Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics-Drying Kinetics and Protein Aggregation.

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 concentrated formulations comprise a significant nonvolatile fraction, drying of drug product at the filling nozzle may occur during line interruptions. In many cases, this is a result of dripping at the filling nozzle and is dependent on environmental factors.

Prolonged In-use Stability of Reconstituted Herceptin in Commercial Intravenous Bags.

Herceptin is a humanized monoclonal antibody that selectively binds to the extracellular domain of human epidermal growth factor receptor 2 (HER2). Herceptin has an important role in the treatment of HER2-positive breast cancer when used in the neoadjuvant, adjuvant, and metastatic settings, and in the treatment of HER2-positive metastatic gastric cancer, and gastroesophageal junction adenocarcinoma. Prior to intravenous infusion, Herceptin must be reconstituted with sterile water for injection and then diluted in intravenous bags with normal saline.

Silicone Migration From Baked-on Silicone Layers. Particle Characterization in Placebo and Protein Solutions.

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. Silicone oil, which is used as lubricant, can migrate into the drug product and may interact with therapeutic proteins. In this study, particles in the size range of 0.

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

Combination products have become popular formats for the delivery of parenteral medications. Bake-on siliconization of glass syringes or cartridges allows good piston break-loose and gliding during injection at low silicone levels. Although widely implemented in industry, still little is known and published on the effect of the bake-on process on the silicone level, layer thickness and chemical composition.

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

Biopharmaceutical products are increasingly commercialized as drug/device combinations to enable self-administration. Siliconization of the inner syringe/cartridge glass barrel for adequate functionality is either performed at the supplier or drug product manufacturing site. Yet, siliconization processes are often insufficiently investigated.

Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under in-use Conditions with Different Administration Materials.

MabThera is an essential component of the standard-of-care regimens in the treatment of non-Hodgkin lymphoma and Chronic Lymphatic Leukemia. MabThera for subcutaneous injection is a novel line extension that has been approved by the European Medicines Agency for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. This study aimed to evaluate in-use stability data of MabThera subcutaneous drug-product solution in single-use syringes for subcutaneous administration according to the European Medicines Agency guideline.

Analysis of thin baked-on silicone layers by FTIR and 3D-Laser Scanning Microscopy.

Pre-filled syringes (PFS) and auto-injection devices with cartridges are increasingly used for parenteral administration. To assure functionality, silicone oil is applied to the inner surface of the glass barrel. Silicone oil migration into the product can be minimized by applying a thin but sufficient layer of silicone oil emulsion followed by thermal bake-on versus spraying-on silicone oil.