Search results for " review"
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Richard Easton
This article reviews the implications of cell-culture conditions on biologic product quality, focusing on glycosylation and analytical techniques for its accurate assessment. Glyco…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
In 2013, according to the Pharmaceutical Research and Manufacturers Association, 69 cell therapies, six of them autologous, or patient-specific treatments, were in clinical trials or being reviewed in…
Article
Host-Cell Protein Measurement and Control
Zhu-Shimoni et al from Genentech published a comprehensive review on the limitations of HCP testing by ELISA with some examples from their process development (5). One example is a HCP named GST-α. GS…
Article
Use of Multivariate Data Analysis in Bioprocessing
In this 33rd article in the “Elements of Biopharmaceutical Production” series, the authors review major developments in use of MVDA in bioprocessing applications that have occurred in the past five ye…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
With peptide mapping, investigators can choose from “a panoply” of enzymes to perform digestions at different locations and review the information in software programs to determine aspects of higher-o…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Stock, American Pharmaceutical Review (Oct. 1, 2010).
2. T. Kingsbury, BioProcess Int. 12 (4) 18-21 (2014).
3. H.F. Giles, E.M. Mount, and J.R. Wagner, The Definitive Processing Guide and Hand…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
According to France, the next step involves a streamlined system of regulatory review of QbD applications that needs to be extended to a “global regulatory alignment.”
The workshop, which includ…
Article
Supplier-Change Management for Drug-Product Manufacturers
This article provides an overview of the pharmaceutical SIC process, including a discussion on the need for control of SICs, a review of change notification scope and content, and a summary of how SIC…
Article
Navigating Emerging Markets: Middle East and North Africa
In a report to the Office of the United States Trade Representative, PhRMA called out these two countries as requiring review. In Algeria, PhRMA cites weak patent protection, government-mandated price…
Article
Quality by design for biotechnology products—part 1
The QbD approach was introduced into the US Food and Drug Administration's chemistry, manufacturing, and controls (CMC) review process in 2004 with the aim of enhancing and modernizing the regulation …