APR Nov/Dec 2022 - 25

« DRUG DEVELOPMENT
as well as a 2DLC main peak purity check to ensure appropriate
method selectivity at the earliest stages of development. To address
IPC control risks, a training program was implemented to ensure
method developers were better equipped to deal with the unique
characteristics of IPC methods. These examples highlight how
the risk survey program has led to and captured improvements in
our performance. However, this analysis also reveals that high and
medium level concerns were not completely eliminated and will
require more attention moving forward.
Conclusions
Here we have presented a risk survey program applied to the
analytical strategy for early to mid- stage development programs. It
is a simple assessment on the performance of analytical methods to
meet their desired stage-appropriate objectives, and it also serves
to capture knowledge and understanding of the method's merits
to improve future development. The risk survey can deliver clear
and actionable outputs because it's driven by evaluating real-world
method performance against consistent scientific expectations
and criteria. By performing risk surveys across a large and diverse
portfolio (>40 projects to date), the program has been able to identify
not only concerns within a given project, but also has the additional
benefits of driving consistent and improved work practices across
the analytical community.
We believe this program can be readily extended beyond small
molecule drug substance programs, such as biologics or drug
product analytical groups, due to similar quality requirements and
analysis techniques, although some modification of categories
and banding criteria would be necessary. By using the risk survey
process, any analytical team can reduce analytical risk in early
development, facilitate stage-appropriate analytical controls, drive
inter-project consistency, and identify improvements to method
development workflows.
References
1.
2.
3.
4.
5.
6.
7.
from Seton Hall University. She previously worked in Analytical Research
Department of Merck and Co. at Rahway, NJ. She joined BristolMyers
Squibb in 2005 where she is an analytical team leader within
Chemical and Synthetic Development. Her work has been focused on
CMC analytical supports for various projects on method development,
validation and transfer in support of process development and clinical
supply of drug substance synthesis.
Peter Tattersall, Ph.D. is a Director in Chemical Process Development
at Bristol-Myers Squibb Company in New Jersey. He received his
Ph.D. from the University of Manchester, UK. He previously worked in
Analytical Development at AstraZeneca, Wilmington. He joined BristolMyers
Squibb in 2003 where he is an analytical team leader within
Chemical and Synthetic Development. He supervises a small group of
analytical chemists working on method development, validation and
transfer in support of process development and clinical supply of drug
substance synthesis.
Qinggang Wang, Ph.D., is currently a Scientific Director in Chemical
Process Development in Bristol-Myers Squibb Company. He received his
Ph. D. in Analytical Chemistry from Tsinghua University, Beijing, China,
and joined BMS in 2003. His work has been focused on CMC analytical
supports for various projects within BMS portfolio, including small
molecules, synthetic peptides and oligonucleotides.
Jonathan Shackman is an Associate Scientific Director in the Chemical
Process Development department of the New Jersey Product Development
group at Bristol Myers Squibb. He received his two BS degrees from the
University of Arizona and Ph.D. in Chemistry from the University of
Michigan. He previously worked at the U.S. National Institute of Standards
and Technology followed as an Assistant Professor of Chemistry at
Temple University in Philadelphia, PA. He joined Bristol Myers Squibb
in 2010 where he primarily focuses on innovative analytical strategies
and technologies to rapidly advance drug development for both small
molecule and biologics from pre-clinical through marketed products.
ICH guideline 9 Quality Risk Management
ICH guideline Q3A Impurities in New Drug Substances
ICH guideline Q3C Impurities: Guideline for Residual Solvents
ICH guideline Q3D Guideline for Element Impurity
ICH guideline M7 Assessment and Control of DNA (Mutagenic) Impurities in Pharmaceutical
to Limit Potential Carcinogenic Risk
ICH guideline Q2 Validation of Analytical Procedures: Text and Methodology
Peter Tattersall, Qinggang Wang, Li Li and Brent Kleintop, NJCG Symposium, 25 Sep 2019
Author Biographies
Li Li, Ph.D. is currently a Senior Principal Scientist at Bristol-Myers
Squibb Company in New Jersey. She received her BSc. at Hunan Normal
University, MS from University of Minnesota at Twin Cities, and Ph.D.
Lianjia Ma, Ph.D. is an Associate Scientific Director in Analytical Division
of Chemical Process Development department within Pharmaceutical
Development at Bristol-Myers Squibb Company in New Jersey. He received
his MS from Iowa State University and Ph.D. from the University of
Minnesota at Twin City. He joined Bristol-Myers Squibb in 2005 where he
is an analytical team leader within Analytical Research and Development.
He worked as Principal Scientist in Celgene from 2018 to 2019 as CMC
analytical lead to support the development of drug substance and drug
product. He supervises a small group of analytical chemists working
on method development, validation and transfer in support of process
development and clinical supply of drug substance synthesis.
Adrian Doggett is a Senior Principal Scientist in the Analytical section of
Chemical and Process Development at Bristol-Myers Squibb Company in
the UK. He received his BSc from Liverpool John Moores University, UK. He
joined Bristol-Myers Squibb in 2002. Currently he is a member of a team
focusing on method development in support of process development.
He has a focus on LC and GC analysis where he is a subject matter expert
within BMS.
www.americanpharmaceuticalreview.com |
| 25
»
http://www.americanpharmaceuticalreview.com
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
