Longmont, CO, USA

Overview

Our Longmont location specializes in the early development of small molecule pharmaceutical products in a fully integrated drug substance and drug product facility. We offer development and manufacturing services to enable IND submissions. Frequently working on molecules right out of discovery, we have process chemistry expertise to design and develop synthetic routes for scale-up into two non-GMP production suites with a capacity of up to 200 L. Four cGMP drug substance production suites with capacity up to 200 L are available to produce drug substance to support clinical trials. Drug product pre-formulation and formulation development is performed on the bench or within our walk-in, non-GMP manufacturing hood. Four fully cGMP compliant drug product manufacturing suites with unidirectional personnel/material flow and supplied by single pass air are available for clinical trial manufacturing and packaging. Dosage forms include powder in capsule, powder in bottle, formulated capsule, and formulated tablet with associated packaging and labeling.

Our site is also equipped to handle potent compounds up to SafeBridge 3A for both drug substances and drug products. The facility also has a research license for the handling of controlled substances.

In addition, we offer both comprehensive analytical support for product development projects as well as standalone analytical services to our clients. This includes method development, validation, and cGMP/non-GMP testing and stability. We are proud to offer a fully equipped materials characterization lab capable of providing testing of elemental impurities by ICP-MS, XRPD, particle size, LC/MS/MS, DSC, TGA, and TGA-GCMS.

Facility Details

• Process chemistry development laboratories (up to 50 L)
• 2 non-GMP API production suites (up to 200 L)
• 4 cGMP API production suites (up to 200 L)
• Preformulation and formulation development non-GMP production space
• 4 cGMP ISO 7 compliant DP Production suites with single pass air and unidirectional personnel/material flow
• Large R&D analytical development and QC laboratories
• FDA-inspected

For our Longmont site’s registration certifications see our forms and certifications.