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Navigating new product development: Uncovering factors and overcoming challenges for success [PDF]

Heliyon
New product development (NPD) frequently encounters failures, whether during the development phase or in the subsequent commercialization stage. These failures can often be attributed to root causes originating in the early stages of NPD, known as the ...
Mohammad Falahat, Shyue Chuan Chong, Cindy Liew   +2 more
doaj   +2 more sources

Molecular Attributes Associated With Refolding of Inclusion Body Proteins Using the Freeze–Thaw Method

Frontiers in Microbiology, 2021
Understanding the structure–function of inclusion bodies (IBs) in the last two decades has led to the development of several mild solubilization buffers for the improved recovery of bioactive proteins.
Priyank Singhvi, Juhi Verma, Neha Panwar, Neha Panwar, Tabiya Qayoom Wani, Akansha Singh, Md. Qudratullah, Arnab Chakraborty, Ankit Saneja, Debi P. Sarkar, Amulya K. Panda   +10 more
doaj   +1 more source

Ranking mAb–excipient interactions in biologics formulations by NMR spectroscopy and computational approaches

mAbs, 2023
Excipients are added to biopharmaceutical formulations to enhance protein stability and enable the development of robust formulations with acceptable physicochemical properties, but the mechanism by which they confer stability is not fully understood ...
Chunting Zhang, Steven T. Gossert, Jonathan Williams, Michael Little, Marilia Barros, Barton Dear, Bradley Falk, Ankit D. Kanthe, Robert Garmise, Luciano Mueller, Andrew Ilott, Anuji Abraham   +11 more
doaj   +1 more source

Type 1 interferon mediated signaling is indispensable for eliciting anti-tumor responses by Mycobacterium indicus pranii

Frontiers in Immunology, 2023
IntroductionThe evolving tumor secretes various immunosuppressive factors that reprogram the tumor microenvironment (TME) to become immunologically cold.
Gargi Roy, Anush Chakraborty, Bharati Swami, Lalit Pal, Charvi Ahuja, Soumen Basak, Sangeeta Bhaskar   +6 more
doaj   +1 more source

Characterizing and understanding the formation of cysteine conjugates and other by-products in a random, lysine-linked antibody drug conjugate

mAbs, 2021
This study describes the characterization of conjugation sites for a random, lysine conjugated 2-iminothiolane (2-IT) based antibody-drug-conjugate synthesized from an IgG1 antibody and a duocarmycin analog-based payload-linker. Of the 80 putative lysine
Difei Qiu, Yande Huang, Naresh Chennamsetty, Scott A. Miller, Michael Hay   +4 more
doaj   +1 more source

A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations

mAbs, 2023
Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration. HCAPs have become successful in the therapeutic sector due to their unique
Indrajit Ghosh, Hiten Gutka, Mary E. Krause, Ryan Clemens, Ramesh S. Kashi   +4 more
doaj   +1 more source

Improved Titer in Late-Stage Mammalian Cell Culture Manufacturing by Re-Cloning

Bioengineering, 2022
Improving productivity to reduce the cost of biologics manufacturing and ensure that therapeutics can reach more patients remains a major challenge faced by the biopharmaceutical industry.
Qin He, Matthew S. Rehmann, Jun Tian, Jianlin Xu, Luzmary Sabino, Erik Vandermark, Ziev Basson, Iris Po, Kathleen Bierilo, Gabi Tremml, Giovanni Rizzi, Erik F. Langsdorf, Nan-Xin Qian, Michael C. Borys, Anurag Khetan, Zheng-Jian Li   +15 more
doaj   +1 more source

High-salinity produced water treatment and desalination

LHB Hydroscience Journal, 2023
Produced water contains salts and minerals of sufficiently high content (salinity > 35%) to be harmful to the ecosystem, making it difficult to dispose of, reinject for enhanced oil recovery, or use for other purposes such as human use and agriculture ...
Abdelaziz Khlaifat, Sherif Fakher, Abdullah D. Ibrahim, Mohamed Elsese, Ahmed Nour   +4 more
doaj   +1 more source

Investigation of anomalous charge variant profile reveals discrete pH-dependent conformations and conformation-dependent charge states within the CDR3 loop of a therapeutic mAb

mAbs, 2020
During the development of a therapeutic monoclonal antibody (mAb-1), the charge variant profile obtained by pH-gradient cation exchange chromatography (CEX) contained two main peaks, each of which exhibited a unique intrinsic fluorescence profile and ...
Wenkui Lan, Joseph J. Valente, Andrew Ilott, Naresh Chennamsetty, Zhihua Liu, Joseph M. Rizzo, Aaron P. Yamniuk, Difei Qiu, Holly M. Shackman, Mark S. Bolgar   +9 more
doaj   +1 more source

A simple approach for effective shearing and reliable concentration measurement of ultra-high-molecular-weight DNA

BioTechniques, 2021
Pipetting and concentration measurement of viscous ultra-high-molecular-weight (UHMW) DNA samples is challenging and often highly imprecise. Effective guidelines for handling UHMW samples are missing in the field.
Paul A ‘Giron’ Koetsier, Eric J Cantor   +1 more
doaj   +1 more source