Search results for " efficacy"
Article
Developing a Robust Bioprocess Using Mechanistic Models
The safety and efficacy of a biopharmaceutical drug are of the highest priority. Therefore, manufacturers have to design, implement and maintain measures to ensure that the bioprocess con…
Article
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
Pandemic Alters Policies and Practices for Drug Development and Regulation
Vaccine experts at the Center for Biologics Evaluation and Research (CBER) worked overtime to clarify the size and diversity of efficacy trials and key analytical assessments needed to gain EUA status…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
The major driver for early-stage gene therapy developers is speed to clinic, where drug efficacy can be proven and used to raise further funding for industrialization. At the same time, the production…
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Setting Up Bioprocessing Systems for Digital Transformation
…y changed the alarm limits on temperature levels or other variables that might impact the safety and efficacy of the final product,” Lenich asserts.
Fitting in AI
The use of artificial intell…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
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Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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Considerations for Improving Outcome in Biopharmaceutical Process Development
In this article, we take a look at how the process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different stra…
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Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Article
Gene Therapies Push Viral Vector Production
Challenges to using non-viral approaches, however, include poorer efficacy, the potential of shorter duration of the gene therapy expression (i.e., repeated dosing may be required), and poor targeted …