Search results for " process" in Articles / App Notes
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This complexity requires more complex manufacturing processes, according to Kate Keeping, senior director of biosimilars research with Decision Resources. With mAbs, notes Dingermann, glycostructures …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
By taking a holistic approach to improving the analytical process, one can identify strategies to increase throughput and reduce development times and the costs of analytical methods. This article dis…
Article
The Future of Biopharma
…acilities
• adoption of single-use systems at clinical and commercial scale
• continuous processing, including perfusion
• high-tech expression systems and other genetic engineering advan…
Article
Optimization of an antibody polishing step
Optimal operating conditions for single units are found by altering just a few process parameters with Design-of-Experiment (DoE) procedures or high-throughput screenings. But what if DoE fails to fin…
Article
Quality by design in biotherapeutics purification white paper
One of these challenges is how process developers might gain a deeper understanding for sources of variability and set mitigation strategies. This white paper summarizes information around resin varia…
Article
Flexible Facilities for Viral Vector Manufacturing
In the viral-vector space, we see process scales from one to 2000 L. There is less variability for lentivirus and gamma retrovirus that is used for virally genetically modified cell therapies (ex-vivo…
Article
Nurturing Knowledge from Disparate Data Streams
“It may be argued, for example, that the relatively simple process of recovering and reviewing chart recordings from a well-maintained paper archive has advantages over the recovery of data from older…
Article
Transformative Medicines Challenge FDA and Manufacturers
…nce criteria based on data from commercial batches, and to conduct stability testing on drug product process validation batches. The company also may find it appropriate to tighten specification limi…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
Modular processing equipment and single-use technologies are positioned for flexible production operations and replication in other locations.
For example, FujiFilm Diosynth expanded its contract …
Article
Analysis of Glycosylation in Biosimilars
To create N-glycosylation, the sugar residues are attached to the side chain of the amino acid asparagine, the initial step of the process being the transfer of a large, lipid-linked glycan donor to t…