Proveris Scientific announces its laboratory compliance with cGMP

Proveris Scientific announces its laboratory compliance with cGMP (Current Good Manufacturing Practices)

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced it is expanding its contract test services laboratory to allow for compliance with cGMP (current Good Manufacturing Practices). This achievement demonstrates Proveris Scientific’s continued pursuit of excellence and mission to help its customers bring optimally-performing orally inhaled and nasal drug products (OINDP) to patients around the world.

Proveris Scientific’s cGMP compliant laboratory operation will now offer submission grade contract test services, as well as development projects, release testing, and stability studies. Compliance with these practices offers customers assurance that test services performed on their drug products meet the highest of quality standards for regulatory submission. The company will also continue to maintain certification to ISO 9001:2015 for both products and services.

The quality system meets both the FDA and EMA cGMP regulations and guidance documents, ensuring systems are in place covering critical areas. These areas include instrument and system validation, personnel training and monitoring, document controls, and control of processes and facilities. It also includes all guidelines relating to process validation, comprehensive corrective and preventive action (CAPAs), vendor qualification, and best laboratory practices, as well as design and management reviews.

Proveris Scientific is the industry leader in providing spray characterization products and technologies for the OINDP market and are experts in spray and aerosol product evaluation. The company has been manufacturing instruments for over twenty-five years and performing OINDP test services for over fifteen years.

“We are excited to elevate our laboratory from its humble beginnings over 15 years ago as the genesis for countless development projects with our customers around the world to the level required for cGMP compliance. This achievement confirms our commitment and continued investment in the OINDP arena and to accelerating the development efforts we are involved in with our customers around the world,” commented Founder and CEO, Dino J. Farina.

“As a testament to our high standards of excellence, we are proud to add cGMP compliance in our laboratory services offering as another milestone in our history,”

commented President, Chip Leveille. “I am very proud of our team here, who make dedication to quality products, services, and the success of our customers a daily focus. It is a great feat for all of us to see our quality culture culminate into this achievement.”

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. The company operates under an ISO 9001:2015 certified quality management system and its laboratory operations are cGMP compliant.

 

Proveris Scientific announces joint scientific poster presentation with H&T Presspart at RDD 2020 Digital Conference

Proveris Scientific announces joint scientific poster presentation with H&T Presspart at RDD 2020 Digital Conference

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that on April 26 at RDD 2020 Digital Respiratory Drug Delivery Conference, Proveris will present a joint poster with H&T Presspart, Blackburn, Lancashire, UK entitled, “The Effect of Ethanol Concentration on pMDI Evaporation Fraction.”

The subject of the study is introducing a technique to quantify the evaporation fraction using a novel measurement method applied to a time-synchronized image sequence of the aerosol spray from pressurized metered dose inhalers (pMDIs). In order to demonstrate the effectiveness of the technique, the study used non-commercial pMDI product samples with three different ethanol concentrations, but identical devices provided by H&T Presspart. The results show the higher the ethanol concentration, the lower the evaporation fraction.

The FDA May 2019 product specific guidance for beclomethasone dipropionate delivered by MDI lists evaporation rate of the aerosol as an in vitro characterization study that is representative and/or predictive of the clinical effect in the deep lung. Due to the aerosolization mechanism of pMDI products, aerodynamic properties such as evaporation rate impact drug delivery and lung deposition. Currently, there are limited evaporation rate studies and technologies available to effectively study the variable bulk mass of aerosols without interrupting the spray.

The non-impaction laser imaging technology of the well-established Proveris SprayVIEW® measurement system offers meaningful insight into drug product evaporation. The approach is significant as it offers Generic OINDP developers a tool for performing in vitro bioequivalence comparisons between Test and Reference products. 

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

About H&T Presspart

H&T Presspart is a pharmaceutical component and device manufacturer for the respiratory drug delivery market, specializing in high-precision injection moulded plastic and deep-drawn metal components. With more than 40 years’ experience, H&T Presspart has a worldwide reputation for competence, quality and innovation in the respiratory drug delivery market. As the healthcare and pharmaceutical sectors continue to evolve, bringing revolutionary drugs to the market, H&T Presspart’s wealth of experience and expertise helps clients in the pharmaceutical industry make the best decisions early in the product and device development process. H&T Presspart’s Inhalation Product Technology Centre (IPTC) supports our customers’ new product developments and strategic initiatives. Founded in 1970 and acquired by the Heitkamp and Thumann group in 2002, H&T Presspart has 3 European manufacturing sites with sales offices around the world.

Lee Dalton joins Proveris as Director of Sales for North America

Lee Dalton joins Proveris as Director of Sales for North America

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that experienced life sciences professional Lee Dalton has joined Proveris as Director of Sales for North America.

Lee joins Proveris with 25 years of experience in account management, business development, and technical sales at life science technology and instrumentation providers including Biotage AB, Abazyme, SeqLL, LLC, GE Healthcare, Cambridge Biomedical, and Zymark. He has worked throughout the Americas supporting scientists in all laboratory areas with their analytical challenges, from sample preparation and analysis to data analysis reporting. 

