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Article Addressing the Challenges in Downstream Processing Today and Tomorrow
The underlying principles of QbD and risk management are contained in ICH Q8 (R2), Q9, and Q10 (50, 54–56). A comprehensive case study of the application of QbD principles to the development of a m…

Article Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production. Smaller recombinant antibody fragments a…

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

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 Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity. Significant growth in the develo…

Article Quality by design for biotechnology products—part 1
This paper focuses on the factors to consider when applying the QbD concepts outlined in ICH Q8(R2), Q9, and Q10 to biotechnology products. The paper is intended to capture and reflect both the curren…

Article Virus-like Particles as Therapeutic Moieties of the Future
VLPs, like native virions, can be non-enveloped or enveloped and icosahedral or pleomorphic (4–7). The uniformity and self-assembly of VLPs, along with their ability to withstand chemical modification…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In contrast to genetic suitability, more traditional genetic stability studies refer to the characterization of the production cell lines used for commercial drug substance manufacturing followed the …

Article N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products. By Aled Jones Protein glycosylation, the addi…

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