---
_id: '13315'
abstract:
- lang: eng
text: Determining cell density and viability with (semi‐)automated methods enables
rapid cell cultivation analysis. However, scientific validation is required, typically
by comparing results to manual counting. To address this, we present a method
to evaluate and compare two cell counting methods exemplified by a manual and
a semi‐automated method (Countstar BioTech). Experiments followed validation parameters
aligned with the International Council for Harmonization (ICH) Q2(R1) guideline
and a dilution series design based on ISO 20391‐2:2019. Both the semi‐automated
and manual methods showed comparable specificity and linearity for Chinese hamster
ovary (CHO)‐K1 cells. The semi‐automated method exhibited superior repeatability
for total cell density, whereas cell viability results showed no significant difference.
author:
- first_name: Selina
full_name: Uhlendorff, Selina
id: '68713'
last_name: Uhlendorff
orcid: https://orcid.org/0000-0002-0502-8032
- first_name: Ulrich
full_name: Odefey, Ulrich
id: '74218'
last_name: Odefey
- first_name: Björn
full_name: Frahm, Björn
id: '45666'
last_name: Frahm
- first_name: Miriam
full_name: Pein-Hackelbusch, Miriam
id: '64952'
last_name: Pein-Hackelbusch
orcid: 0000-0002-7920-0595
citation:
ama: Uhlendorff S, Odefey U, Frahm B, Pein-Hackelbusch M. Performance Comparison
between Semi‐Automated and Manual Cell Counting for Animal Cell Culture. Chemie
Ingenieur Technik. 2025;98(1-2):57-68. doi:10.1002/cite.70048
apa: Uhlendorff, S., Odefey, U., Frahm, B., & Pein-Hackelbusch, M. (2025). Performance
Comparison between Semi‐Automated and Manual Cell Counting for Animal Cell Culture.
Chemie Ingenieur Technik, 98(1–2), 57–68. https://doi.org/10.1002/cite.70048
bjps: Uhlendorff S et al. (2025) Performance Comparison between Semi‐Automated
and Manual Cell Counting for Animal Cell Culture. Chemie Ingenieur Technik
98, 57–68.
chicago: 'Uhlendorff, Selina, Ulrich Odefey, Björn Frahm, and Miriam Pein-Hackelbusch.
“Performance Comparison between Semi‐Automated and Manual Cell Counting for Animal
Cell Culture.” Chemie Ingenieur Technik 98, no. 1–2 (2025): 57–68. https://doi.org/10.1002/cite.70048.'
chicago-de: 'Uhlendorff, Selina, Ulrich Odefey, Björn Frahm und Miriam Pein-Hackelbusch.
2025. Performance Comparison between Semi‐Automated and Manual Cell Counting for
Animal Cell Culture. Chemie Ingenieur Technik 98, Nr. 1–2: 57–68. doi:10.1002/cite.70048, .'
din1505-2-1: 'Uhlendorff, Selina ;
Odefey, Ulrich ; Frahm,
Björn ; Pein-Hackelbusch, Miriam:
Performance Comparison between Semi‐Automated and Manual Cell Counting for Animal
Cell Culture. In: Chemie Ingenieur Technik Bd. 98. Weinheim, Wiley (2025),
Nr. 1–2, S. 57–68'
havard: S. Uhlendorff, U. Odefey, B. Frahm, M. Pein-Hackelbusch, Performance Comparison
between Semi‐Automated and Manual Cell Counting for Animal Cell Culture, Chemie
Ingenieur Technik. 98 (2025) 57–68.
ieee: 'S. Uhlendorff, U. Odefey, B. Frahm, and M. Pein-Hackelbusch, “Performance
Comparison between Semi‐Automated and Manual Cell Counting for Animal Cell Culture,”
Chemie Ingenieur Technik, vol. 98, no. 1–2, pp. 57–68, 2025, doi: 10.1002/cite.70048.'
