Results 81 to 90 of about 15,283 (290)

Applied Biopharmaceutics and Pharmacokinetics

, 1993
xxii;ill.;625hal ...
Shargel, Leon and Yu, Andrew B.C
core  

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

BIOPHARMACEUTICS AND APPROACHES TO DRUG ABSORPTION ENHANCEMENT

Biopharmaceutics is a foundational discipline in pharmaceutical sciences that focuses on the interplay between drug physicochemical properties, formulation design, and physiological factors governing drug absorption and bioavailability.
Shradha. S. Mathpati, Samiksha. S. Dodke, Smita. M. Mali, Priyanka. T. Farakute, Shubhangi. B. Sutar   +4 more
core   +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

Summary workshop report : bioequivalence, biopharmaceutics classification system, and beyond

, 2008
The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics
Baldoni, John M, Shah, Vinod P, Krill, Steve L, Winkle, Helen N, Amidon, Gordon L, Wu, Yunhui, Zhang, Hua, Johnston, Gordon, Fackler, Paul, Abrahamsson, Bertil S I,, Malick, Waseem A, Sun, Duxin, Lipper, Robert A, Yu, Lawrence X, Hartauer, Kerry, Polli, James E, Cook, Jack A   +16 more
core   +1 more source

Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

, 2023
One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and ...
Myong-Jin Kim, Ping Ren, Theresa Chan, Wen-Cheng Yang, Mitchell Frost, Yi Zhang, Yan Wang, Robert Lionberger, Markham Luke   +8 more
core   +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

Establishing an innovative carbohydrate metabolic pathway for efficient production of 2-keto-l-gulonic acid in Ketogulonicigenium robustum initiated by intronic promoters

Microbial Cell Factories, 2018
Background 2-Keto-l-gulonic acid (2-KGA), the precursor of vitamin C, is currently produced by two-step fermentation. In the second step, l-sorbose is transformed into 2-KGA by the symbiosis system composed of Ketogulonicigenium vulgare and Bacillus ...
Cai-Yun Wang, Ye Li, Zi-Wei Gao, Li-Cheng Liu, Meng-Yue Zhang, Tian-Yuan Zhang, Chun-Fu Wu, Yi-Xuan Zhang   +7 more
doaj   +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

Oral biopharmaceutics tools: Recent progress from partnership through the Pharmaceutical Education and Research with Regulatory Links collaboration

, 2022
S.437-446Objectives To summarise key contributions of the Pharmaceutical Education and Research with Regulatory Links (PEARRL) project (2016-2020) to the optimisation of existing and the development of new biopharmaceutics tools for evaluating the in ...
Litou, C., O'Dwyer, P.J., Henze, L.J., Vertzoni, M., Statelova, M., Reppas, C., Pentafragka, C., Box, K.J., Griffin, B.T., Dressman, J.   +9 more
core   +1 more source