Carbon-14 labeled API manufacturing
The development of new drugs is a challenging compromise between time/cost projections and safety/efficacy profiles. Every day lost in the development of a successful drug leads to a direct loss in revenue for the pharmaceutical or biotechnology company.
Carbon-14 labeled API and IMP requirements for Phase 0/I to Phase III mass balance and micro-dosing clinical trials can be met by contract manufacturing in compliance with MHRA and FDA Phase I cGMP guidelines. The short supply and escalating price of carbon-14 labeled building blocks has emphasized the demand for robust synthetic methodologies to incorporate the carbon-14 label efficiently into the API, and outsourcing to a CMO specializing in handling these challenges is a cost-effective approach.
This article published in the Winter 2012/13 edition of Drug Discovery World looks at these challenges and identifies further advantages of outsourcing these services to a CMO, from drug discovery stage to marketing.
Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.