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SECTION
TITLE
ANALYTICAL
TESTING

that can be applied to, for example, all antibodies of type IgG-1 in
animal serum matrices at the pre-clinical phase. With immuno-MS,
drug developers can utilize antibodies that are specific enough to
identify a compound from the matrix at the preclinical stage, and then
later increase antibody specificity as needed. The ability to progress
preclinical testing at high throughput while such antibodies are
being developed is hugely valuable in keeping production moving
and helps to eliminate costly bottlenecks and downtime.
Developed immuno-MS2 methods have also demonstrated the
ability to monitor the structural integrity of mAbs in vivo during
quantitation, a valuable benefit that enables more comprehensive
knowledge of drug metabolism and behavior. Overall, immuno-MS
minimizes the hurdles to biotherapeutic analysis, enables significant
optimization of preclinical processes, and increases confidence
when moving from preclinical to clinical testing. This essential step
defines whether a therapeutic product - and, by extension, the drug
developer themselves - is likely to experience success or failure.

Conclusion
Innovative methodologies are accelerating the development and
bioanalysis of novel biotherapeutic drugs, and enabling organizations
to more accurately assess candidate antibodies at earlier stages in the
pharmaceutical pipeline.
By combining the benefits of the 'gold standard' immunoaffinity
assays traditionally used in bioanalysis and the precise detection
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capabilities of MS, immuno-MS methods enable an accurate,
sensitive, selective, and robust preclinical analysis of mAb drugs.
Techniques based on immuno-MS are becoming increasingly popular
in preclinical analysis, reflecting their ability to optimize this stage
of drug development. As a result of its increased automation and
fast, streamlined sample preparation protocols, immuno-MS can
achieve good sensitivity, speed, and robustness. Unlike techniques
based solely on immunoassays, immuno-MS can be applied to
large subclasses of antibodies in all animal serum matrices without
modification, removing the need to develop new antigen-specific
antibodies for each individual biotherapeutic candidate at an early
stage (typically done at a high cost and on long timelines).
The fast, reproducible, universal approach of automated immuno-MS
optimizes the process of developing successful and effective drug
products, protecting organizations from the delays, costs, and pitfalls
of biotherapeutic production - and helping to make these hugely
promising therapies available to the patients that need them.

References
1.	 Pento, J.T., (2017) Monoclonal Antibodies for the Treatment of Cancer. Int J of Cancer
Research and Treatment
2.	 Tang, J., Zhang, X., Zhou, Y., Min, D. (2020) A fast and simple immuno-mass spectrometry
method for preclinical bioanalysis for IgG1 mAb. App note 73684.
3.	 Johnson, D. E. (2018) Biotherapeutics: Challenges and Opportunities for Predictive
Toxicology of Monoclonal Antibodies. Int J Mol Sci. 2018 Nov; 19(11): 3685.
4.	 Kraljevic, S., Stambrook, P. J., and Pavelic, K. (2004) Accelerating drug discovery. EMBO
reports 2004 Sep; 5(9): 837-842.

Jon Bardsley has over a decade of experience in DMPK and
regulated bioanalytical studies within large pharmaceutical
environments. His passion for the development of robust and
accurate analytical methods for high-throughput studies
has seen him also gain experience working in contract
research organizations. Jon sits on the Reid Bioanalytical committee of the
Chromatography Society and is a subject matter expert in the bioanalysis
community. Following a period as Senior Applications Specialist for
Chromatography, Jon now holds the position of Vertical Marketing Specialist
for Pharma & BioPharma within Thermo Fisher Scientific, to bring relevant
technologies together to help solve customer challenges.
| October/November/December 2020


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PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
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