“Lee has proven experience and expertise in providing the right instrument and laboratory service solutions to pharmaceutical and biotech companies, from discovery through commercialization. We are confident that Lee will be a strong customer advocate and focus on providing our customers with the highest quality solutions that will enable them to be successful.” said Ben Okorodudu, Vice President of Sales for Proveris.

“I am excited to join the Proveris family at a time when the company is investing in key areas such as R&D and its support team”, said Lee. “I believe that Proveris is a unique company that provides an environment allowing for personal and professional growth through unmatched dedication to quality and customer support.”

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.

Proveris Scientific Expands its Technical Service Team

Proveris Scientific expands its technical service team with the addition of engineer Juan Osvaldo Moliére Velez

 Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that it has expanded its technical service team with the addition of engineer Juan Osvaldo Moliére Velez.

Juan will be based at Proveris Headquarters in Hudson, Massachusetts, providing in-house support to Proveris field engineers and directly to customers. He will also be travelling to customer sites to assist with servicing instruments and to train customers on test procedures developed in-house. 

He has 10-plus years of experience, most recently at Illumina where he spent three years installing new gene sequencers, performing preventative maintenance, and on-demand service. Prior to that he served as a field service engineer at Qiagen where he supported customers of the Modaplex system providing direct support and service for in-house systems.

Juan is a mechanical engineer with an educational background based on design and manufacturing prototypes. He has worked for the aerospace industry which provided him with intimate knowledge of jet engine turbines and experience in regulated industries. He has leveraged this knowledge in multiple roles in the medical industry. Juan will report to Proveris Scientific’s VP of Technical Services, Alberto Correia. 

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.

Proveris Scientific announces its 25th anniversary.

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.

COVID-19 UPDATE FOR OUR CUSTOMERS AND PARTNERS

To our customers and partners,

Thank you for your continued business and the opportunity to serve you. We at Proveris Scientific are concerned about the COVID-19 virus and the health and well-being of our customers, collaboration partners, suppliers, and employees. We understand the impact that travel, site, and other restrictions are causing globally and want to let you know how we are operating during this time.

How we are operating and precautionary steps we are taking

For our employees and visitors we:

  • established internal protocols to ensure a safe workplace;
  •  implemented a restricted travel policy globally;
  •  are working with customers to utilize virtual meetings to reduce in-person meetings when possible; and
  • have a professional cleaning service that is on-site each night to clean and sanitize our facility.

For our customers, we are:

  • continuing with on-site service and support where possible;
  • continuing with our application support;
  •  utilizing Proveris Remote Service capabilities to diagnose and resolve instrument issues;
  •  expanding our factory service program (where applicable) to provide service to customers in affected areas; and
  • increasingourProverisLaboratorycapabilitiestoprovideadditionaltestingoptions.

Despite these challenges, we remain dedicated and committed to customer success. Our team is here and ready to work with you to develop solutions that help you meet your needs and be as productive as possible during these uncertain times.

If you have any questions, please do not hesitate to contact your Proveris representative or email us directly.

Sincerely,
Chip Leveille
President, Proveris Scientific

Proveris Laboratories announces the availability of services utilizing a new approach to IVIVC for inhalation drug products

Hudson, MA, May 24, 2019 – Proveris Scientific Corporation, a leading provider of services and technology to advance the science of respiratory drug delivery products, today announced the addition of new services to accelerate product characterization, performance, safety and bioequivalence testing of inhalation drug products by measuring the aerosolization process, regional deposition and bioavailability under more human realistic conditions than existing methods.

These services are aligned with recent efforts to establish in-vitro/in-vivo correlation (IVIVC) and support the FDA’s newly released draft guidance on Beclomethasone Dipropionate that promotes alternate in-vitro studies in lieu of clinical endpoint.

Based on an innovative new proprietary technology, these services have been developed in collaboration with key industry leaders and are now being offered through Proveris Labs.

“We are very excited to offer our customers access to this new technology” comments Alberto Correia, Vice President of Technical Services, “we believe we will provide our customers tremendous insight into the performance of their products and enable a new approach to IVIVC.”

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 their expertise, experience and core technologies. With customers’ success as their central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” that include product innovation, technical services, systems, consumables and educational training. Since its founding in 1995, the company has accelerated the development of the 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, CFDA, 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 on its technology issued in United States, Europe, and Asia. For more information, please visit www.proveris.com.

Proveris appoints Alberto A. Correia as Vice President of Technical Services heading up Proveris Laboratories

Hudson, MA, November 29, 2018 – Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced the appointment of experienced life sciences professional Alberto Correia as Vice President of Technical Services. Al will be responsible for overseeing the management of Field Service Engineering and growing the Proveris Laboratory Services business with new service product offerings, consulting services, and training, as well as expanding instrument and application support products and services.

