Search results for "manufacturing" in Articles / App Notes
Article
State of Quality and Compliance in the Biopharmaceutical Industry
However, after more than 10 years since the launch of these initiatives, manufacturing innovation and product quality do not appear to have improved to the extent originally envisioned. As recent year…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Introduction
Egg-based production is the most commonly used technique for manufacturing of influenza vaccine. This technique has its limitation in that it requires one fertilized egg per produced …
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
We also touch upon continuous versus batch manufacturing.
Topics covered include:
1:47 - Where the industry is headed with real-time analysis
3:17 - Scali…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
These systems can be supplied in volumes ranging from pre-clinical and clinical scale to volumes large enough to satisfy current good manufacturing practice (cGMP)-scale production, he says.
“These…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
European guidance states that if the virus reduction is reproducible and the influencing manufacturing parameters are well defined, chromatography could fit the criteria of an effective step (34). Chr…
Article
From Darwin to Recombinant Fc Multimers
Conference Chairperson Joe Bertolini, R&D director from CSL Behring Australia
PPB 2017 had a full program with six scientific sessions focusing on issues and possibilities around manufacturing, …
Article
Downstream Processing for Cell-Based Therapies
…linical development, significant focus has been directed toward the development of scalable, robust manufacturing processes. Much of the research and development activity in the sector has addressed …
Article
Use of Multivariate Data Analysis in Bioprocessing
Applications involving multivariate data analysis of these complex data sets to extract relevant information could be aimed at process monitoring in a manufacturing setting by detection of process fau…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The international pharmaceutical companies in particular have benefited from applying QbD principles to their manufacturing operations. These companies have seen increased production efficiencies and …
Article
Report from the 12th Plasma Product Biotechnology Forum
With increased knowledge that implemented control strategies, as well as the manufacturing processes, showing no risk of prion contamination, a number of vCJD-related donor deferrals could be removed.…