Fully-Integrated Services for Global Therapeutics Development: Accelerating Progress and Time to Market with integrated CDMO Platforms and Laboratory Testing Services. WuXi Advanced Therapies leverages decades of laboratory testing experience to get your product to market faster and with greater predictability, by overcoming common industry constraints.

1. advancedtherapies.com
Accelerating Progress and Time to Market
with integrated CDMO Platforms and
Laboratory Testing Services
Fully-Integrated
Services for Global
Therapeutics
Development
WuXi Advanced Therapies leverages decades of laboratory testing
experience to get your product to market faster and with greater
predictability, by overcoming common industry constraints.
Services span the drug development process from early
preclinical-to-commercial support, including cell banking and cell
line characterization, analytical method development, QC lot
release and stability, viral clearance validations, and more.
Products we support include: cell therapies, gene therapy vectors,
viral vaccines, recombinant & fusion proteins, monoclonal &
bi/tri-specific antibodies, AB fragments, ADC, blood-derived
products, and tissues.
LABORATORY SERVICES BENEFITS
Comprehensive end-to-end services
ISO-certified facilities
Quality-driven cGMP capabilities
Global regulatory knowledge and guidance
Flexible, collaborative client partnerships
Strong communication, accurate timelines
Supporting both process and product testing
Methods transfer, development, optimization
2001
AppTec Laboratory Services is established,
made up of the St. Paul, Philadelphia and
Atlanta facilities; offerings feature integrated
biotherapeutics services.
2004
Robust QC Laboratory business
established, expansion into CDMO
operations for protein therapeutics.
2008
WuXi PharmaTech acquires AppTec.
CDMO manufacturing transitions to cell
therapies and testing services broaden.
2015 & 2016
Addition of 2 GMP manufacturing
facilities offering clinical-to-commercial
scale for advanced cell & gene therapies.
Focus on expanding analytical develop-
ment and platforms for QC release.
COMING 2019
Planned expansion of QC testing labs
in new 90,000-square-foot site in
Philadelphia that will double capacity,
enable launching of new capabilities,
and ensure security of supply.
2018
U.S. facilities and number of employees
surge in growth, with capabilities fully
supporting QC testing of all products, and
manufacturing of cell & gene therapies.
1981 - 1997
ViroMed Laboratories (est. 1981,
St. Paul) acquires Quality Biotech
(est. 1988, Philadelphia); and Axios
(est. 1995,Atlanta) in 1996-1997.
Decades of History Supporting Biologics & Advanced Therapies

2. Visit advancedtherapies.com to learn more or email info@advancedtherapies.com
WuXiATU-606-092718
Integrated
Testing Services
Preclinical Safety
In-Vivo Proof-of-Concept Studies
GLP Toxicology & Biodistribution
Dose & ROAAnalysis
Efficacy, tk/pK Studies
Starting & Raw Material Testing
Cell Line Characterization
Raw Material, Reagents Testing
Cell Growth/Morphology
Adventitious Agent Testing
Cell Line Genetic Stability
Next-Generation Sequencing
Process Development &
Characterization
cGMP Cell Bank Production
Product Characterization
Process Characterization
Impurities/Residuals Testing
Viral Clearance Validations
Extractables/Leachables of Single-Use Systems
QC Product Lot Release & Stability
Product Identity, Potency, Purity
Adventitious Agent Safety
Compendial Methods Testing
Assay Development & Transfer
Assay Qualification/Validation
In-process, Bulk & Final Product
ICH Compliant Storage Conditions
Container/Closure, Device,
& Product Packaging
Biocompatibility
Package Integrity Testing
Shelf Life / Stability Determination
Extractables & Leachables
Material Chemical Characterization
League Island 1 (LI1)
HQ for Testing & GMP Production
4751 League Island Blvd. / Philadelphia, PA
82,000 sq. ft. • Testing laboratories for virology,
QC analytical, molecular & cell biology, plus GMP
production of cell banks and cell & gene therapies.
League Island 2 (LI2)
Viral GMP Production
4701 League Island Blvd. / Philadelphia, PA
150,000 sq. ft. • Clinical and commercial
manufacturing of gene-mediated cell therapies
and viral vectors.
Commerce Center 3 (CC3)
Non-Viral GMP Production
4000 S. 26th St. / Philadelphia, PA
55,000 sq. ft. • Commercial-scale GMP
manufacturing & processing for cell therapies.
Center for In-Vivo & Medical Device
Solutions
2540 Executive Dr. / St. Paul, MN
83,000 sq. ft. • Biocompatibility/toxicology testing
and GMP contract manufacturing/processing for
tissue-based products.
Center for Analytical Chemistry
Solutions
2520 Pilot Knob Rd. / St. Paul, MN
18,000 sq. ft. • Analytical chemistry/materials
characterization and extractables/leachables
testing.
A new laboratory testing facility is to be added in 2019.
Facilities
Center for Microbial Solutions
1265 Kennestone Cir. / Marietta, GA
50,000 sq. ft. • Microbiology/microbial assays,
wet chemistry, sterilization validation and package
integrity testing.