosimilar Quality Requirements
…objections (4), outlines the agency’s recommendations for the design and evaluation of comparative analytics studies needed to demonstrate biosimilarity between a proposed biosimilar and the referenc…
Article
Biopharma Advances Demand Specialized Expertise
Chambers (SGS): From a CRO point of view, the main productivity improvements in analytics have been from higher throughput systems and data analysis. The move to these faster systems with semiautomate…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…