The right design and execution of clinical in-use and compatibility studies ensures the safety and the right quality of the administered drug product as well as success of your program.

Parenteral products need to be administered correctly, to ensure patient safety and product efficacy. This is to make sure that the patients are receiving the right dose of the active ingredient with appropriate quality. Hence, Health Authorities globally place a high emphasis on providing data to support the in-use stability and compatibility during administration of parenteral drug products. Many biological moieties can show different incompatibilities with administration device, including adsorption, precipitation, particle formation or glycation. Specific challenges can occur with products that have to be dosed in very low amounts and/or with very broad dose range, such as products under so-called “MABEL” dosing per European guidance.

With the large variety of options for administration devices and materials that are available for drug administration globally, this can become a daunting activity.

Our Drug Product Services (Lonza DPS) team has a wide has experience in this field, and can support in designing and executing the in-use and compatibility study and selecting the best options that ensure patient safety as well as clinical and commercial success of the program.

  • Preclinical Administration Set and Testing

    The conditions for preclinical administration can greatly vary from those for clinical administration (e.g. dose range to be administered, concentrations and volumes tested, as well as devices used). The preclinical compatibility testing ensures the use of compatible administration sets to eliminate any risks to the GLP preclinical safety/toxicity studies due to incorrectly dosed and/or unstable drug product or incompatible devices, which may lead to wrong conclusions of the preclinical study.
  • Demonstrating in-use stability and administration device compatibility is essential to ensure patient safety and success of the clinical study. The setup used for administration can greatly vary depending on the indication, route of administration, dose range, as well as devices/material to be used depending on regional availability at clinical sites. The wide expertise of the our DPS team will enable the choice of the right setup early on as well as the timely execution of the often time-critical compatibility study and ensure acceptance by health authorities globally.
  • Health authorities may advise study sponsors to define microbial in-use stability using microbial challenge studies. The later assess the microbial growth potential of the compounded product. This provides guidance for holding times under refrigeration and room temperature based on the risk level.

    Our DPS team supports risk assessments and evaluations to define microbiological in-use times for use in clinical studies and commercial use, and also can perform microbiological studies to evaluate specific products and formulations with regards to potential growth promoting properties that may directly impact use-times that are recommendable from a microbiological quality perspective.

  • Providing clear guidance to the health care professionals for handling and administration eliminates and safety risks to the patients due to potential incorrect product use. Drug product services develops protocols on how a specific product should be handled and used, and can provide trainings and training materials to the clinical centres, demonstrating the correct handling and clarifying any questions from the clinical sites.