ABC Laboratories

ABC Laboratories Overview

Company Description

When developing drugs, we all know that sound, regulatory-compliant science is a must-have. But at Analytical Bio-Chemistry Laboratories, we understand that it’s the business side—the processes, the systems, the communication—that make or break a CRO-sponsor relationship. In recent years, ABC Laboratories has invested heavily in people, processes, facilities and system—reinventing itself to deliver the performance-driven relationship you expect!

Markets Served
Pharmaceutical and bio-pharmaceutical companies, animal health and medical devices

Major Products/Services

Biotech Services (Large Molecule)
Pre-IND immunoassay method optimization and validation
Biomarker analytical development and validation
IND and clinical bioanalytical support
Method feasibility, development,validation and transfer
ICH Stability testing of bulk and finished products for IND/CTA/NDA submissions
Biopharmaceutical product characterization
Biopharmaceutical product testing
Batch release testing
Forced degradation studies
CMC support for regulatory submissions

Pre-Clinical Development Services
In-vitro and in-vivo DMPK
Metabolite ID and quantification
Toxicology dose formulation analysis
Method development & validation
Toxicokinetics
Pharmacokinetic & bioavailability studies

Clinical Development
Method Development and Validation
Human Mass Balance
Dose formulation and bioanalytical testing/sample analysis Phase I-IV
Bioequivalency testing
Drug interference testing
Clinical supply kits

Chemistry, Manufacturing & Controls
Analytical method development/forced degradation
Method validation
Impurity ID & characterization
Analytical support reformulation/formulation
Raw material, component testing/COAs
Reference standard qualification
ICH stability programs
Extractables/leachables programs
Batch release testing
Bioequivalency testing

Custom Synthesis & Radiolabeling
Custom synthesis (API)
Radio-label synthesis (CGMP and non-CGMP)
Stable-label synthesis
Reference standard synthesis and COAs

Environmental Assessments

Facilities
ABC Laboratories opened a new, 90,000 square-foot pharmaceutical development facility in September 2008. Located in the Discovery Ridge Research Park in Columbia, Missouri, the facility was designed for optimal sample flow, operational efficiency, safety and regulatory compliance.