About Michael Fines of MitWellness
Michael is a seasoned executive in the areas of Microbiology, Biology and Chemistry and serves as the Chief Science Officer for MitWellness. While working as Microbiology Laboratory Teaching Assistant at The University of Missouri and simultaneously enrolled in molecular and cell biology courses, Michael perfected his own versions of plant cell culture techniques at home with the idea and intent that he could develop a commercialized version of plant callus stock for commercial production of food stuffs and supplies. He also worked part time with The Department of Defense on an Engineering STEP Program where he got his first taste of strict compliance as well as interaction with other departments including, but not limited to, The Environmental Protection Agency (EPA) and The U.S. Fish and Wildlife Service. He often volunteered to participate in wildlife and water conservation activities for The U.S. Army Corps of Engineers.
Almost immediately after receiving his Bachelor of Science Degree in Biology and Chemistry, he spent almost ten years as Scientist of Biopharmaceutical Characterization at Catalent Pharma Solutions (formerly Aptuit). Michael developed, transferred, and optimized ELISA, (Enzyme-Linked Immune Asaay) electrophoretics (SDS-PAGE, IEF, Capillary E and iCE), liquid chromatography and Polymerase Chain Reaction techniques to characterize large molecule drugs, mostly monoclonal antibodies, in Phases I through III of development. It is here that he gained my first experience with validation activities and developed an understanding and appreciation of statistical analysis.
Prior to working for MitWellness/TNT Manufacturing, Michael worked in early through commercial phase analytical chemistry of small molecule drugs in local start-ups such as Pharmaceutical Research Associates (PRA now ICon) quality laboratory and local Lee’s Summit contract research organization, Excite Pharma Services. He authored and executed protocols for the initial qualification of newly built ISO 5 through ISO 8 cleanrooms for the sterile manufacturing and packaging of various dosage forms of small molecule drugs including parenterals in vials. This was as part of authorship and completion of his contribution to The Site Master Validation Plan giving qualifying status with the FDA to launch Excite’s sterile manufacturing facility in Tonganoxie, Kansas. At that time, Michael belonged to The Parenteral Drug Association (PDA) and hosted with Excite Pharma Solutions The PDA Annual Training and Certification at the Tonganoxie facility where cGMP quality professionals from around the USA and abroad attended to update their standing with Food and Drug Administration (FDA) and Medicines and Healthcare Regulating Agency (MHRA, Europe) to manufacture injectable drugs with safety, quality, identity, potency, purity and sterility at the forefront of their quality engineering. Within PRA/ICON, Michael optimized capsule and oral liquid dose formulations, developed analytical methods of testing and oversaw microbial control of pharmacy production of formulations for clinical trials as performed by pharmacy technicians.