With our extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch. We can label any compound at any stage, including small molecules, peptides, and antibody drug conjugates.
14C is the radioisotope of choice in preclinical and clinical ADME studies. 14C avoids the challenges encountered with tritium labelling, including label exchange and the loss of label due to radioactive decay.
2H, 13C and 15N stable labels are routinely used to prepare stable labelled versions of APIs. Multiple labels are typically incorporated to ensure complete mass resolution from the unlabelled API.
Isotopic labelling imposes many synthetic challenges beyond those found in normal chemical synthesis. When the isotope is radioactive, this becomes even more demanding. That’s why we offer advice on the most appropriate label position for your molecule, including feasibility and metabolic stability.
We can provide a complete suite of solutions for your radiolabelling needs, including:
- Non-GMP and GMP Stable Labelling
- Facilities and Equipment
- ADC Labelling
- QC and analytical support, including method development and validation, method transfer and stability studies
- Storage and Re-purification
We are MHRA certified for 14C IMP and GMP compliance and we are fully equipped to deliver an industry-leading, cost-effective radiolabelling service.
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Over 40 years’ Experience Manufacturing Solid, Oral Dosage Forms
Scaling up from our development services to full scale commercial drug product manufacture or transferring existing commercial products we can meet your commercial drug product manufacturing requirements.
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We offer a wide range of commercial packaging solutions to meet your needs, from initial artwork and pack design, to commercial packaging and distribution.
From our UK and US commercial packaging facilities, we are able to serve global markets. We are MHRA and FDA licensed and h...
Commercial Storage and Distribution
Complementing our commercial manufacturing and packaging services, we provide a range of commercial storage and distribution solutions for solid oral dosage forms and sterile biopharmaceuticals, for both niche / orphan drug products and large scale commercial market volumes.
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