PharmaceuticalOutsourcingQ42020 - 51

SECTION
TITLE
ANALYTICAL
TESTING

Why Choose - When the Best Is
Both? LC-MS and Immunoassays
Jon Bardsley
Vertical Marketing Specialist for Pharma & BioPharma,
Thermo Fisher Scientific

Introduction
In past decades, innovation in biotherapeutics has led to significant
advances in the biopharmaceutical industry. These medicines are
similar in structure to molecules produced naturally in the human
body and can seek out highly specific targets in their treatment of
disease. As a result, they hold promise in treating a range of acute and
chronic conditions.
One highly successful class of biotherapeutic drugs uses monoclonal
antibodies (mAbs), complex proteins that have a proven therapeutic
effect for the treatment of cancer.1 Depending on their design,
these proteins can perform a range of valuable functions including
blocking cell growth, preventing immune system inhibition, driving
the destruction of cancer cell membranes, reducing blood supply to
cancer cells, delivering chemotherapeutic agents to defected cells
while avoiding healthy cells, and more. By mimicking the activity of
antibodies found naturally in the body, mAbs can bind to targeted
antigens, thus flagging them for removal, or can be used in diagnostic
studies aiming to detect and quantify the presence and prevalence
of antigens.
During preclinical analysis, a pharmaceutical organization may have
a dozen mAb candidates to assess. The evidence gathered at this
stage must allow for the go or no/go decision for a given candidate
therapeutic, to reduce risk of failure at a later development stage and
save significant costs. In parallel, the organization must develop the
proof points needed to demonstrate that the candidate will have the
desired therapeutic effect in the human body without dangerous side
effects or health consequences.

From Promising Candidate to
Effective Therapeutic
The preclinical analysis must be accurate, sensitive, selective, and robust to obtain the high-quality pharmacokinetic, pharmacodynamic,
and toxicokinetic data needed to reliably inform and enable important drug development decisions, and accelerate the right candidate
through the pipeline.
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51

Ligand binding assays (LBAs) have traditionally been labeled the
'gold standard' in therapeutic bioanalysis. LBAs are typically sensitive
and selective, as they utilize highly specific antibodies in their
implementation. However, it is cost-ineffective and time-consuming
to generate different antibodies for each biotherapeutic candidate.
LBAs can also suffer from matrix interference, with other sample
components - such as endogenous molecules similar to the analyte
itself - interfering with analysis. This vulnerability introduces potential
risk when transferring the method between matrices.
LBA limitations have led to the emergence of immuno-mass
spectrometry (immuno-MS) as an alternative method of analysis,
which combines the capabilities of LBA and MS to improve the
sensitivity and selectivity of these bioanalytical techniques. Whilst
conventional sample preparation methods for immuno-MS can be
labor-intensive and slow, recent advanced methods are minimizing
such limitations, and accelerating and simplifying the universal
bioanalysis of mAb therapeutic drugs at the preclinical phase.2 This
not only saves time during analysis but also enables organizations
to more accurately and confidently assess the probability of drug
development success earlier in the pipeline.

The Need for Data in Supporting
the Development of Successful
mAb Biotherapeutics
Biotherapeutics - including recombinant proteins and hormones,
cytokines, growth factors, vaccines, and many other types of
complex biomolecules - have accounted for almost half of drug
approvals in recent years. Within this class, mAbs are the most rapidly
growing molecule type for oncology, anti-immunity, and chronic
inflammatory diseases.3 An especially active subclass of mAbs is
found in immunoglobulin G subclass 1 (IgG-1) antibodies, which are
the most common subclass used for oncology, and can be structurally
modified to increase therapeutic efficacy while reducing potential
side effects.3
To develop a successful mAb biotherapeutic, pharmaceutical
organizations seek to identify a selective and potent molecule to
| 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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