Proveris Scientific welcomes back Alyssa Rubino as Technical Data Scientist for Proveris Laboratories

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that it has increased the level of customer support by expanding its laboratory services organization with the addition of Technical Data Scientist, Alyssa Rubino.

Alyssa rejoins the Proveris Laboratories team where for years she provided guidance, not only in designing protocols that allowed complete and efficient characterization of oral and nasal devices, but also in completing data analysis to best leverage the information and accelerate the achievement of project goals. She will report to the Director of Application and Business Development for Proveris Laboratories, Maria Smith. The combination of their talents will provide a broader and more in-depth support offering.

Alyssa will be responsible for ensuring appropriate study design, compiling and analyzing analytical study data, deriving conclusions and key information, and generating reports for all contracted projects to ensure they meet internal, customer, and regulatory standards. Alyssa has more than 10 years of experience in applications engineering, product management, and operations gained from her time with industry leaders such as Tekscan, Ocular Therapeutix, and, of course, Proveris. Utilizing her knowledge, Alyssa will also help drive the implementation of new technologies into Proveris Laboratories and expand the laboratory service offering.

Alyssa holds a Bachelor of Science in Mechanical Engineering from Northeastern University and has co-authored 5 publications on the science of orally inhaled and nasal drug 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.

 

DDL 2022

December 7-9, 2022 | Edinburgh, Scotland

Proveris will sponsor this year’s Drug Delivery to The Lungs (DDL) conference which will be held December 7-9. Attendees to our exhibit will be able to explore new tools for spray characterization, studies for predictive in vitro / in vivo correlation, and precision automated actuation technology for through-life testing.

If you would like to learn more and schedule a meeting with us,
email us at contactus@proveris.com.

Drug Delivery to the Lungs (DDL) is an annual conference covering all aspects of respiratory drug delivery. It attracts a wide variety of attendees, including scientists, academics, clinicians, regulators and industry experts. It offers a venue for lectures, posters and exhibitions.

IDDS 2022

October 27-29 | Suzhou China

Proveris is a platinum sponsor of the 9th Innovative Drug Delivery Solution Summit (IDDS 2022) which will be held in-person from October 27-29 in Suzhou, China.

Proveris Scientific’s partner, Ruty Li of Quantaflux, will attend IDDS. He will be at the Proveris table in the exhibit area and will give a scientific presentation on behalf of Proveris. The presentation will cover analytical instrumentation and testing strategies for pressurized meter dose inhalers (pMDI’s), soft mist inhalers (SMI’s) and unit-dose nasal sprays.

If you would like to learn more and schedule a meeting with him, email us
at contactus@proveris.com.

The 9th Innovative Drug Delivery Solution Summit (IDDS·2022) which cover three special sessions, including regulatory trends and technologies for complex preparations, active packaging technology empowers pharma-cos and innovative packaging for consumer health goods, will be held online and offline during Oct and Nov. The session of regulatory trends and technologies for complex preparations will take place in Suzhou will be open to the biopharmaceutical enterprises and industry peers free of charge. Regulatory trends and technologies for high-end pharmaceutical preparations session of IDDS·2022 will invite regulatory, clinical, pharmaceutical, market experts, and industrial leading players, involve four parallel sessions: regulations and market trends, nasal to brain drug delivery, inhalation formulations and sterile formulations.

3rd Annual Inhalation & Respiratory Drug Products

September 8-9 | Proveris is a sponsor of the 3rd Annual Inhalation and Respiratory Drug Delivery Conference which, which will be held in-person from September 8-9.

Proveris Sales Director, Dr. Deborah Jones, will give a keynote speaker presentation exploring the evidence generic drug developers need to support ANDA approval for their pressurized metered dose inhaler or soft mist inhaler drug product without a clinical trial. It will focus on the in vitro spray characterization approaches; Plume Front Velocity, Spray Duration and Evaporation Fraction/Rate. It will provide data highlighting how these measurements can provide key insights that will accelerate the development process with the goal of getting products to market most efficiently.   

