Results 81 to 90 of about 30,350 (261)

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

Revisiting the Carbon Footprint of Single‐Use Technologies in Biomanufacturing: A Bottom‐Up Analysis Reveals a Paradigm Shift

Biotechnology and Bioengineering, EarlyView.
ABSTRACT The biopharmaceutical industry increasingly relies on single‐use technologies (SUT) for operational flexibility. For a long time, SUT was considered more sustainable than stainless‐steel (SST) systems due to water and energy savings. This study re‐evaluates this paradigm via a detailed bottom‐up analysis of the SUT carbon footprint at the 2000 
Jan Reiners, Katharina Bruno‐Thakur, Daina Romeo, Weronika Kuśmierczyk, Ferdinand Stückler   +4 more
wiley   +1 more source

LLM‐Guided Parameter Optimization for Mechanistic CHO Cell Bioreactor Models

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Mechanistic models of Chinese Hamster Ovary (CHO) cell cultures are essential for efficient bioprocess development and control, yet parameter estimation remains a critical challenge in model calibration. As model complexity increases, the number of parameters grows and their values become highly system‐specific due to biological variability ...
Han Bit Kim, Janghan Lee, Seo‐Yeon Kim, Jihoon Kim, Moo Sun Hong   +4 more
wiley   +1 more source

Machine Learning‐Based PAT Tool for Real‐Time Residual Moisture Monitoring in Lyophilized Biopharmaceuticals Using NIR Spectroscopy

Biotechnology and Bioengineering, EarlyView.
ABSTRACT There is a growing demand in the pharmaceutical industry to optimize analytical methodologies, reducing time and resource consumption while ensuring rapid process development and cost‐efficient manufacturing. Indeed, Food and Drug Administration (FDA) introduced the Process Analytical Technology (PAT) as an initiative enabling manufacturers to
Samuele Fiorenza, Mariapia D'Urso, Ambra Massei, Nunzia Falco, Davide Fissore, Enza Torino   +5 more
wiley   +1 more source

Comparative Analysis of Bioreactor Design and Scale‐Up for Cultivated Meat Using Monte Carlo‐Based Timescale Modeling

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Cultivated meat offers a sustainable alternative to conventional livestock production but faces significant scale‐up challenges, particularly in bioreactor design for mammalian cell suspension cultures. This study presents a comparative analysis of stirred tank reactors (STR), bubble columns (BC), and airlift reactors (ALR) to assess their ...
Pieter Jan Theodoor Brorens, Marcel Ottens, Cees Haringa   +2 more
wiley   +1 more source

Purification of Advanced Therapeutics by Flow‐Through Pseudo‐Affinity Chromatography: Bi‐Specific mABs, Fc Fusion Proteins, and Adeno‐Associated Viruses

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Modern biopharmaceutical manufacturing requires purification platforms capable of processing structurally and functionally diverse products while addressing the challenge of removing persistent and high‐risk host cell proteins (HCPs).
Wenning Chu, Eduardo Barbieri, Arianna Minzoni, Shriarjun Shastry, Jacob P. LeBarre, Qingbo Shu, Taufika Williams, Xuanwen Li, Divya Chandra, Xuankuo Xu, Jerome Bill, David Roush, Joseph Taris, Patrick Gilbert, Andre Kiesewetter, Oliver Rammo, Michael Schulte, Christopher Major, Trina Mouchahoir, Steven Cramer, Cristiana Boi, Ruben G. Carbonell, Abraham Lenhoff, Stefano Menegatti   +23 more
wiley   +1 more source

Bioprocess intensification: aspirations and achievements

BioTechniques, 2020
Bill Whitford
doaj   +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

Inventory Replenishment and Transshipment for Distributed Autologous Cell Therapy Manufacturing Networks

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Autologous cell therapy (AuCT) manufacturing networks must balance two competing objectives: reducing cost and improving patient access to time‐sensitive therapy. This study compares three AuCT manufacturing network designs: a centralized network with a single manufacturing facility, a coordinated point‐of‐care (POC) network in which POCs can ...
Zhaowei Li, Chelsea C. White III, Kan Wang, Ben Wang   +3 more
wiley   +1 more source

High Cell Density Cultivation of HEK293 Cells Using a 2L Membrane‐Stirred Bioreactor

Biotechnology and Bioengineering, EarlyView.
ABSTRACT The use of perfusion systems for the continuous cultivation of animal cells at high cell density (HCD) for the production of recombinant proteins, viruses, and viral vectors has many advantages. Besides an enhancement of volumetric productivity and high cell viability, the product quality can be improved through a steady‐state environment ...
Lennart Jacobtorweihe, Yasemin van Heuvel, Kathrina Scheiermann, Patrick Bongartz, Yvonne Genzel, Udo Reichl   +5 more
wiley   +1 more source