VVT Process Flow Overview Brochure

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Partner with BioReliance® Services for

Faster Vector Production and Testing


World-class process development and manufacturing for viral therapeutic
products. From small scale to large scale manufacturing and fill finish, we have
Draw On Our
Experience
the proven commercial execution and regulatory expertise to drive the success
of your program.

25 years
of experience working with a broad
>500
Clinical production lots
LENTIVIRUS, AAV,
ADENOVIRUS,
RETROVIRUS for Viral Vector Manufacturing
range of platforms and vector systems for Phase 1 – Phase 3

>1m
Global
Quality vials filled
System

Benefit from our wealth of experience and best-in-class biosafety and


characterization testing of clinical and commercial products, including:
• Comprehensive cell bank manufacturing, testing, and storage services
• Viral bank manufacturing, testing, and storage services
• A portfolio of gene therapy-specific platform assays and routine testing services
• Custom assay development services to support your unique testing needs
• Consultative CMC regulatory compliance guidance offered by industry experts

Upstream Processing Downstream Processing


Services Services

Cell Lines & Virus Seeds Viral Clearance


Production and Testing Services
Identity Safety

Raw Material & Drug Substance


Plasmids Testing Testing
Biosafety &
Characterization
Testing Merck
Cell & Virus Drug Product Frankfurter Strasse250
Characterization Release Testing 64293 Darmstadt, Germany
MerckMillipore.com
Potency Purity

© Merck KGaA, Darmstadt, Germany and/or its affiliates. Merck, Benzonase, BioReliance, Cogent, Fractogel, Integritest, Lit. No. MK_BR3311EN Ver. 1.0 The life science business of Merck
Millipak, Millipore, Millistak, Mobius, Natrix, Novaseptum, Pellicon, SAFC, M Lab and the vibrant M are trademarks of Merck 1/2021 operates as MilliporeSigma in
KGaA, Darmstadt, Germany. All other trademarks are the property of their respective owners. More information on our the U.S. and Canada.
branded products and services on www.merckmillipore.com.
Integrated Vector Production Solutions
Mobius® Single-Use
Manufacturing
EX-CELL® VirusExpress™ NovaSeptum®
Mobius®
Millistak+® Mobius® FlexReady Benzonase®
Mobius® Single-use technologies to
CD Insect Lentiviral GO Sterile HC Pro Synthetic Solution for Endonuclease
200L Bioreactor Power MIX meet your changing
Cell Medium Production Sampling System Depth Filter Clarification Safety Plus
Platform Emprove® Expert manufaturing requirements

Cell Culture Nucleic


Cell and Virus
Media and Clarification Acid
Early PD
Growth
services Cell Lines Digestion

Raw Cell & Virus


Unpurified
Bank Production, Validation
Materials Bulk
Testing Viral & Gene Therapy Characterization
& Storage Services Testing
Validation
Services
Manufacturing
Viral vector manufacturing
from development through
commercialization.
Mobius®
Fractogel® Mobius® FlexReady Pellicon® 2
Pellicon® 2 Cogent® FlexReady
EMD IEX Solution for Ultrafiltration
XL50 TFF System Solution
Chromatography Chromatography Cassettes
for TFF
Resins

Ultrafiltration/ Chroma- Ultrafiltration/


Diafiltration tography Diafiltration
From solving your unique upstream and downstream
challenges, to meeting urgent manufacturing timelines, and Validation
Validation Viral Services
navigating uncertain regulatory guidelines, a knowledgeable Services Clearance

partner can help move your cell and gene therapy from hype
to hope.

At Merck, we’re giving shape to cell and gene therapy development


Excipients for
Millipak® Final
every day. We bring 30+ years of expertise, and a global Gene Therapy
Fill Filters
Formulation
organization to integrate leading manufacturing technologies with
process development, scale-up, safety testing, and the regulatory
experience to meet your therapy’s needs.

Draw on our experience to bring your cell and Final Filtration


gene therapies to life.
Final
Validation
Product
Services
Testing

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