Search results for " industry" in Articles / App Notes
Article
Prescribing Caution for Biosimilars
Recognizing the authority US states have over biosimilar and interchangeable biologic medicines, the Biotechnology Industry Organization (BIO) developed five principles on biologic substitution that w…
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The Development and Application of a Monoclonal Antibody Purification Platform
Next Steps
As cell culture titers continue to increase, the biopharmaceuticals industry will be faced with new challenges, including greater product heterogeneity and increasing impurity levels…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1). QTPP is defined in ICH Q8 (R2) as "a prospective …
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
They’ve been making presentations throughout last year at various industry conferences and they’ve published several articles over the last year that talked about their approach to the development of …
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PDA's Technical Report for Biotech Cleaning Validation
For these reasons, limits for the manufacture of bulk actives in biotech are generally established based on industry standard practice of about 5–10 ppm TOC for upstream processes and 1–2 ppm for down…
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Quality Considerations for Using AI in Bio/Pharma
The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization ser…
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Considerations in depth filter scale-up
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in diffe…
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Selected courses from cell culture and downstream process development to scale-up and manufacturing
Built upon our expertise in the biopharmaceutical and biotechnological industry, our course curricula cover theory, applications, instrument use, process development and software.
Examples of avai…
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You are invited to attend DiPIA 2024
We bring peers together from across the industry to share best practices, research, and new applications. This conference is dedicated to the surface plasmon resonance (SPR) technology as featured in …
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A Closer Look at Affinity Ligands
The high specificity and ease of operation of Protein A ligand affinity chromatography has made it the technology of choice and the “darling” of the mAb purification platform process in industry.
Cu…