Biosimilars: Regulatory Trends And Manufacturing Considerations

| August 28, 2018

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Unlike well-defined chemical medicinal products and their generic counterparts, biologics and their biosimilar counterparts employ sophisticated bioprocessing technologies that utilize living systems for their manufacture. Because these complex heterogeneous protein molecules are produced in living systems, their exact characteristics are subject to inherent batch-to-batch variability. Given the variability of biologics characteristics including its manufacturing complexity, biosimilars must undergo a much more rigorous regulatory pathway for approval compared to generic drugs.

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Direvo Industrial Biotechnology GmbH

Direvo is a biotechnology company with a focus on the biomass conversion industry. Direvo identifies bottlenecks and weaknesses in current industrial processes in this sector and develops and implements biology-based solutions together with large and small industrial partners.

OTHER ARTICLES

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Direvo Industrial Biotechnology GmbH

Direvo is a biotechnology company with a focus on the biomass conversion industry. Direvo identifies bottlenecks and weaknesses in current industrial processes in this sector and develops and implements biology-based solutions together with large and small industrial partners.

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