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View Proveris' drug development & contract analytical services for orally inhaled, dry powder & nasal drug products (OINDPs) on PharmaCompass.
Q1. What is Proveris Scientific? What analytical services does it offer?
Proveris Scientific delivers innovative testing platforms, laboratory services, contract test services and deep product knowledge to customers who develop, manufacture, or test orally inhaled Dry Powder (DPI) and nasal drug products (OINDPs).
For over two decades, Proveris Scientific has collaborated closely with pharmaceutical companies, device suppliers, contract development and research organizations, manufacturing firms and regulatory agencies worldwide. Their shared commitment to raising industry standards and providing effective therapies drives this focus.
By comprehending the essential quality attributes that impact the performance of orally inhaled and nasal drug products (OINDPs), Proveris Scientific's team of engineers, scientists, and service professionals can assist you in ensuring successful product development and preventing late-stage development failures.
Proveris Scientific's global customer base includes top innovator and generic pharmaceutical companies, device manufacturers, contract development organizations (CDO), contract research organizations (CRO), contract manufacturing organizations (CMO) and regulatory agencies. Proveris conducts comprehensive product testing to gain insights into the challenges of developing OINDP products and ensuring their successful launch into the market.
Proveris works in its own laboratory, collaborates with a broad array of industry influencers, and possesses distinctive knowledge and experience in synthesizing the complexities of orally inhaled nasal drug products (OINDPs) to deliver value-oriented solutions to its clientele.
Proveris Scientific offers various analytical services which are listed below:
- Proveris assesses the suitability of various OINDP delivery devices for compounds, optimizes device parameters for optimal effectiveness and eradicates testing variables to maintain batch-to-batch reproducibility, thereby streamlining regulatory submissions.
- Proveris Scientific possesses the ability to unravel the intricate relationships between formulation, device, and human usage-essential knowledge required for timely and effective OINDP product development and commercialization.
- Working closely with customers, Proveris can provide immediate insights into critical spray and aerosol parameters, as well as expert advice on the regulatory and operational complexities of orally inhaled Dry Powder (DPI) and nasal drug products. Proveris offers its services to companies working on new product innovations, generic drug development, and commercially released product manufacturers.
- As a pioneering leader in nasal spray analysis and testing and drug development, Proveris Scientific can provide comprehensive assistance at every stage, starting from formulation and device screening, method development, through-life product testing, and regulatory submission.
- Proveris Scientific offers an array of services, including hand actuation studies, formulation screening, device selection, droplet size distribution, uniformity of delivered dose, spray content uniformity, spray pattern, plume geometry, pump delivery, fire down (nasal), and pump robustness.
- It offers the industry's most complete selection of products and services that specifically focus on metered dose and soft mist inhalers. Along with in vitro inhalation drug analysis, it also provides predictive clinical assessment, bioequivalence and IVIVC studies.
- Proveris has recently introduced the INVIDA™ platform, which enables the measurement of aerosol dispersion and regional deposition of inhaled drugs under human-realistic breathing profiles. This cutting-edge technology is a valuable tool for understanding your product's in vivo performance, providing a visual representation of your product's placement within the respiratory tract, along with quantitative measurements of drug deposition.
Proveris Scientific's customer base includes top innovator and generic pharmaceutical companies, device manufacturers, CDO/CRO/CMOs, and regulatory agencies. It is also collaborating with regulatory agencies and leading OTC companies to develop suitable testing methodologies for these products.
Q2. How can Proveris Scientific help you with early development for OINDPs?
Proveris Scientific offers innovative testing platforms, contract laboratory services, contract testing services and deep product expertise to customers involved in the development, manufacturing, or testing of orally inhaled and nasal drug products (OINDPs).
- Human Actuation Studies
Proveris employs its Ergo™ technology to precisely measure how trained testers in the targeted population uses the product; and the data is immediately transferred for statistical analysis. All key actuation parameters, such as stroke length, velocity, acceleration and hold time, are obtained through the study, and can be adjusted for further optimization.
- Method Development
Proveris Scientific provides full method development services for all spray characterization tests, including spray pattern, plume geometry and Droplet Size Distribution (DSD), and delivers comprehensive reports in just a few weeks. Proveris-certified methods can be transferred through all stages of the method development cycle, from early development to manufacturing.
- Drug Product Characterization Studies
Proveris offers drug product characterization studies which includes a range of services, such as analysis of shot weight, spray pattern, plume geometry, droplet size distribution, uniformity of delivered dose, along with inter- and intra-container product testing, storage effect or dosing orientation, and product actuation force evaluation.
