MTS Recommends... Analytical Strategy in the Development of Biosimilars

Analytical Strategy in the Development of Biosimilars

The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.

M. DiPaola, “Analytical Strategy in the Development of Biosimilars," BioPharm International 30 (8) 2017.

Why are 'Bio' Test Methods So Tricky to Validate?

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Responding To Regulatory Inspection Observations: Do's and Don'ts

By Martin Lush, Global VP, NSF Health Sciences, in Outsourced Pharma

"It’s Friday, it’s late, and you are just leaving for the weekend. The inspection you hosted two weeks ago remains a painful memory. The exit meeting didn’t go well — five major observations, all relating to your quality system. When your boss enters your office, you know it’s not to wish you a good weekend. She looks stressed, anxious, and keen to off-load a big problem …"