Search results for " therapeutic"
Article
Expanding the Emerging Therapeutic Horizon
Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges. Aspects such as demand for accelerate…
Article
Working With Advanced Therapeutics: You Bring the Idea, We Bring the Map
Plasmids. mRNA. Oligos. Cell and gene therapies. Antibody variants. Vaccines. We all know these advanced therapies hold huge potential. But developing them isn’t straightforward, and fai…
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Analysis of mRNA Therapeutics and Vaccines
Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
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Article
mRNA Processing Workflow for Vaccines and Therapeutics
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Learn more on key considerations when setting up a messenger RNA (mRNA) process with this infographic.
Resource
Advancing Future Therapeutics
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The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medi…
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Impurity Testing of Biologic Drug Products
“On the other hand, the impurity may exaggerate or enhance the therapeutic protein’s bioactivity in an uncontrolled way, leading to adverse events. Some impurities (especially host cell proteins) may …
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
By Luhong He, Christopher Frye
Abstract
The Chinese hamster ovary (CHO) cell lines used for the production of recombinant therapeutic proteins are immortalized cells with a relatively high degre…
Article
Advances in Engineering of Protein-Based APIs
Peptides and peptidomimetic therapeutics offer the advantages of mAbs but in smaller molecules that may be formulated for oral delivery.
Advanced modeling tools are enabling the rapid engineerin…
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The Importance of Partnering for Bioanalytical Studies
Importance of bioanalytical studies
BioPharm: Why is it so important to conduct bioanalytical studies during the development process of a new biological therapeutic?
Bose (Emery Pharma): Bio…