Search results for "EMA"
Article
Make buffer preparation more time and cost efficient with inline conditioning
Simplify Buffer Preparation
The volume and number of buffers for a typical downstream process can be considerable.
Preparation of these buffers is a challenge that in-line conditioning can o…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Also, if producing at commercial scale, which regulatory standard is needed? Is the product approved by FDA, the European Medicines Agency (EMA), the China FDA, Brazil’s National Health Surveillance A…
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Continuous Processing for the Production of Biopharmaceuticals
With the growing demand for biosimilars and an ever-increasing pressure for reduction in manufacturing costs, the biotech industry seems to exhibit a flourishing interest in the development of continu…
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Biopharma in 2015: A Year for Approvals and Innovations
Biosimilar approval remained active globally as well. Immediately following its acquisition by Pfizer, Hospira announced a major milestone in February, 2015: its first monoclonal antibody (mAb) biosim…
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Cleaning of Dedicated Equipment: Why Validation is Needed
Clean equipment will not remain clean indefinitely depending on the length of the storage period and the condition of the storage environment. Cleaning validation studies, therefore, should demonstrat…
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Ligand-Binding Assays and the Determination of Biosimilarity
…ss of developing a biosimilar and something that is expected by both the European Medicines Agency (EMA) and FDA, according to Gino Grampp, R&D policy director for Amgen. Physicochemical assays for t…
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Mechanistic Modeling: Does it Have a Future in Process Development?
A mechanistic model is typically based on the laws of mathematics, physics, and physical chemistry. So, the parameters in these models actually have physical meaning.
What is the benefit of having…