Search results for "manufacturing"
Article
Re-use of Protein A Resin: Fouling and Economics
Figure 1: Pie chart illustrating type of Protein A media used for monoclonal antibodies/Fc-fusion protein manufacturing.
Number of cycles
As discussed previously, biotech manufacturers typical…
Article
Viral Clearance Challenges in Bioprocessing
Upstream viral clearance
Using media with a low level of viral contamination can lead to major problems in biologics manufacturing. Cell-culture media and other raw materials, particularly those de…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
There were no benefits or need for platform development or expanding manufacturing capabilities. Cell culture was performed using numerous methods, including roller bottles and stirred tank bioreactor…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
…, and manufacture medical products—and revised regulatory practices for evaluating clinical data, manufacturing operations, and procedures for submitting and analyzing information.
Most vis…
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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.…
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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…
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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…