Results 91 to 100 of about 47,170 (292)

Host Cell Protein Challenges in Antibody Processing: Insights Into Persistence and Mitigation Strategies

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Persistence of HCPs remains a major purification challenge in biopharmaceutical manufacturing with direct consequences for product quality, patient safety, and regulatory compliance. Over the last two decades, deeper insights into the mechanisms driving HCP persistence have clarified why certain proteins evade removal during purification ...
Younghoon Oh, Andrew Cooke, Harshal Soni, Susan Liu, Mamadou Bah, Brianna Bellis, Laura Smith, Michael Capaldi, Nicholas Levy, Erik Wilhelm, Kristopher Barnthouse   +10 more
wiley   +1 more source

Lynfocytic colitis: clinical case

, 2018
Biomedical and biopharmaceutical research : jornal de investigação biomédica e ...
Tavares, Nelson, Sousa, Bruno
core   +1 more source

Characterizing Markets for Biopharmaceutical Innovations: Do Biologics Differ from Small Molecules? [PDF]

Much has been written about the seemingly less formal, more agile biotechnology industry and its extensive interactions with academia and startups, as well as its distinct scientific, manufacturing and regulatory profile.
Mark Trusheim, Murray L. Aitken, Ernst R. Berndt   +2 more
core  

Ferritin as a Nanoparticle Scaffold for Plant‐Produced Next‐Generation Subunit Vaccines

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Protein nanoparticles offer an innovative approach to next‐generation subunit vaccine development by displaying antigenic sequences on the nanoparticle surface. Compared to traditional subunit vaccines, protein nanoparticle vaccines often show improved interaction with the immune system due to their particulate size and repetitive epitope ...
Jordan T. VanderBurgt, Richard Strasser, Christopher P. Garnham, Rima Menassa   +3 more
wiley   +1 more source

A General Workflow for Tangential Flow Filtration Perfusion Scale‐Up

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Tangential flow filtration (TFF) perfusion using hollow‐fiber modules offers substantial advantages over other mammalian cell retention technologies. Recently, increased awareness of Starling flow has helped to enhance filtration performance to similar, or even higher levels compared to alternative technologies.
Patrick Romann, Ken Lee, Venkatesh Natarajan, Daniel Ley, Claes Nymand Nilsson, David Garcia‐Munzer, Dominik Schieman, Mahbod Hajighasemi, Alex Zaytsev, Jason Friedman, Loic Chappuis, Tobias Habicher, Colin Jaques, Alex Cohen, Matthew Gagnon, Edward Chan, Daniel J. Karst, Philip Giller, Antony Sibilia, Andrew L. Zydney, Thomas K. Villiger   +20 more
wiley   +1 more source

Unmasking Glycoforms: Lectin‐Based Profiling and Functional Implications of Targeted Glycosylation Knockouts in Chinese Hamster Ovary Cells

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Monoclonal antibody (mAb) glycosylation is a critical quality attribute that is difficult to rationally engineer and rapidly assess during cell line development. Here, we investigate whether cell‐surface glycosylation can serve as a surrogate readout of mAb product glycosylation following targeted glycogene engineering in CHO cells.
Cristina Abascal Ruiz, Sheryl Li Yan Lim, Jacobus Brink, Sara Carillo, Eoin Casey, Jonathan Bones, Ioscani Jiménez del Val   +6 more
wiley   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Enabling Bioprocess Upscaling Prediction Through Hybrid Modelling and Transfer Learning Under Small‐Data Scenarios

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Accurate prediction of bioprocess scale‐up is critical for accelerating the deployment of novel and sustainable biomanufacturing systems. However, this remains challenging as multi‐scale data is expensive to generate and mechanistic understanding is often incomplete, leading upscaling decisions to rely heavily on empirical expertise. This work
Harvey Al‐Ramadhan, Fernando Vega‐Ramon, Keju Jing, Dongda Zhang   +3 more
wiley   +1 more source

Development of a Stable CHO Cell Line for High-Level Expression and Purification of Recombinant Darbepoetin Alfa

Journal of Tropical Life Science
Recombinant Darbepoetin alfa (DARB), an erythropoiesis-stimulating agent, is widely used in treating anemia linked to chronic kidney disease and chemotherapy.
Dwi Purno Widekdo, Nashi Widodo, Muhaimin Rifa'i, Yoga Dwi Jatmiko   +3 more
doaj   +1 more source