Results 111 to 120 of about 1,377,424 (162)

Impact of Poloxamer 188 Material Attributes on Proteinaceous Visible Particle Formation in Liquid Monoclonal Antibody Formulations.

Journal of Pharmacy and Science, 2022
Surfactants such as Poloxamer 188 (PX188) play an important role in controlling particle formation in biotherapeutic formulations due to interfacial stresses. This study demonstrates for the first time that hydrophobicity of PX188 is a potential critical
Kohei Soeda, M. Fukuda, Masaya Takahashi, H. Imai, Kengo Arai, Satoshi Saitoh, R. S. Kishore, Nuria Sancho Oltra, Jérémy Duboeuf, Daisuke Hashimoto, Yuji Yamanaka   +10 more
semanticscholar   +1 more source

A validated spectro densitometric regulatory compliant USP-HP-TLC protocol for quantification of polyphenols and antioxidants from polyherbal formulations containing Terminalia species.

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2022
The phytochemical profiles of ethno-medicinal plants from Southern Asia have been extensively studied, due to their wide utilization in various traditional systems of India, Bhutan, Maldives, Nepal and China. Terminalia bellirica (Gaertn.) Roxb.
C. Bidikar, P. Hurkadale, S. Nandanwadkar, H. Hegde   +3 more
semanticscholar   +1 more source

Near Infrared Spectroscopy as a PAT Tool for Monitoring and Control of Protein and Excipient Concentration in Ultrafiltration of Highly Concentrated Antibody Formulations.

International journal of pharmaceutics, 2021
Excipient concentrations are critical quality attributes of monoclonal antibody (mAb) drug products and affect their safety and efficacy. In manufacturing processes, mAb products are formulated into the buffer containing the desired excipients using ...
Garima Thakur, Vishwanath Hebbi, A. Rathore   +2 more
semanticscholar   +1 more source

Chitosan-based formulations of drugs, imaging agents and biotherapeutics

Advanced Drug Delivery Reviews, 2010
This preface is part of the Advanced Drug Delivery Reviews theme issue on “Chitosan-Based Formulations of Drugs, Imaging Agents and Biotherapeutics”. This special Advanced Drug Delivery Reviews issue summarizes recent progress and different applications of chitosanbased formulations.
Amidi, M., Hennink, W.E.
openaire   +2 more sources

pH and excipient profiles during formulation of highly concentrated biotherapeutics using bufferless media

Biotechnology and Bioengineering, 2020
AbstractSeveral models have been developed to describe the shifts in pH and excipient concentrations seen during diafiltration of monoclonal antibody (mAb) products accounting for both Donnan equilibrium and electroneutrality constraints. However, these models have assumed that the mAb charge is either constant or only a function of pH, assumptions ...
Mario G. Jabra, Yinying Tao, John F. Moomaw, Zhao Yu, Brian J. Hotovec, Steven B. Geng, Andrew L. Zydney   +6 more
openaire   +2 more sources

Formulation Approaches and Strategies for PEGylated Biotherapeutics

2013
This chapter will begin with a brief review of the PEGylated biotherapeutic product landscape (commercial products and known molecules in development) and then discuss various product development approaches and issues. Several topics pertinent to PEGylated biotherapeutics formulation development include manufacturability, linker and conjugate stability,
Roger H. Pak, Rory F. Finn
openaire   +1 more source

Product-Specific Impact of Viscosity Modulating Formulation Excipients During Ultra-High Concentration Biotherapeutics Drug Product Development

Journal of Pharmaceutical Sciences, 2021
Developing ultra-high concentration biotherapeutics drug products can be challenging due to increased viscosity, processing, and stability issues. Excipients used to alleviate these concerns are traditionally evaluated at lower protein concentrations.
Danika, Rodrigues, Laura M, Tanenbaum, Renuka, Thirumangalathu, Sandeep, Somani, Kai, Zhang, Vineet, Kumar, Ketan, Amin, Santosh V, Thakkar   +7 more
openaire   +2 more sources

Azelaic acid-willow bark extract-panthenol – Loaded lipid nanocarriers improve the hydration effect and antioxidant action of cosmetic formulations

, 2020
The classic medication recommended in acne and atopic dermatitis comprises the administration of antibiotics, corticosteroids and topical steroids. To overcome some inconveniences of using synthetic antibiotics, e.g. irritation, inflammation and dryness,
L. V. Arsenie, I. Lacatusu, O. Oprea, N. Bordei, M. Bacalum, N. Badea   +5 more
semanticscholar   +1 more source

A High-Throughput Microbial Viability Assay to Evaluate Lyoprotectants for Live Biotherapeutic Products.

Molecular Pharmaceutics
Many cell-based therapies, such as live biotherapeutic products (LBPs), require preservation of cell viability during manufacturing, transportation, and storage before being delivered to patients.
Haixi Cui, Jonathan T. Feng, Sonali Kumari, Hua Yu, Di Yu, Hanping Feng, Stephen W. Hoag   +6 more
semanticscholar   +1 more source

Characterization of Subvisible Particles in Biotherapeutic Pre-Filled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock.

Journal of Pharmacy and Science, 2019
Subvisible particles (SbVP) are a critical quality attribute for biotherapeutics. Particle content in pre-filled syringes (PFS) of a biotherapeutic can include protein particles and silicone oil particles (SiOP).
N. Jiao, Gregory V. Barnett, Twinkle R. Christian, L. Narhi, N. Joh, M. Joubert, S. Cao   +6 more
semanticscholar   +1 more source