Developing methods, guidelines, and strategies that will improve the stability of protein drugs in the real-world.

RealHOPE consist of five work packages that each addresses the five project goals set for the project. The second work package is called GOLD and will develop tools and methods for simulation of real-life events during drug product handling that mimic the effects on drug product quality. The project team will collaborate with work packages SHAPE and HIGH as well as with EFPIA partners to developing methods, guidelines, and strategies that will aid the managing of protein drugs in the real-world.

Methods for simulation and handling

The work package GOLD has two arms: developing methods suited for simulation of real-world handling by patients, and handling in hospital pharmacy setting, respectively. These two arms will address different ways of handling and different technical devices used in handling. mAbs will be studied, but other modalities may also be included. Exact type of modalities and detailed description of molecules cannot be provided at this time and will be subject to material availability and legal consent, as well as the outcome of SHAPE and HIGH studies.

Pinpointing generic situations

GOLD is designed to a have tasks that are focused on more generic stress situations (e.g. interfaces, dilution, light), which subsequently ca be combined into a simulation set-up covering several stress factors, both on a bench top scale and on a miniaturised scale. To this end, miniaturised device system will be developed to minimise the amount of protein formulation needed for a comprehensive simulation of stresses. Particular attention is directed to simulations set-ups that correspond to drug preparation for IV-bags and subsequent handling, and the effects of injection on proteins.

Collaboration with RealHOPE work packages SHAPE and
HIGH plus EFPIA partners

The work package will connect back to SHAPE for the fact-finding mission, and to HIGH for improved design of robotic compounding and for the interpretation of characterisation using the Probe Drum instrument. Between SHAPE and GOLD two smaller investigational studies will be carried out regarding transport of prepared protein drug doses in IV-bags. In SHAPE, real life transports will be carried out by either pneumatic transfer system in a hospital or by logistics companies. Simulations of these transport events will be part of GOLD. For injections, methods to simulate the effects of the passage through the needle will be set up.

The simulation methods and the miniaturised device will be transferred to the EFPIA partners and tested by implementation in their development laboratory setting. This activity will provide insights on method reproducibility and how they can be implemented by EFPIA partners for drug development process, with the aim to build more robust formulations that are more forgiving in the real-life handling.