Drug Product Formulation Development
Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic.
Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer early-phase accelerated programs for NCEs and generic drug development for human and veterinary applications (ANDAs and ANADAs).
Alcami’s formulation development scientists provide full chemistry, manufacturing, and controls (CMC) services for drug candidates that encompass all biopharmaceutical classification system schemes (BCS Class I through Class IV) including the more challenging not freely soluble, unstable, or poorly bioavailable compounds. Our formulation and analytical experts can provide creative solutions to your toughest pharmaceutical challenges, including products with extremely low or high drug loads, poor flow, or homogeneity problems.
Access our team’s extensive experience developing parenteral and topical formulations. We have developed our operations and quality systems to effectively and efficiently process small and large molecules for administration by injection, including solutions, suspensions, emulsions, and lyophilized products. All of these product types have been successfully transferred for clinical and commercial use by Alcami’s team of formulation development experts.
Core Capabilities - Pharmaceutical Product Formulation
- Accelerated first-in-human clinical trial materials
- API polymorph screening
- API salt form selection
- API structural chemistry
- Bioavailabilty enhancement
- Blinding and over-encapsulation
- Clinical formulation development
- Commercial dosage form design
- Drug candidate selection
- Drug excipient compatibility studies
- Drug product lifecycle management
- Drug substance preformulation studies
- Injectable prototype development
- Matching placebo development
- Pediatric formulation development
- Pharmaceutical process development
- Powders for reconstitution
- Preclinical formulation development
- Quality by design (QbD)
- Solid oral dose prototype development
- Technology transfer and process scale-up
Ready to Get Started?
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