Top 10 problems encountered in IND or BLA submissions

24th October 2013

Category: Bioanalytical / Regulatory

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By: Dr Daniel Galbraith, CSO

During the Well Characterised Biological Congress an FDA reviewer gave us an insight into some of the common problems encountered in IND or BLA submissions with a list of the Top 10 inadequacies. Number 1 – The lack of procedural details contained within the submission. What was clear was that the FDA requires a working SOP More

Prospect of plant based production methodologies for Trastuzumab (Herceptin)

8th October 2013

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO

The production of Biosimilar Monoclonal Antibodies often follows the same or similar production methodologies to the innovator product, Chinese Hamster Ovary Cells being the most common method. However there is nothing in the current guidelines to prevent the use of other production systems for these products. In the paper published by Grohs et al., 2010 More

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