Results 101 to 110 of about 15,283 (290)

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies

, 2016
In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications.
Heimbach, Tycho, Kesisoglou, Filippos, van Asperen, Judith, Chung, John   +3 more
core   +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

Solubility, Permeability, and Dissolution Rate of Naftidrofuryl Oxalate Based on BCS Criteria

, 2020
The Biopharmaceutics Classification System (BCS) was conceived to classify drug substances by their in vitro aqueous solubility and permeability properties.
Hanna Piotrowska-Kempisty, Izabela Ibragimow, Anna Olejnik, Piotr Igor Czaklosz, Marta Kus-Slowinska, Monika Wrzaskowska   +5 more
core   +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

IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 4 : Prediction accuracy and software comparisons with improved data and modelling strategies

, 2020
Oral drug absorption is a complex process depending on many factors, including the physicochemical properties of the drug, formulation characteristics and their interplay with gastrointestinal physiology and biology.
Moir, Andrea, Heimbach, Tycho, Lin, Wen, Nguyen-Trung, Anh-Thu, Carlert, Sara, He, Handan, Mattinson, Alex, Daublain, Pierre, Darwich, Adam S., Patterson, Claire, Wong, Suet, Wood, J. Matthew, Bevernage, Jan, Zhu, Wei, Engman, Helena, Schäfer, Kerstin Julia, Boulu, Laurent, Henrion, Louis, Schmid, Katrin, Rostami-Hodjegan, Amin, Wu, Fan, Tuunainen, Johanna, Franek, Frans, Tistaert, Christophe, Barker, Ric, Jamei, Masoud, Ollier, Celine, Pepin, Xavier, van Osdol, Bill, Pathak, Shriram M., Zhang, Jin, Bolger, Michael B., Thörn, Helena, Nicolas, Olivier, Manthena, Varma, Pappinen, Sari, Tannergren, Christer, Nguefack, Jean-Flaubert, Ruston, Linette, Karlsson, Eva, Jackson, Claire, Nguyen, Mai Anh, Murphy, Donal, Szeto, Ke, Lindley, David, Wang, Yuya, Beilles, Stephane, Carr, Robert, Laru, Johanna, Vaidhyanathan, Shruthi, Brown, Jonathan, Flanagan, Talia, Xia, Binfeng, Modi, Sweta, Ahmad, Amais, Turner, David, Aarons, Leon, Good, David, Budhdeo, Shanoo, Berg, Staffan, Patel, Aarti, Darwich, Adam S.,, Xu, Christine, Xiojun, Ren, Lloyd, Richard, Hanisch, Gunilla, Louit, Guillaume, Korjamo, Timo, Abrahamsson, Bertil, Mullin, James M.   +69 more
core   +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

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

Adult and pediatric physiologically‐based biopharmaceutics modeling to explain lamotrigine immediate release absorption process

CPT: Pharmacometrics & Systems Pharmacology
Physiologically‐based biopharmaceutics modeling (PBBM) has potential to accelerate the development of new drug and formulations. An important application of PBBM is for special populations such as pediatrics that have pharmacokinetics dependent on the ...
Edilainy Rizzieri Caleffi‐Marchesini, Amanda Antunes Herling, Julia Macente, Rodolfo Hernandes Bonan, Priscila deFreitas Lima, Rafaela Moreno, Veriano Alexandre, Nitin Bharat Charbe, Fernanda Belincanta Borghi‐Pangoni, Rodrigo Cristofoletti, Andréa Diniz   +10 more
doaj   +1 more source

Mechanistic Digital Model for Real‐Time Monitoring and Optimization of Adenovirus Production

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Adenoviral vectors are a critical vaccine platform, with billions of vaccine doses administered during the COVID‐19 pandemic. In addition, they are promising therapeutics for cancer treatment. To advance their manufacturing, real‐time monitoring of adenovirus production is essential for process optimization, yield improvement, and product ...
Xingge Xu, Daniel Rüdiger, Jeongbin Shin, Shawninder Chahal, Amine Kamen   +4 more
wiley   +1 more source

The Korea Chemical Bank: Over 25 years of national chemical infrastructure alongside KRICT's 50‐year journey

Bulletin of the Korean Chemical Society, EarlyView.
This graphic abstract illustrates the role of the Korea Chemical Bank (KCB) as a central national hub that integrates government R&D, academic compound deposits, and industrial drug discovery throughout the latter half of KRICT's 50‐year history. Abstract Since its establishment in 2000 under the Korea Research Institute of Chemical Technology (KRICT),
Seul‐Gee Hwang, Su‐Min Kang, Soon Hee Hwang, Yuri Lee, Suyoun Lee, Ho‐Jin Kwon, Sunjong Yu, Soo Hee Kim, Eun Suk An, Sun Ho Kim, Sun Woo Kim, Hyeon Kyu Lee, Min Sung Kim, Seung Yeon Lee, Mali Prakash, Jaehyeon Park, Gehyeong Lee, Yuno Lee, Nam‐Chul Cho   +18 more
wiley   +1 more source