Search results for " techniques" in Articles / App Notes
Article
Good Manufacturing Practices: Challenges with Compliance
The equipment and methods for biologics analytical work are very different to that of small molecules, and it’s important to have access to the instrumentation and analytical techniques required.
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Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Cell therapy source material losses resulting from sub-optimal cell preservation and storage techniques can result in bottlenecks that slow the entire manufacturing process. Biopreservation and cryopr…
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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Successfully Moving Regulated Data to the Cloud
To successfully use machine-learning techniques, organizations need to produce large amounts of data. But as highlighted earlier, a large amount of data is one of the main reasons that organizations a…
Article
Biomanufacturing: The Cost of Unskilled Workers
Advances in cell and gene therapies are predicted to disrupt the biomanufacturing industry, requiring new techniques and technologies to be established. The need for process development expertise incr…
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Advances in Engineering of Protein-Based APIs
“Humanization techniques using complementary determining regions grafting or phage display have enabled the advancement of numerous antibody therapeutics (such as trastuzumab, pembrolizumab, and romos…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
…Chromatography Scale-Up: Don't Get Tied Down by Bed Height
• Combine Chromatography Techniques: Get the Right Purity/Yield of Protein
• Impurity Testing of Biologic Drug Products
• …
Article
Scalable Viral Vector Manufacturing
For example, single-use bioreactors, filtration, and chromatography techniques are suitable for virus production.
Due to the diversity of viruses, platform solutions are challenging to implement e…