mla: Uhlendorff, Selina, et al. “Performance Comparison between Semi‐Automated and
Manual Cell Counting for Animal Cell Culture.” Chemie Ingenieur Technik,
vol. 98, no. 1–2, 2025, pp. 57–68, https://doi.org/10.1002/cite.70048.
short: S. Uhlendorff, U. Odefey, B. Frahm, M. Pein-Hackelbusch, Chemie Ingenieur
Technik 98 (2025) 57–68.
ufg: 'Uhlendorff, Selina u. a.: Performance Comparison between Semi‐Automated
and Manual Cell Counting for Animal Cell Culture, in: Chemie Ingenieur Technik
98 (2025), H. 1–2, S. 57–68.'
van: Uhlendorff S, Odefey U, Frahm B, Pein-Hackelbusch M. Performance Comparison
between Semi‐Automated and Manual Cell Counting for Animal Cell Culture. Chemie
Ingenieur Technik. 2025;98(1–2):57–68.
date_created: 2025-12-08T07:26:52Z
date_updated: 2026-03-27T17:14:42Z
department:
- _id: DEP4029
- _id: DEP4028
doi: 10.1002/cite.70048
intvolume: ' 98'
issue: 1-2
keyword:
- Cell density
- Cell enumeration
- Cell viability
- CHO-K1
language:
- iso: eng
main_file_link:
- open_access: '1'
oa: '1'
page: 57–68
place: Weinheim
publication: Chemie Ingenieur Technik
publication_identifier:
eissn:
- 1522-2640
issn:
- 0009-286X
publication_status: published
publisher: Wiley
quality_controlled: '1'
status: public
title: Performance Comparison between Semi‐Automated and Manual Cell Counting for
Animal Cell Culture
type: scientific_journal_article
user_id: '45666'
volume: 98
year: '2025'
...
---
_id: '12400'
abstract:
- lang: eng
text: Determining cell density and cell viability is fundamental for any cell cultivation
process. In addition to the manual counting method using hemocytometers, (semi-)automated
methods offer advantages such as lower variability and shortened analysis times.
However, these methods should provide at least comparable results to the manual
method, which is why a comparison of methods is essential. We conducted a dilution
series experimental design according to ISO 20391-2:2019 and compared two cell
counting methods based on validation parameters aligned with the ICH Q2(R1) guideline.
Regarding specificity and linearity, the manual (hemocytometer) and semi-automated
(Countstar BioTech®) method exhibited similar results in the two evaluated characteristics
total cell density and cell viability of CHO-K1 cells. Regarding repeatability
of determining total cell density, the semi-automated method achieved significant
(α = 0.05) better results with average relative standard deviations of < 6 %,
than the manual method with average relative standard deviations of > 9 %. Concerning
repeatability of the cell viability measurement, no significant difference between
the two methods were shown. These results show the suitabililty of the dilution
series experimental design. For the applied example, they indicate that the investigated
semi-automated method is an appropriate alternative to the manual method.
author:
- first_name: Selina
full_name: Ramm, Selina
id: '68713'
last_name: Ramm
orcid: https://orcid.org/0000-0002-0502-8032
- first_name: Ulrich
full_name: Odefey, Ulrich
id: '74218'
last_name: Odefey
- first_name: Björn
full_name: Frahm, Björn
id: '45666'
last_name: Frahm
- first_name: Miriam
full_name: Pein-Hackelbusch, Miriam
id: '64952'
last_name: Pein-Hackelbusch
orcid: 0000-0002-7920-0595
citation:
ama: 'Ramm S, Odefey U, Frahm B, Pein-Hackelbusch M. Semi-automated vs. manual:
Comparative study of cell culture counting methods using validation parameters.
Published online 2024. doi:10.1101/2024.05.30.596619'
apa: 'Ramm, S., Odefey, U., Frahm, B., & Pein-Hackelbusch, M. (2024). Semi-automated
vs. manual: Comparative study of cell culture counting methods using validation
parameters. bioRxiv. https://doi.org/10.1101/2024.05.30.596619'
bjps: 'Ramm S et al. (2024) Semi-Automated vs. Manual: Comparative
Study of Cell Culture Counting Methods Using Validation Parameters.'
chicago: 'Ramm, Selina, Ulrich Odefey, Björn Frahm, and Miriam Pein-Hackelbusch.
