Search results for " glycosylation"
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
The molecule exhibits monoclonal antibody (mAb) behavior, however, with a challenging glycosylation profile and complex tertiary and quaternary structures. Consequently, low product recovery and pur…
Article
Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
By Cynthia A. Challener
Fusion proteins are engineered proteins that contain domains from di…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
These products are subject to post-translational modifications such as glycosylation, phosphorylation, methylation, hydroxylation, and sulfation that affect their activity and immunogenicity. Conditio…
Article
Platform Approach Speeds Process Development
Multiple CHO host cell lines with different glycosylation properties are available to help provide best possible match to a desired product profile and anticipated expression levels. New CHO DG44 and …
Article
Ensuring the Quality of Biologicals
The rationale is that there is a direct relationship between glycosylation and the manufacturing process. This new approach is aligned with the development approach for biosimilars and involves commun…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Steps can be taken to reduce aggregation regardless of aggregate size, such as modifying proteins through glycosylation or PEGylation, but product efficacy or dosage could change as a result. “Given t…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
…cking material in a non-ideal way, or perhaps be continuously heterogeneous as a result of extensive glycosylation or PEGylation with extended conformations vastly different from those of well-folded…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Production of the vaccines in insect cells is also beneficial, because they impart non-mammalian glycosylation, thus increasing the immunogenicity and enabling the vaccines to be effective at low dose…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“One expects that there will be minor differences in, for example, glycosylation patterns or the extent of deamination in a monoclonal antibody product. One expects that there will be slight differenc…