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:
• 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
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.