“Semi-Automated vs. Manual: Comparative Study of Cell Culture Counting Methods
Using Validation Parameters.” bioRxiv, 2024. https://doi.org/10.1101/2024.05.30.596619.'
chicago-de: 'Ramm, Selina, Ulrich Odefey, Björn Frahm und Miriam Pein-Hackelbusch.
2024. Semi-automated vs. manual: Comparative study of cell culture counting methods
using validation parameters. bioRxiv. doi:10.1101/2024.05.30.596619,
.'
din1505-2-1: 'Ramm, Selina ; Odefey, Ulrich ; Frahm,
Björn ; Pein-Hackelbusch, Miriam:
Semi-automated vs. manual: Comparative study of cell culture counting methods
using validation parameters, bioRxiv (2024)'
havard: 'S. Ramm, U. Odefey, B. Frahm, M. Pein-Hackelbusch, Semi-automated vs. manual:
Comparative study of cell culture counting methods using validation parameters,
(2024).'
ieee: 'S. Ramm, U. Odefey, B. Frahm, and M. Pein-Hackelbusch, “Semi-automated vs.
manual: Comparative study of cell culture counting methods using validation parameters.”
bioRxiv, 2024. doi: 10.1101/2024.05.30.596619.'
mla: 'Ramm, Selina, et al. Semi-Automated vs. Manual: Comparative Study of Cell
Culture Counting Methods Using Validation Parameters. bioRxiv, 2024, https://doi.org/10.1101/2024.05.30.596619.'
short: S. Ramm, U. Odefey, B. Frahm, M. Pein-Hackelbusch, (2024).
ufg: 'Ramm, Selina u. a.: Semi-automated vs. manual: Comparative study of
cell culture counting methods using validation parameters, o. O. 2024.'
van: 'Ramm S, Odefey U, Frahm B, Pein-Hackelbusch M. Semi-automated vs. manual:
Comparative study of cell culture counting methods using validation parameters.
bioRxiv; 2024.'
date_created: 2025-01-29T13:48:31Z
date_updated: 2025-07-29T13:23:30Z
department:
- _id: DEP4000
- _id: DEP4028
- _id: DEP4014
doi: 10.1101/2024.05.30.596619
language:
- iso: eng
main_file_link:
- open_access: '1'
url: https://www.biorxiv.org/content/10.1101/2024.05.30.596619v1
oa: '1'
publication_status: published
publisher: bioRxiv
status: public
title: 'Semi-automated vs. manual: Comparative study of cell culture counting methods
using validation parameters'
type: preprint
user_id: '83781'
year: '2024'
...
---
_id: '13359'
abstract:
- lang: eng
text: Extracellular vesicles (EVs) have been recognized as major signaling mediators
in a variety of physiological and pathophysiological conditions. Their paracrine
effects are promoted via bioactive molecules. However an essential first step
before a potential application of EVs in regenerative medicine is a batch-to-batch
reproducibility of their therapeutic efficacy. For this a qualitative and quantitative
testing of their potency is a necessary step. An adapted in vitro wound assay
will be presented using a newly developed scratch machine and a computational-aided
read-out. One of the major reasons for the onset of arteries clotting is gaining
weight. During the development towards adipocytes, differentiating mesenchymal
stem cells are highly metabolically active, which can activate primary endothelial
cells (ECs).This is a crucial first step towards artery clotting. These activated
ECs migrate in the adapted wound assay, which can be evaluated. We are able to
count quantitatively the migrated ECs, monitor their migration behavior, e.g.
speed, and isolate the migrated ECs to investigate their altered signal transduction
pathways by comparing them with the non-migrating ECs. By evaluating the migration
behavior, we record functional testing of EV potency, which was better than what
could be archived using a Boyden Chamber.
