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JAIMA (Japan Analytical Instruments Manufacturers Association) / ETC (Enabling Technology Consortium) - - Beyond Biopharma Analysis – Characterization of New Pharmaceutical Modalities to Understand Its Active and Formulated State
Tuesday, March 09, 2021: 8:30 AM - 11:40 AM
Speaker(s)
Description
Analytical solutions for new pharmaceutical modality are presented focusing more on methods for understandings of formulated state and structure of protein for Biopharma & Biotherapeutics, therapeutic protein. Recent analytical methods by Raman spectroscopy, Cryo–EM, and X-ray crystallography are introduced together with data science approach for better understanding of analytical data for therapeutic protein development.
Additional Info
Presentations:
- Session Number: S25-01
- Tuesday, March 09, 8:30 AM - 9:05 AM
Precise atomic structures of drug-target molecules complexed with drug candidate molecule(s) or drug molecule(s) will give valuable information on drug development and/or drug optimization. The first structure of protein (myoglobin) was determined by X-ray crystallography in 1958. Since then, various techniques have been developed and improved, and recent progress on...
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- Session Number: S25-02
- Tuesday, March 09, 9:05 AM - 9:40 AM
It has been recently recognized that subvisible particles, mainly, protein aggregates, in biopharmaceuticals have potential to elicit immune responses and could possess the immunogenicity. Owing to recent development of analytical methods, subvisible particles and protein aggregates ranging from nanometer to micron range can be now properly monitored. Meanwhile, therapeutic proteins...
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- Session Number: S25-03
- Tuesday, March 09, 9:40 AM - 10:15 AM
The modality landscape has expanded to find medicines for targets that are undruggble with small molecules or protein therapeutics. Nucleotide-based therapeutics are popular, with several recent approvals and many candidates in pharmaceutical pipelines for modulating disease associated proteins. Protein over-production is druggable by small interfering RNA (siRNA) and antisense oligonucleotides...
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- Session Number: S25-04
- Tuesday, March 09, 10:30 AM - 11:05 AM
The ability to obtain data rich information of a chemical process at near real-time speeds is critical to fully understand and control a given procedure. The gold standard in measuring all components involved in a complex process is chromatography. Traditional chromatographic approaches require tedious steps such as manual sampling, sample...
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- Session Number: S25-05
- Tuesday, March 09, 11:05 AM - 11:40 AM
Damaging stresses to proteins occur at all stages of the life history of protein drug product, from manufacturing to delivery to the patients. To develop safe and effective protein products, it is critical to understand the mechanisms for aggregation and particle formation, and the mechanisms for protein stabilization against the...
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