Search results for " biopharma"
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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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Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
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Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…
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Milestones and Moderate Progress in 2012 Drug Approvals
Twelve biopharmaceutical marketing applications were approved in the United States and/or the European Union in 2012 (see Table I). Approval numbers for the past year are in line with those recorded o…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.
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The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medi…
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ML and AI Implementation Insights for Bio/Pharma Manufacturing
A recent survey of biopharma industry manufacturing leaders found that creating machine learning (ML) and artificial intelligence (AI) solutions catering to manufacturing segments can quickly…
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Optimizing your Cell Culture Process to Improve Productivity
Jeanne Linke Northrop: What industries would need these analytical testing for cell culture?
Mary Szorik: We mainly work with biopharma companies that are producing therapeutic proteins, biosim…