author:
- first_name: Patrick
full_name: Babczyk, Patrick
last_name: Babczyk
- first_name: Ulrich
full_name: Odefey, Ulrich
id: '74218'
last_name: Odefey
- first_name: Edda
full_name: Tobiasch, Edda
last_name: Tobiasch
citation:
ama: Babczyk P, Odefey U, Tobiasch E. Testing the Potency of Extracellular Vesicles
Derived from Differentiating Mesenchymal Stem Cells with an Adapted Wound Assay.;
2024.
apa: 'Babczyk, P., Odefey, U., & Tobiasch, E. (2024). Testing the Potency
of Extracellular Vesicles derived from Differentiating Mesenchymal Stem Cells
with an Adapted Wound Assay. 1. Conference on Targeting Extracellular Vesicles,
Mitochondria and Microbiota: Crucial Impact, Malta.'
bjps: Babczyk P, Odefey U and Tobiasch E (2024) Testing the Potency of
Extracellular Vesicles Derived from Differentiating Mesenchymal Stem Cells with
an Adapted Wound Assay. .
chicago: Babczyk, Patrick, Ulrich Odefey, and Edda Tobiasch. Testing the Potency
of Extracellular Vesicles Derived from Differentiating Mesenchymal Stem Cells
with an Adapted Wound Assay, 2024.
chicago-de: Babczyk, Patrick, Ulrich Odefey und Edda Tobiasch. 2024. Testing
the Potency of Extracellular Vesicles derived from Differentiating Mesenchymal
Stem Cells with an Adapted Wound Assay.
din1505-2-1: 'Babczyk, Patrick ; Odefey, Ulrich ; Tobiasch,
Edda: Testing the Potency of Extracellular Vesicles derived from Differentiating
Mesenchymal Stem Cells with an Adapted Wound Assay, 2024'
havard: P. Babczyk, U. Odefey, E. Tobiasch, Testing the Potency of Extracellular
Vesicles derived from Differentiating Mesenchymal Stem Cells with an Adapted Wound
Assay, 2024.
ieee: P. Babczyk, U. Odefey, and E. Tobiasch, Testing the Potency of Extracellular
Vesicles derived from Differentiating Mesenchymal Stem Cells with an Adapted Wound
Assay. 2024.
mla: Babczyk, Patrick, et al. Testing the Potency of Extracellular Vesicles Derived
from Differentiating Mesenchymal Stem Cells with an Adapted Wound Assay. 2024.
short: P. Babczyk, U. Odefey, E. Tobiasch, Testing the Potency of Extracellular
Vesicles Derived from Differentiating Mesenchymal Stem Cells with an Adapted Wound
Assay, 2024.
ufg: 'Babczyk, Patrick/Odefey, Ulrich/Tobiasch, Edda: Testing the Potency
of Extracellular Vesicles derived from Differentiating Mesenchymal Stem Cells
with an Adapted Wound Assay, o. O. 2024.'
van: Babczyk P, Odefey U, Tobiasch E. Testing the Potency of Extracellular Vesicles
derived from Differentiating Mesenchymal Stem Cells with an Adapted Wound Assay.
2024.
conference:
end_date: 2024-10-18
location: Malta
name: '1. Conference on Targeting Extracellular Vesicles, Mitochondria and Microbiota:
Crucial Impact'
start_date: 2024-10-17
date_created: 2026-02-05T13:13:46Z
date_updated: 2026-02-10T12:33:36Z
department:
- _id: DEP4028
language:
- iso: eng
publication_status: published
status: public
title: Testing the Potency of Extracellular Vesicles derived from Differentiating
Mesenchymal Stem Cells with an Adapted Wound Assay
type: conference_speech
user_id: '83781'
year: '2024'
...
---
_id: '10216'
abstract:
- lang: eng
text: Wet granulation is a frequent process in the pharmaceutical industry. As a
starting point for numerous dosage forms, the quality of the granulation not only
affects subsequent production steps but also impacts the quality of the final
product. It is thus crucial and economical to monitor this operation thoroughly.
