Search results for " conjugates"
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…
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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Best Practices in Qualification of Single-Use Systems
Ducry, Antibody-Drug Conjugates (Humana Press, 2013).
Article
Aseptic Processing: Keeping it Safe
Concerns related to operator safety exist when dealing with highly potent or cytotoxic drugs, such as is the case with the manufacture of antibody drug conjugates (ADCs) with cytotoxic payloads. To pr…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
High-Throughput Process Development in an Historical Environment
The value of HTPD methodology was helpful, with different aluminum salts and different types of vaccines (virus-like particles, polysaccharide conjugates, and proteins) evaluated.
Winning an Oly…
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Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.
Aug 2, 2014
By: Cynthia Challener, PhD
Pharmaceutical Technology
Volume 37, Iss…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.
The characterization of proteins involves identification of their complex …
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
HPCE methods for the identification and quantitation of antibodies, their conjugates and complexes. J Pharm Biomed Anal. 1997;16:377–93.
19. Hunt G, Nashabeh W. Capillary electrophoresis sodium do…