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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
Development Services
We offer the full range of GLP and non-GMP services customized to meet the demands of product development. These services focus on finding scalable new routes or making existing routes more effective for your intended audience. Furthermore, we may support formulation research or animal studies with bigger amounts of your lead target, reducing the burden on your priceless internal resources.
Our development services span across following capabilities:
- Lead optimization
- Advanced intermediate synthesis
- Library synthesis
- Fluorescent & biotin tagging of small molecules
- Multi-gram intermediate synthesis
- Chemical Route Development
- Route Scouting
- Alternative Route Development
- Process Development
Process Optimization - Non-GMP manufacturing
- Custom Synthesis
- Stable Isotope Labeling
- Radiolabeling
- Controlled Substance Manufacturing
GMP 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.
Chemistry Manufacturing & Controls (CMC) Support
An important component of the drug development process is communicating your approach to regulators. CMC is a regulatory framework in the pharmaceutical industry that ensures the quality, safety, and consistency of drug products from early development through commercial production. The CMC document is your opportunity to demonstrate your understanding of the molecule that you are developing while establishing a strong manufacturing protocol with reproducible results.
A complete and strong CMC document is important to the success of your molecule and, by extension, your organization. APS Pharma will help you create a coherent CMC document from beginning or reinforce an existing document in preparation for initial submission or subsequent filing.
This is how we support your CMC document preparation:
- 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
- Radiolabeling
Analytical Services
For an iron clad IND submission, it is critical to have robust analytical infrastructure to ensure consistent results in the API manufacturing. This can be achieved by diverse analytical methods that not only ascertain the identity of the API but also help ensure that the API conforms to the quality standards defined by regulatory authorities.
To prove control, careful application of the right test procedures that have been adequately qualified or validated is essential. These days, the emphasis is on being able to show control and continual development, as well as knowing not only your target molecule but also its intrinsic impurity profile. Therefore, it is crucial to take route design and control into consideration as well as to use suitable test methods early in the development cycle.
At APS Pharma we have the expertise to develop these analytical controls to support your pre-clinical 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)