Al comes with significant experience establishing manufacturing and laboratory operations, optimizing contract service offerings, and building strategic business alliances gained from his time with industry leaders such as: Horizon Technologies, SeqLL, Harvard Apparatus Regenerative Medicine, Cambridge Biomedical, VelQuest Corp, Unisyn Technologies, Zymark Corporation, Genex Corporation, Millipore Corporation, and Waters Associates. Al is also recognized for managing collaborations with leading key opinion leaders, and as a dynamic speaker at international conferences and meetings on various compliance topics including electronic record requirements, data acquisition, and 21 CFR Part 11.

“Al brings a blend of technical knowledge in the Pharmaceutical/Biotechnology areas with a lifetime dedication to customer service”, said Chip Leveille, President of Proveris. “His experience base includes designing, building and running a GMP Phase 1 and 2 manufacturing facility and a GLP CLIA/CAP commercial diagnostic lab. I believe he understands and will implement what is necessary for us to intelligently grow the Proveris Laboratory Services business.”

“Adding Al to the team strengthens our experience base,” said Dino Farina, Founder and CEO of Proveris. “He has spent his career developing customer centric organizations that have provided unmatched value to both the company and the partners they work with.”
“I am excited to join the Proveris family at a time when we expand our offerings to our customers”, said Al Correia, “I believe that combining cutting edge technology with a dedication to making our customers successful will result in a powerful team and a winning scenario for all involved.”

About Proveris Scientific
Proveris Scientific Corporation advances the science of spray and aerosol products by driving new technology development for high performance spray characterization, capture, and analysis while leveraging our expertise, experience, and core technologies. With customers’ success as their central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” that include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of the 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, CFDA, 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 on its technology issued in United States, Europe, and Asia.

Proveris Achieves External Certification to the ISO 9001:2015 Quality Standard

Proveris Scientific Achieves External Certification to the ISO 9001:2015 Quality Standard
Hudson, MA, October 9, 2018 – Proveris Scientific Corporation, a leading provider of services and technology to advance the science of aerosol and spray products, today announced that it has achieved certification status under international quality standard, ISO 9001:2015.

This is a major accomplishment for the organization, having transitioned from the previous 2008 edition of the standard, while concurrently moving to its new facility in Hudson, MA. Proveris achieved its certification through TUV Rheinland of North America, Inc., its certification body accredited through ANAB. Proveris’s ISO 9001:2015 certification is in force with an expiration date in October, 2021. “We are highly committed to delivering quality products and services to our customers globally,” says Proveris Scientific Founder and CEO, Dino Farina. “We recognize that continual improvement is an essential part of achieving customer satisfaction and we constantly strive to exceed our customers’ expectations for quality.”

About Proveris Scientific
Proveris Scientific Corporation advances the science of spray and aerosol products by driving new technology development for high performance spray characterization, capture, and analysis while leveraging our expertise, experience and core technologies. With customers’ success as their central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” that include product innovation, technical services, systems, consumables and educational training. Since its founding in 1995, the company has accelerated the development of the 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, CFDA, 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 on its technology issued in United States, Europe, and Asia. For more information, please visit www.proveris.com.

Proveris Appoints John Masciola as Vice President of Product Development

Hudson, MA, August 10, 2018 – Proveris Scientific Corporation, a leading provider of services and technology to advance the science of aerosol and spray products, today announced the appointment of experienced life sciences professional John Masciola, as Vice President of Product Development.

“We are very excited to have John on the Proveris team” said Chip Leveille, President of Proveris. “His experience and expertise in building and running development organizations with a specific focus on the introduction of new technologies is an important piece as we continue our focus on advancing spray and aerosol science.”

John has more than 20 years of experience developing products for the life sciences sector from drug discovery through QC. John comes to Proveris with significant expertise in all phases of product development including engineering, automation, regulatory, imaging, fluidics, and spectroscopy technologies gained from his time with industry leaders Parker Precision Fluidics, Perkin Elmer, Caliper Life Sciences, Zymark and Brooks Automation. John is a recognized leader for creating strong development teams, executing strategic roadmaps, and delivering and maintaining software-intensive scientific and industrial products throughout their lifecycles.

“I am excited to be part of Proveris’ growth strategy and to drive innovation within the spray and aerosol markets” said Masciola, “I look forward to working with our global customers and the Proveris team to deliver innovative, high value solutions to the complex challenges of successfully bringing spray and aerosol products to market.”

“John represents another big step in our growth” said Dino Farina, Founder and CEO of Proveris. “His extensive experience, product development acumen, and passion for developing customer-centric “complete solutions” will help us quickly commercialize the cutting-edge technologies coming out of our advanced research arm, Proveris Labs, with a focus on customer success. I look forward to working with John to realize our vision of helping customers bring the best performing spray and aerosol products to the global market”.

About Proveris Scientific

Proveris Scientific Corporation advances the science of spray and aerosol products by driving new technology development for high performance spray characterization, capture, and analysis while leveraging our expertise, experience and core technologies. With customers’ success as their central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” that include product innovation, technical services, systems, consumables and educational training. Since its founding in 1995, the company has accelerated the development of the 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, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2008 by TUV Rheinland of North America and has more than 20 patents on its technology issued in United States, Europe, and Asia.