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Bioanalysis of novel Biotherapeutic Modalities

Journal of Applied Bioanalysis will be publishing a specially focused issue dedicated to Bioanalysis of novel Biotherapeutic Modalities.The Journal of Applied Bioanalysis invites the submission of abstracts on topics related to the special issue topic. Abstract proposals will be used to select and invite papers for final review and consideration. Not selected papers for this special issue will be published in a separate regular issue of Journal of Applied Bioanalysis

 

Guest Editors:

Linzhi Chen PhD (Boehringer Ingelheim, USA) and Morse Faria PhD (PPD Laboratories, USA).

 

Introduction

The past decade has witnessed the rapid advancement and adoption of liquid chromatography / mass spectrometry (LC/MS) technologies for biotherapeutic analysis, largely driven by the ever-increasing trend of treating human disease with biotherapeutics. With advances in modern science and clinical experience, biotherapeutics are rapidly expanding to novel modalities, such as nanobodies, bispecifics, fusion proteins, conjugated monoclonal antibody products, etc., in targeting new and increasingly sophisticated therapies. Collectively, these trends amplify the increasing demand for improvement of existing analytical methodologies as well as the development of new tools to analyze and characterize these complex biological products in greater detail.

The majority of LC/MS biotherapeutic analysis focuses on product characterization, quality control and bioanalysis in support of preclinical and clinical developments. Compared to conventional methods (e.g., ligand-binding assays), LC/MS provides direct measurement of the analyte, rather than relying on indirect signals that come from one or more immune interactions. LC/MS has a wider linear dynamic range, greater selectivity, lesser reagent dependency, faster assay development, and capability of analyzing multiplexing targets at once.

There are a variety of bioanalytical strategies using LC/MS that are being developed and implemented to rapidly assess the wide variety of forms of biotherapeutics as they progress from preclinical discovery into clinical development. These strategies focus on innovative isolation techniques, including immunocapture/affinity enrichment, specific detection by LC/MS, and data processing strategies of various forms of a biotherapeutic protein including intact, reduced to subunits, and digested into specific peptides. In particular, hybrid immunocapture-LC/MS platform offers high selectivity and increased sensitivity by taking advantage of the high specificity of the immunoaffinity capture reagent and the resolution power of LC/MS. Recent advances in micro-flow UPLC has further improved LC/MS sensitivity.
This special issue is dedicated to recent development and applications in LC/MS bioanalysis of novel biotherapeutic modalities.

 

We would welcome the submission of manuscripts for this special issue on following topics (but not limited to):

- LC-MS Hybrid
- IA-LC-MS/MS
- Immunocapture
- Novel biotherapeutic modalities
- Monoclonal antibodies
- Antibody-drug conjugates
- Fusion proteins

 Manuscripts submitted, however not accepted for publication in this specially focused issue, but meeting all required publication standards of the Journal of Applied Bioanalysis, will be published in a regular journal issue. Author guidelines can be downloaded here. To submit your manuscript, please click this link

 

 The timeline for this special focused issue is as follows:

  • Manuscript submission opens on:   February 1, 2019.
  • Deadline submission of first drafts:  August 1, 2019.

 

Open Access Manuscript Fees

All content of Journal of Applied Bioanalysis is free accessible (open access). There are Article Processing Charges (APC) for this special focused issue of € 359

 

Manuscript submission

First-draft manuscripts have to be submitted via the Manuscript Manager submission and tracking platform. Submit your manuscript here  

 

 

Special Issue Editors

LC96x96

Linzhi Chen, PhD (Boehringer Ingelheim Pharmaceuticals, CT, USA).
Dr. Chen Dr. is a Sr. Research Fellow at Boehringer Ingelheim Pharmaceuticals. He received his Ph.D. in organic chemistry from the University of Mons, Belgium where he studied gas-phase ion chemistry by mass spectrometry. After completed his postdoctoral research on ion-molecule reactions, he began his industry career with 3M Co. where he spend 5 years on metabolite identification/profiling, bioanalysis and pharmacokinetics. He joined Boehringer Ingelheim Pharmaceuticals in 2001 to lead a bioanalytical group in support of small molecule drug development. In recent years he has been providing LC/MS-based bioanalytical support to biotherapeutic development programs, and developed a number of LC/MS assays for various biotherapeutic proteins such as nanobodies, Fabs, bispecifics and mAbs, as well as oligonucleotides. His group also developed immunocapture-LC/MS methodology for simultaneous ADA isotyping and semi-quantitation. His recent interest focuses on LC/MS determination of in vivo biomodifications of biotherapeutics and their impact on PK/PD.

 

MF 96x96

Morse Faria, PhD (PPD Laboratories, Richmond, VA, USA).
obtained his bachelor degree in Pharmaceutical sciences from Goa University, India in and Master of Pharmacy degree from University of Mumbai, India. He completed his Ph.D. in Pharmaceutical Sciences from Virginia Commonwealth University, USA. He is currently working as a Research Scientist at Pharmaceutical Product Development, USA. Prior to obtaining his Ph.D., Dr. Faria worked as Research Associate at Wockhardt Ltd., Mumbai, India and as a Lecturer in Pharmacy, University of Mumbai, India. He is a reviewer for various bioanalytical journals including Bioanalysis, Journal of Chromatography B and Journal of Pharmaceutical and Biomedical Analysis. Dr. Faria’s main area of research focus is quantitative bioanalysis using liquid chromatography and tandem mass spectrometry (LC-MS/MS). He specializes in bioanalysis of protein molecules (biomarkers and biotherapeutics) from biological specimens to support drug discovery and drug development.

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