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Article ; Online: Agitation-Induced Aggregation of Lysine- And Interchain Cysteine-Linked Antibody-Drug Conjugates.

Johann, Florian / Wöll, Steffen / Winzer, Matthias / Gieseler, Henning

2023 Volume 113, Issue 5, Page(s) 1265–1274

Abstract: Drug conjugation to an antibody can affect its stability, which depends on factors such as the conjugation technique used, drug-linker properties, and stress encountered. This study focused on the effects of agitation stress on the physical stability of ... ...

Abstract	Drug conjugation to an antibody can affect its stability, which depends on factors such as the conjugation technique used, drug-linker properties, and stress encountered. This study focused on the effects of agitation stress on the physical stability of two lysine (ADC-K) and two interchain cysteine (ADC-C) conjugates of an IgG
MeSH term(s)	Cysteine ; Lysine ; Immunoconjugates ; Antibodies, Monoclonal ; Hydrophobic and Hydrophilic Interactions
Chemical Substances	Cysteine (K848JZ4886) ; Lysine (K3Z4F929H6) ; Immunoconjugates ; Antibodies, Monoclonal
Language	English
Publishing date	2023-12-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2023.12.003
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Article ; Online: Evaluation of Packaging Materials in Freeze-Drying: Use of Polymer Caps and Nested Vials and Their Impact on Process and Product Attributes.

Wenzel, Tim / Gieseler, Henning

AAPS PharmSciTech

2021 Volume 22, Issue 3, Page(s) 82

Abstract: Current trends in the pharmaceutical industry led to a demand for more flexible manufacturing processes with smaller batch sizes. Prepackaged nested vials that can be processed as a unit were introduced into the market to fulfill this need. However, vial ...

Abstract	Current trends in the pharmaceutical industry led to a demand for more flexible manufacturing processes with smaller batch sizes. Prepackaged nested vials that can be processed as a unit were introduced into the market to fulfill this need. However, vial nests provide a different thermal environment for the vials compared to a hexagonal packaging array and could therefore influence product temperature profiles, primary drying times, and product quality attributes. Polymer caps with the possibility of vial closure inside the freeze-drying chamber were developed to remove the risks and need of a crimping process. A general concern with the use of such caps is the possibility of an increase in resistance to water vapor flow out of the vial. This case study investigated the effect of the LyoSeal
MeSH term(s)	Desiccation/methods ; Drug Industry/methods ; Drug Industry/standards ; Drug Packaging/methods ; Drug Packaging/standards ; Freeze Drying/methods ; Freeze Drying/standards ; Polymers/standards ; Temperature
Chemical Substances	Polymers
Language	English
Publishing date	2021-02-23
Publishing country	United States
Document type	Evaluation Study ; Journal Article
ZDB-ID	2052070-0
ISSN	1530-9932 ; 1530-9932
ISSN (online)	1530-9932
ISSN	1530-9932
DOI	10.1208/s12249-021-01953-8
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Article ; Online: Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations.

Wenzel, Tim / Gieseler, Henning

AAPS PharmSciTech

2021 Volume 22, Issue 2, Page(s) 57

Abstract: Recent advances in molded vial manufacturing enabled manufacturers to use a new manufacturing technique to achieve superior homogeneity of the vial wall thickness. This study evaluated the influence of the different manufacturing techniques of molded ... ...

Abstract	Recent advances in molded vial manufacturing enabled manufacturers to use a new manufacturing technique to achieve superior homogeneity of the vial wall thickness. This study evaluated the influence of the different manufacturing techniques of molded vials and glass compositions on vial heat transfer in freeze-drying. Additionally, the influence of using empty vials as thermal shielding on thermal characteristics of edge and center vials was investigated. The vial heat transfer coefficient K
MeSH term(s)	Drug Packaging/methods ; Freeze Drying/methods ; Glass/chemistry ; Hot Temperature ; Technology, Pharmaceutical/methods
Language	English
Publishing date	2021-01-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2052070-0
ISSN	1530-9932 ; 1530-9932
ISSN (online)	1530-9932
ISSN	1530-9932
DOI	10.1208/s12249-021-01926-x
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Article ; Online: Features in Backgrounds of Microscopy Images Introduce Biases in Machine Learning Analyses.

