Search results for " aggregation"
Article
Reimagining Affordable Biosimilars
…ts to extrapolate the potential of a post-translational variant of a biotherapeutic product (such as aggregation, oxidation, and isomerization) on safety and efficacy (12,13).
Impurities. The …
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Measurement of aggregation levels was determined by size-exclusion chromatography (SEC) using ultra performance liquid chromatography (UHPLC) (Waters) with Empower software that used an Acquity UPLC B…
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Antibody Production in Microbial Hosts
Co-expression of foldases and molecular chaperones (Skp, FkpA, DsbA, and DsbC) helps in disulfide bond formation, prevention of misfolding, and aggregation of heterologous proteins (9). E. coli has se…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Elimination of process collection and hold steps is a major benefit of continuous processing, concurs Snow, as product degradation and aggregation typically happen in these phases. Langer notes that p…