Search results for "analytical" in Articles / App Notes
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…
Article
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…
Article
Automating Bioprocesses
In addition, good process analytical technology (PAT) and ‘soft sensors’ (i.e., predicting values based on modeling) are important to ensure product quality. It is important to understand how disturba…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Due to limitations in the analytical capability of the SEC method used, and the relatively low aggregate level, it was not possible to quantitatively assign the percent of dimer versus higher-order mu…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
The Tide Stays High
…, especially in those services that cater to clinical development (clinical supplies manufacturing, analytical services, clinical packaging, and clinical research). Many CDMOs have told PharmSource t…