Greenblott, David N / Johann, Florian / Snell, Jared R / Gieseler, Henning / Calderon, Christopher P / Randolph, Theodore W

Journal of pharmaceutical sciences

2024 Volume 113, Issue 5, Page(s) 1177–1189

Abstract: Subvisible particles may be encountered throughout the processing of therapeutic protein formulations. Flow imaging microscopy (FIM) and backgrounded membrane imaging (BMI) are techniques commonly used to record digital images of these particles, which ... ...

Abstract	Subvisible particles may be encountered throughout the processing of therapeutic protein formulations. Flow imaging microscopy (FIM) and backgrounded membrane imaging (BMI) are techniques commonly used to record digital images of these particles, which may be analyzed to provide particle size distributions, concentrations, and identities. Although both techniques record digital images of particles within a sample, FIM analyzes particles suspended in flowing liquids, whereas BMI records images of dry particles after collection by filtration onto a membrane. This study compared the performance of convolutional neural networks (CNNs) in classifying images of subvisible particles recorded by both imaging techniques. Initially, CNNs trained on BMI images appeared to provide higher classification accuracies than those trained on FIM images. However, attribution analyses showed that classification predictions from CNNs trained on BMI images relied on features contributed by the membrane background, whereas predictions from CNNs trained on FIM features were based largely on features of the particles. Segmenting images to minimize the contributions from image backgrounds reduced the apparent accuracy of CNNs trained on BMI images but caused minimal reduction in the accuracy of CNNs trained on FIM images. Thus, the seemingly superior classification accuracy of CNNs trained on BMI images compared to FIM images was an artifact caused by subtle features in the backgrounds of BMI images. Our findings emphasize the importance of examining machine learning algorithms for image analysis with attribution methods to ensure the robustness of trained models and to mitigate potential influence of artifacts within training data sets.
MeSH term(s)	Microscopy ; Machine Learning ; Neural Networks, Computer ; Algorithms ; Bias
Language	English
Publishing date	2024-03-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2024.03.003
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Book ; Online ; Thesis: Innovative Technologies in Freeze-Drying and Their Effect on Process Design, Drying Behavior and Product Quality: A Case Study for Controlled Ice Nucleation and Novel Packaging Systems

Wenzel, Tim [Verfasser] / Gieseler, Henning [Akademischer Betreuer] / Gieseler, Henning [Gutachter]

2021

Author's details	Tim Wenzel ; Gutachter: Henning Gieseler ; Betreuer: Henning Gieseler
Keywords	Medizin, Gesundheit ; Medicine, Health
Subject code	sg610
Language	English
Publisher	Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
Publishing place	Erlangen
Document type	Book ; Online ; Thesis
Database	Digital theses on the web

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Article ; Online: Merits and Limitations of Dynamic Vapor Sorption Studies on the Morphology and Physicochemical State of Freeze-Dried Products.

Kunz, Claudia / Gieseler, Henning

Journal of pharmaceutical sciences

2018 Volume 107, Issue 8, Page(s) 2179–2191

Abstract: The goal of the present study was to assess the applicability of dynamic vapor sorption analysis of freeze-dried products. Water vapor sorption profiles of intact and ground cakes were recorded to determine the relevance of powder handling. Grinding ... ...

