Search results for "analytical"
Article
CDMOs Driving Emerging Bio/Pharma Success
Without the access to CDMOs, companies would need to invest at least $10 million in facilities and a similar amount on manufacturing, analytical, and quality professionals. It would take at least two …
Article
Navigating Data Integrity in the Modern Lab
By Amber Lowry
Understanding the role of both people and technology in the maintenance of data integrity in the analytical laboratory is crucial as companies move toward predominate…
Article
QbD Improves Cell-Culture Process Control
Real-time quality control
Integrating process analytical technology (PAT) into the bioproduction process enables the biomanufacturer to move from a quality-by-testing approach to a QbD approach, w…
Article
Reducing Cross-Contamination Risks in Process Chromatography
On the other hand, he notes that established processes with strict limits on process control parameters may need to use traditional processing tools because the analytical and functional performance o…
Article
Contract Manufacturing Through the Years
An average of 35 deals per year was done in the 2014-2016 period involving drug product and substance manufacturers, packagers, formulators, and analytical services providers. The pace seems to have p…
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The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
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Article
Fusion Proteins Pose Manufacturability Challenges
…g the cell culture or purification steps, according to Matt Kalo, associate director of the protein analytical chemistry department at Genentech.
For example, the low-pH elution step used in the …
Article
Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Extractable organic compounds and trace elements from the single‑use components were identified and semi‑quantitated with a complementary set of analytical techniques. The low levels of extractabl…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Modeling can make process robustness studies more efficient, aid process monitoring efforts, and can facilitate implementation of process analytical technology (PAT). The authors believe the industry …
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…