Search results for " report"

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…

Article 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Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…

Article 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…

Article 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…

Article Missed last year's HTPD conference? Read the extended reports from Avignon, France.
An extended report has now been compiled, capturing some of the presentations from the conference. We hope that this book will serve as a resource and summary of the first-rate talks and discussions, …

Resource FDA’s Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biolog…

Article 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…

Article Report from the 2nd High-Throughput Process Development conference in Avignon, France
The 2nd International High-Throughput Process Development (HTPD) Conference took place June 4-7, 2012 in the historical location of Avignon, France. 117 participants from 19 countries met at the cla…

Resource The CMC Biotech Working Group’s Report on A-Mab: A Case Study in Bioprocess Development
In August of 2008, company representatives from Abbott, Amgen, Eli Lilly & Company, Genentech, GlaxoSmithKline, MedImmune, and Pfizer were brought together on a case study focusing on the principles…

Article 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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