Search results for " monoclonal"
Article
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 …
Article
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…
Article
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…
Article
NIST Spectroscopic Measurement Standards
…ntration measurements by providing an industrially relevant reference material, a well-characterized monoclonal antibody.
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Article
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 …
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Industry Adoption of Single-Use Systems Remains Low
Abzena, a CDMO, conducts development and GMP manufacture of antibody drug conjugates at its Bristol facility and conducts development and GMP manufacture of monoclonal antibodies and other recombinant…
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Impurity Testing of Biologic Drug Products
This is true even when considering different monoclonal antibody therapeutics. Consequently, while similar strategies may be used for different protein therapeutics, true ‘toolbox’ approaches/platform…
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Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments, for example, Fab fragments. Various cleaning strategies and …
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Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …