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Almac Sciences

CDMO

Business Category : Drug Substance, Drug Additives, Intermediate、CMO、Contract Service- Analysis & test 、Pharmaceutical manufacturing、Chemical product manufacturing

Main Service Region : Japan、United States、Korea, Republic of、Taiwan、Europe(excluding UK)、United Kingdom

Product & Service

14C Radiolabelling

Service Category :API

We provide industry-leading 14C labelled drug substance and drug product services to meet your quality, cost and delivery expectations. With our extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds, we can label any compound from simple molecules to complex structures including small molecules, peptides and bio conjugates, in our MHRA approved facilities.

 

14C is the radioisotope of choice in preclinical and clinical ADME studies, avoiding the challenges encountered with tritium labelling such as label exchange and the loss of label due to radioactive decay.

Isotopic labelling imposes many synthetic challenges beyond those found in normal chemical synthesis, and when the isotope is radioactive this adds further safety and regulatory requirements. By choosing Almac as your isotope labelling provider you will have access to our wealth of experience in both stable- and radio-labelled synthesis.

We provide a complete suite of solutions for your needs, including: non-GMP and GMP radiolabelling / stable labelling, bio conjugate labelling, quality control and analytical support (including method development, validation / transfer and stability studies), storage and repurification.

 

Why choose Almac for 14C radiolabelling?

Our proven track record in synthesis and purification, coupled with our seamless analytical and QC integration, ensures your labelled product will be manufactured with the desired chemical and radiochemical purity and rigorously analysed using validated equipment. Our strong quality culture will ensure the material manufactured will satisfy the requirements of the relevant regulatory authority.

 

“I was very impressed by the planning and execution by the Almac 14C team in the GMP synthesis of our target. Timelines and goals were met. The team also showed flexibility to respond to our ever changing needs”

Client testimonial

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