Search results for "manufacturing" in Articles / App Notes
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…
Article
Improving Process-Scale Chromatography
“Protein A enables a platform process for mAbs, thus enabling higher throughput of projects through process development and manufacturing,” she says.
Alternatives to Protein A chromatography are a…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
To be successful, however, the lead partner will need an understanding of biomanufacturing facility design, engineering, qualification, and validation, as well as the operational aspects of combining …
Article
The Metrics of Quality Culture
Conclusion
When establishing a metrics program, companies should evaluate numerous data input points including, but not limited to, product-quality attributes, manufacturing site performance, peop…
Article
Fluid Handling in Biopharma Facilities
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling and storage of fluids is essential to limit the possibility of contamination. Facili…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
In that instance between Sandoz and Amgen, Sandoz did not disclose its manufacturing processes and FDA application to Amgen, the patent holder for Neupogen (filgrastim). A California judge ruled, howe…