History
The Plough Center for Sterile Drug Delivery Solutions, formerly known as the Parenteral Medications Laboratories educates individuals in sterile product preparation, develop a basis for research into parenteral medications, and provide service to the pharmaceutical industry and others. The Plough Center operations initiated over 50 years ago as a non-profit organization managed by University of Tennessee Health Science Center (UTHSC). There two Plough center locations within UTHSC campus at Memphis. The Plough Center is the result of a cooperative effort between The University of Tennessee and many private corporations who have special interests in injectable medications. Accordingly, private industry has generously contributed money and equipment to make these laboratories possible. The Laboratories contain a core-processing complex designed for academic instruction as well as for the processing of sterile dosage forms. It provides the capacity for small-scale manufacturing of sterile preparations. The faculty and staff associated with the Plough Center Program offer formulation services in the development of sterile dosage forms, manufacture small lots of products for clinical investigation, develop and determine stability of new sterile products, and apply research projects in parenteral medications technology.
The Plough Center facility located at 3N Dunlap Street at the corner of Dunlap Street and Madison Avenue is focused in discovery formulation, formulation development, formulation research & development and to support preclinical and very early Phase I clinical trial materials (CTM). The new Plough Center facility is located at 208 S Dudley Street is capable of supporting all stages of clinical trial programs or even commercial volumes of niche sterile drug products. Both cleanroom facilities operate under cGMP conditions. The Plough Center at two locations together contain approximately 3,900 sq. ft. GMP-compliant core processing facility along with 9000 sq. ft. of research and training labs designed for the development, preparation, production and testing of small volume parenteral (SVPs). The core of the aseptic area of the new cGMP facility is equipped with modern glovebox/isolator/tunnel technology for compounding and fill-finish operations and the old cGMP facility has an ISO 8 area for compounding and an ISO 7 area with ISO 5 laminar flow hoods for aseptic fill-finish operations.
The multifold future missions of Plough Center include, supporting discovery stage programs, preclinical and IND, ANDA, NADA, 505 (b) (2) and orphan drug-IND enabling clinical formulations. In parallel, Plough Center is also passionate to train and educate scientific community by continue offering its highly acclaimed “Comprehensive Industrial Course in the Preparation of Parenteral Products”. This one week-long course consists of both lectures from reputed speakers from respective files covering pharmaceutically relevant topics and hands-on training in true cleanrooms conditions how to perform sterile manufacturing following cleanroom behaviors. This is the one and only hands on training course conducted today in true cleanroom environment following pharmaceutical settings.