Search results for "manufacturing"
Article
SEC in the Modern Downstream Purification Process
Despite the relative predictability of SEC separations, method development at small scale is crucial to ensure a smooth transition from the bench- to manufacturing-scale operations.
With SEC, it i…
Article
FDA Approves First Biosimilar
Manufacturing considerations
While Novartis says no immunogenicity or antibodies against rhG-CSF were detected throughout the head-to-head PIONEER study, immunogenicity issues can be introduced at…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
All of this testing extends the production time and increases the manufacturing cost.
Cell-culture technology
Cell-culture technology enables the use of raw materials that are readily ava…
Article
Operational Excellence: More Than Just Process Improvement
Not the least of these sustainable benefits are improved quality and compliance
Consider another vaccine manufacturer that faced recurring compliance problems in two key manufacturing operations. T…
Article
Evolving demands of process development services
Put these factors together and there is a need for contract development and manufacturing organizations (CDMOs) that can handle integrated and accelerated pathways with a full suite of technologies fr…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Traditional cell-culture based biomanufacturing is a mature technology; however, it is tied to a living cell, which necessitates a great deal of complexity. That complexity ranges from the creation of…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
To reduce upfront expenses and to overcome limited manufacturing experience, developers will also often choose to work with a contract development and manufacturing organization (CDMO), who may contri…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
“Although full CMC [chemistry, manufacturing, and controls] information is not required until the market application dossier is submitted, a useful strategy is to prepare a comprehensive report that d…
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
In my view, it's where within the manufacturing process, there are a combination of single-use (SU) materials and re-usable materials in contact with the process and associated fluids. This often refe…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
To support this development, mAbxience, a Spanish biotechnology company specialized in research, development, and manufacture of biosimilar drugs, is committed to provide the manufacturing of highqua…