STIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps.
Downstream Processing
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Fouling Mechanisms of Filters in the Harvest Development of Monoclonal Antibody Therapeutics—Pt 2
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Fouling Mechanisms of Filters in the Harvest Development of Monoclonal Antibody Therapeutics—Pt 1
The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters.
Stepping Up Process Control with Single-Use Systems
SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.
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A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
How to implement a risk-based approach to eliminate viruses using orthogonal technologies.
The industry and government must collaborate to develop robust technologies and quicker, more flexible manufacturing approaches for vaccine development.
New technologies such as virus-like particles are promising weapons in the battle against pandemic influenza.
Ten biopharmaceuticals gained marketing authorization in the US or EU in 2008, although only four were new approvals.
Membrane-based TFF technology can ease scale-up and provide a higher recovery percentage compared to conventional purification methods.
Automated in-line dilution can help solve capacity, financial, and quality concerns that biopharmaceutical manufacturing plants may be facing.
It is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
Needle-free vaccine delivery platforms can solve the problems of stockpiling, cold-chain management, and pandemic preparedness.
To assess current trends in separation and purification, BioPharm International turned to Mandar Dixit, head of product management?filtration technologies, Sartorius Stedim Biotech; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; Richard Pearce, program director of purification, Millipore Corporation; and Jon Petrone, global technical director, Pall Life Sciences.
A stable alternative to Protein A chromatography.
Why staining is crucial in flow decay studies.
Select the best approach to determine critical quality attributes.
Through metabolomics, the metabolic underpinnings of cellular changes can be rapidly pinpointed, directing process development scientists to key areas for cell culture optimization.
By considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
Microbial systems such as E. Coli and yeasts are most effective for producing antibody fragments.
How to maintain product stability and prevent particulates.
A prove-free system monitors accurately at very small scale.
Biodefense start-up companies have an abundance of options when seeking funding.
Can increase in ionic strength result in higher viscosity?
The future of therapeutic MAbs lies in the development of economically feasible downstream processes.
Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
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