About the Plough Center
The emergence of The Plough Center as a stand-alone entity within the UTHSC Memphis campus is the result of a cooperative effort between The University of Tennessee and many private corporations who have special interests in injectable medications and their generous investments.
The Plough Center for Sterile Drug Delivery Solutions, formerly known as the Parenteral Medications Laboratories (PML) started over 50 years ago to educate and train students and professionals in sterile product preparation, develop a basis for research into parenteral medications, and provide service to the pharmaceutical industry and others.
The Plough Center contains a core processing cleanroom settings with supporting critical quality attributes in compliance with ICH and US-FDA guidelines and regulations designed for aseptic parenteral dosage form manufacturing as well as laboratories for academic instruction. It provides the capacity for small-scale manufacturing of sterile preparations. The faculty and staff associated with the Plough Center Program offer following services in the development of sterile dosage forms, manufacture sterile formulated parenteral products for preclinical and clinical investigation and that include,
- Discovery Projects
- Patient focused business models
- Pre-formulation studies
- Reverse formulation engineering
- Analytical services that include method development and method validations
- Quality control testing and product release
- Comprehensive pharmaceutical aseptic training courses
- Research collaborations within campus and off-site collaborations
- NanoSpace platform: Nanosuspensions, nanoemulsions, micronized forms and liposomal encapsulation technology experts
- Preclinical sterile and non-sterile dosage manufacturing
- Operations fully in accordance with ICH and cGMP guidelines
- All types of parenteral sterile dosage forms (SVP vials, lyo forms, syringes & ampoules)
- Tech transfer of established project and site-change project implementations
- Sterilization and Lyo-cycle validations
- QbD process optimizations
- Feasibility and engineering batches
- Proof-of-concept scale-up batches, registration lots and validations
- Clinical and commercial support
- Generic, orphan drug and innovative therapeutics
- Scaled-up pharmacy compounding
- Semi-solid capabilities
- Product stability studies (short-term/long-term)
- Adaptable business model to client needs