Search results for " PD"
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
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
These studies are designed at three levels: detection of drug in the newborn, PD effect of the drug in the newborn, and long-term (two-year) safety of the newborn. Most of these studies are not perfor…
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
Using the same equipment for development and manufacturing could help minimize technical transfer costs and resources, he wrote in his PDA presentation notes, and could reduce inventory overheard whil…
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
(For a description of process characterization, see PDA Technical Report No. 42). The refinement of the design space is based on the QTPP and the knowledge gained throughout development. As knowledge …
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In experience with the authors’ CHO cell lines, a typical cell age from a 5000-L production bioreactor is found to be approximately 30 PD including the cell age of a WCB, seed train, and bioreactor ex…
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…