ServicesAcanthus Pharma provides customers with a tailored product offering
matched to their needs to best help them accelerate their internal
programs towards the next milestone
We offer our customers a full range of non-GMP and GLP services focused on the development of their products. These services may be focused on finding a new or scalable route or optimizing an already identified route to your target. Perhaps you require larger quantities of your lead target to help fuel animal or formulation studies and do not want to tie up your valuable internal resources.
Acanthus Pharma is here to serve your unique needs in the following:
- Chemical Route Development
- Route Scouting
- Alternative Route Development
- Process Development
- Process Optimization
- Non-GMP manufacturing
- Custom Synthesis
- Stable Isotope Labeling
- Controlled Substance Manufacturing
As your program advances from pre-clinical to clinical development you will need to start manufacturing your product under CGMP controls. We are here to support you with our GMP manufacturing services at a range of scales. From gram to kilogram, we can support you in several ways with full access to the documents you will require to support your CMC filings with the regulatory agencies.
Working Together. Smarter and Faster.
In today’s regulatory environment, being able to demonstrate that you understand your molecule and have control of the manufacturing is critical to regulatory success. This is achieved through the use of analytical testing.
Judicious use of the appropriate test methods, suitably qualified or validated, is critical to demonstrate control. Today the focus is on understanding not just your target molecule but also the inherent impurity profile that your molecule possesses and being able to demonstrate control and continuous improvement. It is therefore critical to be using appropriate test methods early in the development cycle as well as considering route design and control.
At Acanthus Pharma we understand how to build these controls and develop appropriate analytical methods to support your preclinical and clinical journey.
- Analytical Method Development
- Analytical Method Qualification
- Analytical Method Validation
- Stability Studies (Real-time and Accelerated)
- Process/Degradation Impurities Mapping
- Reference Standard Preparation (Primary and Impurities)
Communicating your strategy with the regulatory agencies is another critical aspect of the drug development journey. From the molecule and chemistry point of view, the CMC document is your roadmap. The CMC document, Chemistry and Manufacturing Controls document, is the medium through which you communicate to the regulatory agency that you understand the molecule you are developing, the intrinsic characteristics of the molecule (stability, physical and chemical characteristics) and how to synthesize and manufacture at scale.
Having a comprehensive and robust CMC document is critical to the success of your molecule and thus your company. At Acanthus Pharma Inc., we are here to support you in creating your CMC document from scratch or strengthening the document to prepare for initial submission or subsequent filing.
This is a non-exhaustive list of services that we offer. It should not be considered a checklist as every molecule is unique and the CMC document will ultimately reflect that uniqueness.
- General characterization reports
- Salt Screening
- Polymorph Screening
- Crystallization studies/optimization
- Mutagenic Impurity Risk Assessment
- Elemental Impurities Risk Assessment
- Route scouting
- RSM selection support documents
- Raw Material Sourcing
- Stability Studies
- Stable Isotope Labeling