scispace - formally typeset
Search or ask a question
Institution

BIA Separations (Slovenia)

CompanyLjubljana, Slovenia
About: BIA Separations (Slovenia) is a company organization based out in Ljubljana, Slovenia. It is known for research contribution in the topics: Monolithic HPLC column & Monolith. The organization has 84 authors who have published 152 publications receiving 4883 citations.


Papers
More filters
Journal ArticleDOI
TL;DR: This review gives an overview on thenanoplex downstream challenges and chromatography based analytical methods for efficient monitoring of the nanoplex production.
Abstract: Downstream processing of nanoplexes (viruses, virus-like particles, bacteriophages) is characterized by complexity of the starting material, number of purification methods to choose from, regulations that are setting the frame for the final product and analytical methods for upstream and downstream monitoring. This review gives an overview on the nanoplex downstream challenges and chromatography based analytical methods for efficient monitoring of the nanoplex production.

55 citations

Journal ArticleDOI
TL;DR: It was concluded that for a given monolith the protein capacity can be derived from the data obtained by the new method, which was shown to be suitable for determining the amount of ionic groups on both anion and cation monolithic columns.

53 citations

Journal ArticleDOI
TL;DR: The Michaelis-Menten constant K(m) and the turnover number k(3) of the immobilized enzymes were found to be flow-unaffected and indicate the absence of a diffusional limitation in immobilized CIM enzyme reactors.

53 citations

Journal ArticleDOI
TL;DR: The CIM disk applied as an enzyme reactor proved to be a successful replacement for conventionally used packed-bed columns and as such it was well suited for on-line monitoring of bioprocesses.

52 citations

Journal ArticleDOI
TL;DR: Results showed that droplet digital PCR (ddPCR) performs better than quantitative real-time PCR (qPCR), in terms of robustness and assay variance, and this was especially relevant for partially purified (in-process) samples, and the importance of sample preparation prior to PCR analysis is demonstrated.
Abstract: One of the main challenges in the gene therapy viral vector development is to establish an optimized process for its large scale production This requires optimization for upstream and downstream processes as well as methods that enable the step-by step analytical characterization of the virus, the results of which inform the iterative refinement of production for yield, purity and potency The biggest problem here is a plethora of viral vector formulations, many of which interfere with analytical techniques We took adeno-associated virus (AAV) as an example and showed benefits of combined use of molecular methods and transmission electron microscopy (TEM) for viral vectors' characterization and quantification Results of the analyses showed that droplet digital PCR (ddPCR) performs better than quantitative real-time PCR (qPCR), in terms of robustness and assay variance, and this was especially relevant for partially purified (in-process) samples Moreover, we demonstrate the importance of sample preparation prior to PCR analysis We evaluated viral structure, presence of aggregates and impurities with TEM analysis and found that these impacted the differences in viral titers observed by qPCR and ddPCR and could be altered by sample preparation These results serve as a guide for the establishment of the analytical methods required to provide measures of identity and purity for AAV viral vectors

52 citations


Authors

Showing all 84 results

NameH-indexPapersCitations
Aleš Štrancar381223748
Djuro Josic361774580
Aleš Podgornik36903274
Thomas Muster33677766
Miloš Barut23451500
Matjaž Peterka17321222
Petra Kramberger1423642
Janez Jančar1114425
Jana Vidič1019686
Nika Lendero Krajnc1019395
Urh Černigoj925267
Rok Košir914456
Peter Brne88330
Marko Banjac710206
Lidija Urbas78241
Network Information
Related Institutions (5)
Hoffmann-La Roche
43K papers, 1.6M citations

80% related

Merck & Co.
48K papers, 1.9M citations

79% related

Food and Drug Administration
19.5K papers, 691.2K citations

79% related

Bristol-Myers Squibb
21K papers, 932.5K citations

77% related

Pfizer
37.4K papers, 1.6M citations

77% related

Performance
Metrics
No. of papers from the Institution in previous years
YearPapers
20219
20203
20193
20184
201712
20168