CMC-Product Development & Manufacturing

 

We are a full spectrum CDMO with Formulation, Analytical, and Novel Drug Delivery platforms supporting NCE, 505b(2), and ANDA products from pre-clinical through Phase III Clinical Trial Material (CTM) manufacturing.

Our facilities house the latest analytical instrumentation for a full range of testing, including API/Product release, stability, and dissolution.

Our broad portfolio of Product Development and CMC services spans drug product development, analysis, and clinical trial materials’ delivery and supply, from preclinical stages through Phase III Clinical Trial Material (CTM) Manufacturing.

We have proven expertise and a successful track record in the following areas:

Formulation Development

Our Formulation development staff have the experience to develop a variety of finished products. These include:

• GLP formulations for pre-clinical studies
• First-in-human (FIH) formulations
• Solubility and bioavailability enhancement
• Permeability enhancement
• API-in-bottles and API-in-capsules
• Blend-in-bottles and blend-in-capsules
• Oral Solids – tablets and capsules (IR and MR)
• Oral Liquids
• Liquid-filled Capsules
• Placebo Matching
• Sterile Injectables
• Semisolids and Topicals
• Ophthalmics
• Nasal

Novel Drug Delivery Platforms

Our scientists have hands-on experience and have published in scientific journals on the following novel drug delivery technologies.

• Liposomes
• Microspheres
• In-situ Gels
• Solid Dispersions
• Injectable Depots
• Nanosuspensions
• Solid Lipid Nanoparticles
• Self-Emulsifying Drug Delivery Systems (SEDDS)

Manufacturing

• Phase I-II Clinical Trial Material (CTM) Manufacturing
• Phase III and Commercial Manufacturing (Coming Q3 2024)

Analytical Services

• Analytical Method Development, Validation and Transfer
• Stability Testing and Storage at all ICH Conditions
• IVRT and IVPT Testing
• API and Finished Product Testing
• Impurity identification
• Extractable and Leachable studies
• Elemental Impurities
• Nitrosamines
• Microbial Testing
• QC Release of Commercial Products

Compliance History

With an outstanding compliance history, the CMC team at Frontage operates under strict adherence to ICH and US FDA GMP guidelines. Our CMC facilities and processes undergo routine audits and inspections from sponsors and regulatory authorities.

Value to Our Clients

• Integrated: One-stop shop for product development
• Customer Focused: Flexible setup to meet client requirements
• Quick and Responsive: Keep client engaged and timely updates on project status
• Strong Problem-Solving Skills: Help clients overcome challenging technical hurdles
• Strong Quality and Compliance Track Record