Impact of residual impurities and contaminants on protein stability
W Wang, AA Ignatius, SV Thakkar - Journal of pharmaceutical sciences, 2014 - Elsevier
Production of recombinant proteins generates a variety of process-related impurities. The
multistep manufacturing processes may introduce many potential contaminants into the final …
multistep manufacturing processes may introduce many potential contaminants into the final …
Antibody-drug conjugates: design, formulation and physicochemical stability
SK Singh, DL Luisi, RH Pak - Pharmaceutical research, 2015 - Springer
The convergence of advanced understanding of biology with chemistry has led to a
resurgence in the development of antibody-drug conjugates (ADCs), especially with two …
resurgence in the development of antibody-drug conjugates (ADCs), especially with two …
Stress factors in protein drug product manufacturing and their impact on product quality
TK Das, A Sreedhara, JD Colandene, DK Chou… - Journal of …, 2022 - Elsevier
Injectable protein-based medicinal products (drug products, or DPs) must be produced by
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …
Vaporized hydrogen peroxide sterilization in the production of protein therapeutics: Uptake and effects on product quality
M Meleties, BM Cooper, D Marcano-James… - Journal of …, 2023 - Elsevier
The aseptic filling of drug products is carried out in pharmaceutical isolators that have been
sterilized. A commonly used method for achieving a high level of sterility assurance is …
sterilized. A commonly used method for achieving a high level of sterility assurance is …
The “New Polyethylene Glycol Dilemma”: polyethylene glycol impurities and their paradox role in mAb crystallization
C Hildebrandt, L Joos, R Saedler, G Winter - Journal of Pharmaceutical …, 2015 - Elsevier
Polyethylene glycols (PEG) represent the most successful and frequently applied class of
excipients used for protein crystallization. PEG auto-oxidation and formation of impurities …
excipients used for protein crystallization. PEG auto-oxidation and formation of impurities …
Design-oriented regression models for H2O2 decontamination processes in sterile drug product manufacturing considering rapidity and sterility
K Yabuta, H Futamura, K Kawasaki, M Hirao… - International journal of …, 2018 - Elsevier
We developed regression models for designing rapid and effective H 2 O 2 decontamination
processes in the manufacturing of sterile drug products such as injectables …
processes in the manufacturing of sterile drug products such as injectables …
Assessing the impact of sanitization methods for regenerated cellulose ultrafiltration/diafiltration membrane on membrane integrity and protein quality
X Cong, W Chen, L Wang, Y Wan - Biotechnology Progress, 2023 - Wiley Online Library
Abstract Ultrafiltration/diafiltration (UF/DF) is typically the final step in downstream
processing of recombinant monoclonal antibody (mAb) products, which serves for protein …
processing of recombinant monoclonal antibody (mAb) products, which serves for protein …
Late‐Stage Product Characterization: Applications in Formulation, Process, and Manufacturing Development
CP Chan, L Shi - Biophysical Methods for Biotherapeutics …, 2014 - Wiley Online Library
This chapter summarizes the key considerations in applying biophysical characterization
tools on protein therapeutics during phase Ill/commercial process development. The …
tools on protein therapeutics during phase Ill/commercial process development. The …
Formulation and Stability
K Tsumoto, A Young, S Ohtake - Antibody‐Drug Conjugates …, 2016 - Wiley Online Library
Antibody‐drug conjugates (ADCs) are highly potent, targeted‐therapy compounds,
designed to bind specifically to cancer cells of interest, minimize side effects, and provide a …
designed to bind specifically to cancer cells of interest, minimize side effects, and provide a …
Drug Product Considerations for Biosimilars
Biosimilars are increasingly important for the expansion of access to life-saving biologics
and to reduce the cost of prescription medicine. The design of the drug product for a …
and to reduce the cost of prescription medicine. The design of the drug product for a …