- Device Screening
Proveris Scientific provides device screening services for inhalation and nasal products, which involve assessing the actual spray performance of all formulation and device combination candidates and evaluating all critical quality attributes (CQAs) to identify the best device-formulation pairing.
- Novel Device Characterization
Proveris Scientific offers novel device characterization services that includes characterization of unit/bi dose devices, syringes with atomizers, nasal powders, topical spray continuous valves and other innovative devices.
Q3. How does Proveris help in the development of Unit-dose Nasal Drugs?
Developing a successful unit-dose nasal spray or unit-dose nasal powder is a complex process that requires a thorough understanding of the interactions between formulation, device, and human usage. Proveris Scientific has over 25 years of experience in the development of orally inhaled and nasal drug products (OINDPs), and can provide valuable insight and understanding to accelerate product success. Proveris Scientific offers contract testing services in its cGMP-compliant lab to evaluate the complex relationships between formulation, device, and human usage.
Human actuation studies are carried out with trained testers using its patented Ergo™ technology, while screening experiments are performed following the controlled Proveris by Design™ approach.
Viota® Unit-Dose software is optimized to control the unique requirements of unit-dose devices, resulting in increased accuracy and precision in a robust format. The software works with spray, syringe, pressurized aerosol devices, and both liquid and powder formulations for systemic (central nervous system, immune system), nose-to-brain, and local delivery.
Product characterization services include evaluation of delivered dose, droplet size distribution, actuation force, spray Pattern (SP), plume Geometry (PG), plume velocity, force to actuate, nasal deposition, and airway deposition.
Q4. What are some of Proveris' product offerings?
Proveris Scientific offers analytical method development and contract testing services along with various oral and inhalation products that are given below:
SprayVIEW® Measurement System
It has been designed to meet rigorous testing standards for orally inhaled and nasal drug products (OINDPs). It sets the industry standard for measuring and analyzing spray pattern and plume geometry that are produced by spray and aerosol generating devices. This system has been validated and is being used in the development and production of OINDPs by leading pharmaceutical companies, contract development organizations (CDOs), contract research organizations (CROs) and contract manufacturing organizations (CMOs), device manufacturers, and regulatory agencies worldwide.
Vereo : Automated Actuators for PMDI Inhaler Devices
It delivers unrivaled performance for automated actuation. Automated actuation and shaking of pMDI devices eliminates the variables associated with manual actuation and ensures consistent parameters across tests. It provides precise and reproducible control over stroke length, contact and end-of-stroke limits, actuation velocity, hold time and release velocity..
Kinaero CX : PMDI Collection System
By utilizing the unrivaled performance of the Vereo® Automated Actuator, the Kinaero Cx offers a dependable automated solution that enhances the consistency of sample collection for testing delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). The Kinaero Cx enables precise control over shaking parameters, shake-to-fire timing, actuation parameters, and flow rate, ensuring reproducible results.
Kinaero: High-Throughput PMDI Fire-Down System
The Kinaero™ High-Throughput Fire-Down System is a solution designed to precisely automate shaking and actuation of up to 10 devices simultaneously, ensuring consistent dose delivery for every shot throughout the devices' lifespan. This is necessary because improper manual shaking and shake-to-fire intervals during testing can result in variations in delivered dose ranging from 75-320% of the label claim per actuation.
Accessories
Device Holders : Proveris' experts work with its customers to create custom device holders that allow human-realistic automated actuation. Proveris Scientific's expertise in OINDP extends to the creation of custom device holders for OTC products, including continuous valve spray cans, fragrance pumps, and other household products.
Universal Cassettes : For its Kinaero high throughput pMDI fire-down system, Proveris Scientific offers three main device cassette options compatible with over 20 currently marketed MDI device designs.
Spray Content Uniformity and Waste Collection Kits
These ergonomic and user-friendly kits offer a simple solution for waste and sample collection across a wide range testing applications. The easy-on/easy-off design allows integration with other test workflows such as Droplet Size Distribution (DSD) and Spray Pattern (SP) analysis.
Sample Collector Kit : It is designed for spray content uniformity and pump delivery of delivered dose weights.
Its precise nozzle tip alignment ensures complete spray collection and eliminates sample loss associated with "spray and flip" manual methods.
It standardizes collection for consistent technique across lab operators to eliminate user variability.
It includes a sample tube cap for sample processing.
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