Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Daniel Borchert"'
Publikováno v:
AIMS Bioengineering, Vol 7, Iss 4, Pp 254-271 (2020)
A Process characterization is a regulatory imperative for process validation within the biopharmaceutical industry. Several individual steps must be conducted to achieve the final control strategy. For that purpose, tools from the Quality by Design (
Externí odkaz:
https://doaj.org/article/9dfd9b62adad4485b5f9d3faf0ffee8e
Publikováno v:
NeoBiota, Vol 18, Iss 0, Pp 103-118 (2013)
Increasing trends in global trade make it extremely difficult to prevent the entry of all potential invasive species (IS). Establishing early detection strategies thus becomes an important part of the continuum used to reduce the introduction of inva
Externí odkaz:
https://doaj.org/article/30dedefb953f4221b538ba4a135cbca3
Publikováno v:
AIMS Bioengineering, Vol 7, Iss 4, Pp 254-271 (2020)
A Process characterization is a regulatory imperative for process validation within the biopharmaceutical industry. Several individual steps must be conducted to achieve the final control strategy. For that purpose, tools from the Quality by Design (
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2fa2de110906c8e691d7c5f5d56c3f50
https://doi.org/10.3934/bioeng.2020022
https://doi.org/10.3934/bioeng.2020022
Publikováno v:
Drug Discovery Today. 24:1795-1805
Multiple obstacles are driving the digital transformation of the biopharmaceutical industry. Novel digital techniques, often marketed as 'Pharma 4.0', are thought to solve some long-existing obstacles in the biopharma life cycle. Pharma 4.0 concepts,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::34f2e7c60381b1c858588595e6bcdf9a
https://doi.org/10.1016/j.drudis.2019.06.005
https://doi.org/10.1016/j.drudis.2019.06.005
Autor:
Christoph Herwig, Yvonne E. Thomassen, Daniel Borchert, Diego A. Suarez-Zuluaga, Patrick Sagmeister
Publikováno v:
Bioprocess and Biosystems Engineering
Root cause analysis (RCA) is one of the most prominent tools used to comprehensively evaluate a biopharmaceutical production process. Despite of its widespread use in industry, the Food and Drug Administration has observed a lot of unsuitable approac
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::507763893daf4c0b413d1c544539cfca
http://europepmc.org/articles/PMC6514075
http://europepmc.org/articles/PMC6514075
Autor:
Daniel Borchert, Nicole N. Driessen, Diego A. Suarez-Zuluaga, Wilfried A.M. Bakker, Yvonne E. Thomassen
Publikováno v:
Vaccine. 37(47)
Bioprocess development generates extensive datasets from different unit operations and sources (e.g. time series, quality measurements). The development of such processes can be accelerated by evaluating all data generated during the experimental des
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8ab419ebaf7161888aa786fe9c7dd441
https://pubmed.ncbi.nlm.nih.gov/31337593
https://pubmed.ncbi.nlm.nih.gov/31337593
Publikováno v:
Bioengineering, 6(4):114
Bioengineering
Volume 6
Issue 4
Bioengineering
Volume 6
Issue 4
Risk assessments (RAs) are frequently conducted to assess the potential effect of process parameters (PPs) on product quality attributes (e.g., a critical quality attribute (CQA)). To evaluate the PPs criticality the risk priority number (RPN) for ea
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a5beadfb571e24d8389e2fc416a8eef8
https://doi.org/10.3390/bioengineering6040114
https://doi.org/10.3390/bioengineering6040114