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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
May 14-15, 2018 | Montreal, Canada
Global Summit on
Biopharma & Biotherapeutics
T
he presentation will look at the role of impurities in
complex biological molecules. Typically, there are
no therapeutic benefits to be derived from impurities.
Therefore, all impurities should be removed or controlled
to the extent possible to meet product specifications, good
manufacturing practices (GMP), or other quality or safety-
based criteria and drug products should contain no higher
levels of residual impurities than can be supported by safety
data and/or process capability. The focus will then switch to
regulatory requirements for impurities that are enshrined in
ICH Q3A / ICH Q3B and ICH Q6B; as well as other related
impurity guidance for residual solvents (ICH Q3C), residual
elemental impurities (ICH Q3D) and residual mutagenic
impurities (ICH M7).
The presentation will then focus on the typical types of
impurities in biological molecules before looking at an
assessment of the process capability (Cpk) and impurity
purging capability of the process. Then the focus will switch
to allowable safety margins and the typical risk assessments
that are needed to support the safety margins, before
providing some concluding remarks.
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:
davidelder2110@gmail.comSetting impurity specifications for biologicals
David P Elder
GlaxoSmithKline, United Kingdom