Possible obstacles and pitfalls during biopharmaceutical processing of high concentration liquid formulations (HCLF)
July 14-17, 2019
There is an evolving need of high concentration liquid formulations in the field of biologicals over the last years. An increase in protein concentration allows administering the desired therapeutic dose preferably within a single injection due to a considerably reduced drug product volume. Thus, the usage of high concentrated liquid formulations is associated with a higher degree of freedom with regard to e.g. primary packaging material such as syringes, small volume applicators as well as route of administration. Both are leading to a higher patient convenience, ideally to self-administration and thus hospital or medical personnel independency. However, a higher protein concentration can result in increasing viscosities, which entails challenges regarding administration to the patient or biopharmaceutical processing steps (e.g. purification, fill and finish). In literature, key interactions of high concentration liquid formulations are described, which are of importance for the purification (e.g. Donnan effect for diafiltration) or the fill and finish step (e.g. differences in densities). This oral presentation will give an overview of obstacles and pitfalls within certain biopharmaceutical processing steps of HCLFs as well as approaches to tackle them.
Daniel Molnar, "Possible obstacles and pitfalls during biopharmaceutical processing of high concentration liquid formulations (HCLF)" in "Biological and Pharmaceutical Complex Fluids III: Protein Self-Assembly, Rheology and Interfacial Properties", Samiul Amin, Manhattan College, USA Miguel Rodrigues, University of Lisbon, Portugal Paolo Arosio, ETHZ, Switzerland Eds, ECI Symposium Series, (2019). https://dc.engconfintl.org/bpcf_iii/12