Spectrum Overview
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
From DROPS to DRUMS<br />
Introduction<br />
to the<br />
<strong>Spectrum</strong><br />
Experience
<strong>Overview</strong><br />
<strong>Spectrum</strong> is a global chemical manufacturer<br />
supplying many market segments:<br />
Specialty<br />
Chemicals<br />
API<br />
&<br />
Pharma<br />
Food<br />
Personal<br />
care<br />
CMO<br />
US company, private owned.<br />
Founded in 1971, <strong>Spectrum</strong> Chemicals is a manufacturer<br />
and distributor of fine chemicals and laboratory products<br />
with the largest selection of monograph chemicals for<br />
manufacture available from a single source.
Global Positioning<br />
Manufacturing & distribution sites:<br />
• Los Angeles, CA<br />
• New Brunswick, NJ<br />
• Shanghai, China<br />
Sourcing & market presence:<br />
• NAFTA & LATAM<br />
• China<br />
• India<br />
• Europe<br />
All US production<br />
facilities are ISO<br />
9001:2008 certified, FDA<br />
registered and operate<br />
under current Good<br />
Manufacturing Practices<br />
(cGMP).
Integrated Quality (IQ TM ) System<br />
• Dedicated cGMP Facilities<br />
• FDA-registered and inspected facilities in California<br />
and New Jersey<br />
• Operate under SOPs based on ISO 9001:2008<br />
standards & FDA cGMP guidelines<br />
• Experienced in FDA, DEA, USDA, DOT and other<br />
Government Agency Requirements<br />
• Traceable documentation always in place<br />
• Changes management and change notification<br />
• Full protection of IP and technology transfer
Specialty<br />
Chemicals<br />
Core Capabilities<br />
from drops to drums<br />
Biochemicals<br />
Dehydrated Culture Media<br />
Accumedia Serology &<br />
Immunology<br />
Bioorganics<br />
Biotech Reagents<br />
Nucleic Acids Isolation<br />
Reagents<br />
Amino Acids<br />
Sugars<br />
Organics<br />
Inorganics<br />
Metals<br />
Metal Salts<br />
Precious Metal Compounds<br />
Rare Earth Salts<br />
Organometallics<br />
Pharmaceutical Intermediates<br />
Active Pharmaceutical<br />
Ingredients<br />
Excipients<br />
Fine Chemicals<br />
Nutraceuticals<br />
Cosmetic Ingredients<br />
Life Science<br />
Biotech Grades<br />
Electrophoresis Products<br />
Chromatography<br />
DNA Ladders & Markers<br />
High Purity Laboratory Reagents<br />
Anhydrous Solvents<br />
Biological Buffers<br />
Chemical Grades<br />
ACS<br />
USP / NF<br />
BP, EP, JP<br />
FCC<br />
Technical<br />
Custom Testing<br />
Controlled Substances
Specialty<br />
Chemicals<br />
Core Capabilities<br />
Specialty chemicals for R&D and manufactory, buffers,<br />
solutions, biological,cGMP chemicals and organics.<br />
• Over 45,000 chemicals<br />
• More than 500 additional products added annually<br />
Available in laboratory sizes, bulk or custom production<br />
Bio-tech products (e.g. serum, antibodies, enzymes, microbial media)<br />
Analytical equipment and supplies
Core Capabilities<br />
API<br />
&<br />
Pharma<br />
Personal<br />
care<br />
• USP/NF, FCC, BP, EP, JP grade chemicals, buffers,<br />
cGMP standard solutions, high purity and sterile water<br />
(Corning®)<br />
• APIs & Excipients<br />
• Cosmetics Nutritional Personal Care Products<br />
• Formulation development and testing<br />
• cGMP final forming and packaging<br />
Food<br />
• Food & Beverage graded Products<br />
• Dietary supplements<br />
• Kosher Certified Materials
CMO<br />
Core Capabilities<br />
Fine Chemicals and Intermediates (Bulk)<br />
• Consistent quality from discovery through<br />
commercialization<br />
• Competitive and cost<br />
effective sourcing<br />
• Certified products<br />
following US and FDA<br />
standards every step of<br />
the supply chain
CMO<br />
Core Capabilities<br />
from drops to drums<br />
Custom Synthesis & Contract Manufacturing<br />
More than 40 years of experience as a chemistry outsourcing<br />
partner to the pharmaceutical and biotechnology industries.<br />
Highly qualified staff of Ph.D. chemists will follow your project<br />
from early stage discovery through commercialization,<br />
promoting “good karma chemistry” rules:<br />
High yield, short batch-cycle-times<br />
Run reactions as concentrated as safely possible<br />
Avoid highly diluted steps<br />
Minimize waste: by products recovery, solvents recycle (if possible)<br />
Avoid hazardous and critical/expensive raw materials<br />
Ensure environmental friendly processes
CMO<br />
Core Capabilities<br />
from drops to drums<br />
Areas of Expertise<br />
• Synthesis of new chemicals<br />
• Multi-Step Synthetic Routes<br />
• Chemical Process Development<br />
• Proof of concept<br />
• Process development & scale up<br />
• Technology Transfer<br />
• Analytical method development<br />
& validation<br />
• Contract manufactory<br />
• cGMP production of clinical<br />
trial materials<br />
• cGMP Manufacture of API’s<br />
• Controlled substances<br />
manufacture (DEA II-V)<br />
• Customized Formulation<br />
• Customized Packaging
CMO<br />
Core Capabilities<br />
from drops to drums<br />
Equipment Range cGMP<br />
• Multi-Purpose Glass-Lined Reactors from 20 to 500 Gallons<br />
• 50, 150, 200, & 300 gallon reaction vessels<br />
• 300 gallon hydrogenation vessel<br />
• Temperature range from -15°C to 250°C<br />
• High-Pressure Autoclave Capacity<br />
• High-Efficiency Distillation and Fractionation<br />
• High-Vacuum and Inert Atmosphere<br />
• Vacuum drying oven<br />
Additional capacity<br />
• Multi-purpose hasteloy reactors<br />
from 500 to 2000 gal<br />
• Tanks 200-3000 gal<br />
• Dryers SS body/ Glass tray<br />
• Centrifuges SS 316
Analytical Support<br />
• Dedicated labs and experienced staff in New Jersey,<br />
California, and China<br />
• State of the art analytical equipment (ICP/MS, GC,<br />
HPLC, AA, FTI-IR etc.)<br />
• China Lab is ISO 17025 (Reference Lab)
<strong>Spectrum</strong> Additional Services<br />
• Change Control<br />
• Batch Traceability<br />
• Lot Sequestration<br />
• Supply Chain Verification<br />
• Regulatory Compliance Support<br />
• Technical Product Support<br />
• Country of Origin Certification<br />
• Safety Data Sheet<br />
• Certificate of Analysis (web site)<br />
• Allergen Statement<br />
• BSE/TSE Statement<br />
• Kosher Letter<br />
• NAFTA Certificate of Origin<br />
• ICH stability studies<br />
• Submission & maintenance<br />
of DMF files<br />
• Support for IND, NDA and<br />
ANDA filing
800.610.7006<br />
customsynthesis@spectrumchemical.com<br />
Annalisa Tomba Gorski<br />
Director of Specialty Chemicals<br />
Tel: (310) 516.8000 Ext. 5787<br />
Cell: (971) 998.0118<br />
email: atomba@spectrumchemical.com<br />
Visit us at <strong>Spectrum</strong>Chemical.com
Change language