Search results for "manufacturing" in Articles / App Notes
Article
Best Practices for Selecting a Top-Quality Cell Line
…cible results—with all product quality attributes consistent with the desired profile—with high manufacturing efficiency, according to Ian Collins, senior director of process development at Catalent.…
Article
A Look at the Affinity Chromatography Landscape
Beyond impurity removal for “simple” proteins
Affinity chromatography in biologics manufacturing has typically served as a method for removal of process-related impurities such as host-cell protei…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Thus, glycan structure is a critical quality attribute (CQA) that must be monitored during drug manufacturing.
Glycan composition profiling is commonly used to track the structural diversity of…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical manufacturing because it has a potential safety impact on the end user and because aseptic filling is a highly tec…
Article
Platform Technologies Improve Protein Expression
In addition, any technologies underlying these platforms have at that stage been well-studied, making them predictable, and predictability creates manufacturing comfort. They are also expected to spee…
Article
Single-use Bioreactors Have Reached the Big Time
Challener
Single-use bioreactors available from various vendors today are robust and provide the high-performance necessary for commercial manufacturing of biopharmaceuticals. Significant advances…
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…