Search results for "antibodies"
Article
Perfusion Culture Using TFF or ATF as Cell Retention Method
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Perfusion processes have many advantages such as being favorable for product quality and supporting efficient facility utilization by offering the possibility…
Article
Scalable Viral Vector Manufacturing
Viruses are much larger than recombinant proteins and antibodies, and therefore tailored purification technologies must be used. The scalability factor must be considered as well. We strongly recommen…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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Putting Viral Clearance Capabilities to the Test
Bergmann concurs and notes that while these guidance documents work well for monoclonal antibodies and therapeutic proteins, “use of the guidelines for novel types of products can be challenging” and …
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Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Surface plasmon resonance (SPR) has become a go-to tool for biotherapeutic characterization, and most approved antibody therapeutics have passed through a Biacore SPR system.
Stay up-to-date wit…
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Cleaning Protein A Resins with 1 M NaOH
With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material i…
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Chromatography Scale-Up: Don’t Get Tied Down by Bed Height
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When scaling, you can make better use of existing chromatography columns while avoiding overcapacity.
Keeping a constant residence time is a well-est…
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NIST Spectroscopic Measurement Standards
NIST Spectroscopic Measurement Standards
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance mea…
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Making the Move to Continuous Chromatography
In the case of antibodies, the industry is now working well above 3 g/L, even up to 5 g/L, with titers of 10 g/L being described. “To really maximize productivity, the kinetic effects of adsorption:de…
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Understanding Validation and Technical Transfer, Part I
Validation of a purification process for monoclonal antibodies differs substantially from validation of a steam-sterilization process for a drug product in its final container. Terminal sterilization …