Advances in Mass spectrometry Biosimilars and LBA-Biomarker analysis
ABC Biologics welcomes you to attend the international conference on “Advances in Mass spectrometry, Biosimilars and LBA-Biomarker analysis”will be taking place in Bangalore on 22 September 2017.
Conference is anticipating more than 100+ attendees and 10 speakers across the globe. The conference is going to bring together research institutions and industries to explore and discuss the advances, challenges in mass spectrometry and bioanalysis. The conference will be addressing large molecule (protein and peptides), Biosimilar, Biomarker analysis more specifically.
The conference will also identify how industry and in particular the biosciences manufacturing sector can be the best supporters to meet the challenge of changing global biologics demands in health care sector.
High level scientists from the world class research institutions and top notch industry expert’s lectures are highlighting the conference. Conference is going to promote exchanging ideas between scientist and industry experts which strengthens the research networking skills and development.
This is an exceptional opportunity for industry beginners to learn more and experts to share the experiences to gain more knowledge.
The intending participants can confirm their participation by registering for the conference along with your colleagues. Avail the delegate’s early bird offer.
- The conference is aimed to present recent advances and challenges of mass spectrometry in bioanalysis (Biosimilars and LBA-Biomarkers). It is a common forum for discussing day to day research challenges in bioanalysis by using LC-MS/MS and other analytical instruments.
- A practical approach to “fit-for-purpose” validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies.
- Measurement or characterization in a biological matrix related to intended use like predictive, diagnostic, prognostic, theragnostic, PK/PD, patient selection/stratification, specific Vs pathways, actual/surrogate end point are going to be discussed as part of the LBA-biomarkers.
- A pragmatic approach on protein, peptide analysis through hybrid ligand binding-LC-MS/MS assays will be demonstrated during the session.
- Recombinant DNA-derived therapeutic proteins. Head to head comparison of biosimilar products, biosimilar products and it’s regulatory guidance, choice of reference product and establishing biosimilarity, data analysis and transparency in reporting will be addressed.
- Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
- This conference will provide a conclave for exchange of ideas and authoritative views by leading scientists as well as huge experiences in regulatory and biologics portfolio. The versatile speakers and pragmatic wise also take place which will catch the attention of the research scholars and academicians as well as professionals to attend. It will help to enrich the knowledge as well as current requirements of the global bioanalysis industry.
- Mass spectrometry in Bioanalysis (Biosimilars, LBA Biomarker)
- Advances and trends in mass spectrometry (LC-MS/MS more specifically)
- Novel detection technology in mass spectrometry
- Specificity and sensitivity issues in Bioanalysis
- Ionization and fragmentation of Biomolecules/Improved ionization techniques
- Software platforms and 21 CFR part 11 compliances
- Challenges and proven approaches in the development of LBAs
- Bioanalytical trends and due diligence in macromolecular assays
- LBA-MD,MV,PV,CV (validations) strategies and regulatory updates/audits
- Challenges in sample preparation and extraction techniques
- Characterization, storage of key reagents (antibodies, tracers, matrices)
- Cross reactivity of metabolites and endogenous estimation
- Evaluating stability experiments and handling failures
- Failure investigations and ISR conclusions
- Fit-for-purpose biomarker method validation approach
- Advanced approaches and techniques in disease diagnosis
- Biomarkers and its challenges in oncology-Molecular analysis
- Flow cytometry, GLP compliance, CAP,CLIA
- Biomarkers in pharma and medical regulations
- Case Studies – From Biomarkers research to commercial product
- Quality, safety, and efficacy of full licensed biotherapeutics products
- GMP and Regulatory compliance on evaluation of SBPs
- Intellectual property rights and licensing on SBPs and RBPs
- Analytical techniques and stability challenges in SBPs
- Equivalence and non-inferiority biosimilar designs
- Non clinical In-vitro/In-vivo assays and clinical PK/PD analysis and immunogenicity
- Comprehensive physiochemical and biological characterization
- Innovative techniques and strategies for improving novel SBPs
- Comparative studies between biosimilars and chemical drugs
- Quick reference to regulatory approved drugs for facts and useful information