Immunogenicity to biotherapeutics–the role of anti-drug immune complexes

M Krishna, SG Nadler - Frontiers in immunology, 2016 - frontiersin.org
Biological molecules are increasingly becoming a part of the therapeutics portfolio that has
been either recently approved for marketing or those that are in the pipeline of several …

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 …

Limitations of animal studies for predicting toxicity in clinical trials: is it time to rethink our current approach?

GA Van Norman - JACC: Basic to Translational Science, 2019 - jacc.org
Animal testing is used in pharmaceutical and industrial research to predict human toxicity,
and yet analysis suggests that animal models are poor predictors of drug safety in humans …

Immunogenicity risk profile of nanobodies

C Ackaert, N Smiejkowska, C Xavier… - Frontiers in …, 2021 - frontiersin.org
Nanobodies (Nbs), the variable domains of camelid heavy chain-only antibodies, are a
promising class of therapeutics or in vivo imaging reagents entering the clinic. They possess …

Impact of product-related factors on immunogenicity of biotherapeutics

SK Singh - Journal of pharmaceutical sciences, 2011 - Elsevier
All protein therapeutics have the potential to be immunogenic. Several factors, including
patient characteristics, disease state, and the therapy itself, influence the generation of an …

[HTML][HTML] Multivalent protein-drug conjugates–An emerging strategy for the upgraded precision and efficiency of drug delivery to cancer cells

N Porębska, K Ciura, A Chorążewska… - Biotechnology …, 2023 - Elsevier
With almost 20 million new cases per year, cancer constitutes one of the most important
challenges for public health systems. Unlike traditional chemotherapy, targeted anti-cancer …

Engineering and characterization of the long‐acting glucagon‐like peptide‐1 analogue LY2189265, an Fc fusion protein

W Glaesner, A Mark Vick, R Millican… - Diabetes/metabolism …, 2010 - Wiley Online Library
Abstract Background Glucagon‐like peptide‐1 (GLP‐1) receptor agonists are novel agents
for type 2 diabetes treatment, offering glucose‐dependent insulinotropic effects, reduced …

Immunogenicity of protein pharmaceuticals

R Dingman, SV Balu-Iyer - Journal of pharmaceutical sciences, 2019 - Elsevier
Protein therapeutics have drastically changed the landscape of treatment for many diseases
by providing a regimen that is highly specific and lacks many off-target toxicities. The clinical …

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies

R Ponce, L Abad, L Amaravadi, T Gelzleichter… - Regulatory Toxicology …, 2009 - Elsevier
An evaluation of potential antibody formation to biologic therapeutics during the course of
nonclinical safety studies and its impact on the toxicity profile is expected under current …

Challenges and approaches for the development of safer immunomodulatory biologics

JG Sathish, S Sethu, MC Bielsky, L De Haan… - Nature Reviews Drug …, 2013 - nature.com
Immunomodulatory biologics, which render their therapeutic effects by modulating or
harnessing immune responses, have proven their therapeutic utility in several complex …