Contract Development of lipid-based active ingredients, extracts and formulations
Stabican offers flexible solutions that enable you to move your challenging fat-soluble molecules and/or extracts through each early development phase with efficiency and speed (e.g. Δ9-THC, psilocin, nicotine and vitamin A, D, E and K). Our early development solutions enable you to:
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• Overcome complex formulation challenges: bioavailability, solubility, stability, process
• Navigate a complex regulatory environment (IND, filing, etc.)
• Build success in early development to enable commercial success
• Shorten timelines to get to market quicker
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Our approach to successful product development
Stabican has access to all the necessary tools, process, technologies and services to facilitate
your product development to clinical trials and market launch:
Feasibility
We offer early-stage formulation development.
In a first experimental feasibility phase, we can support the following:
• Experimental design
• Extract/isolate sourcing
• Preliminary Preclinical testing (dissolution, bioavailability, etc)
• Specification development
• Technology development and IP
Proof of Concept
In case of feasibility is proven successfully, we support the development of your Target Product Profile (TPP) with the following:
• Dosage form selection
• Prototype batches for evaluation
• Preclinical testing (dissolution, bioavailability, etc)
• Supply chain
• QA/QC plan
• GMP transfer
Drug Product Development
When Proof of Concept is confirmed, the final stage of product development is supported by us with:
• EU-GMP extract/isolate supply
• GMP Clinical Test analysis
• Process validation and optimization
• Full development of analytical methods
• Scale-up from lab to pilot to commercial
• Product Release
• QA/QC support and regulatory support
• GMP Manufacturing, up to pilot scale/Phase 3
Tablets, Capsules, Granules, patches, liquids, inhalables
When preparing for market launch, we can negotiate Tech Transfer or Contract Manufacturing.
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