The 3rd Annual Inhalation and Respiratory Drug Delivery Conference is modeled for senior manager representatives, experts and main decision makers who are interested to be acquainted with the latest approaches and inventions of the respiratory drug products delivery field. It will cover the latest innovations and trends in inhalation and respiratory market, formulation & delivery of inhaled therapies, the new challenges and approaches of the inhaler models and technologies. The agenda will include content on global regulatory CMC requirements, key studies on the latest trends in inhalation devices and personalized treatments with large and small molecules for different respiratory diseases. Presentations will be focused on the topics, such as: cell therapy, inhaled vaccines and the future potential for high-dose applicants and available liquid inhalation devices. 

Learn more and register visit HERE.

Proveris Scientific names Ramesh Chand as Associate Director of rapidly growing GMP contract test business, Proveris Laboratories

Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, today announced Ramesh Chand has been named Associate Director of Proveris Scientific’s rapidly growing GMP contract test business, Proveris Laboratories.

Ramesh Chand is a scientific expert with more than 16 years of professional experience within the Orally Inhaled and Nasal Drug Product (OINDP) development community, including analytical, formulation development, process development, device selection and characterization, scale-up/technical transfer and preclinical aerosol development on both innovator and generic drug products. His work also encompasses nebulization and nose-to-brain nasal delivery of biologics. As Associate Director of Proveris Laboratories, he will oversee the day-to-day laboratory operations, ensuring quality and regulatory standards are upheld and will assist Proveris Research in introducing innovative technologies to advance inhalation science and development. His diverse expertise will shape strategic direction and will allow Proveris to expand their menu of services.

Ramesh earned his Master of Science in chemical engineering, from Missouri University of Science and Technology, which included thesis work focused on ‘Generation and Characterization of Aerosols.’ Prior to joining Proveris, he worked for Moderna Therapeutics in Cambridge, MA as the Principal Scientist of Drug Product Development (Respiratory), Amneal Pharmaceuticals, Piscataway, NJ as a Senior Research Scientist, Inhalation Product Development, Lovelace Biomedical, Albuquerque, NM as Senior Research Associate and GlaxoSmithKline, Research Triangle Park, NC as an Associate Scientist, Inhaled Product Development. With his regular contributions to research, Ramesh has co-authored more than 15 respiratory articles.

“Ramesh is a significant addition to the Proveris Laboratories team,” commented Dino Farina, CEO, Proveris Scientific. “His experience in OINDP drug development combined with his research will provide our customers access to proven expertise that will help them achieve their goals quickly and at the highest quality. In addition, he will be a key player in helping Proveris Research deliver new and innovative technologies through Proveris Labs for the advancement of inhalation science and drug development”

Ramesh added, “I am excited to join Proveris at a time when the company is rapidly advancing the test services business. Proveris is uniquely positioned in supporting OINDP development programs. I believe the addition of innovative technologies and expanded capabilities will immensely benefit customer’s respiratory drug development.”

About Proveris Scientific
Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving innovative 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, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TÜV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.

Proveris expands product portfolio with new Kinaero Cx™ pMDI Collection System for delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing

Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, adds Kinaero Cx™ pMDI Collection System to its product portfolio to automate the pMDI shaking, priming, dose sample collection, and fire-down for DDU and APSD testing.

The Kinaero Cx system incorporates proven Vereo® Automated Actuator technology to precisely control product shaking, actuation parameters, and shake-to-fire timing enabling consistent dose delivery for HPLC analysis. Compliance with EU Annex 11 and US FDA 21 CFR Part 11 is ensured by the operation and data management software with technical controls for electronic records, electronic signatures, audit trails, and data/system/user traceability. As an alternative to manual operation, the system offers benefits such as minimizing both the risk of out-of-specification shots and the downtime that could result from analyst fatigue or CAPA investigations.

The Kinaero Cx system’s flexible design simplifies testing by offering a single platform for DDU and APSD sample collection. Utilizing a unique snap-fit design for the back-end adapter to both the DUSA tube and the waste collector, the system allows for easy installation and removal for sample prep when performing DDU testing. In addition, quick set up for APSD testing is achieved with a cascade impaction kit for placement and orientation of either the Anderson cascade impactor (ACI) apparatus with vertically stacked sample plates or the next generation impactor (NGI) with horizontally placed sample plates.

