Cell & Gene Therapy preclinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

1. CELL & GENE THERAPY
Preclinical Development Solutions
With specialized expertise, coordinated capabilities and focused
investments across preclinical, clinical and post-approval phases,
we’ll help you to reduce the time and risk in your product’s development.
Pharmacology
~300 human and mouse
cell lines (20+ cancer
histotypes)
Human xenograft and
mouse syngeneic tumor
models
In vivo imaging
Cellular content and
function elucidation
Flow cytometry
IHC and histology
Biomarkers
Strategy
Assay development
RUO and regulated
testing
Genomics and proteomics
Specialty services
Companion diagnostics
Bioanalysis
Biodistribution, persistence,
level and shedding of product
and/or transgene
qPCR, flow cytometry, ELISA
and imaging
Immunogenicity
assessment – NAb assays
Toxicology
Acute, tumorigenicity and
tolerability studies
Models: NHP, rodent and canine
Specialized routes of
administration
Dose confirmation – GLP
characterization
EU and social housing
Automated infusion
Jacketed External Telemetry
Delivering
development
solutions for
cell and gene
therapy products
20+
YEARS
Conducted
using cell and
gene products
in the last 4
years (mostly
in vivo)
300+
PRECLINICAL
STUDIES
Supported the development of
BOTH
GENE
REPLACEMENT
THERAPIES
Published
in peer-
reviewed
journals
FDA approved
CAR-T therapies and helped
advance the first 2 FDA-approved
10RD
PAPERS

2. CELL GENE THERAPY
Preclinical Development Solutions
Regulatory Strategic
Product Consulting
Target product profile
Regulatory agency interactions
Integrated development strategies focused on
value inflection points
Differentiation strategy
Scientific review and gap analysis
Regulatory review and registration path
Dossier assembly, publishing and submission
CMC Analytical Testing
Analytical control strategy development
Phase-appropriate method development and
validation
Safety, identity, strength, quality and
purity testing
Comparison of preclinical and clinical lots using
same qualified method(s)
Lot release and stability
Clinical Development Preparation
Unique datasets
– Ideal site selection
– Optimal patient recruitment
– More accurate forecasting
Project management and oversight
First in Human/dose range-finding design
Proof of Mechanism/Proof of
Concept design
Medical monitoring and specialized
training for AEs
Commercialization
Market access and strategy
Value communication
Evidence generation
Precision Medicine Solutions Designed Around You®
Visit us at www.covance.com/CGT
Covance is the drug, medical device and diagnostics business segment of LabCorp, a leading
global life sciences company. COVANCE is a registered trademark and the marketing name for
Covance Inc. and its subsidiaries around the world.
The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440
Europe / Africa +00.800.2682.2682 +44.1423.500888
Asia Pacific +800.6568.3000 +65.6.5686588
© Copyright 2019 Covance Inc. SSCGT003-0819
with Regulatory Agencies
(FDA, EMA, MHRA, PMDA,
NMPA) since 2015
(all product types
therapeutic areas)
57INTERACTIONS
of cell and gene therapy
product experience
7MODALITIES
conducted for cell and
gene therapies in the last
4 years
42+
CLINICAL STUDIES
in peer-reviewed journals
in the last 3 years
(across all areas)
130+
PUBLICATIONS