Here, we report on identifying different phases of a granulation process using
a machine learning approach. The phases reflect the water content which, in turn,
influences the processability and quality of the granule mass. We used two kinds
of microphones and an acceleration sensor to capture acoustic emissions and vibrations.
We trained convolutional neural networks (CNNs) to classify the different phases
using transformed sound recordings as the input. We achieved a classification
accuracy of up to 90% using vibrational data and an accuracy of up to 97% using
the audible microphone data. Our results indicate the suitability of using audible
sound and machine learning to monitor pharmaceutical processes. Moreover, since
recording acoustic emissions is contactless, it readily complies with legal regulations
and presents Good Manufacturing Practices.
article_number: '2153'
author:
- first_name: Ruwen
full_name: Fulek, Ruwen
id: '79527'
last_name: Fulek
- first_name: Selina
full_name: Ramm, Selina
id: '68713'
last_name: Ramm
orcid: https://orcid.org/0000-0002-0502-8032
- first_name: Christian
full_name: Kiera, Christian
last_name: Kiera
- first_name: Miriam
full_name: Pein-Hackelbusch, Miriam
id: '64952'
last_name: Pein-Hackelbusch
orcid: 0000-0002-7920-0595
- first_name: Ulrich
full_name: Odefey, Ulrich
id: '74218'
last_name: Odefey
citation:
ama: Fulek R, Ramm S, Kiera C, Pein-Hackelbusch M, Odefey U. A machine learning
approach to qualitatively evaluate different granulation phases by acoustic emissions.
Pharmaceutics. 2023;15(8). doi:https://doi.org/10.3390/pharmaceutics15082153
apa: Fulek, R., Ramm, S., Kiera, C., Pein-Hackelbusch, M., & Odefey, U. (2023).
A machine learning approach to qualitatively evaluate different granulation phases
by acoustic emissions. Pharmaceutics, 15(8), Article 2153. https://doi.org/10.3390/pharmaceutics15082153
bjps: Fulek R et al. (2023) A Machine Learning Approach to Qualitatively
Evaluate Different Granulation Phases by Acoustic Emissions. Pharmaceutics
15.
chicago: Fulek, Ruwen, Selina Ramm, Christian Kiera, Miriam Pein-Hackelbusch, and
Ulrich Odefey. “A Machine Learning Approach to Qualitatively Evaluate Different
Granulation Phases by Acoustic Emissions.” Pharmaceutics 15, no. 8 (2023).
https://doi.org/10.3390/pharmaceutics15082153.
chicago-de: Fulek, Ruwen, Selina Ramm, Christian Kiera, Miriam Pein-Hackelbusch
und Ulrich Odefey. 2023. A machine learning approach to qualitatively evaluate
different granulation phases by acoustic emissions. Pharmaceutics 15, Nr.
8. doi:https://doi.org/10.3390/pharmaceutics15082153,
.
din1505-2-1: 'Fulek, Ruwen ; Ramm, Selina ; Kiera,
Christian ; Pein-Hackelbusch, Miriam
; Odefey, Ulrich: A machine learning
approach to qualitatively evaluate different granulation phases by acoustic emissions.
In: Pharmaceutics Bd. 15. Basel, MDPI (2023), Nr. 8'
havard: R. Fulek, S. Ramm, C. Kiera, M. Pein-Hackelbusch, U. Odefey, A machine learning
approach to qualitatively evaluate different granulation phases by acoustic emissions,
Pharmaceutics. 15 (2023).
ieee: 'R. Fulek, S. Ramm, C. Kiera, M. Pein-Hackelbusch, and U. Odefey, “A machine
learning approach to qualitatively evaluate different granulation phases by acoustic
emissions,” Pharmaceutics, vol. 15, no. 8, Art. no. 2153, 2023, doi: https://doi.org/10.3390/pharmaceutics15082153.'
mla: Fulek, Ruwen, et al. “A Machine Learning Approach to Qualitatively Evaluate
Different Granulation Phases by Acoustic Emissions.” Pharmaceutics, vol.
