“Integrating i.v.STATION at St-Antonius' clinical pharmacy operations provides a safe, accurate, and efficient way to compound mAbs, and additionally a very unique opportunity to reduce the waste of these very expensive biological medications. We are very excited about the mAbs project and look forward to jointly-develop this unique i.v.STATION functionality, and being the first scientists to provide proof of accurate and automated reconstitution of complex mAbs, such as Infliximab, Rituximab and Trastuzumab” stated Dr. Ewoudt van de Garde, Clinical Pharmacist-Epidemiologist, St-Antonius Hospital.
“Although i.v.STATION has already compounded “live” mAbs for patients and fully-demonstrated its financial and clinical benefits, our focus so far has been on eliminating drug and diluent exchange errors while minimizing costs, drug quantity mistakes, and sterility risks. Now it is time to provide scientific evidence of the additional importance of drug efficacy and reduction of oncology drugs' patient side effects made possible through our exclusive Mechatronics solutions and the protocol-development assistance from St-Antonius. These jointly-developed mAbs protocols will be made available to our global customer network,” stated Gaspar DeViedma, Health Robotics' Executive Vice President.
Human monoclonal antibody therapies are very complex and expensive biological drugs that are well known to display poor biophysical properties, such as low stability and propensity to aggregate. Drug manufacturers' reconstitution instructions for lyophilized mAbs often state that: “shaking-induced foaming should be avoided to prevent inaccuracies in drug dosage, and that diluents should be added very slowly to inhibit protein aggregation.” Protein aggregation can result from the shaking process that increases the water-air interface and induces mechanical stress. mAbs are also very sensitive to mechanical stress induced by agitation or rapid expulsion from a syringe. Compounding mistakes if noticed and reported to pharmacy supervisors result in repeat compounding and waste, costing thousands of dollars (or euros); if not noticed and/or reported potentially result in patient side effects and/or reduced treatment efficacy.