AB BioTechnologies, a privately-held pharmaceutical contract service provider, is expanding its services to include pre-clinical manufacturing at its Bloomington, IN, facility.

New drug candidates must undergo pre-clinical studies to establish a toxicology profile and assess the safety, efficacy and bioactivity prior to filing an investigational new drug (IND) application. AB BioTechnologies has the capabilities and experience to perform the early-stage development work—formulation, process, and analytical—through good laboratory practice (GLP) manufacturing to support pre-clinical/toxicology studies.

“AB BioTechnologies is excited to announce our newest service offering, GLP manufacturing,” said Jeff Schwegman, founder and chief executive officer, AB BioTechnologies. “This is a natural progression for our company, given our existing pharmaceutical development capabilities. We are constantly looking for ways to make outsourcing easier for our clients and feel this expansion will help streamline the path to the clinic.”

AB BioTechnologies will perform GLP manufacturing at their existing facility. Implementation of processes is underway and they anticipate successful completion of a third-party audit by the end of Q3 2016.