Mr. Guardino is currently the founder and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical and Biotechnology industries with microbiological compliance and concerns. In this role Mr. Guardino has gained significant experience in microbial contamination and control issues for positron emission tomography (PET) drugs, as well s PET drug GMPs. Prior to this role Mr. Guardino served as the Director of the Microbiology Lab for AAIPharma Services Corp. where he oversaw a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. In this role Mr. Guardino interacted with many clients and client companies offering consulting and testing services. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years and supervised an industrial microbiology lab for five years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span 20 years. Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological testing requirements; release and stability requirements and testing; down-stream / purification process contamination and control for biotechnology products; disinfectant qualification; water system and environmental validation. He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including training for FDA CDER and CBER branches.
- Guardino, Robert F., Early History of Microbiology and Microbiological Methods in UEncyclopedia of Rapid Microbiological MethodsU, Michael J. Miller, Ed., Davis Healthcare International Publishing, LLC, 2005.
- Monds, H. and Guardino, R., Stability Program with Microbiological Points to Consider Throughout Drug Development in Microbiology in Pharmaceutical Manufacturing, Richard Prince, Ed., 2nd Edition, Davis Healthcare International Publishing, LLC, 2008.
- Guardino, Robert F, and Jones, Kevin, Selection of Sterility Test Isolators, Contamination Control, Summer 2007.