Results 221 to 230 of about 2,536 (255)

High concentration biotherapeutic formulation and ultrafiltration: Part 1 pressure limits

Biotechnology Progress, 2016
High therapeutic dosage requirements and the desire for ease of administration drive the trend to subcutaneous administration using delivery systems such as subcutaneous pumps and prefilled syringes. Because of dosage volume limits, prefilled syringe administration requires higher concentration liquid formulations, limited to about
Herb, Lutz, Joshua, Arias, Yu, Zou
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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
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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
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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
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Turning diverse analytical data into actionable knowledge for enzymatically driven polysorbate degradation risk assessment and control in biotherapeutic protein formulations

Journal of Pharmaceutical and Biomedical Analysis Open
Alex Dow, Divya Chandra, Shannon Rivera
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Live Biotherapeutics : importance of formulation and lyophilization parametersand an example of a clinical application

2023
In recent years, probiotics have expanded from their traditional classification as “health promoting food” to the development of live biotherapeutic products (LBP). Traditional probiotics are marketed as food/dietary supplements while LBPs are drug products intended for treatment or prevention of diseases.
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Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways

Journal of Pharmaceutical Sciences, 2008
Polysorbates 20 and 80 (Tween 20 and Tween 80) are used in the formulation of biotherapeutic products for both preventing surface adsorption and as stabilizers against protein aggregation. The polysorbates are amphipathic, nonionic surfactants composed of fatty acid esters of polyoxyethylene sorbitan being polyoxyethylene sorbitan monolaurate for ...
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Impact of citrate on mitigating iron mediated polysorbate 80 degradation in biotherapeutic formulation placebos

Journal of Pharmaceutical Sciences
Polysorbate 80 (PS80), a widely used polymeric surfactant in biotherapeutic formulation, possesses a unique structural composition that effectively prevents protein aggregation in highly concentrated protein drug formulations. However, PS80 is susceptible to hydrolysis, due to the presence of fatty acid esters that can be enzymatically hydrolyzed, The ...
Rong-Sheng Yang, Chengbei Li, Liliana Henriquez, Hongxia Wang, Jainik Panchal, Wendy Zhong, Hillary Schuessler   +6 more
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The cost of convenience: Evaluating economic differences in SQ and IV biotherapeutic formulations.

Journal of Clinical Oncology
e23163 Background: Subcutaneous (SQ) formulations of anti-neoplastic biotherapeutics provide an alternative to intravenous (IV) administration, offering shorter administration times and eliminating the need for IV access, but also increasing the potential for injection site complications ...
Puneeth Indurlal, James W. Gilmore, Alti Rahman, Brian Patrick Mulherin, Lalan S. Wilfong   +4 more
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Smith G (2023) Electrical impedance PAT for biotherapeutic freeze-drying. Marcus Evans 14th Biologics Formulation, Development And Drug Delivery Sept 14-15th

2023
Podium presentation at Marcus Evans 14th Biologics Formulation, Development And Drug Delivery Series Sept 14-15th 2023, LondonCite as: Smith, G. (2023) Electrical impedance PAT for biotherapeutic freeze-drying. Podium presentation at Marcus Evans 14th Biologics Formulation, Development And Drug Delivery Series, London UK.
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