Clik here to view.
The Need for a New Process
Surveying BPI readers’ experiences SANJA GJENERO (WWW.SXC.HU) Better, faster, safer: The current drug-development “paradigm” emerging from the FDA is pushing for innovations that reduce process...
View ArticleClik here to view.
Software Simplifies Accounting for Batch Genealogy
As an updated US FDA guidance document emphasizes, the life sciences industry needs to use data to better understand manufacturing processes and sources of variation to minimize product risk and...
View ArticleClik here to view.
Shrinking the Costs of Bioprocess Development
Process development for large-scale bioproduction is generally more labor-intensive, time-consuming, and expensive than for comparable nonbiological processes because of the large number of individual...
View ArticleClik here to view.
Putting All the Pieces Together
Most people in the industry are struggling with quality by design and how it relates to the acceleration of process development. Many are confused by the new FDA approach to bioprocess development,...
View ArticleClik here to view.
DoE Helps Optimize a Cell Culture Bioproduction System
Typical serum-free culture media used in bioprocessing can have 60–90 components at differing concentrations to feed a single cell line. Media used to grow different cell lines for bioprocessing...
View ArticleClik here to view.
Creation of a Well Characterized Small Scale Model for High-Throughput...
Streamlining process development has been the focus of the biotechnology industry over the past several years. To be financially viable in the current market, a company has to be competitive in all...
View ArticleThe Need for a New Process
Surveying BPI readers’ experiences SANJA GJENERO (WWW.SXC.HU) Better, faster, safer: The current drug-development “paradigm” emerging from the FDA is pushing for innovations that reduce process...
View ArticleSoftware Simplifies Accounting for Batch Genealogy
As an updated US FDA guidance document emphasizes, the life sciences industry needs to use data to better understand manufacturing processes and sources of variation to minimize product risk and...
View ArticleShrinking the Costs of Bioprocess Development
Process development for large-scale bioproduction is generally more labor-intensive, time-consuming, and expensive than for comparable nonbiological processes because of the large number of individual...
View ArticlePutting All the Pieces Together
Most people in the industry are struggling with quality by design and how it relates to the acceleration of process development. Many are confused by the new FDA approach to bioprocess development,...
View ArticleDoE Helps Optimize a Cell Culture Bioproduction System
Typical serum-free culture media used in bioprocessing can have 60–90 components at differing concentrations to feed a single cell line. Media used to grow different cell lines for bioprocessing...
View ArticleCreation of a Well Characterized Small Scale Model for High-Throughput...
Streamlining process development has been the focus of the biotechnology industry over the past several years. To be financially viable in the current market, a company has to be competitive in all...
View Article
