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
Exponential advances in new technologies and computing such as mathematical modeling of pharmacokinetics (PK) and pharmacodynamics (PD), organ-on-a-chip platforms, in-silico algorithms, and transgenic…
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
According to Michael O’Brien, vice-president of Pfizer Pharmaceutical Sciences Technology & Innovation Group, who spoke about the units at the 2015 Parenteral Drug Association Annual (PDA) Meeting on …
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
The outcome is often "quality by conformance" and a rigid, static manufacturing operation that is more susceptible to multiple manufacturing changes post licensure, thus requiring continuous updating …
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
…of the production vessel measured by elapsed chronological time in culture, by population doubling (PD) of the cells, or by passage level of the cells when sub-cultivated by a defined procedure for d…
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…