Search results for "QbD; biopharmaceuticals; analytical…"

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Tackling Analytical Method Development for ADCs
Feb 01, 2015 By Cynthia Challener, PhD BioPharm International Volume 28, Issue 2 The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time. ABSTRACT Monoclonal antibodies represent a significant portion of sales in the biopharma…

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing. Jul 01, 2018 Increasing demand for biologics is drivin…

Article Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations. By Cynthia A. Challener Single-use bioreactors available from various vendors…

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 Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern. By Feliza Mirasol The advancement of digit…

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