15, no. 8, 2153, 2023, https://doi.org/10.3390/pharmaceutics15082153.
short: R. Fulek, S. Ramm, C. Kiera, M. Pein-Hackelbusch, U. Odefey, Pharmaceutics
15 (2023).
ufg: 'Fulek, Ruwen u. a.: A machine learning approach to qualitatively evaluate
different granulation phases by acoustic emissions, in: Pharmaceutics 15
(2023), H. 8.'
van: Fulek R, Ramm S, Kiera C, Pein-Hackelbusch M, Odefey U. A machine learning
approach to qualitatively evaluate different granulation phases by acoustic emissions.
Pharmaceutics. 2023;15(8).
date_created: 2023-08-15T10:48:15Z
date_updated: 2025-07-29T13:21:40Z
department:
- _id: DEP4022
- _id: DEP4028
- _id: DEP4014
doi: https://doi.org/10.3390/pharmaceutics15082153
external_id:
isi:
- '001119084200001'
pmid:
- '37631367'
intvolume: ' 15'
isi: '1'
issue: '8'
keyword:
- wet granulation
- acoustic classification
- machine learning
- convolutional neural networks
language:
- iso: eng
main_file_link:
- open_access: '1'
url: https://www.mdpi.com/1999-4923/15/8/2153
oa: '1'
place: Basel
pmid: '1'
publication: Pharmaceutics
publication_identifier:
eissn:
- '1999-4923 '
publication_status: published
publisher: MDPI
quality_controlled: '1'
status: public
title: A machine learning approach to qualitatively evaluate different granulation
phases by acoustic emissions
type: scientific_journal_article
user_id: '83781'
volume: 15
year: '2023'
...
---
_id: '9627'
author:
- first_name: Selina
full_name: Ramm, Selina
id: '68713'
last_name: Ramm
orcid: https://orcid.org/0000-0002-0502-8032
- first_name: Ruwen
full_name: Fulek, Ruwen
id: '79527'
last_name: Fulek
- first_name: Veronika Anna
full_name: Eberle, Veronika Anna
last_name: Eberle
- first_name: Christian
full_name: Kiera, Christian
last_name: Kiera
- first_name: Ulrich
full_name: Odefey, Ulrich
id: '74218'
last_name: Odefey
- first_name: Miriam
full_name: Pein-Hackelbusch, Miriam
id: '64952'
last_name: Pein-Hackelbusch
orcid: 0000-0002-7920-0595
citation:
ama: Ramm S, Fulek R, Eberle VA, Kiera C, Odefey U, Pein-Hackelbusch M. Compression
Density as an Alternative to Identify an Optimal Moisture Content for High Shear
Wet Granulation as an Initial Step for Spheronisation.; 2023.
apa: Ramm, S., Fulek, R., Eberle, V. A., Kiera, C., Odefey, U., & Pein-Hackelbusch,
M. (2023). Compression Density as an Alternative to Identify an Optimal Moisture
Content for High Shear Wet Granulation as an Initial Step for Spheronisation.
Ph.D. Student’s Symposium on Tabletting Technology 2023, Rosenberg.
bjps: Ramm S et al. (2023) Compression Density as an Alternative
to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial
Step for Spheronisation. .
chicago: Ramm, Selina, Ruwen Fulek, Veronika Anna Eberle, Christian Kiera, Ulrich
Odefey, and Miriam Pein-Hackelbusch. Compression Density as an Alternative
to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial
Step for Spheronisation, 2023.
chicago-de: Ramm, Selina, Ruwen Fulek, Veronika Anna Eberle, Christian Kiera, Ulrich
Odefey und Miriam Pein-Hackelbusch. 2023. Compression Density as an Alternative
to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial
Step for Spheronisation.
