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Radiolabeling: Manufacture of 14C-Labelled Drug Product

The approach taken for a client who trusted Almac for the manufacture and supply of 14C-labelled antibody drug conjugate for their drug development program.
A large pharmaceutical organization approached Almac for the supply of a 14C-labelled drug product (IMP) to be provided as a powder in capsule formation. The 14C-API was required at a final specific activity of 1µCi/mg and as a particular polymorph (Form B) with a particle size of <5µm.

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