Chemistry, Manufacturing and Controls
Arcinova staff have extensive experience in the Chemistry, Manufacturing and Controls (CMC) aspects of molecule development which, in the pharmaceutical arena, spans the discovery interface to First in Human clinical studies and beyond.
Our services, some of which are individually detailed below, can be provided either on a stand alone basis or as part of an integrated service offering depending on your particular CMC needs.
Clinical Manufacturing, QC Testing and Supply
The manufacture and supply of dose forms is critical to the success of any pharmaceutical development program, whether they are required for phase I safety trials or those to establish product efficacy.
Arcinova specialise in the development, validation and documentation of a range of chromatographic and non-chromatographic test methodologies.
High quality stability testing of APIs or Drug Products is a critical part of the drug development process, ensuring that suitable and justifiable, re-test dates or shelf-lives are applied during all clinical phases.
Arcinova offers a wide range of pharmaceutical microbiology services – often as an integral part of formulation development, manufacturing and release testing programmes for sterile or non-sterile products – but also on a transactional basis.
Impurity/Degradation Product Identification
The application of specialist spectroscopic knowledge, including the use of in-house NMR and accurate mass spectroscopy equipment, to challenging drug development issues and impurity / metabolite identification studies.
Materials Science Capabilities
Pharmaceutical materials science is an integral component of both drug substance and drug product characterisation within Arcinova.
Nuclear Magnetic Resonance Spectroscopy
Our NMR facilities are GMP and GLP compliant. A diverse range of nuclei and experiments can be employed, in conjunction with numerous probeheads, for unequivocal structure determination.
Arcinova has the capability to develop, manufacture, characterise, analyse and administer nanosuspension products as part of either preclinical or clinical investigative studies.
The teams at Arcinova can provide advice and support for preparation of regulatory dossiers, particularly with respect to the CMC content. For more information, please check our Consultancy page.