Search results for "manufacturing"
Article
Automating Bioprocesses
…on to a batch record is part of ‘Level 3’ of the ISA 95 model, which includes the definition of manufacturing operations management (MOM) applications. Manufacturing execution systems (MES) that impl…
Article
Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
Article
Going Small to Achieve Success on the Commercial Scale
Challener
Biopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specified physicochemical and pharmacokinetic p…
Article
Raw Material Variability
It would seem that raw materials used in bioprocessing operations are a relatively straightforward factor given the overall complexity of commercial manufacturing. In fact, they give a surprisingly di…
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, …