Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
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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This study outlines methods for an alternative protein-polishing process for challenging proteins.
. This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.
Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.
Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.
Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.
With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.
Amid debate about “fake news,” peer-review papers offer vital, objective insight.
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
The authors present a shift toward more integrated purification processes.
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
Optimize practices and meet requirements using electronic data integrity systems.
Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
Sartorius Stedim Biotech expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes.
The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
Can bioprocessing runs be consistently replicated in an inherently variable production environment?
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.
For cellular materials, new ultra scale-down devices inform large-scale downstream processing techniques.
Chromatography modeling can enhance bioprocessing efficiencies.
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
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