Search results for " formulation"
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Automation Trend in Fill/Finish Reduces Contamination Risk
These current trends include the increased use of isolator/RAB technologies, more high-speed operations, more diversity in formulation and delivery systems, and other innovative approaches—such as one…
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CDMOs Driving Emerging Bio/Pharma Success
• Regulatory pathways such as the breakthrough therapy designation enable smaller clinical programs and faster approval times, while the 503(b)2 pathway for new formulations of older products may mea…
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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…