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Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
…mg/mL protein concentration) was prepared in a formulation that contained a buffering agent (10 mM), surfactant, cryoprotectant (disaccharide) and bulking agent (glycine). The formulation samples wer…

Article Re-use of Protein A Resin: Fouling and Economics
The Protein A ligand has been attached to a large variety of different base matrices such as cross-linked agarose, surface modified porous glass, coated polystyrene, hydrogel filled into a ceramic she…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
“In addition to leachable and extractables, there is also risk for nutrient loss by adsorption onto the plastic surface. These concerns can be addressed by screening these materials for compatibility …

Article Tools for Continuous Bioprocessing Development
Because volume and surface area scale differently with length, even in similar benchtop bioreactors, the physical and chemical environment seen by the cells will be different from what is seen on the …

Article Single-Domain Antibodies for Brain Targeting
Camelid VhH and shark V-NAR domains display long surface loops, often larger than human antibodies and are able to penetrate cavities in target antigens (14). They are, in general, soluble and can be …

Article A Closer Look at Affinity Ligands
The matrix is typically in the form of small 50–150 micron beads that are highly porous to provide a large surface area, maximizing antibody binding potential for higher yields from fixed-volume colum…

Article Strategizing for Rapid Changeovers in Biologics Manufacturing
Several activities must be performed in a facility to avoid any risk of cross-contamination between Product A and Product B, in particular via a thorough cleaning-in-place of all equipment surfaces in…

Article Design and Qualification of Single-Use Systems
…porate essentially the same design requirement statement: “Equipment should be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermed…

Article Challenges of Protein Aggregation During Purification
In one case, the unfolding of a protein from its native to a denatured state may lead to exposure of previously interior hydrophobic structures that can bind to similarly hydrophobic surfaces on other…

Article Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
When scaling-up, the ratio of the total vessel volume (m3) to the surface available for heat and gas transfer (m²) increases, which means that agitation and gas flow rate must be increased non-li…

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