By Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com
I always look forward to the AAPS National meeting. It is
the one time of year in which I can re-connect with old colleagues, clients and
other friends in the industry. It never ceases to amaze me the inter-connectedness
of the industry and shows that it is truly a small world. The conference
presents multiple opportunities to hear about the latest developments in the
field, but also to present our own data. I have the privilege of participating
in a number ABC laboratory presentations.
On Tuesday, October 27, Exhibitor Seminar Room 4
·
Analytical Method Transfer: Practice and
Pitfalls
Dr. Wayland Rushing and Dr. Glenn
Petrie
This seminar will outline how to
plan and execute a successful method transfer. This process is oft times not
given proper attention and is seen as a “check box” activity. However, there
are multiple hazards arising from this attitude that can result in a tremendous
loss in time and money. Dr. Rushing and I will discuss method appropriate best
practices, as well as several case studies.
·
The Critical Role of CMC in Your IND Submission
Dr. Glenn Petrie and Dr. Wayland
Rushing
Submitting an IND is a tremendous
task, particularly the CMC section. This seminar will cover various aspects of
CMC including:
o
General requirements
o
Minimal requirements and safety
o
The CMC continuum
o
Risk and Reward: Analytical, formulation and
Stability
The goal is to provide information
to optimize your CMC section in terms of time and money, resulting in a
successful IND submission.
On Thursday, October 29, 10:30-11:30 AM, Exhibit Hall WA3
I will be presenting Poster R6208 “Development
and Validation of a Polysorbate 20 Assay in a Therapeutic Antibody Formulation
by RP-HPLC and Charged Aerosol Detector (CAD).
o
Polysorbate 20 is a key excipient utilized in
biotherapeutic formulations. This poster examines the validation data for an
accurate and precise method for assay of Polysorbate 20 in the presence of a
high concentration of monoclonal antibody.
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