din1505-2-1: 'Ramm, Selina ; Fulek, Ruwen ; Eberle,
Veronika Anna ; Kiera, Christian
; Odefey, Ulrich ; Pein-Hackelbusch,
Miriam: Compression Density as an Alternative to Identify an Optimal
Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation,
2023'
havard: S. Ramm, R. Fulek, V.A. Eberle, C. Kiera, U. Odefey, M. Pein-Hackelbusch,
Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation, 2023.
ieee: S. Ramm, R. Fulek, V. A. Eberle, C. Kiera, U. Odefey, and M. Pein-Hackelbusch,
Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation. 2023.
mla: Ramm, Selina, et al. Compression Density as an Alternative to Identify an
Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for
Spheronisation. 2023.
short: S. Ramm, R. Fulek, V.A. Eberle, C. Kiera, U. Odefey, M. Pein-Hackelbusch,
Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation, 2023.
ufg: 'Ramm, Selina u. a.: Compression Density as an Alternative to Identify
an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step
for Spheronisation, o. O. 2023.'
van: Ramm S, Fulek R, Eberle VA, Kiera C, Odefey U, Pein-Hackelbusch M. Compression
Density as an Alternative to Identify an Optimal Moisture Content for High Shear
Wet Granulation as an Initial Step for Spheronisation. 2023.
conference:
end_date: 2023-03-15
location: Rosenberg
name: Ph.D. Student's Symposium on Tabletting Technology 2023
start_date: 2023-03-13
date_created: 2023-03-16T09:46:10Z
date_updated: 2025-07-29T13:23:12Z
department:
- _id: DEP4022
- _id: DEP4028
- _id: DEP4014
language:
- iso: eng
publication_status: published
status: public
title: Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation
type: conference_speech
user_id: '83781'
year: '2023'
...
---
_id: '9568'
abstract:
- lang: eng
text: Pellet production is a multi-step manufacturing process comprising granulation,
extrusion and spheronisation. The first step represents a critical control point,
since the quality of the granule mass highly influences subsequent process steps
and, consequently, the quality of final pellets. The most important parameter
of wet granulation is the liquid requirement, which can often only be quantitatively
evaluated after further process steps. To identify an alternative for optimal
liquid requirements, experiments were conducted with a formulation based on lactose
and microcrystalline cellulose. Granules were analyzed with a Powder Vertical
Shear Rig. We identified the compression density (ρpress) as the said alternative,
linking information from the powder material and the moisture content (R2 = 0.995).
We used ρpress to successfully predict liquid requirements for unknown formulation
compositions. By means of this prediction, pellets with high quality, regarding
shape and size distribution, were produced by carrying out a multi-step manufacturing
process. Furthermore, the applicability of ρpress as an alternative quality parameter
to other placebo formulations and to formulations containing active pharmaceutical
ingredients (APIs) was demonstrated.
article_number: '2303'
author:
- first_name: Selina
full_name: Ramm, Selina
id: '68713'
last_name: Ramm
orcid: https://orcid.org/0000-0002-0502-8032
- first_name: Ruwen
full_name: Fulek, Ruwen
id: '79527'
last_name: Fulek
- first_name: Veronika Anna
full_name: Eberle, Veronika Anna
last_name: Eberle
- first_name: Christian
full_name: Kiera, Christian
last_name: Kiera
- first_name: Ulrich
full_name: Odefey, Ulrich
id: '74218'
last_name: Odefey
- first_name: Miriam
full_name: Pein-Hackelbusch, Miriam
id: '64952'
last_name: Pein-Hackelbusch
orcid: 0000-0002-7920-0595
citation:
ama: Ramm S, Fulek R, Eberle VA, Kiera C, Odefey U, Pein-Hackelbusch M. Compression
Density as an Alternative to Identify an Optimal Moisture Content for High Shear
Wet Granulation as an Initial Step for Spheronisation. Pharmaceutics. 2022;14(11).
doi:https://doi.org/10.3390/pharmaceutics14112303
apa: Ramm, S., Fulek, R., Eberle, V. A., Kiera, C., Odefey, U., & Pein-Hackelbusch,
M. (2022). Compression Density as an Alternative to Identify an Optimal Moisture
Content for High Shear Wet Granulation as an Initial Step for Spheronisation.
