UPDATE


Interview: Where are we now? Bioanalysis Zone catches up with Omnia Ismaiel a year later…


Omnia Ismaiel Chromatographic Sciences Department, PPD Laboratories, Richmond, VA, USA Omnia.Ismaiel@ppdi.com Q


What is the main takeaway from your com- mentary, ‘Do we have mature LC–MS/MS


methodology for therapeutic monoclonal antibody bioanalysis?’ LC–MS/MS methodologies for biotherapeutics consist of several different aspects, such as sample preparation,


selection of internal standard and


finding suitable surrogate peptides. If you suc- cessfully optimized them, you would end up with robust methodology, excellent reproducibility and accurate results.


Q


Could you give us a quick update on how your work and research focuses/the field


have progressed? My work focuses on development and validation of LC–MS/MS methods for therapeutic proteins, peptides, glycan analysis and high resolution MS. An increasing number of new biotherapeutic modalities are emerging. Many of these new novel therapeutics have complex structures and have led to significant bioanalytical challenges, such as needing multiple PK assays to adequately describe safety and efficacy, as well as establishing ‘what to measure’.


Q


What do you think made your interview so p opular with the Bioanalysis Zone audience?


I think it is the topic itself. Therapeutic proteins are a rapidly growing field and, as described above, are increasing in complexity. The added structural complexities have forced alternative or synergistic method development strategies capable of provid- ing the necessary PK/TK data for assessing safety and efficacy. LC–MS/MS has shown great flexibil- ity and success for therapeutic protein bioanalysis and augments traditional LBA methodologies. Having mature LC–MS/MS methodologies to support the analysis of biotherapeutics is critical, due not only to the ever- changing structural complexities,


but also for regulatory submissions. The increas- ing popularity of using LC–MS/MS for biothera- peutic analysis has led to the need to reach a large audience, scientist and regulators alike, and is one of the main goals in the bioanalysis field.


Q


The aim of the ‘Author’s perspective’ series is to help the audience gain a better under-


standing and exclusive insights into articles pub- lished in Bioanalysis. What value do you think this adds to publishing your article? I think it has a great value. It provides more pop- ularity and wide distribution of the published articles. Many scientists follow the ‘Author’s per- spective’ series, as well as interviews, online panel discussions and webinars hosted on Bioanalysis Zone to ensure they are up-to-date with the con- tinuously improving and fast-growing field. In addition, it provides a means to ask ‘field experts’ questions and learn more about research progress and trends. Different perspectives from different labs sharing ideas and scientific data will build an extremely strong channel of knowledge and scientific judgement.


Q


What do you envisage for the future of your work with LC–MS/MS?


I anticipate more applicability and novelty of LC–MS based methods


for biotherapeutics,


since there are different modalities continu- ously introduced into the field. I expect ultra- sensitive, high-throughput, multiplexing and unique LC–MS strategies that may support dif- ferent drug discovery stages, and enable chal- lenged assays that may not be achievable by other techniques.


Disclaimer The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Future Science Group.


www.bioanalysis-zone.com


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