March 30, 2020
A look back at key milestones in its history of shaping in vitro testing in the OINDP industry
Hudson, MA, March 30, 2020 – Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, today announced its 25th Anniversary and is taking this opportunity to look back at the key milestones in its history of shaping in vitro testing in the OINDP industry.
A rich and eventful history
Proveris Scientific Corporation was founded on March 30, 1995, as Image Therm Engineering, Inc., by inventor Dino Farina to innovate in vitro testing solutions for difficult to characterize orally inhaled and nasal drug products (OINDPs) critical to the treatment of lung disease, chronic allergies, and central nervous system disorders. With the goal to facilitate the understanding of the complex relationship between formulation, device, and human usage and the need for precise, consistent dose delivery to patients, Mr. Farina and his team set out to develop a range of tools for pharmaceutical companies and regulatory agencies to provide important early guidance on how to properly characterize these complex combination drug products.
By 1999 the company’s first patent application was filed for its spray pattern and plume geometry technology, and two years later in 2001 the patent application for its automated actuation technology was filed. These inventions would serve as the launch point for the company’s SprayVIEW® Measurement System and Vereo® Automated Actuators, today’s gold standards for OINDP drug product characterization.
In 2004, the company launched its laboratory services business focused on method development, optimization of actuation parameters, and device and formulation screening using its Ergo™, Vereo, and SprayVIEW technologies. In 2005, it released the Indizo® Automated Nasal Spray Collection System for pump delivery and spray content uniformity testing of various types of nasal spray products. In 2006, the company’s flagship software platform, Viota®, was launched to support its growing customer base with a focus on meeting demanding requirements for ease of use and regulatory compliance. At year 10 in 2006, having made a significant mark in the OINDP community, Image Therm Engineering, Inc., adopted a new name – Proveris Scientific Corporation – to demonstrate its focus and dedication to a science-based approach of “testing the truth.”
Proveris continued to respond to market needs with the introduction of the Kinaero™ High-Throughput pMDI Fire Down System in 2018, a solution for through-life testing workflow which precisely automates shaking and actuation of up to 10 devices simultaneously for uniform dose delivery. In 2019, the contract test services business, Proveris Laboratories, released INVIDA™ In Vitro Inhalation Drug Analysis platform to study aerosol performance under human-realistic breathing conditions employing physiologically relevant models of the human respiratory tract. In addition, Proveris has extended the application of the SprayVIEW system to include plume front velocity and evaporation rate measurement capability in accordance with recent FDA guidance referring to alternative approaches to demonstrate bioequivalence in metered dose and soft mist inhalers.
A pioneering role in the market
Proveris has served a pioneering role in the OINDP market and enabled innovator and generic drug development by coupling innovative instrumentation with software which demonstrates compliance with 21 CFR Part 11. It prides itself on being a cooperative, committed, and responsive partner that measures its performance against the success of its customer’s products.
The company’s collaboration with regulatory agencies began in September 2002, when a SprayVIEW system was sent on loan to the St. Louis, Missouri, facility of the U.S. Food and Drug Administration (FDA) for an independent evaluation of the technology. Just seven months later, in April 2003, with technical inputs from Mr. Farina, the FDA released a new Draft Guidance to Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (UCM070111). This included an explicit reference to key aspects of technology at Proveris, including non-impaction spray pattern and plume geometry measurements based on laser light sheet illumination using high-speed imaging, as well as the use of automated actuation to mimic human usage. In addition, the FDA purchased their first Proveris actuator for a separate study they were performing at the time.
Proveris has extended this model as it established new relationships with regulators in China and other major countries around the world. In 2014, Proveris installed the first instrument purchased by the China National Institute of Food and Drug Control (NIFDC) at its Beijing facility. In 2019, the first Proveris instrument was purchased by the Shanghai Institute for Food and Drug Control (SIFDC) in Shanghai, China, marking the beginning of testing services for customers in Asian markets.
About Proveris Scientific
Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving new technology development for high performance spray characterization, capture, and analysis, while leveraging its expertise, experience, and core technologies. With customer success as its central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” which include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of top spray and aerosol drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, China NMPA (National Medical Products Administration, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TUV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.