Pharmaceutics, 14(11), Article 2303. https://doi.org/10.3390/pharmaceutics14112303
bjps: Ramm S et al. (2022) Compression Density as an Alternative to
Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial
Step for Spheronisation. Pharmaceutics 14.
chicago: Ramm, Selina, Ruwen Fulek, Veronika Anna Eberle, Christian Kiera, Ulrich
Odefey, and Miriam Pein-Hackelbusch. “Compression Density as an Alternative to
Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial
Step for Spheronisation.” Pharmaceutics 14, no. 11 (2022). https://doi.org/10.3390/pharmaceutics14112303.
chicago-de: Ramm, Selina, Ruwen Fulek, Veronika Anna Eberle, Christian Kiera, Ulrich
Odefey und Miriam Pein-Hackelbusch. 2022. Compression Density as an Alternative
to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial
Step for Spheronisation. Pharmaceutics 14, Nr. 11. doi:https://doi.org/10.3390/pharmaceutics14112303,
.
din1505-2-1: 'Ramm, Selina ; Fulek, Ruwen ; Eberle,
Veronika Anna ; Kiera, Christian
; Odefey, Ulrich ; Pein-Hackelbusch,
Miriam: Compression Density as an Alternative to Identify an Optimal Moisture
Content for High Shear Wet Granulation as an Initial Step for Spheronisation.
In: Pharmaceutics Bd. 14. Basel, MDPI (2022), Nr. 11'
havard: S. Ramm, R. Fulek, V.A. Eberle, C. Kiera, U. Odefey, M. Pein-Hackelbusch,
Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation., Pharmaceutics.
14 (2022).
ieee: 'S. Ramm, R. Fulek, V. A. Eberle, C. Kiera, U. Odefey, and M. Pein-Hackelbusch,
“Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation.,” Pharmaceutics,
vol. 14, no. 11, Art. no. 2303, 2022, doi: https://doi.org/10.3390/pharmaceutics14112303.'
mla: Ramm, Selina, et al. “Compression Density as an Alternative to Identify an
Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for
Spheronisation.” Pharmaceutics, vol. 14, no. 11, 2303, 2022, https://doi.org/10.3390/pharmaceutics14112303.
short: S. Ramm, R. Fulek, V.A. Eberle, C. Kiera, U. Odefey, M. Pein-Hackelbusch,
Pharmaceutics 14 (2022).
ufg: 'Ramm, Selina u. a.: Compression Density as an Alternative to Identify
an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step
for Spheronisation., in: Pharmaceutics 14 (2022), H. 11.'
van: Ramm S, Fulek R, Eberle VA, Kiera C, Odefey U, Pein-Hackelbusch M. Compression
Density as an Alternative to Identify an Optimal Moisture Content for High Shear
Wet Granulation as an Initial Step for Spheronisation. Pharmaceutics. 2022;14(11).
date_created: 2023-03-03T11:23:01Z
date_updated: 2025-07-29T13:22:53Z
department:
- _id: DEP4022
- _id: DEP4028
- _id: DEP4014
doi: https://doi.org/10.3390/pharmaceutics14112303
external_id:
isi:
- '000883998100001'
pmid:
- '36365122'
intvolume: ' 14'
isi: '1'
issue: '11'
keyword:
- wet granulation
- liquid requirement
- granulation endpoint
- compression density
language:
- iso: eng
main_file_link:
- open_access: '1'
url: https://www.mdpi.com/1999-4923/14/11/2303
oa: '1'
place: Basel
pmid: '1'
publication: Pharmaceutics
publication_identifier:
eissn:
- 1999-4923
publication_status: published
publisher: MDPI
status: public
title: Compression Density as an Alternative to Identify an Optimal Moisture Content
for High Shear Wet Granulation as an Initial Step for Spheronisation.
type: scientific_journal_article
user_id: '83781'
volume: 14
year: '2022'
...