Monoclonal antibody infusions (mAb‐i) are administered for the treatment of variousdiseases. They are often transported over long distances from the compounding site tothe site of administration. However, transport studies are typically carried out with theoriginal drug product but not with compounded mAb‐i. To address this gap, the impactof mechanical stress on the formationof subvisible/nanoparticles in mAb‐iwasinvestigated by dynamic light scattering and flow imaging microscopy. Different mAb‐iconcentrations were subjected to vibrational orbital shaking and stored at 2–8°C up to35 days. The screening revealed that pembrolizumab and bevacizumab infusions showthe highest propensity for particle formation. Especially bevacizumab at lowconcentrations exhibited an increase in particle formation. Because of the unknownhealth risks associated with the long‐term application of subvisible particles (SVPs)/nanoparticles in infusion bags, stability studies carried out in the frame of licensingapplication procedures should also focus on SVP formation in mAb‐i. In general,pharmacists should minimize the time of storage and mechanical stress during transport,especially in the case of low‐concentrated mAb‐i. Moreover, if siliconized syringes areused, they should be washed once with saline solution to minimize particle entry.
Authors: Mona Abdel‐Tawab 1,2| Srijib Banerjee 3| Roland Kirchner 3| Thomas Wellenhofer 4| Lukas Hahn 5| Lorenz Meinel 5| Ulrike Holzgrabe 5| Manfred Schubert‐Zsilavecz 2| Andreas Seidl 3| Franz Stadler 6
1 Central Laboratory of German Pharmacists,Eschborn, Germany; 2 Insitute for Pharmaceutical Chemistry,Johann‐Wolfgang‐Goethe University,Frankfurt, Germany; 3 Leukocare AG, Munich, Germany; 4 Bahnhof Pharmacy, Freilassing, Germany; 5 Institute for Pharmacy and Food Chemistry,Julius‐Maximilian University, Würzburg,Germany; 6 Foundation for Drug Safety, Munich,Germany
Read the whole article here.