Filling unit operation for biological drug products: Challenges and considerations
M Adler, A Allmendinger - Journal of Pharmaceutical Sciences, 2023 - Elsevier
One of the key unit operations during the aseptic fill-finish process of parenteral products,
such as biologics, is the filling process of the formulated, sterile filtered drug substance into …
such as biologics, is the filling process of the formulated, sterile filtered drug substance into …
Syringe filling of high-concentration mab products using peristaltic pump-based mechanism: challenges and mitigation strategies
KG Desai, JD Colandene, A Gidh, S Hanslip… - Journal of …, 2022 - Elsevier
Syringe filling of high-concentration mAb formulation during manufacturing of large-scale
drug product batches may present challenges such as product deposition onto the area of …
drug product batches may present challenges such as product deposition onto the area of …
Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics—Drying Kinetics and Protein Aggregation
A Allmendinger, Y Ni, A Bernhard… - PDA Journal of …, 2022 - journal.pda.org
The fill-finish process of highly concentrated protein formulations poses several technical
challenges and, in particular, the filling process is critical to ensure filling accuracy. As highly …
challenges and, in particular, the filling process is critical to ensure filling accuracy. As highly …