From cell factories to patients: Stability challenges in biopharmaceuticals manufacturing and administration with mitigation strategies

A Elsayed, N Jaber, M Al-Remawi… - International Journal of …, 2023 - Elsevier
Active ingredients of biopharmaceuticals consist of a wide array of biomolecular structures,
including those of enzymes, monoclonal antibodies, nucleic acids, and recombinant …

Study of Oncolytic Virus Preservation and Formulation

L Pan, X Liu, D Fan, Z Qian, X Sun, P Wu, L Zhong - Pharmaceuticals, 2023 - mdpi.com
In recent years, oncolytic viruses (OVs) have emerged as an effective means of treating
cancer. OVs have multiple oncotherapeutic functions including specifically infecting and …

Trends in light and temperature sensitivity recommendations among licensed biotechnology drug products

JJ Kim, JD Pritts, M Ngo, CR Estoll, VA Rao - Pharmaceutical Research, 2023 - Springer
Purpose Inherent structural and functional properties of biotechnology-derived therapeutic
biologics make them susceptible to light-and temperature-induced degradation and …

[HTML][HTML] Directional freezing and thawing of biologics in drug substance bottles

SS Peláez, HC Mahler, J Huwyler… - European journal of …, 2024 - Elsevier
Biological drug substance (DS) is typically stored frozen to increase stability. However,
freezing and thawing (F/T) of DS can impact product quality and therefore F/T processes …

Characterization of Freezing Processes in Drug Substance Bottles by Ice Core Sampling

SS Peláez, HC Mahler, PR Vila, J Huwyler… - AAPS …, 2024 - Springer
Freezing of biological drug substance (DS) is a critical unit operation that may impact
product quality, potentially leading to protein aggregation and sub-visible particle formation …

Next generation 3D printing platform for the fabrication of personalized pills

VR Kulkarni - 2023 - repositories.lib.utexas.edu
Abstract 6 in 10 adults in the US suffer from chronic conditions which can range from heart
and metabolic diseases to cancer and HIV. The commonality of all these chronic disorders is …