Developments and opportunities in continuous biopharmaceutical manufacturing

O Khanal, AM Lenhoff - MAbs, 2021 - Taylor & Francis
Today's biologics manufacturing practices incur high costs to the drug makers, which can
contribute to high prices for patients. Timely investment in the development and …

A common framework for integrated and continuous biomanufacturing

J Coffman, M Brower… - Biotechnology and …, 2021 - Wiley Online Library
There is a growing application of integrated and continuous bioprocessing (ICB) for
manufacturing recombinant protein therapeutics produced from mammalian cells. At first …

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 …

Continuous precipitation for monoclonal antibody capture using countercurrent washing by microfiltration

Z Li, Q Gu, JL Coffman, T Przybycien… - Biotechnology …, 2019 - Wiley Online Library
There is renewed interest in the possibility of using precipitation for initial capture of high‐
value therapeutic proteins as part of an integrated continuous downstream process …

Truly continuous low pH viral inactivation for biopharmaceutical process integration

DL Martins, J Sencar, N Hammerschmidt… - Biotechnology and …, 2020 - Wiley Online Library
Continuous virus inactivation (VI) has received little attention in the efforts to realize fully
continuous biomanufacturing in the future. Implementation of continuous VI must assure a …

Protein aggregation and mitigation strategy in low pH viral inactivation for monoclonal antibody purification

W Jin, Z Xing, Y Song, C Huang, X Xu, S Ghose, ZJ Li - MAbs, 2019 - Taylor & Francis
Significant amounts of soluble product aggregates were observed during low-pH viral
inactivation (VI) scale-up for an IgG4 monoclonal antibody (mAb IgG4-N1), while small-scale …

Potential of continuous manufacturing for liposomal drug products

RD Worsham, V Thomas, SS Farid - Biotechnology journal, 2019 - Wiley Online Library
Over the last several years, continuous manufacturing of pharmaceuticals has evolved from
bulk APIs and solid oral dosages into the more complex realm of biologics. The …

White paper on high‐throughput process development for integrated continuous biomanufacturing

MN São Pedro, TC Silva, R Patil… - Biotechnology and …, 2021 - Wiley Online Library
Continuous manufacturing is an indicator of a maturing industry, as can be seen by the
example of the petrochemical industry. Patent expiry promotes a price competition between …

Continuous manufacturing of monoclonal antibodies: Automated downstream control strategy for dynamic handling of titer variations

G Thakur, V Bansode, AS Rathore - Journal of Chromatography A, 2022 - Elsevier
Handling long-term dynamic variability in harvest titer is a critical challenge in continuous
downstream manufacturing. This challenge is becoming increasingly important with the …

Complete or periodic continuity in continuous manufacturing platforms for production of monoclonal antibodies?

N Kateja, A Tiwari, G Thakur… - Biotechnology …, 2021 - Wiley Online Library
Background Monoclonal antibodies (mAbs) currently dominate the biotherapeutic market.
This has resulted in significant efforts towards the development of a continuous integrated …