[HTML][HTML] Manufacturing challenges and rational formulation development for AAV viral vectors

A Srivastava, KMG Mallela, N Deorkar… - Journal of pharmaceutical …, 2021 - Elsevier
Adeno-associated virus (AAV) has emerged as a leading platform for gene delivery for
treating various diseases due to its excellent safety profile and efficient transduction to …

Review of the current state of protein aggregation inhibition from a materials chemistry perspective: Special focus on polymeric materials

R Rajan, S Ahmed, N Sharma, N Kumar, A Debas… - Materials …, 2021 - pubs.rsc.org
Protein instability caused by exposure to external additives or severe stress may result in
different diseases. Of these diseases, many are triggered by protein misfolding and …

Stability of protein pharmaceuticals: an update

MC Manning, DK Chou, BM Murphy, RW Payne… - Pharmaceutical …, 2010 - Springer
Abstract In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning
et al., Pharm. Res. 6: 903–918, 1989), which has been widely referenced ever since. At the …

Achieving long-term stability of lipid nanoparticles: examining the effect of pH, temperature, and lyophilization

RL Ball, P Bajaj, KA Whitehead - International journal of …, 2017 - Taylor & Francis
The broadest clinical application of siRNA therapeutics will be facilitated by drug-loaded
delivery systems that maintain stability and potency for long times under ambient conditions …

Challenges in the development of high protein concentration formulations

SJ Shire, Z Shahrokh, JUN Liu - Journal of pharmaceutical sciences, 2004 - Elsevier
Abstract Development of formulations for protein drugs requiring high dosing (in the order of
mg/kg) may become challenging for solubility limited proteins and for the subcutaneous (SC) …

Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways

BA Kerwin - Journal of pharmaceutical sciences, 2008 - Elsevier
ABSTRACT Polysorbates 20 and 80 (Tween® 20 and Tween® 80) are used in the
formulation of biotherapeutic products for both preventing surface adsorption and as …

Effects of glycosylation on the stability of protein pharmaceuticals

RJ Solá, KAI Griebenow - Journal of pharmaceutical sciences, 2009 - Elsevier
In recent decades, protein-based therapeutics have substantially expanded the field of
molecular pharmacology due to their outstanding potential for the treatment of disease …

Key interactions of surfactants in therapeutic protein formulations: a review

TA Khan, HC Mahler, RSK Kishore - European journal of pharmaceutics …, 2015 - Elsevier
Proteins as amphiphilic, surface-active macromolecules, demonstrate substantial interfacial
activity, which causes considerable impact on their multifarious applications. A commonly …

Instability of therapeutic proteins—An overview of stresses, stabilization mechanisms and analytical techniques involved in Lyophilized proteins

A Butreddy, KY Janga, S Ajjarapu, S Sarabu… - International journal of …, 2021 - Elsevier
Solid-state is the preferred choice for storage of protein therapeutics to improve stability and
preserve the biological activity by decreasing the physical and chemical degradation …

The physics of protein self-assembly

JJ McManus, P Charbonneau, E Zaccarelli… - Current opinion in colloid …, 2016 - Elsevier
Understanding protein self-assembly is important for many biological and industrial
processes. Proteins can self-assemble into crystals, filaments, gels, and other amorphous …