Search results for "modeling"
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Effective biopharmaceutical production is achieved in part through target-specific, quality-optimized cell culture media. Balancing the many individual media components required to achieve high tite…
Poster
Adenovirus production in a single-use stirring tank bioreactor system
Adenovirus vectors are attractive delivery systems for vaccines and cancer treatment. Scalable and cost-efficient production technologies are needed to enable manufacturing of safe and efficacious c…
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
The use of modeling to develop bioprocessing operations and systems—spurred by quality-by-design efforts—can help biopharma companies to better understand processes and equipment and to optimize manuf…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
Article
Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
Article
Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…
Poster
Scale-up and process economy calculations of a dAb purification process using ready-to-use products
Purification of a domain antibody (dAb) in a chromatography capture step was successfully scaled from laboratory to pilot scale using ready-to-use equipment and ready-made buffers. The scaled-up pro…
Article
Establishing Acceptance Criteria for Analytical Methods
Figure 3: Accuracy to precision modeling. (Courtesy of author)
Summary and Conclusion
Moving from relative measures of analytical method goodness…