Assessment of sensor concepts for 100% in-process control of low-volume aseptic fill-finish processes
T Dreckmann, W Aipperspach, K Pfleghar… - PDA Journal of …, 2020 - journal.pda.org
The pharmaceutical industry is currently being confronted with new and complex challenges
regarding the aseptic filling of parenterals, especially monoclonal antibodies, particularly for …
regarding the aseptic filling of parenterals, especially monoclonal antibodies, particularly for …
Low Volume Aseptic Filling of Monoclonal Antibodies
T Dreckmann - 2021 - edoc.unibas.ch
The basic idea of targeted drug therapy was already described in the late 19th century by
Paul Ehrlich referred as" magic bullet". This idea is already reality today and there are many …
Paul Ehrlich referred as" magic bullet". This idea is already reality today and there are many …
Filling of high-concentration monoclonal antibody formulations: investigating underlying mechanisms that affect precision of low-volume fill by peristaltic pump
W Shieu, D Lamar, OB Stauch… - PDA Journal of …, 2016 - journal.pda.org
Filling of high-concentration/viscosity monoclonal antibody formulations into vials or
syringes by peristaltic pumps is an industrial standard. Control of the peristaltic pump on fill …
syringes by peristaltic pumps is an industrial standard. Control of the peristaltic pump on fill …
[HTML][HTML] Rheological investigation of manufacturability and injectability of highly concentrated monoclonal antibody formulations
AM Allmendinger - 2014 - edoc.unibas.ch
Highly concentrated protein therapeutics offer a convenient way for subcutaneous (sc) drug
administration by the patient him-/herself or a healthcare professional. As the therapy eg …
administration by the patient him-/herself or a healthcare professional. As the therapy eg …
Using single-use systems in aseptic fill-finish: material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill …
J Markarian - Biopharm International, 2016 - go.gale.com
Single-use systems (SUS), also called disposable technology, can improve manufacturing
efficiency by reducing the time needed for cleaning and cleaning validations. In addition …
efficiency by reducing the time needed for cleaning and cleaning validations. In addition …
[HTML][HTML] Low volume aseptic filling: Impact of pump systems on shear stress
T Dreckmann, J Boeuf, IS Ludwig, J Lümkemann… - European Journal of …, 2020 - Elsevier
Low volume aseptic filling of parenterals, particularly monoclonal antibodies is becoming
increasingly important with the development of more and more intravitreal drugs and high …
increasingly important with the development of more and more intravitreal drugs and high …
Filling of high-concentration monoclonal antibody formulations into pre-filled syringes: investigating formulation-nozzle interactions to minimize nozzle clogging
W Shieu, OB Stauch, YF Maa - PDA journal of pharmaceutical …, 2015 - journal.pda.org
Syringe filling of high-concentration/viscosity monoclonal antibody formulations is a complex
process that is not fully understood. This study, which builds on a previous investigation that …
process that is not fully understood. This study, which builds on a previous investigation that …
Filling of high-concentration monoclonal antibody formulations into pre-filled syringes: filling parameter investigation and optimization
W Shieu, SA Torhan, E Chan, A Hubbard… - PDA Journal of …, 2014 - journal.pda.org
Syringe filling, especially the filling of high-concentration/viscosity monoclonal antibody
formulations, is a complex process that has not been widely published in literature. This …
formulations, is a complex process that has not been widely published in literature. This …
[PDF][PDF] Low-volume aseptic filling using a linear peristaltic pump
T Dreckmann, IS Ludwig, J Luemkemann… - PDA J. Pharm. Sci …, 2021 - researchgate.net
The pharmaceutical industry has been confronted with new and complex challenges,
particularly with regard to the aseptic filling of parenterals, including monoclonal antibodies …
particularly with regard to the aseptic filling of parenterals, including monoclonal antibodies …
[HTML][HTML] Process control of drug product continuous manufacturing operations—a study in operational simplification and continuous improvement
J Medendorp, S Shapally, D Vrieze, K Tolton - Journal of Pharmaceutical …, 2020 - Springer
Purpose The purpose of this manuscript is to demonstrate that implementation of gravimetric
measurements provides the same assurance of product quality and process control as …
measurements provides the same assurance of product quality and process control as …