Search results for " biopharma" in Articles / App Notes
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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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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…
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Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Read more here…
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Updating Viral Clearance for New Biologic Modalities
Next-gen biopharma processing
Recent innovations, particularly in filter membranes and chromatography resins, have further helped to improve viral clearance performance.
“In general, chromatog…
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Next Generation Process Chromatography
Fibro is a new chromatography platform that enables the purification of therapeutic antibodies with speed and flexibility, addressing the current challenges of biopharma production, which includes the…
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Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
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Moving PAT from Concept to Reality
Still on the learning curve
The biopharmaceutical industry and regulatory agencies have recognized the value of PAT. Although many large multinational manufacturers have adopted and implemented va…
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The Good and Bad of Biosimilars
Biosimilars have been around for years, but the biopharma industry – as well as the healthcare community – has been slow to embrace them. Today, however, the competition is really beginning to heat …