Search results for " name" in Articles / App Notes
Article
What’s In a Name? For Biosimilars, A Lot
Naming for small-molecule drugs
BioPharm: What is current practice for small-molecule generic drugs in terms of a product’s name and its monograph? How do monograph and name typically relate?
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Article
FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
Article
FDA Approves First Biosimilar
For now, FDA is using a “placeholder” nonproprietary name—filgrastim-sndz—to identify the product, but the agency does not mean for this to indicate it has made a decision on a comprehensive naming po…
Article
mAbs to Watch in 2016
Obiltoxaximab—Elusys Therapeutics’ mAb, obiltoxaximab, which will go by the trade name Anthim, differs significantly from the rest of the mAb pack. The investigational agent for the treatment of inhal…
Article
N-Glycan Analysis of Biotherapeutic Proteins
What’s in a (glycan) name?
To inexperienced researchers, an initially intractable idiosyncrasy of N-glycan analysis is the number of N-glycan nomenclatures in current use. This can complicate inte…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
Digitalization: The Route to Biopharma 4.0
Digitalization in process development
For any production process, there are two key attributes, namely scientific knowledge and technical know-how. Scientific knowledge comprises process developme…
Article
Gene Therapies Push Viral Vector Production
In general, there are two types of gene therapies, namely ex-vivo and in-vivo, Chaudhary points out. “In ex-vivo, cells are modified outside the patient’s body and the corrected version is transplante…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Broadly, there can be four boundaries for mass transfer limitations at the bead level, namely, external mass transfer through the film layer (kfilm) around the bead particle, diffusion through the por…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Viral testing/detection level
As the name indicates, the main purpose of this level is to detect adventitious viruses. Early detection is essential in order to deploy an adequate respo…