Trends in upstream and downstream process development for antibody manufacturing

P Gronemeyer, R Ditz, J Strube - Bioengineering, 2014 - mdpi.com
A steady increase of product titers and the corresponding change in impurity composition
represent a challenge for development and optimization of antibody production processes …

Whey protein hydrolysates as a source of bioactive peptides for functional foods–Biotechnological facilitation of industrial scale-up

A Dullius, MI Goettert, CFV de Souza - Journal of Functional Foods, 2018 - Elsevier
Whey proteins, which possess the highest nutritional quality of all food proteins, are an
optimal source of functional food ingredients. Enzymatic hydrolysis of whey proteins …

Purifying biopharmaceuticals: knowledge-based chromatographic process development

AT Hanke, M Ottens - Trends in biotechnology, 2014 - cell.com
The purification of biopharmaceuticals is commonly considered the bottleneck of the
manufacturing process. Increasing product diversity, along with growing regulatory and …

High-throughput process development for biopharmaceutical drug substances

R Bhambure, K Kumar, AS Rathore - Trends in biotechnology, 2011 - cell.com
Quality by Design (QbD) is gaining industry acceptance as an approach towards
development and commercialization of biotechnology therapeutic products that are …

Improved virus purification processes for vaccines and gene therapy

P Nestola, C Peixoto, RRJS Silva… - Biotechnology and …, 2015 - Wiley Online Library
The downstream processing of virus particles for vaccination or gene therapy is becoming a
critical bottleneck as upstream titers keep improving. Moreover, the growing pressure to …

Anything but conventional chromatography approaches in bioseparation

ACA Roque, AS Pina, AM Azevedo… - Biotechnology …, 2020 - Wiley Online Library
While packed bed chromatography, known as conventional chromatography, has been
serving the biopharmaceutical industry for decades as the bioseparation method of choice …

Accelerating biologics manufacturing by modeling or: is approval under the QbD and PAT approaches demanded by authorities acceptable without a digital-twin?

S Zobel-Roos, A Schmidt, F Mestmäcker, M Mouellef… - Processes, 2019 - mdpi.com
Innovative biologics, including cell therapeutics, virus-like particles, exosomes, recombinant
proteins, and peptides, seem likely to substitute monoclonal antibodies as the main …

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

V Chopda, A Gyorgypal, O Yang… - Journal of Chemical …, 2022 - Wiley Online Library
Continuous bioprocessing is significantly changing the biological drugs (or biologics)
manufacturing landscape by potentially improving product quality, process stability, and …

High-throughput isotherm determination and thermodynamic modeling of protein adsorption on mixed mode adsorbents

BK Nfor, M Noverraz, S Chilamkurthi… - … of Chromatography A, 2010 - Elsevier
The thermodynamic modeling of protein adsorption on mixed-mode adsorbents
functionalized with ligands carrying both hydrophobic and electrostatic groups was …

Downstream bioprocessing: recent advances and future promise

SM Cramer, MA Holstein - Current Opinion in Chemical Engineering, 2011 - Elsevier
Dramatic improvements in cell culture titers, product quality constraints, new regulatory
directives, and the emergence of biosimilars have necessitated the development of more …