Search results for " therapeutic"
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Get a strong start in oligonucleotide manufacturing
Oligonucleotide therapeutics hold incredible promise. How can you harness their full potential? When starting process development, you need to know where to focus, and you need a scalable a…
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Process Development challenges for mRNA vaccines and beyond
Key insights from industry experts on the future of therapeutic mRNA manufacturing.
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Enhancing Resins Addresses Purification Concerns
“These empty capsids do not contain the therapeutic gene of interest and can elicit an undesirable patient immune response (4). Therefore, removal of these empty capsid particles is critical during th…
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Innovative Chromatography Resins Can Improve Purity and Quality
Ihre also notes that there continues to be strong demand for new mAbs to address new therapeutic areas and rising requests from customers of contract development and manufacturing organizations (CDMOs…
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Gene Therapies Push Viral Vector Production
• AAV exhibits reduced risk of ectopic integration of the therapeutic DNA.
“Adenovirus (AV) was the first viral vector investigated for gene therapy use; however, after the death of a pati…
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Can Vaccine Development Be Safely Accelerated?
The company has also developed specific carrier molecules for its mRNA products, including lipid nanoparticles (LNPs), developed in partnership with Acuitas Therapeutics and Arcturus Therapeutics). It…
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Best Practices for Selecting a Top-Quality Cell Line
…ular approach to generate high-quality cell lines that meet the production needs of each recombinant therapeutic protein. At the foundation of each cell-line development program, according to Fisch, …
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Design Considerations for a Commercial Cell and Gene Therapy Facility
The workflows of a cell therapy or a gene therapy differ from each other and from those of therapeutic antibodies, so the design and layout of the manufacturing facility must take these workflows into…
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Addressing the Complex Nature of Downstream Processing with QbD
We have definitely seen therapeutic proteins becoming more complex and have had challenges at times with the downstream process. In one case, we had an engineered antibody, which possessed properties …
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…