Array specializes in rapid
development of novel, scaleable processes,
custom synthesis and clinical manufacturing.
Our world-class scientific team addresses
a critical bottleneck in accelerating
drug discovery through the efficient production
of material for preclinical and early
clinical studies.
Facilities,
Instrumentation & Support
- State-of-the-art research center
- cGMP production facility with validated
utility systems including HVAC, deionized
water, chilled glycol and compressed
air
- Three cGMP kilo-labs including fixed
100-L equipment
- Class 10,000 booth with drying and
packaging capabilities
- Milligram to Kilogram scale
- Analytical capabilities including
DSC, TGA, HPLC, SFC and NMR
- QC/QA support meeting all cGMP requirements
for API production
- 21 CFR Part 11 compliant laboratory
equipment and instrumentation
World-Class
Process Chemists
Our process chemists have a track record
of success in re-engineering complex medicinal
chemistry routes and creating novel processes
for the production of clinical candidates.
Our efforts reduce the number of steps
in complex medicinal chemistry processes
and improve yields to allow for the rapid
synthesis and scale-up of drug candidates.
Comprehensive Analytical Support
Our experienced analytical chemists develop
and validate analytical methodology to
support the API synthetic campaign. Our
team uses state-of-the-art, qualified
and validated instrumentation to assure
cGMP compliance for the intermediates
and API testing.
Quality Assurance & Regulatory
Our quality assurance and regulatory team
ensures that all cGMP API collaborations
are performed under FDA requirements.
The certified team performs both internal
and external auditing to comply with all
applicable national and international
regulations.
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