Extending the molecular application range of gas chromatography

E Kaal, HG Janssen - Journal of Chromatography A, 2008 - Elsevier
Gas chromatography is an important analytical technique for qualitative and quantitative
analysis in a wide range of application areas. It is fast, provides a high peak capacity, is …

IgG1 aggregation and particle formation induced by silicone–water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers

P Basu, R Thirumangalathu, TW Randolph… - Journal of …, 2013 - Elsevier
Understanding and mitigating particle formation in prefilled syringes are critical for ensuring
stability of therapeutic proteins. In the current study, siliconized beads were used as a model …

Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes

A Gerhardt, BH Nguyen, R Lewus, JF Carpenter… - Journal of …, 2015 - Elsevier
Silicone oil is used as a lubricant in glass pre-filled syringes (PFS) but can contribute to the
generation of particles within protein formulations in PFS. To mitigate the production of such …

Silicone migration from baked-on silicone layers. Particle characterization in placebo and protein solutions

S Funke, J Matilainen, H Nalenz… - Journal of …, 2016 - Elsevier
A significant number of therapeutic proteins are marketed as pre-filled syringes or other
drug/device combination products and have been safely used in these formats for years …

Albinterferon α2b adsorption to silicone oil–water interfaces: effects on protein conformation, aggregation, and subvisible particle formation

P Basu, AW Blake-Haskins, KB O'Berry… - Journal of …, 2014 - Elsevier
Silicone oil used as a lubricant in prefilled syringes has the potential to induce formation of
particles in protein formulations. In the current study, we used a therapeutic fusion protein …

Optimization of the bake-on siliconization of cartridges. Part I: Optimization of the spray-on parameters

S Funke, J Matilainen, H Nalenz… - European Journal of …, 2016 - Elsevier
Biopharmaceutical products are increasingly commercialized as drug/device combinations
to enable self-administration. Siliconization of the inner syringe/cartridge glass barrel for …

Oligomeric carbon and siloxane series observed by matrix‐assisted laser desorption/ionisation and laser desorption/ionisation mass spectrometry during the analysis …

B Apicella, A Ciajolo, M Millan… - … in mass spectrometry, 2004 - Wiley Online Library
Oligomeric carbon and siloxane series have been observed by matrix‐assisted laser
desorption/ionisation mass spectrometry (MALDI‐MS), during the analysis of the …

Optimization of the bake-on siliconization of cartridges. Part II: Investigations into burn-in time and temperature

S Funke, J Matilainen, H Nalenz… - European Journal of …, 2016 - Elsevier
Combination products have become popular formats for the delivery of parenteral
medications. Bake-on siliconization of glass syringes or cartridges allows good piston break …

21 Practical Considerations for Freeze-Drying in Dual Chamber Package Systems

DL Teagarden, SM Speaker, SWH Martin… - Freeze Drying …, 2010 - taylorfrancis.com
INTRODUCTION The market for injectable drugs is increasing due in large part to the
development of biotherapeutics for previously untreatable ailments, such as rheumatoid …

Packaging of Pharmaceutical dosage forms

TJ Ambrosio - Modern Pharmaceutics, Fourth Edition Revised and …, 1996 - taylorfrancis.com
The close relationship between a pharmaceutical preparation and its package is of major
concern to the industrial pharmacist. Faulty packaging of pharmaceutical dosage forms can …