Our Services, and Our Process
Our Services, And More Information
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Product Development Program
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Formulation Development
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Clinical Manufacturing
Product Development Program
Stage I - Feasibility
Bench-top Fills for non-GLP studies
Fills for GLP studies
Preliminary Assay Development
Pre-formulation
Process Research
Microbiological Research
Stability Screen
Stage II - Pre-Clinical
Formulation
Assay Development & Validation
Assay Tech Transfer
Process Development
LAL Endotoxin Specification
Microbiological Development
Stability Screen
Stage III - Clinical
Aseptic Fill cGMP
Product Release Testing
Stage IV - Stability
Stability Study - Accelerated (FDA, ICH)
Our Services
Ophthalmics:
Our expertise in the development of ophthalmic formulationsallows Bio-Conceptto anticipate and address challenges that areunique to ophthalmic products. We offer specialized insight into preservative systems, ingredients, buffers and other excipients. Aqueous solutions, emulsions and suspensions are formulated and filled into plastic bottles with a dropper tip and cap. We also have experience with gels and ointments. Our flexible hand-fill process allows us to customize manufacturing requirements to address a variety of fill volumes and container options.
Liquid Injectables:
Bio-Concept has over 25 years of experience with injectables from small molecules to larger polymers and proteins. Our customized development process and hand-fill manufacturing promotes conservation of API during the early stages of development. Parentals are filled in small glass vials with rubber closures and aluminum crimp seals.
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