Advanced Clinical Diagnostics, Inc. Labs. (ACD, Inc.) was started in 1987 by Dr. Thombre as a small basement operation. The current facility now occupies about 22,000 square feet and is solely owned and occupied by ACD, Inc. Labs.

Activities at this site involve manufacture, production, research and development, shipping, repository activity for various cell lines and microorganisms, research based work for various biotechnologies, pharmaceutical and biomedical related projects, animal facilities and some warehouse space. For many a years our main production has consisted of numerous cell lines and cell-based assay systems manufactured under F.D.A. regulations (510 k), such as GMP and GLP.

We have experience with custom research in various biological, clinical, biotechnology, pharmaceutical, toxicology and medical device testing services, the production of numerous monoclonal and polyclonal antibodies for ELISA-based rapid diagnostic products, large scale production of numerous viruses, Chlamydia, microorganisms, fungi, toxins of biological origin, bacterial and surface antigens, mycobacterium and PPD production, tissue and organ cells and cell lines from primary organs, both malignant and normal. Our services include tests for sterility, growth promoters, sterilization monitors, microbiological and viral organisms, endotoxins, antimicrobial preservative effectiveness, germicidal and disinfection effectiveness, antibiotic preservative effectiveness and monitoring of active pharmaceutical ingredients. In vivo and in vitro toxicological testing on small and large animals for various medical devices is available.

ACD, Inc.'s cell line production facilities include vertical laminar flow walk-in hoods with positive pressure, such that sterile cell culture work, filtering, filling, automatic pipetting, and capping can be performed. Numerous Bio-safety cabinets and Laminar flow hoods, large numbers of CO2 and regular incubators, large Ultra low freezers, numerous liquid nitrogen containers with varying capacity with an alarm system for low nitrogen levels, ultra and high speed centrifuges, numerous table top refrigerated or non refrigerated centrifuges, lyophilizers, autoclaves and milli-Q water systems are also included.

We have fully equipped shipping facilities for overnight, next day air shipments, with years of experience in shipping both frozen (shipped with dry ice) and live cells at ambient temperature within the US and around the world.

As part of the several 510(k) and the numerous research projects we have worked on, we have developed our cell bank and a mini repository for various microorganisms.

The quality of our products and services is maintained by adhering to GMP and GLP standards; in addition, our clean room facility is HEPA filtered, i.e. 0.3 µ or larger particles are removed. These areas are monitored for bioburden. Our particle count results indicate that these areas are less than class 100. Personnel are required to wear gloves, hair covers, face masks, shoe covers and lab gowns when working. Batch history records are maintained for each lot produced. Each lot of manufactured materials is routinely tested for all criteria set for QC requirements. Good record keeping is strictly followed, and our facility is subject to FDA inspections.

Dr. P. Thombre obtained his Ph.D. (Cancer immunotherapy) in Immunobiology from Cleveland State University , Cleveland , Ohio , and completed a number of advanced courses at nearby Case Western Reserve University . He worked at the University Hospital (Clinical virology and infectious diseases testing Lab), and at the Cleveland Clinic Foundation (immunopathology). He attended medical school at the Medical College of Ohio, Toledo , Ohio . After deciding not to pursue an M.D. degree, he worked at Case Western Reserve University and as a consultant to companies in the biotechnology industry. In 1987, he started Advanced Clinical Diagnostics, Inc.

Other Investigators and additional personnel are available to provide backup technical help, as such needs may arise. With the available staff ACD. Inc. Labs has maintained, expanded and improved upon on a small humble operation, so as to bring about an efficient, smooth transition and to maintain a well-developed system to track, procure, archive, and control inventory to distribute reagents. Our personnel are dedicated to provide the best of services and products.

With the above personnel, equipment, facilities and experience, ACD, Inc. is fully capable and ready to serve the scientific community not just as a service, but with thorough understanding and a strong sense of mission.