Results 111 to 120 of about 70,680 (286)

Gaussian Processes for Predictive QSAR Modeling of Chromatographic Processes

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Chromatography is a key unit operation in the biopharmaceutical manufacturing process used for protein purification and polishing. Design and optimization of these processes are resource‐intensive resulting from the complex combinatorial design space.
Harini Narayanan, Douglas Nolan, Lijuan Li, Edward King, Andrew Fiordalis, David Benjamin Nickel, George Parks, J. Christopher Love   +7 more
wiley   +1 more source

Cellular immune breadth of an Omicron-specific, self-amplifying monovalent mRNA vaccine booster for COVID-19

npj Vaccines
Selecting a booster vaccine strategy that generates cellular immune breadth is crucial for effectively recalling cellular reservoirs upon infection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants.
Durgesh Kumar, Kshitij Gaikwad, Rushank Gunnale, Sandeep Vishwakarma, Shalu Shukla, Shalini Srivastava, Janhavi Gopal, Bhalchandra Vaidya, Amit Saraf, Rohan Gurjar, Swarnendu Kaviraj, Ajay Singh, Arjun Raghuwanshi, Praveen Agarwal, Laxman Savergave, Sanjay Singh, and the GEMCOVAC-OM Study Investigators   +16 more
doaj   +1 more source

An efficient multiple imputation algorithm for control-based and delta-adjusted pattern mixture models using SAS

, 2016
In clinical trials, mixed effects models for repeated measures (MMRM) and pattern mixture models (PMM) are often used to analyze longitudinal continuous outcomes.
Tang, Yongqiang
core   +2 more sources

Quantitative Analysis Reveals Hitchhiking Drives Polysorbate Hydrolase Persistence Via Host Cell Protein–Antibody Interactions

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Polysorbate‐degrading host cell proteins (HCPs) represent a critical challenge in the manufacturing of monoclonal antibody therapeutics due to their potential to persist during downstream processing. While their enzymatic activity has been characterized, the role of direct HCP‐mAb interactions, particularly those involving polysorbate ...
Melanie Maier, Lukas Griesinger, Matthias Franzreb, Simon Kluters   +3 more
wiley   +1 more source

Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance [PDF]

, 2006
Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity.
Chenine, Moustafa, Garcia Lozano, Marianela, Kabilan, Vandana   +2 more
core   +1 more source

Multimodal Chromatography in the Downstream Processing of mAb‐Based Products: Mechanisms, Strategies, and Applications

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Multimodal chromatography has emerged as a powerful tool for the purification of monoclonal antibodies (mAbs) and their derivatives—including antibody fragments (Fabs), Fc‐fusions, bispecific (BsAb), and antibody–drug conjugates (ADCs)—offering enhanced selectivity through the integration of ionic, hydrophobic, hydrogen‐bonding, and π–π ...
Amin Javidanbardan, Marco P․ C․ Marques, Ana M. Azevedo, Daniel G. Bracewell, Stephen Goldrick   +4 more
wiley   +1 more source

Mediated Electrochemical Probing and Machine Learning for Cysteine and Reduced Monoclonal Antibody Quantification

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Biopharmaceutical manufacturing requires robust analytics and process controls throughout production to insure high yield of quality products. New methodologies for rapidly accessing and integrating data‐rich information from complex dynamic biological environments are of great interest.
Kayla Chun, Varun Kochar, Evelyn Jaskowiak, Chen‐Yu Chen, Divya Muthusamy, Dana Motabar, Eunkyoung Kim, Gregory F. Payne, William E. Bentley   +8 more
wiley   +1 more source

Lectin based glycoprotein analysis [PDF]

, 2008
Many of the biopharmaceutical therapeutics entering the market and currently in clinical trails are recombinant glycoprotein molecules, the glycan moieties of which have a significant impact on efficacy and immunogenicity.
Clarke, Paul A., Goel, Alok, O'Connell, Michael, O'Connor, Brendan, Thompson, Roisin   +4 more
core  

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

Engineered Bacterial Ligand From Streptococcus pneumoniae on Macroporous Resins for Selective Affinity Capture of Secretory IgA

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Secretory immunoglobulin A (sIgA) is a promising emerging biopharmaceutical candidate, but it currently lacks a standardized platform for purification. To address this, a novel affinity chromatography resin was developed by immobilizing protein variants of the Streptococcus pneumoniae surface protein, SpsA, as an affinity ligand.
David Scheich, Andres Männik, Oliver Meikar, Joan Teyra, Laura Kibena, Sebastiaan Eeltink, Rainer Hahn, Alois Jungbauer, Nico Lingg   +8 more
wiley   +1 more source