R&D And Analytic For Early Stage Development

Source: Pharmaceutics International

Early-Stage Development is in Pii’s DNA

Pii has been a proud CDMO partner for more than 28 years, supporting programs from early stages of development through commercialization. Pii’s extensive experience in understanding different analytical requirements allows us to better serve our partners’ needs. And we are proud to offer several of these capabilities in house.

Pii’s main lab has more than 70 HPLC and UPLC systems from Waters and Agilent to support a variety of complex formulations requiring specialized methods, including those for light-sensitive products. Pii’s experienced Analytical Research and Development team, working in conjunction with our Quality Control unit, will help optimize, develop, validate or verify the methods to meet our partners’ needs for programs, which range from early-phase clinical trials through late stages of tech transfer and beyond.

In addition to Pii’s LC system capabilities, we offer a variety of other testing solutions, including particle size distribution analysis using Malvern’s Zetasizer that can help determine zeta-potential and molecular size for detection of aggregates and small particles. In addition, Pii houses a Malvern Mastersizer 3000 supporting particle size analysis for particles from 0.1 micron to 3 millimeters.

Pii utilizes Agilent’s ICPMS system for elemental impurities and heavy metals analysis. The ICPMS is used to detect metals and several non-metals in liquid samples at very low concentrations. Pii leverages the in-house ICPMS to determine whether a product requires routine analysis and evaluation in conjunction with the principles of ICHQ3D, which provides guidance on the process to evaluate and control elemental impurities in the drug product through risk management.

To support our evaluation of in vitro dissolution testing, Pii has more than 20 dissolution baths supporting multiple dosage forms, including tablets, capsules, non-sterile liquids and suspensions, and even extended-release injectables. Pii’s in-house experts have the ability to develop and validate methods, and even optimize existing methods, to achieve a robust drug release profile for submission and routine analysis.

Our gas chromatography systems check for residual solvents in a drug substance, for example, to ensure these impurities, if present, are within acceptable limits.

Additionally, differential scanning calorimetry, or DSC, is important during early stages of development to measure the physical properties of changes in the state of a material, along with temperature, over time.

Pii also has the ability to support raw material testing in house, as well as analysis of physiochemical characteristics such as moisture content and pH testing.

And our ICH capability chambers range from -20 degrees Celsius to 40 degrees Celsius to support the variety of dosage forms.

All of these previously mentioned services are supported by Pii’s in-house stability testing capabilities from early development through commercialization. Pii’s in-house, analytical capabilities align with our other core development functions so that our scientific team can focus on the key product criteria to accelerate timelines and scale up formulations.


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Pharmaceutics International