Search results for " start" in Articles / App Notes
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
“Accelerated clinical development becomes more common and faster, leading to very short times between start of process development and commercialization,” Laird says.
“And, with the increased f…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Since the first survey, which was started in collaboration with the American Society for Microbiology, critical bioprocessing issues have grown. The annual report has expanded to include 60 questions …
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Putting Viral Clearance Capabilities to the Test
The source of starting materials and raw materials used in production are of primary concern, says Bergmann, and a risk assessment identifies which viruses are likely to be contaminants and the levels…
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Cleaning Protein A Resins with 1 M NaOH
If not removed, these impurities can build up on the protein A resin and start to leach into the process material in subsequent cycles. The presence of cell culture nutrients in the harvest feed loade…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Freedom to Roam During Protein Purification Runs
Consider this scenario: You have started a run in the lab and want to get some work done in your office. You may want to plan for the next run, analyze previous runs, prepare a presentation or work on…
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Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
FDA Framework Spurs Advanced Therapies
“We expect that these customers will also benefit from the new regulations, and Lonza’s Process Development team has started seeing a growing number of enquiries of this nature,” Keene says.
Need …
Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
QbD Improves Cell-Culture Process Control
QbD starts by defining the relevant target product profile and CQAs.
Subsequently, development of the manufacturing process takes into account the likely impact that process parameters will hav…