Abstract	The goal of the present study was to assess the applicability of dynamic vapor sorption analysis of freeze-dried products. Water vapor sorption profiles of intact and ground cakes were recorded to determine the relevance of powder handling. Grinding prior to measurements appeared to be related with a more rapid uptake of water vapor and crystallization. Crystallization may be prevented when analyzing intact cakes. More hygroscopic materials appeared to require a longer time to achieve a constant mass. The specific surface area of different freeze-dried products was calculated from the sorption isotherms using water, organic solvents, and krypton. The specific surface areas calculated for mannitol with water and ethanol was in good agreement with krypton data. False high values were obtained from water vapor sorption of the investigated amorphous materials. The results were slightly improved by the application of vacuum. For trehalose and sucrose, no sorption and thus faulty results were detected with the studied organic solvents. The degree of crystallinity of mannitol within a binary formulation could not be determined by dynamic vapor sorption. Differences in sorption and crystallization tendencies of mannitol and sucrose that were freeze-dried separately and in a binary mixture were considered as the root cause.
MeSH term(s)	Algorithms ; Crystallization ; Excipients/chemistry ; Freeze Drying/methods ; Mannitol/chemistry ; Povidone/chemistry ; Steam/analysis ; Sucrose/chemistry ; Trehalose/chemistry
Chemical Substances	Excipients ; Steam ; Mannitol (3OWL53L36A) ; Sucrose (57-50-1) ; Trehalose (B8WCK70T7I) ; Povidone (FZ989GH94E)
Language	English
Publishing date	2018-04-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2018.04.016
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Factors Influencing the Retention of Organic Solvents in Products Freeze-Dried From Co-Solvent Systems.

Kunz, Claudia / Gieseler, Henning

Journal of pharmaceutical sciences

2018 Volume 107, Issue 8, Page(s) 2005–2012

Abstract: Controlling residual solvent levels is a major concern in pharmaceutical freeze-drying from co-solvent systems. This review provides an overview of the factors influencing this process and estimates their potential to reduce residual solvents in freeze- ... ...

Abstract	Controlling residual solvent levels is a major concern in pharmaceutical freeze-drying from co-solvent systems. This review provides an overview of the factors influencing this process and estimates their potential to reduce residual solvents in freeze-dried products. Decreased solvent contents are potentially correlated with the lower solid content, complete excipient crystallization, higher water solubility, and smaller molecular sizes of the solvent. Although no general rule can be derived for the selection of appropriate freezing conditions, the freezing stage appears to play a major role in subsequent volatile retention. In contrast, diverse secondary drying conditions do not appear to impact the amount of solvent retained in lyophilisates, and modification of this stage is thus not assumed to be expedient. Co-solvents are strongly entrapped in an amorphous product matrix as soon as the local moisture content decreases below a certain level. Thus, the moisture content in the dried product layer adjacent to the sublimation interface might be a key factor. Therefore, extension of the high moisture content period during the primary drying phase as well as a postlyophilization humidification of the dried products are presumably promising approaches to promote solvent release.
MeSH term(s)	Adsorption ; Crystallization ; Diffusion ; Drug Compounding/methods ; Excipients/chemistry ; Freeze Drying/methods ; Solubility ; Solvents/chemistry ; Water/chemistry
Chemical Substances	Excipients ; Solvents ; Water (059QF0KO0R)
Language	English
Publishing date	2018-04-09
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2018.04.001
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Article ; Online: Design of Vacuum-Induced Freezing Protocols for High Fill Volume Formulations in Freeze-Drying: A Strategic Approach.

Wenzel, Tim / Gieseler, Margit / Gieseler, Henning

Journal of pharmaceutical sciences

2020 Volume 109, Issue 10, Page(s) 3035–3044

Abstract: This case study proposes a development strategy for the SynchroFreeze vacuum-induced surface freezing technology for challenging high fill volume model systems. Critical steps during the development of a nucleation protocol are discussed as an example ... ...

Abstract	This case study proposes a development strategy for the SynchroFreeze vacuum-induced surface freezing technology for challenging high fill volume model systems. Critical steps during the development of a nucleation protocol are discussed as an example approach for implementing vacuum-induced surface freezing for high fill volume products. Slow pressure ramps and hold steps at adequate pressures have been found to be crucial for avoiding defects caused by either excessive outgassing or incomplete degassing. The evaporative mass loss during the SynchroFreeze procedure is characterized and thermal gradients during nucleation for several model systems with concentrations in the 50-400 mg/mL range are analyzed. The technology results in a measurable mass loss that may be relevant for low fill volume formulations. Thermal data show a pronounced temperature gradient throughout the entire product solution during nucleation by vacuum-induced surface freezing. The formulation composition, concentration, and shelf temperature have been shown to influence this temperature gradient. Reliable nucleation was achieved for sucrose formulations with concentrations up to 200 mg/mL at shelf temperatures minimally below the equilibrium freezing point.
MeSH term(s)	Freeze Drying ; Freezing ; Temperature ; Transition Temperature ; Vacuum
Language	English
Publishing date	2020-07-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2020.06.025
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Investigation of Two Different Pressure-Based Controlled Ice Nucleation Techniques in Freeze-Drying: The Integral Role of Shelf Temperature After Nucleation in Process Performance and Product Quality.