The Kinaero Cx system enables a fast, smooth workflow for unparalleled ease of use. Sample collection is performed in three quick and easy steps, with control provided through our intuitive software and local database for data storage. Analysts set up methods to specify shots into the dosage sampling unit apparatus (DUSA), cascade impactor throat, and waste collector locations. An on-board sensor confirms the inhaler positioning for mating inhalers of different geometries to these three locations. There is no teaching required and users can easily switch between different inhaler types using device holder inserts adapted to various inhaler geometries.

The Kinaero Cx system offers increased throughput when used alongside the Kinaero™ pMDI High Throughput Fire-Down System. The Kinaero Fire-Down System precisely automates shaking and actuation to waste of up to 10 devices simultaneously, ensuring uniform dose delivery for every shot when transitioning between the beginning, middle, and end of life stages for an inhaler device. Both systems utilize a powerful common software platform which offers all tools to ensure full regulatory compliance (FDA 21 CFR Part 11).

Proveris Scientific’s Senior Product Manager, Ian Flaherty, commented: “An aim for the product design team at Proveris is the evolution of our product portfolio to allow customers to meet complex regulatory requirements and produce consistent high quality data. Our 25-plus years of experience in the OINDP space has taught us much about the potential for automation in reducing the variability associated with inhaler testing. The Kinaero Cx takes these learnings a step further and is designed to be an accessory to our very well-known Vereo Actuator, providing another layer of automation to benefit our customers. The solution is elegant and easy to use, and the powerful software platform will meet our customer’s strict demands for ensuring data integrity and traceability.”

The Kinaero Cx system in all its functionality will be demonstrated in the Proveris workshop at the upcoming RDD 2022 conference in Orlando, Florida. Whitepapers with published data will be made available, upon request, following the workshop on May 3rd, 2022.

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, 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 issued on its technology.

RDD 2022

May 1-5, 2022 | Florida, USA

Proveris is an exhibitor and workshop presenter at this year’s Respiratory Drug Delivery, RDD 2022, which will be held in-person from May 1-5 and as a virtual conference from April 25-June 30.

Our in-person workshop scheduled for Tuesday, May 3, will last 60 minutes, and will repeated three times during the day to ensure conference delegates have the greatest opportunity to attend. Workshop presenters are Lynn Jordan, Senior Applications Manager, and Ian Flaherty, Senior Product Manager.

The workshop entitled, ‘Automated pMDI Handling for Dose Content Uniformity Testing and Aerodynamic Particle Size Distribution,’ will cover a new platform from Proveris Scientific to automate the pMDI shaking, priming, dose collection, and fire down for Dose Content Uniformity (DCU) and Aerodynamic Particle Size Distribution (APSD). Currently DCU and APSD are primarily manual processes, subject to the variability. The workshop will review testing requirements and compare the results of the manual versus automated process using the Proveris Kinaero CxTM Automated pMDI Collection System. Comparison data from both processes will be reviewed for several pMDI products, highlighting the improved performance that can be achieved by holding the testing variables consistent with the automated method. In addition, the discussion will cover the parameters available for automated mixing, an integral part of any suspension based pMDI. The workshop will conclude with a product demonstration for DCU sample preparation using the Kinaero Cx pMDI Collection System.

The exhibition session runs from 11:30 AM–2:20 PM and to 5:00 PM-7:00 PM on Monday, May 2 and on Tuesday, May 3. The Proveris team attending the conference are Ben Okorodudu, Senior Vice President of Sales, Lee Dalton, Sales Director for the Americas, Lynn Jordan, Senior Applications Manager, and Ian Flaherty, Senior Product Manager. Visit with them at the Proveris table. Schedule a private meeting or product demonstration of our new Kinaero Cx pMDI Collection System.

If you would like to learn more and schedule a meeting or product demo with us, email us at contactus@proveris.com.

