What is it?
We identify drug impurities and degradation products that typically arise during synthesis. This is a vital step in the drug development process because highly reactive impurities have the potential to react with DNA.
How does it work?
We perform impurity and degradation product identification through mutagenicity assessments. A variety of software tools can be employed to perform the necessary assessments to comply with ICH M7 guidelines.
Why choose Arcinova?
Our flexible approach allows us to provide this service both on a stand-alone basis or as part of an integrated service. If a complete identification service is required we can combine expertise with our on-site analytical team.
Get In TouchWhat is it?
Microbial analysis is essential for ensuring that pharmaceutical products are safe and that they meet rigorous quality and regulatory specifications. We support clinical manufacturing and quality control for both non-sterile and sterile products.
How does it work?
Arcinova’s on-site microbiologists can assist manufacture through microbial monitoring and simulation tests. An advantage of having specialists close at hand during process testing is that samples can be taken as close to the source as possible. Quality control for sterile product release testing involves sterility, endotoxin and in-process testing. Microbiological enumeration and tests for specified microorganisms are also supplied for the quality control testing of non-sterile products.
Why choose Arcinova?
Our skilled microbiologists excel at method development through their extensive experience working with difficult products that have not previously been analysed. For extemporaneous injectable products, we offer same day turnaround for endotoxin testing. We are specialists in the microbial analysis of radiolabelled compounds and are able to handle cytotoxic and high potency compounds.
Get In TouchWhat is it?
Stability testing of drug products is a vital step in the drug development process. It provides evidence of how a product changes over a given time period and defines the effects of different environmental factors.
How does it work?
We produce and interpret high quality analytical, microbiological and materials science-based stability data. Our drug product stability testing offerings are supported by the use of our state-of-the-art, 'walk-in', ICH compliant stability chambers and a number of smaller, reach-in, units for investigative studies. We can also evaluate the effects of light exposure on drug products through our ICH compliant photo-stability testing equipment.
Why choose Arcinova?
Clients benefit from our extensive experience in drug product stability testing. We are also responsible for the analytical testing of material within drug substance and isotopic labelling divisions. We can therefore support your drug product across the development pipeline.
Get In TouchWhat is it?
The Arcinova Quality Control (QC) testing team is responsible for the analytical testing of material within drug substance, drug product and isotopic labelling divisions. Our Qualified Person (QP) certifies Investigational Medicinal Products (IMP) prior to release.
How does it work?
For Drug Product QC testing, we analyse clinical products and IMPs based on pre-approved specifications. Our testing methodologies are developed and validated on-site, with the release of products performed by our in-house QP before distribution to clinical trials.
Why choose Arcinova?
We can offer full GMP QC testing and QP release on-site, alongside a flexible approach for clients that require technical transfer for testing. Our dedicated team of experts are always ready to provide suggestions for improvement.
Get In TouchWhat is it?
The Drug Product team develop, manufacture, test, release and supply a wide range of clinical products.
How does it work?
We produce a variety of product types that are required for early clinical trials including liquids for oral dispensation, radiolabelled products for oral or IV human AME trials and capsules containing APIs. Our nanosuspensions can be prepared through both ball milling and high-pressure homogenisation methods to the litre scale. Arcinova’s all-in-one facility is licensed to manufacture both oral and sterile IMPs. We also record the chain of custody between the on-site packaging of products, to receipt at the clinical site.
Why choose Arcinova?
Our experienced scientists can guide clients towards the best development and manufacturing pathway for their product. We have extensive experience of delivering diverse product types and we relish new challenges. The Drug Product team also has the distinctive ability to manufacture products containing cytotoxic and radiolabelled drugs on-site, reducing the time taken to reach clinical trials.
Get In Touch
