Pharm Res (2018) 35: 142 https://doi.org/10.1007/s11095-018-2415-4 RESEARCH PAPER Kinetics and Characterization of Non-enzymatic Fragmentation of Monoclonal Antibody Therapeutics 1 1 1 1 Sahithi Ravuluri & Rohit Bansal & Nidhi Chhabra & Anurag S. Rathore Received: 5 July 2017 /Accepted: 22 April 2018 /Published online: 14 May 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 ABSTRACT results are expected to assist end users in formulation devel- Purpose To understand non-enzymatic hydrolytic fragmen- opment as well as in monitoring stability of biotherapeutic tation of a monoclonal antibody therapeutic under tempera- products. ture stressed conditions and investigating possible mechanism for the same. . . KEY WORDS fragmentation kinetic modeling mass Methods The mAb therapeutic was incubated at 50°C in . . spectrometry monoclonal antibodies size exclusion phosphate buffer at pH 6.5 and fragmentation was monitored chromatography at different ionic strengths under stressed conditions. The in- cubated mAb was sampled at regular time intervals by ana- lytical Size Exclusion Chromatography (SEC). Results It was observed that 57% of the mAb product frag- ABBREVIATIONS mented over 4 days into two fragment species – Fc-Fab and DAD Diode array detector Fab with molecular weights of 97 KDa and 47 KDa, respec- DLS
Pharmaceutical Research – Springer Journals
Published: May 14, 2018
It’s your single place to instantly
discover and read the research
that matters to you.
Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.
All for just $49/month
Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly
Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.
Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.
Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.
All the latest content is available, no embargo periods.
“Hi guys, I cannot tell you how much I love this resource. Incredible. I really believe you've hit the nail on the head with this site in regards to solving the research-purchase issue.”Daniel C.
“Whoa! It’s like Spotify but for academic articles.”@Phil_Robichaud
“I must say, @deepdyve is a fabulous solution to the independent researcher's problem of #access to #information.”@deepthiw
“My last article couldn't be possible without the platform @deepdyve that makes journal papers cheaper.”@JoseServera