Chelator Production at Macrocyclics encompasses a wide range of techniques and products. Chelators are organic compounds that are capable of bonding metals. Macrocyclics produces both cyclic chelators or Macrocycles and acyclic chelators. Both of these basic chelator structures may also be produced in their monofunctional or bifunctional modes. Bifunctional chelators are particularly useful, as they bind metals and also may be attached to other molecules in increase their functionality.
Chelator Production at Macrocyclics encompasses a wide range of techniques and products. Chelators are organic compounds that are capable of bonding metals. Macrocyclics produces both cyclic chelators or Macrocycles and acyclic chelators. Both of these basic chelator structures may also be produced in their monofunctional or bifunctional modes. Bifunctional chelators are particularly useful, as they bind metals and also may be attached to other molecules in increase their functionality
Production at Macrocyclics employs a number of organic synthetic schemes and approaches. Most chelators are produced as racemic mixtures but some products may be produced as pure stereoisomers. Macrocyclics is capable of producing is products in quantities ranging from milligrams to kilograms. The quality of our products is superior to most competitors due to our careful attention to detail and the fact that this is the only class of compounds produced at Macrocyclics. Chelator production is not merely our specialty; chelator production is our existence.
Our technical staff has an aggregate of over 50 years of organic synthesis and coordination chemistry experience. We are also developing the necessary skills to extend our chelator production capabilities into the bioconjugation arena.
A critical aspect of chelator production is the ability to produce these products under cGMP conditions. When the products in which the chelators are employed must be used in humans, the level of quality and scrutiny for the production rises significantly. Macrocyclics is developing cGMP capabilities so that it can produce the chelators for clinical trials and ultimately for commercial production of finished pharmaceuticals. The company is hiring analytical chemists, production chemists and quality assurance supervisors to ensure that it can meet the rigorous requirements for cGMP production.
In each country, one or more governmental organizations will usually regulate cGMP activities within the pharmaceutical industry. In the United States, the Food and Drug Administration regulates the approval, manufacture and sale of all pharmaceuticals. They set guidelines under which pharmaceutical products must be manufactured and those guidelines are usually adopted as part of cGMP's throughout the industry. FDA guidelines are intended to ensure that companies abide by Code of Federal Registry CFR21 Part 10, which is the Federal law that mandates the conditions under which pharmaceutical products must be produced. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an international body that seeks to set common standards that are accepted across national boundaries. This council meets periodically to review requirements and update its recommendations