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alliedacademies
Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
May 14-15, 2018 | Montreal, Canada
Global Summit on
Biopharma & Biotherapeutics
The presentation will look at a comparison of biologicals vs.
small molecules, highlighting some of the key challenges
inherent with biological molecules. Before looking at the main
degradation pathways for therapeutic proteins (taken as an
exemplar of complex biological molecules) and reviewing the
stability challenges facing biological development organizations.
The presentation will then focus on the “Cold Chain” challenge,
highlighting that over half of the top 50 biological drugs in
the world require cold chain, i.e. refrigerated storage and
distribution due to stability concerns. Cold chain storage and
transportation, and some of the challenges and regulatory
considerations will then be reviewed, focusing on global good
distribution practice (GDP) requirements before providing
concluding remarks to complete the presentation.
Speaker Biography
Dr. Elder has 40 years of service within the pharmaceutical industry, with Sterling,
Syntex and for the last 23 years with GSK. He is now an independent CMC consultant
with broad based experience in formulation and analytical method development.
Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr.
Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and
chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is
the immediate past chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a
member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences.
He has published over 131 papers in international journals and has given 17 webinars
and over 138 presentations at international symposia. He has co-edited a book on the
Analytical Characterization and Separation of Oligonucleotides and their Impurities
and on ICH Quality Guidelines.
e:
David P Elder
GlaxoSmithKline, United Kingdom
Stability, storage and cold chain supply of biologics