Search results for " formulation" in Articles / App Notes
Article
Impurity Testing of Biologic Drug Products
“Aggregates are of particular concern, either in soluble dimer/oligomer form or subvisible particle form,” notes Jay Kang, director of analytical and formulation development at Patheon, part of Thermo…
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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 …
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Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…
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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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Fusion Proteins Pose Manufacturability Challenges
Development of a custom formulation may also be needed to minimize aggregation over time to enable long-term storage.
It is important to note, according to Kalo, that the design of fusion proteins…
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Critical Quality Attributes Challenge Biologics Development
When developing a commercial process and formulation, appropriate analytical, structural, and biological assays are developed that are capable of studying the components in a heterogeneous biologics p…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Thermodynamic-based adsorption models that are based on Mollerup’s formulation have also been used by many researchers (18). Recently, pH and temperature dependence have also been incorporated into th…
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Drug Quality Key to Innovation and Access
And pressure to combat the devastating opioid epidemic across the United States highlights the need for innovative methods to produce new formulations to treat pain that also resist abuse and misuse. …
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Microbiological Testing: Time is of the Essence
Due to the recent discovery of this phenomenon and the various formulations of drug substances and drug products, there have been difficulties in developing proper studies for LER.
Rapid solutions:…