Search results for "Mabs" in Articles / App Notes
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Coffman, Christopher Gallo, and Ranga Godavarti
ABSTRACT
In recent years, most pharmaceutical companies have focused on the development of monoclonal antibodies (mAbs). Increasing upstream t…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Biotech therapeutics, particularly complex products such as monoclonal antibodies (mAbs), can have numerous quality attributes that can potentially impact safety and/or efficacy of the product (2). Id…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Monoclonal antibodies (MAbs) are an important class of therapeutic proteins in biotechnology and have been developed to treat a variety of indications to fill significant unmet medical needs.1 MAbs ge…
Article
New Therapies Present Scaling Challenges
In addition, mammalian cell culture technology has advanced such that producing multi-kilogram quantities of therapeutic mAbs in one batch is now commonplace (1). With a cell therapy, however, establi…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Of these, mAbs comprise large, multi-domain proteins that require complex machinery for proper protein folding, assembly, and post-translation modifications. These modifications can profoundly affect …
Article
Antibody Production in Microbial Hosts
Rathore, Jyoti Batra
The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs) and related products that are capable of treating…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
As a consequence, downstream processing must accept and handle higher titers of mAbs in harvested cell-culture fluid (HCCF), and vendors of mAb purification technologies must develop chromatography re…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
Different from mAbs
Considering the differences between monoclonal antibody (mAb) production and cell/gene therapy production is also important when establishing a cell/gene therapy facility. Al…
Article
N-Glycan Analysis of Biotherapeutic Proteins
More than half of all biotherapeutics are glycosylated (2), including monoclonal antibodies (mAbs), Fc-fusion proteins, clotting factors, and cytokines such as erythropoietin. Of these, mAbs represent…
Article
Preclinical Evaluation of Product Related Impurities and Variants
The reversible nature of the modifications that result in the charge heterogeneity of mAbs (particularly that of acidic variants) makes them susceptible to changes over the course of storage. This nec…