To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...
The manufacture of biological products is a complex process that involves continual refinement throughout product development, post-approval and marketing. Reasons to alter the manufacturing process ...
It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...
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