Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY DESCRIPTION

Markets Served
Pharma and bio-pharmacuetical companies, with a focus on virtual, small, and mid-sized drug developers.

COMPANY BACKGROUND

Date Founded 1968
# of employees 310
Annual Revenues N/A

If you're looking for a relationship with a partner who has the capabilities you expect from a mega-CRO, but are tired of vying for the attention you deserve, consider ABC Laboratories. We bring four decades of analytical expertise to all stages of drug development, plus an uncommon commitment to customer service. At ABC, we understand that getting you to the next milestone requires more than good science—it takes regulatory knowledge, operational excellence and a “can do” culture. We look forward to earning the opportunity to become your analytical laboratory of choice!

FACILITIES

ABC Laboratories celebrated its 40th anniversary this year with the opening of a new, 90,000 square foot pharmaceutical development facility. Located in the Discovery Ridge Research Park in Columbia, Missouri, the facility was designed for optimal sample flow, operational efficiency, safety and regulatory compliance. The facility has four main laboratory modules: two for CGMP Analytical support and one for GLP-compliant, DMPK and Bioanalytical services.

SERVICES & CAPABILITIES

Preclinical/Clinical (GLP): Expert radio-labeling synthesis (including CGMP 14C API supporting human mass balance), in-vitro and in-vivo DMPK; method development and validation; expert quantitative analysis of drug and metabolites; dose formulation and bioanalytical testing.

CMC & QC Solutions (CGMP): Analytical support and quality control for API and drug product; release and stability-indicating methods; trace impurity identification and characterization, extractables/leachables programs; stability programs and release testing

Environmental Assessments: ABC draws on 40 years of experience identifying and quantifying test substances in soil, water, complex media and biological tissues to deliver the complete package of environmental assessment tests required by the FDA, as well as radiolabeling synthesis to support specific study requirements