Search results for " fragment"
Article
Impurity Testing of Biologic Drug Products
…nd field flow fractionation (FFF) for aggregate measurement; capillary gel electrophoresis (CGE) for fragment measurements; capillary isoelectric focusing (cIEF) for charge heterogeneity, biochemical…
Article
Preclinical Evaluation of Product Related Impurities and Variants
While the former quantifies levels of the oxidized, f-Met, and reduced impurities in the samples, the latter measures the levels of aggregates and fragments. Further, enzyme linked immunosorbent assay…
Article
Process Development: What May Lie Ahead in 2018?
Such next-gen antibodies include antibody drug conjugates, engineered antibodies, bispecific antibodies, antibody fragments, antibody-like proteins and biosimilar antibody therapies.
The productio…
Article
Unifying Continuous Biomanufacturing Operations
They concluded that compared with fed-batch--where charge isoforms, aggregates, fragments, and N-linked glycosylation were variable from batch to batch--“the enhanced control and constant cellular env…
Article
Evaluating E&L Studies for Single-Use Systems
The main organic extractables identified were rubber and plastic materials formulation/manufacturing (polymer fragments, glycols, etc.) and additives (plasticizers, vulcanizing agents, lubricants, sol…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
…ming Buffer Challenges With In-Line Conditioning
A Platform Approach to Purification of Antibody Fragments
References
1. Walker, Nigel, Innovation at the Heart of Biopharmaceutical Indust…
Article
Process Chromatography Selection for Downstream Processing Applications
Affinity resins like Capto L (antigen-binding fragments [Fabs], domain antibodies [dAbs], etc.), heparin, and blue dye-based resins are also used. For peptides, reversed-phase chromatography is anothe…
Poster
Residual DNA analysis in influenza vaccine processing
However, these kits are developed mainly for purification of DNA fragments from gel electrophoresis or genomic DNA from tissues such as blood or cultured cells, and do not have recovery as a priority.…
Article
Biosimilars: Making the Switch Comes with Challenges
The differences were due to the presence or absence of strong national champions of the biosimilar versions, national tender systems, incentives to prescribers, and fragmented decision making within c…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Will the facility be manufacturing monoclonal antibodies, recombinant proteins, vaccines, antibody-drug conjugates, or fragment antibodies? Also, will the products be mammalian cell-derived or microbi…