Chemical Services for Pharmaceutical Development

Ricerca is a leading USA-based, independent drug development organization. We provide the full spectrum of services needed to support the commercial development and launch of innovative new pharmaceuticals. Our extensive client base ranges from the established research-based multinational drug companies to emerging biopharmaceutical companies focused on the discovery and development of small-molecule drugs. Our project approach is tailored to meet the specific technical and timing needs of the client's development program.

Our specific capabilities include:

Synthetic Chemistry

• De Novo Synthesis
• Chiral Synthesis
• Analogs
• Metabolite/Degradant Identification and Synthesis
• Radiolabeled Synthesis ( 3 H/14 C/32 P/35 S)
• Analytical Standards

Process Chemistry

• Route Discovery and Definition
• Process Improvement/Optimization
• Robustness/Process Limits Testing

Analytical Chemistry

• Full FDA GLP/GMP Compliance
• Comprehensive problem-solving support with diversified staff of over 30 scientists. Expertise in HPLC, GC, GC-MS, thermal, microscopy, XRD, ICP, FTIR, UV/Vis, dissolution testing, and an extensive suite of classical chemical and physical tests
• Microbiological laboratory for endotoxin and microbial limits testing
• Methods development/qualification/validation

Process Development/Engineering

• Process Scale-up/Demonstration
• Engineering Data Acquisition
• Technology Transfer to Commercial Scale

Preparation/Custom Processing

• Preparation of pharmaceutical intermediates under cGMP controls
• Preparation of active pharmaceutical ingredients (APIs) under cGMP controls
• Multigram to multiton amounts (process-dependent)

Ricerca’s Chemical Services Facilities

• Modern, well-equipped organic chemistry laboratories
• Analytical laboratories incorporating a broad range of qualified analytical equipment
• Five (5) chemical preparations laboratories
• Reactor capacities to 50 liters
• Operated in compliance with US FDA cGMP regulations
• Multipurpose batch processing pilot plants
• Reactor capacities from 10 to 750 gallons
• GLS/SS materials of construction
• Standard temperature range: -20° C to +165° C
• Standard pressure range: FV to 450 psig
• Isolation/finishing rooms for drying, milling, blending, and packaging operations
• Complete support equipment
• Oated in compliance with US FDA cGMP regulations

Other Ricerca Services Include:

• Medicinal chemistry drug discovery programs
• Parallel drug discovery lead optimization programs in microbiology and oncology
• IND-enabling drug safety studies
• CMS development programs
• Stability studies, including photostability F
• Forced degradation
• Polymorph characterizations
• cGMP specifications development
• Custom development and validation of analytical methods for bulk pharmaceuticals, impurities, and metabolites