Search results for " fragments" in Articles / App Notes
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…
Article
Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Figure 3: Selectivity between monoclonal antibody (mAb) monomers and aggregates at a higher sample load following the optimized first polishing step in a lab-scale column, showing the percentage of fr…