Plough Center Personnel
Frank P. Horton II
Mr. Horton has extensive experience in the development and validation of steam sterilization and dry heat processes as well as the validation of lyophilization processes. He has more than 20 years’ experience in training personnel in aseptic processing of parenteral dosage forms in both industry as well as academia. He is a validated fill team member and is involved in all aspects of contract manufacturing for Phase I clinical trials. He is also involved in educating pharmacy students in aseptic technique and processing. He is a lab instructor in the Comprehensive Industrial Course in the Preparation of Parenteral Products teaching steam sterilization cycle development and validation. Additionally, Mr. Horton is responsible for all the day to day operations of the Plough Center for Sterile Drug Delivery Systems and his previous industry experience makes him a valued member of the PCSDDS team.
Pavan Balabathula, PhD
Senior Research Specialist
Dr. Balabathula has more than 5 years of experience in research, training and manufacturing
of sterile dosage forms. He conducts research and analytical studies for development
of novel drug products according to federal guidelines which includes pre-formulation
studies and formulation development of sterile dosage forms for new chemical entities
for pre-clinical & Phase I studies. He develops & validates HPLC assays for drug product
testing & stability testing. He is a validated team member for sterile manufacturing
of parenteral products under cGMP for pre-clinical and Phase I & Phase II clinical
studies. He is involved in proper documentation of Batch Production Record’s for finished
products. He trains professionals from pharmaceutical industry & regulatory agencies
in the Comprehensive Industrial Course in the Preparation of Parenteral Products.
He is also a lab instructor for Pharm.D. students and trains them in aseptic techniques.
Senior Research Assistant
Plough Center for Sterile Drug Delivery Systems
Stornes has more than 33 years of experience at the University of Tennessee Health Science Center, with more than 25 of those years in the former Parenteral Medications Laboratory - now Plough Center for Sterile Drug Delivery Systems. She has over 25 years experiience in instructing/training pharmaceutical industry personnel in procedures used in aseptic preparation and processing of sterile product. She is a validated team member of the sterile parenteral products manufacturing team. She is responsible for environmental monitoring and all other routine monitoring and testing required for the operation of the Plough Center for Sterile Drug Delivery Systems cleanroom facility. She also has the role of research support in the Plough Center.
Mr. Nguyen has over 15 years of technical experience in a pharmaceutical and manufacturing environment with an emphasis on research & development, laboratory facility space and requirements, quality control, and production. At GTx Inc., he has maintained and overseen assigned laboratory equipment and facilities in compliance with all applicable regulatory requirements (EPA, OSHA, and FDA) which include equipment calibration and maintenance and environmental monitoring. He has extensive knowledge in qualification and validation, industry specific laboratory software & hardware, and GxPs regulatory safety measures. He also provided technical guidance in area of expertise as well as drafting and review of technical GxPs documentation such as investigations and SOPs. He brings a wealth of knowledge and experience on regulatory requirements to the GMP facility at UTHSC.
Bivash Mandal, PhD
Senior Research Specialist
Dr. Mandal has more than 5 years of experience in Research & Development, Manufacturing, and Quality Control of parenteral drug products for preclinical and clinical trial supplies at the Plough Center. He has pharmaceutical industry R & D experience in formulation, process development and scale up. He is a validated fill team member of the cGMP manufacturing facility at Plough Center. He has experience in formulation, aseptic fill-finish operations, filtration, lyophilization, HPLC, stability studies, and sterility testing. He has expertise in the environmental monitoring techniques for the cleanrooms. He has over 8 years of academic research experience in nanotechnology based parenterals for malignant and infectious diseases. He instructed Pharm D students on aseptic processing and sterile compounding techniques. He has a number of scientific journal publications, US patent application, and conference presentations. In November 2014, he received the prestigious AAPS Graduate Research Award in FDD sponsored by Bristol-Myers Squibb Company.
Nivesh K. Mittal, PhD
Senior Research Specialist
Dr. Mittal has more than five years research experience in the field of nanotechnology based targeted drug delivery systems, development of lyophilization cycles for parenteral drug products, and pre-formulation and formulation development of poorly soluble drug molecules. He has a number of publications including a pending patent for liposomes for hematological malignancies. He has industrial experience in the development of novel drug delivery systems and is a validated fill team member for the sterile manufacturing of aseptic drug products under cGMP for pre-clinical and Phase I and Phase II clinical studies. He trains professionals from industry in the development of validated HPLC assay’s for analytical and stability testing of parenteral drug products. He also instructs on how aseptically manufactured drug products can be evaluated for their sterility. Dr. Mittal’s experience and expertise of formulation, manufacturing and analysis of sterile drug products make him an essential part of the team at The Plough Center.