Wenzel, Tim / Gieseler, Margit / Gieseler, Henning

Journal of pharmaceutical sciences

2020 Volume 109, Issue 9, Page(s) 2746–2756

Abstract: The purpose of this study was to investigate the impact of shelf temperature modifications during application of controlled ice nucleation techniques on process data and critical product quality attributes for a challenging, high-concentration and high- ... ...

Abstract	The purpose of this study was to investigate the impact of shelf temperature modifications during application of controlled ice nucleation techniques on process data and critical product quality attributes for a challenging, high-concentration and high-fill volume amorphous model system. Different freezing programs were applied and compared for the mechanistically different depressurization and vacuum-induced surface freezing techniques. Critical process data, such as product temperature and drying time, were analyzed. The final products were characterized with a focus on product morphology, residual moisture, reconstitution time and stability. The shelf temperature directly after primary nucleation showed a major influence on process performance and product quality attributes, with an isothermal hold step at an intermediate temperature leading to optimal results in terms of homogeneity and reduction of product temperatures and drying time for the model system used. The different controlled ice nucleation techniques led to significantly different results in terms of product morphology and process data, showing that the two mechanistically different controlled nucleation techniques are not interchangeable.
MeSH term(s)	Desiccation ; Freeze Drying ; Freezing ; Ice ; Temperature
Chemical Substances	Ice
Language	English
Publishing date	2020-06-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2020.05.020
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Article ; Online: Cycle Development in a Mini-Freeze Dryer: Evaluation of Manometric Temperature Measurement in Small-Scale Equipment.

Wenzel, Tim / Gieseler, Margit / Abdul-Fattah, Ahmad M / Gieseler, Henning

AAPS PharmSciTech

2021 Volume 22, Issue 4, Page(s) 143

Abstract: The objective of this research was to assess the applicability of manometric temperature measurement (MTM) and SMART™ for cycle development and monitoring of critical product and process parameters in a mini-freeze dryer using a small set of seven vials. ...

Abstract	The objective of this research was to assess the applicability of manometric temperature measurement (MTM) and SMART™ for cycle development and monitoring of critical product and process parameters in a mini-freeze dryer using a small set of seven vials. Freeze drying cycles were developed using SMART™ which automatically defines and adapts process parameters based on input data and MTM feedback information. The freeze drying behavior and product characteristics of an amorphous model system were studied at varying wall temperature control settings of the cylindrical wall surrounding the shelf in the mini-freeze dryer. Calculated product temperature profiles were similar for all different wall temperature settings during the MTM-SMART™ runs and in good agreement with the temperatures measured by thermocouples. Product resistance profiles showed uniformity in all of the runs conducted in the mini-freeze dryer, but absolute values were slightly lower compared to values determined by MTM in a LyoStar™ pilot-scale freeze dryer. The resulting cakes exhibited comparable residual moisture content and optical appearance to the products obtained in the larger freeze dryer. An increase in intra-vial heterogeneity was found for the pore morphology in the cycle with deactivated wall temperature control in the mini-freeze dryer. SMART™ cycle design and product attributes were reproducible and a minimum load of seven 10R vials was identified for more accurate MTM values. MTM-SMART™ runs suggested, that in case of the wall temperature following the product temperature of the center vial, product temperatures differ only slightly from those in the LyoStar™ freeze dryer.
MeSH term(s)	Freeze Drying/instrumentation ; Manometry/methods ; Technology, Pharmaceutical/instrumentation ; Temperature
Language	English
Publishing date	2021-04-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	2052070-0
ISSN	1530-9932 ; 1530-9932
ISSN (online)	1530-9932
ISSN	1530-9932
DOI	10.1208/s12249-021-02014-w
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