Respiratory Drug Delivery, RDD®, is an international conference for researchers, regulators, business professionals and suppliers active in pulmonary and nasal drug delivery. It provides a venue for expert speakers to cover topics including new therapeutic opportunities, drug delivery technologies, regulatory science, and novel in vitro, in vivo and clinical testing methods.

Inhalation China 2022

TBD | China

Proveris Scientific’s partner in China, Ruty Li of Quantaflux, will attend the 6th Inhalation China Symposium. He will be at the Proveris table in the exhibit area and will give a scientific presentation on behalf of Proveris.

If you would like to learn more and schedule a meeting with him, email us at contactus@proveris.com.

Inhalation China Symposium is organized by Fudan University School of Pharmacy, Pharmaceutical Preparation Committee of Shanghai Pharmaceutical Association, and co-organized by Reed Sino Pharma and Shanghai Pharma. Experts from Central CFDA, Local CFDA, technology companies, R&D organizations, universities, and hospitals speak about current topics related to inhalation drug delivery science, applications, and technology.

Proveris Scientific expands research team with the addition of accomplished research scientist, Prateek Nath, Ph.D.

Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, today announced Prateek Nath has joined as a research scientist in Proveris Scientific’s growing research team.

 

Prateek will perform a range of research activities to advance new technology platforms at Proveris. His focus will be to design and build a wide variety of research-grade prototypes and run experiments on these prototypes to generate proof statements for scientific hypotheses related to aerosol science, human physiology, and drug delivery. In addition, Prateek will actively participate in Proveris’s research collaborations with academic, industrial, and government organizations. 

Prateek holds a Ph.D. in solid mechanics and minors in applied mathematics and materials science from Brown University in Providence, Rhode Island. He earned his Master of Science in mechanical design and optimization from Indian Institute of Technology, Bombay, India, and his Bachelor of Science in mechanical engineering from University of Pune. Prior to joining Proveris, Prateek worked as a computational modeling engineer for Johnson and Johnson in Raynham, Massachusetts, as a research engineer for Bose Corporation in Framingham, Massachusetts, and as a postdoctoral research fellow for Oak Ridge National Laboratory in Oak Ridge, Tennessee. Prateek holds nine U.S. Patents and has authored multiple publications and conference presentations.

Proveris Scientific’s Founder and CEO, Dino Farina, commented, “I’m excited to have Prateek join the Proveris team. Prateek’s significant engineering experience from Oak Ridge National Laboratory, Bose Corporation, and J&J are perfect complements to Proveris’s advanced research focus on integrating human physiology, aerosol science, and drug delivery into better tools for predictive performance modeling of orally inhaled and nasal drug 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, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TÜV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.

Maria Smith appointed as Director, Application and Business Development for Proveris Laboratories

Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, today announced the appointment of Maria L. Smith, M.Sc., to the newly established role of Director, Application and Business Development for Proveris Laboratories. This is a new position focused on addressing the rapid growth of the cGMP contract test services and the introduction of new technologies. 

Maria joins Proveris with more than 14 years of CDMO experience in the development and test of orally inhaled and nasal drug products (OINDPs). She has extensive experience in spray characterization, as well as working with customers on problem resolution and compliance. She has authored 10 publications on spray characterization and is well known across the industry for her professionalism, experience, and expertise.

Maria will help drive the growth of Proveris Laboratories contract test services through the expansion of new applications and technologies. In addition, she will serve as a liaison to regulatory agencies, industry groups, and customers to educate on new technology approaches and how they can be used to support in-vitro in-vivo correlation (IVIVC) and bioequivalence (BE).   

Proveris Scientific’s President, Chip Leveille, commented, “Maria’s fourteen years of laboratory experience in spray/particulate science (nasal and oral products) with leading CDMO’s brings a deep understanding of drug development and testing as it pertains to inhalation products. She has extensive knowledge of Proveris systems and particle characterization techniques to develop and characterize aerosol and spray delivered drug devices. We are excited to have Maria on board to further establish and enhance Proveris technologies as critical approaches to drug approval and product release.”

 

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, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TÜV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.