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products - with quality and delivery you can count on every time.

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Spectrum has more than 40 years of custom synthesis experience as a chemistry outsourcing partner to the pharmaceutical and biotechnology industries. We provide a full range of contract research and manufacturing services, including the custom synthesis of new chemical entities (NCE’s) through commercial cGMP manufacture of active pharmaceutical ingredients (API’s), DEA Controlled Substances (Schedules II-V) and their chemical intermediates. Our highly qualified staff of Ph.D. chemists will follow your project in our facilities from discovery through commercialization, providing an unparalleled level of service throughout the R&D, scale-up and manufacturing process.


• Custom Synthesis of NCE’s
• Rapid Scale-Up of Discovery Leads
• Multi-Step Synthetic Routes
• Controlled Substances Manufacture (DEA Schedules II-V)
• Chemical Process Development
• Process Validation
• cGMP Manufacture of Clinical Trial Materials
• cGMP Manufacture of Commercial API’s
• Technology Transfer
• Analytical Method Development and Validation
• Customer Audit Support
• Customized Packaging

Spectrum Custom Synthesis offers our customers a unique experience, combining the personalized service and responsiveness of a mid-size company with the resources, logistics, and technical depth of much larger companies.

 
    Research and Production Facilities
 

 

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Our FDA registered and inspected facilities are designed and engineered to accommodate projects ranging from a multi-gram custom synthesis for drug discovery through multi-ton cGMP manufacturing. Utilizing a wide range of temperatures, pressures, and other reaction parameters, our kilo lab, pilot, and production reactor capacity allows the greatest flexibility in scouting the most efficient synthetic route for your particular molecule.


• Full Glassware R&D and Kilo Lab Synthesis Suites
• Complete On-Site Analytical Support
• 1200+ Gallon Total Reactor Capacity
• Multi-Purpose Glass-Lined Reactors from 20 to 500 Gallons
• Stainless Steel 50 Gallon Reactor
• Temperature Capability from -15°C to 250°C
• High-Pressure Autoclave Capacity
• High-Efficiency Distillation and Fractionation
• High-Vacuum and Inert Atmosphere Chemistry and Purification
• Vacuum Oven Drying for Solids
Custom Blends and Formulations

 

 
    cGMP Quality Systems and Regulatory Compliance
 

Spectrum Custom Synthesis has in place the documentation, validation, and qualification systems to ensure compliance with the FDA, DEA, ICH, WHO and other worldwide regulatory entities. Our expertly trained Quality Assurance and Regulatory Affairs team works closely with our customers to navigate the regulatory maze associated with compliance to worldwide cGMP standards, securing quotas for controlled substances, regulatory filings, and audits.


Spectrum Custom Synthesis fiercely protects the confidentiality and security of Intellectual Property (IP) and Technology Transfer Agreements, whether provided by our customer or developed by our Scientists.

• FDA Registered and Inspected Facilities
• Excellent FDA Inspection History
• Qualified Equipment and Utilities
• Sample, Test and Control Protocols for Raw Materials
• ICH Stability Studies
• Submission and Maintenance of DMF Files
• Support with CMC Documentation
• Support for IND, NDA and ANDA Filings
• Full-Time Regulatory Affairs Support
• Permits & Quotas for Controlled Substances
• cGMP Compliant SOP’s
Full Protection for IP and Technology Transfers


 

 
    Core Synthetic Technologies
 

 

 

Spectrum has extensive experience in the following chemical transformations, utilizing a toolbox of main-group, inorganic, and organometallic reagents and catalysts to afford the most efficient and cost effective route to meet our customer’s individual requirements. Spectrum Scientists also optimize our chemical transformations with an eye to sustainable green chemistry and minimization of waste streams.


Acetylation
• Alkylation
• Amination
• Asymmetric Synthesis
• Catalysis
• Chlorosulfonation
• Condensations
• Diazotization
• Diels-Alder
• Esterification
• Friedel-Crafts
• Halogenation
• Heterocycles
• Hydrogenation
• Hydrolysis
• Main-Group Chemistry
• Organometallics
• Oxidation
• Reduction
• Sulfonation
Suzuki Coupling