Search results for " industry"
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
“The Sf9/BV genetic engineering technology is now well established in the biopharmaceutical industry, and has for example been used for the production of a licensed human papilloma virus vaccine and a…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Where practical and meaningful, a statistical method of determining the number of batches is recommended, although there is no standard industry approach. Statistical methods inherently incorporate th…
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EMA Collaborates with HTA Assessment Networks
“The matter of quality is a new area for HTAs,” says Paul Catchpole, director of values and access at the Association of the British Pharmaceutical Industry (ABPI), London. “Once a product like a bios…
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Navigating Emerging Markets: Middle East and North Africa
“Pharmaceutical Industry,” The Jordanian Association of Pharmaceutical Manufacturers (August 2013).
10. CIA, The World Factbook 2013-14 (Washington, DC: Central Intelligence Agency, 2013).
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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FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1).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…