Transformation of Biopharmaceutical Manufacturing Through Single-Use Technologies: Current State, Remaining Challenges, and Future Development

Abstract

Single-use technologies have transformed conventional biopharmaceutical manufacturing, and their adoption is increasing rapidly for emerging applications like antibody–drug conjugates and cell and gene therapy products. These disruptive technologies have also had a significant impact during the coronavirus disease 2019 pandemic, helping to advance process development to enable the manufacturing of new monoclonal antibody therapies and vaccines. Single-use systems provide closed plug-and-play solutions and enable process intensification and continuous processing. Several challenges remain, providing opportunities to advance single-use sensors and their integration with single-use systems, to develop novel plastic materials, and to standardize design for interchangeability. Because the industry is changing rapidly, a holistic analysis of the current single-use technologies is required, with a summary of the latest advancements in materials science and the implementation of these technologies in end-to-end bioprocesses.

Sensors and Techniques for On-Line Determination of Cell Viability in Bioprocess Monitoring

“…Invasive probes which are sterilized within the reactor are usually not well suited to single-use application as they cannot always reliably guarantee the integrity of the sterile barrier. Non-invasive spectroscopic methods, on the other hand, can be easily implemented in SU bioreactors, which also prevents the risk of cross-contamination [ 19 ]. However, one challenge which must be overcome for sensor application in SU bioreactors is the permeability of the plastic reactor material for electromagnetic waves, to enable measurement in the reactor bag without loss of intensity or interference effects.…”

Adaptation of the binding domain ofLactobacillus acidophilusS-layer protein as a molecular tag for affinity chromatography development

“…At the core of the downstream process, chromatography is the critical step but also the most expensive one 8 9 . To reduce critical costs associated with this step different approaches have been evaluated including the adoption of single-use technologies 10 .…”

Improving the reproducibility of size distribution of protein crystals produced in continuous slug flow crystallizer operated at short residence time

“…Naturally, the biological function of a proteins is determined by its folded structure, which is intrinsically determined by the amino acid sequence. From a chemical point of view, according to the widely accepted nomenclature rules, "oligopeptides" contain fewer than 15 amino acids, "polypeptides" are comprised of approximately 15-50 amino acid residues, and "protein" indicates polypeptides that have more than 50 amino acids [104]. Unlike proteins, most peptides lack well defined secondary and tertiary structures [105].…”