Testing the stability in and compatibility of drug product with its container closure material and equipment used for the respective route of administration.
In-use stability studies are conducted to evaluate how a pharmaceutical product maintains its quality, safety, and efficacy during its intended use after the product has been opened or prepared for administration. These studies simulate conditions that reflect the actual handling and use by patients or healthcare professionals, considering worst-case handling scenarios.
At ProJect Pharmaceutics, we (recommend) conducting in-use stability studies as early as possible, preferably at the time of formulation selection, in order to detect possible incompatibilities as early as possible, and in the worst case, to avoid a formulation change in clinical trials. Assessing the compatibility of the formulation ingredients and the active ingredient with the potentially intended infusion media (usually 5% glucose or 0.9 % saline, in rare cases a specially developed infusion medium in case of incompatibility with conventional infusion media) and the consumables to be used for the subsequent route of administration can not only help in the selection of the leading formulation candidate, but also save time and costs in later phases.
We conduct in-use stability studies for all classes of molecules for which we also offer formulation and process development, i.e. biologics, ADCs, cytotoxic drugs, small molecules, and peptides. Our in-use safety laboratory is equipped with infusion stands for infusion via gravity and with perfusor pumps. We also operate a red-light laboratory for handling light-sensitive substances.
As part of our broad service portfolio, we offer and perform in-use stability studies since 2015 and have completed a number of > 25 experimental study designs of the following main development objectives:
- Compatibility testing with common types of infusion media (5 % glucose, 0.9 % sodium chloride)
- Storage stability (hold times) in IV bags and IV infusion consumables (e.g. testing maximum in-use duration)
- Stability testing of reconstituted lyophilization solution
- Simulation of handling steps (e.g. opening/closing the vial, withdrawing doses by syringe or vial adapter/spike/CSTD, etc.)
- Simulation of administration procedure (e.g. simulation of IV infusion over defined time frame)
- Evaluation of adsorption phenomena (e.g. adsorption study IV bag content vs IV line content)
- Recovery from IV equipment
- Sub-visible particles (SVP) kinetics by light obscuration (LO)
- Dilution study for dose simulation
- Evaluation of DP methods compatibility with low concentration levels of diluted DP
Compatibility testing with in-use consumables:
- Syringe (of common suppliers) and needle (different Gauge sizes) for drug transfer
- Vial adaptor, syringe adaptor and bag spike of closed system transfer devices (CSTD
- IV infusion bag
- IV infusion line, secondary attachment/extension line, filter, and catheter/cannula
- Perfusor syringe and perfusor line
- Chemical stability for degradation products (HPLC)
- Physical stability for pH, visual appearance according to Ph. Eur. (color (Ph. Eur. 2.2.2), clarity (Ph. Eur. 2.2.1), visible particles (Ph. Eur. 2.9.20)), sub-visible particles (USP<787>) by LO, and viscosity
- Microbiological testing for sterility (external)
- Potency (external)
Related services prior clinical application:
- Extractable volume study
- Overfill volume study
- Filtration study
- Volume accuracy testing
- Evaluation of matrix effects
- Dose formulation study
ProJect Pharmaceutics is registered with worldwide suppliers of consumables for in-use stability studies (such as BBraun, Becton Dickinson, ICU Medical, etc.), which enables us to order consumables even in smaller quantities.
If you are searching for a partner lab that conduct in-use stability studies on a flexible basis, contact us.