Search results for " report" in Articles / App Notes
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“Release handling is much easier when batch reporting, the data historian, and data analytics are maintained in a central place,” she says. “Process data can be accessed while a process is running wit…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
The report highlights operational savings from using concentrated stock solutions along with a buffer stock blending system. Savings vary based on the size of the facility and the capital cost require…
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
Gene Therapies Push Viral Vector Production
Some of the downsides include a limited payload, difficulty achieving high titers and functional titers, and difficulty in pseudotyping, Carstens reports.
The promise of AAV
Of the different v…
Article
Driving Improved Access to Biosimilars
According to reports on May 13 and May 21 in the Regulatory Affairs Professional Society Journal, the draft updates 2015 guidance on quality that FDA had withdrawn after receiving critical comments fr…
Article
2019 HTPD Conference is Approaching. What Happened Last Time?
The extended report, available as download, captures 15 of the presentations. Here’s a summary.
Article
2019 HTPD Conference Abstract Submissions Are Coming Up: What Happened Last Time?
The extended report, available as download, captures 15 of the presentations. Here’s a summary.
Article
2019 HTPD Conference Is Announced. What Happened Last Time?
The extended report, available as download, captures 15 of the presentations. Here’s a summary.
Article
Sephadex™ Size Exclusion Resin Turns 60
It all started with a paper that began: ”We wish to report a simple and rapid method for the fractionation of water soluble substances.” This is what lead to the discovery.
See video
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…n and amino acids, and these three CQAs will receive initial focus in the group’s initial research reports. The group is also using return on investment analysis as well as internal rate of return, p…