Search results for "analytical" in Articles / App Notes
Article
Evolution of the Monoclonal Antibody Purification Platform
What is unique about mAbs from a processing perspective is the applicability of developing a common process and analytical platform (2, 3). Some process development related attributes with respect to …
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
What this means is that there will, obviously, be extensive characterization of the biosimilar product using what the FDA refers to as state-of-the-art analytical techniques.” Levine adds that human c…
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Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…
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Process Development and Control for New Modalities
Advancements in technology for manufacturing and online analytical monitoring have not caught up to the innovative drug candidates and emerging modalities present in the candidate pipeline today. Lack…
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What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Joining me today is Christopher Woolstenhulme, lead analytical scientist of manufacturing sciences at Cytiva. Thank you so much for being here today, Let’s begin.
Megan Manzano: What are s…
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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.
Read more here >>>
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
But it's also the reliance on analytical colleagues to assay your fractions, and you need to establish a good relationship with your analytical colleagues to get successful in this.
BioPharm In…
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Genetic Vaccine Platforms Demonstrate Their Potential
However, for genetic vaccines, this means developing a whole new battery of analytical methods, especially around purity and potency,” Christy states. “Methods exist, but these generally are research-…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…