What is it?
Stability testing provides evidence of how time and changes in the environment affect the quality of an API. It is used to establish a re-test period for the API and determine the most suitable conditions for storage.
How does it work?
We produce high quality stability data through a combination of analytical, microbiological and materials science methodologies. Our service is supported by state-of-the-art facilities, including 'walk-in', ICH compliant stability chambers and a number of smaller, reach-in units. ICH compliant photo-stability testing equipment is also available to study the effects of light stress on materials and packaging.
Why choose Arcinova?
Our expert team also supplies stability testing for our drug product and isotopic labelling divisions. Clients can therefore benefit from our services across the drug development pathway.
Get In TouchWhat is it?
Solid form screening and selection helps identify the most appropriate API form for development.
How does it work?
The material science team works closely with drug substance to provide expert advice on the most appropriate salt form, polymorph or particle size for an API. Solid state characterisation is performed using a wide range of analytical techniques, including X-Ray powder diffraction, thermal analysis and hygroscopy.
Why choose Arcinova?
The close integration of services on-site allows us to constantly collaborate and define the best API form for drug substance development. Clients benefit from having a wide range of experts working together to solve problems. Solid state screening is offered both as a stand-alone service, or as part of an integrated drug development program.
Get In TouchWhat is it?
We have access to scale up and pilot plant assets, ensuring an integrated drug substance manufacturing and supply service from preclinical to full scale commercial launch.
How does it work?
Arcinova has access to additional scale up and pilot plant assets to complement our on-site facilities. The pilot plant has a capacity range between 50lt and 1300lt, and is capable of producing 5-100kg in batch. We have a range of internal manufacturing assets from multigram to multikilogram capacity (multitonne p.a capability). Our investment in innovative and flexible modular manufacturing technology will further enhance our capabilities. The technology enables us to quickly configure reactors for drug substance (API) manufacture and then rapidly reassemble reactors for the next project.
Why choose Arcinova?
Clients benefit from the greater flexibility we can provide. The scale up process is executed by dedicated Arcinova staff and supported by the long-established skills, infrastructure and capacity of our manufacturing partners.
Get In TouchWhat is it?
Our facilities can provide both GMP and non-GMP manufacturing with the ability to generate kg per day quantities.
How does it work?
Our facilities have increased to include both batch and flow reactor systems. Current on-site capabilities include 5lt GMP and non-GMP process chemistry facilities with full thermal control. Our 20lt state-of-the-art GMP and non-GMP reactor streams are housed in dedicated walk-in fume cupboards. The reactor streams are fully integrated into a dedicated server, enabling real-time process optimisation.
Why choose Arcinova?
Our facilities have received significant investment in the technology needed to meet the increased demand for small-scale product manufacture. Our highly skilled team can swiftly respond to individual client needs, developing the best strategy for drug substance manufacture.
Get In TouchWhat is it?
We work with clients to select and develop optimum routes for drug substance manufacture.
How does it work?
We combine rapid route selection with the implementation of innovative solutions to produce the shortest pathway to a drug substance. The Arcinova Process Research and Development philosophy targets optimal velocity for drug substance delivery. This ensures drug substance supply to meet our clients urgent clinical trial needs, while enhancing process efficiency to lower costs and generate higher purity. Our work also involves defining the best route for product manufacturing scalability.
Why choose Arcinova?
Our expertise in flow chemistry, synthetic biology and biocatalysis can significantly reduce processing time. We can quickly deliver high purity drug substances scaled up for further manufacture through the integration of a highly-skilled team, cutting-edge facilities and an innovative approach to problem solving. Our team is made up of specialists with diverse skillsets, specially selected for their background in process research and development.
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