Cargando…

Specification-driven acceptance criteria for validation of biopharmaceutical processes

Intermediate acceptance criteria are the foundation for developing control strategies in process validation stage 1 in the pharmaceutical industry. At drug substance or product level such intermediate acceptance criteria for quality are available and referred to as specification limits. However, it...

Descripción completa

Detalles Bibliográficos
Autores principales:	Marschall, Lukas, Taylor, Christopher, Zahel, Thomas, Kunzelmann, Marco, Wiedenmann, Alexander, Presser, Beate, Studts, Joey, Herwig, Christoph
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2022
Materias:	Bioengineering and Biotechnology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9537461/ https://www.ncbi.nlm.nih.gov/pubmed/36213075 http://dx.doi.org/10.3389/fbioe.2022.1010583

Ejemplares similares

Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones
por: Taylor, Christopher, et al.
Publicado: (2021)

Workflow for Criticality Assessment Applied in Biopharmaceutical Process Validation Stage 1
por: Zahel, Thomas, et al.
Publicado: (2017)

Cyberbiosecurity for Biopharmaceutical Products
por: Mantle, Jennifer L., et al.
Publicado: (2019)

Ionic-liquid-based approaches to improve biopharmaceuticals downstream processing and formulation
por: Almeida, Catarina, et al.
Publicado: (2023)

Corrigendum: Ionic-liquid-based approaches to improve biopharmaceuticals downstream processing and formulation
por: Almeida, Catarina, et al.
Publicado: (2023)

CDMOs Play a Critical Role in the Biopharmaceutical Ecosystem
por: Kurata, Hideyuki, et al.
Publicado: (2022)

Nanophytomedicines for the Prevention of Metabolic Syndrome: A Pharmacological and Biopharmaceutical Review
por: Nouri, Zeinab, et al.
Publicado: (2020)

Process Engineering of Biopharmaceutical Production in Moss Bioreactors via Model-Based Description and Evaluation of Phytohormone Impact
por: Ruiz-Molina, Natalia, et al.
Publicado: (2022)

Streamlining the Characterization of Disulfide Bond Shuffling and Protein Degradation in IgG1 Biopharmaceuticals Under Native and Stressed Conditions
por: Coghlan, Jill, et al.
Publicado: (2022)

Biopharmaceutical-Type Chinese Hamster Ovary Cell Cultivation Under Static Magnetic Field Exposure: A Study of Genotoxic Effect
por: Rekena, Alina, et al.
Publicado: (2021)

Methods and criteria for validating the multimodal functions of perinatal derivatives when used in oncological and antimicrobial applications
por: Silini, Antonietta R., et al.
Publicado: (2022)

The Rocky Road From Fed-Batch to Continuous Processing With E. coli
por: Kopp, Julian, et al.
Publicado: (2019)

Validation of an immersive virtual reality device accepted by seniors that preserves the adaptive behavior produced in the real world
por: Delbes, Lisa, et al.
Publicado: (2022)

Reducing Organic Load From Industrial Residual Process Brine With a Novel Halophilic Mixed Culture: Scale-Up and Long-Term Piloting of an Integrated Bioprocess
por: Mainka, Thomas, et al.
Publicado: (2022)

Corrigendum: Reducing Organic Load From Industrial MDA Residual Process Brine With a Novel Halophilic Mixed Culture: Scale-Up and Long-Term Piloting of an Integrated Bioprocess
por: Mainka, Thomas, et al.
Publicado: (2022)

Repetitive Fed-Batch: A Promising Process Mode for Biomanufacturing With E. coli
por: Kopp, Julian, et al.
Publicado: (2020)

Muscle-driven forward dynamic active hybrid model of the lumbosacral spine: combined FEM and multibody simulation
por: Remus, Robin, et al.
Publicado: (2023)

In-line product quality monitoring during biopharmaceutical manufacturing using computational Raman spectroscopy
por: Wang, Jiarui, et al.
Publicado: (2023)

Editorial: Continuous Biomanufacturing in Microbial Systems
por: Herwig, Christoph, et al.
Publicado: (2021)

Editorial: Recent Advances in Continuous Cultivation
por: Zinn, Manfred, et al.
Publicado: (2021)

Boosting Recombinant Inclusion Body Production—From Classical Fed-Batch Approach to Continuous Cultivation
por: Kopp, Julian, et al.
Publicado: (2019)

Comparison of Neck Injury Criteria Values Across Human Body Models of Varying Complexity
por: Johnson, Dale, et al.
Publicado: (2020)

The Lazarus Escherichia coli Effect: Recovery of Productivity on Glycerol/Lactose Mixed Feed in Continuous Biomanufacturing
por: Kittler, Stefan, et al.
Publicado: (2020)

Omics-Driven Biotechnology for Industrial Applications
por: Amer, Bashar, et al.
Publicado: (2021)

Editorial: Fiat lux! Light-driven and light-controlled synthetic biological parts, devices, systems and processes
por: Stano, Pasquale, et al.
Publicado: (2023)

Application of Multi-Criteria Decision Analysis Techniques for Informing Select Agent Designation and Decision Making
por: Pillai, Segaran P., et al.
Publicado: (2022)

Assessment of the sensitivity of thoracic injury criteria to subject-specific characteristics using human body models
por: Piqueras, Ana, et al.
Publicado: (2023)

The Correlation Between Quality of Life and Acceptability of Disability in Patients With Facial Burn Scars
por: Zhang, Xiuni, et al.
Publicado: (2019)

Normative Criteria and Their Inclusion in a Regulatory Framework for New Plant Varieties Derived From Genome Editing
por: Hamburger, David J. S.
Publicado: (2018)

Biomechanical evaluation of different strain judging criteria on the prediction precision of cortical bone fracture simulation under compression
por: Fan, Ruoxun, et al.
Publicado: (2023)

Macrophage-Driven Biomaterial Degradation Depends on Scaffold Microarchitecture
por: Wissing, Tamar B., et al.
Publicado: (2019)

Bio-driven visual saliency detection with color factor
por: Wang, Yan, et al.
Publicado: (2022)

Evaluation of musculoskeletal models, scaling methods, and performance criteria for estimating muscle excitations and fiber lengths across walking speeds
por: Luis, Israel, et al.
Publicado: (2022)

Voluntary-Driven Elbow Orthosis with Speed-Controlled Tremor Suppression
por: Herrnstadt, Gil, et al.
Publicado: (2016)

Haptic Glove Using Tendon-Driven Soft Robotic Mechanism
por: Baik, Siyeon, et al.
Publicado: (2020)

Synthetic Biology-Driven Microbial Production of Resveratrol: Advances and Perspectives
por: Feng, Chao, et al.
Publicado: (2022)

Systems and synthetic biology-driven engineering of live bacterial therapeutics
por: Kim, Kangsan, et al.
Publicado: (2023)

Evaluation of Head Injury Criteria for Injury Prediction Effectiveness: Computational Reconstruction of Real-World Vulnerable Road User Impact Accidents
por: Wang, Fang, et al.
Publicado: (2021)

Application of multi-criteria decision analysis techniques and decision support framework for informing select agent designation for agricultural animal pathogens
por: Pillai, Segaran P., et al.
Publicado: (2023)

Application of multi-criteria decision analysis techniques and decision support framework for informing plant select agent designation and decision making
por: Pillai, Segaran P., et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_jtgjvfvvqghrccfcoe7r1n9og1