White Paper on Continuous Bioprocessing
@inproceedings{Cooney2014WhitePO, title={White Paper on Continuous Bioprocessing}, author={Charles L Cooney and Konstantin B. Konstantinov}, year={2014} }
There is a growing interest in realizing the benefits of continuous processing in biologics manufacturing, which is reflected by the significant number of industrial and academic researchers who are actively involved in the development of continuous bioprocessing systems. These efforts are further encouraged by guidance expressed in recent FDA conference presentations. The advantages of continuous manufacturing include steady state operation, consistent product quality, reduced equipment size…
99 Citations
Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities
- BusinessPDA Journal of Pharmaceutical Science and Technology
- 2017
A novel mathematical algorithm is introduced to determine the most optimal equipment scheduling configuration that maximizes the mass output for a facility producing a single product.
Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.
- BusinessAnnual review of chemical and biomolecular engineering
- 2018
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development, driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance.
Single pass diafiltration integrated into a fully continuous mAb purification process
- Biology, EngineeringBiotechnology and bioengineering
- 2018
This work illustrates the feasibility of incorporating a single pass diafiltration step into an end‐to‐end continuous protein purification process and several critical design aspects were incorporated to minimize system complexity and reduce the buffer volume requirements.
Continuous Manufacturing of Recombinant Therapeutic Proteins: Upstream and Downstream Technologies.
- BiologyAdvances in biochemical engineering/biotechnology
- 2018
This review first discusses approaches for continuous cell culture, with a focus on perfusion-enabling cell separation technologies including gravitational, centrifugal, and acoustic settling, as well as filtration-based techniques.
Continuous counter‐current chromatography for capture and polishing steps in biopharmaceutical production
- BiologyBiotechnology journal
- 2016
Different continuous multi‐column chromatography processes are discussed, associated with increased productivity per cycle and decreased buffer consumption, whereas the typical purity‐yield trade‐off of classical batch chromatography can be surmounted by continuous processes for polishing applications.
Development of perfusion cell culture processes for the manufacturing of therapeutic recombinant proteins
- Biology
- 2019
The work presented in this thesis was performed in an industrial environment that is in transition from a well established batch-like production platform, to continuous manufacturing and focuses more specifically on perfusion cell cultures.
Continuous bioprocessing: The real thing this time?
- Engineering, BiologymAbs
- 2014
A report from the sessions that focused on continuous bioprocessing during the 10th Annual bioProcessUK Conference (London, December 2013), where the aim was to understand better the challenges and opportunities for continuous bioProcessing in the biop rocessing sector.
Integrated continuous biomanufacturing platform with ATF perfusion and one column chromatography operation for optimum resin utilization and productivity
- Engineering, BiologyPreparative biochemistry & biotechnology
- 2018
This approach is the first report on using a single column for the implementation of an integrated continuous biomanufacturing platform and offers a cost-effective and flexible platform process for the manufacture of therapeutic proteins.
Ultra scale-down concepts to address early stage process development challenges in integrated continuous bioprocessing
- Engineering
- 2017
The benefits of continuous bioprocessing, e.g. accelerated process development and scale-up, reduced capital costs, and standardisation, could be achieved through facility automation, universal…
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