Lab Services
Services for Early Development
What would it be worth to your organization to achieve a successful product submission—even earlier than anticipated?
Our unique, patented Proveris by Design™ process measures the human usage performance of an OINDP according to current FDA and ICH guidelines for in vitro testing. Using a step-by-step protocol that takes pharmaceutical spray and aerosol drug products from pump selection to release testing, we can help streamline your submission package and give your application every chance to succeed.
Our scientific team employs rigorous Quality-by-Design (QbD) methodologies to:
- Measure how representative populations in the drug product’s age and gender range use the product
- Use this data to create an optimized range of actuation parameters that can be used to perform spray and aerosol tests for the life of the product
- Provide a full suite of test services ultimately resulting in submission-ready data
Human Actuation Studies
- Uses Proveris Ergo™ technology to accurately quantify how trained testers in the targeted population actuate the product; data is immediately transferrable to statistical analysis
- Translates usage information into parameters that enable Vereo® automated actuators to reproduce the actuations in a human-realistic way
- All key actuation parameters (stroke length, velocity, acceleration, hold time, etc.) are obtained through the study and can be varied for further optimization
Method Development
- Full method development services for all spray characterization tests—spray pattern, plume geometry and DSD—with comprehensive reports within weeks
- Proveris-certified methods can be transferred through all stages of the development cycle from early development through manufacturing QC
Drug Product Characterization Studies
- Shot weight, spray pattern, plume geometry, droplet size distribution
- Uniformity of delivered dose, uniformity of delivered mass
- Inter-/intra-container through-life product testing (beginning, middle, end-of-life)
- Effect of storage/ dosing orientation
- Shaking Studies
- Tail-off characteristics
- Priming/Repriming characteristics
- Product Actuation Force evaluation
Device Formulation Screening
- Evaluation of actual spray performance on all the formulation and device combination candidates
- Evaluation of all critical quality attributes (CQAs) to select the best device-formulation combination
Novel Device Characterization
- Unit/Bi Dose devices
- Syringes with atomizers
- Nasal powders
- Nose-to-brain technologies
- Topical spray continuous valves
- Other novel devices
Drug Deposition Studies/ Alternative In-Vitro Approach
- Testing under human-realistic conditions to determine true product performance for predictive in vivo correlation
- Ability to test dry powder (DPI), breath actuated (BAI), and soft mist inhalers (SMI) in addition to all common pmdi device types
- All testing performed using controllable physiologically relevant breathing profiles achieved using patented technology
Access current, relevant resources for respiratory drug development & quality control.
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From a Proveris Sales Associate