Search results for " analytical"
Article
USP Publishes Monoclonal Antibody Guidelines
…olecules that would be more amenable to a “platform approach” both in terms of manufacturing and analytical development.
USP has been involved in developing quality standards for biologics as par…
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Labeling of Biosimilars
“The inclusion of the preclinical and clinical data [only] on the biosimilar is misleading because the assessment of biosimilarity is primarily based on extensive analytical comparisons [on quality] w…
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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 …
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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…
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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…