Search results for " report" in Articles / App Notes
Article
PDA's Technical Report for Biotech Cleaning Validation
As discussed in the recently published PDA Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation, well–designed laboratory-scale studies can be performed using design of ex…
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Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
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Novavax Reports on Two Vaccine Efficacy Studies
The company reported a vaccine efficacy of 100% against moderate or severe disease and success among high-risk populations.
Novavax also reported on June 14, 2021, data from a co-administration st…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
While the erosion curve will be much less steep than it is for traditional pharmaceutical products, those companies are among those that will face sales declines, Moody's reports.
But upside oppor…
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Report from the 12th Plasma Product Biotechnology Forum
Since the first meeting in 1999, the PPB forum has established itself as the key international forum for the plasma manufacturing industry – read our report for the highlights of the 2022 conference…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…
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Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…
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Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear.
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
The annual report has expanded to include 60 questions with nearly 500 pages of analysis and data (1,2). Manufacturing capacity issues have always been at the core of the annual survey, but as the ind…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
…ological reagents and reference materials, study design, laboratory protocols, and data analysis and reporting (3). Although each contributes to a systemic problem that requires extensive changes in …