Search results for "biopharma 4.0" 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
Cell Culture Process
In this video, Mary Szorik and Alicia Elwood at Cytiva, discuss the rationale for cell culture and analytical testing as well as the types of tests that can lead …
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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
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
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Next Generation Process Chromatography
Chromatography is an essential part in the production of all biopharmaceuticals. Without it the industry would not be able to produce therapeutics in an economic manner. This is true for monoclonal …
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
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Regulators have been en…
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Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
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Process analytical technology (P…
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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 …