Quality Control
of Viral Vaccine
and Viral Vector
Production
Growing in
Importance
While inactivated or live attenuated vaccines dominate Quality Control of the Viral Vaccine
the market today, a new generation of viral vaccines
known as recombinant viral vectors or virus-like-par- and Viral Vector Production
ticles (VLPs) are in the pre-clinical and clinical devel-
opment phases. Viral vectors are also widely used for Process — Ensuring That Your
gene therapy and oncolytic applications.
Product Is Safe, Effective, and Pure.
Take a look at the example production process map,
with the most important QC applications, and see
where our products and services can help you over-
come some of your quality control challenges from
master viral seed (MVS) and master cell bank (MCB)
all the way to final product release testing.
Raw material testing In-process control Final release
Find out more
For more information, please visit
sartorius.com
Sartorius QC Solutions Upstream Process
9 Biosafety and Characterization 3 Mycoplasma Testing
3 Mycoplasma Testing 4 Bioburden
5 Virus Analytics
9 Biosafety, Replication
l m n Competence and
Unprocessed Characterization
Cell Bank Virus Seed
Bulk Harvest
a b Optional: c
Microcarrier
Seed Expansion Virus Propagation Removal; Cell Removal Bulk Harvest
Cell Lysis
1 Viability and Cell Count 1 Viability and Cell Count 5 Virus Analytics
2 Metabolites Measuring 2 Metabolites Measuring
4 Bioburden
5 Virus Analytics
k
Media Preparation Medium, Feeds
9 Biosafety and Characterization
3 Mycoplasma Testing
4 Bioburden
Typically performed by the vendor
Your Application
1 2 3
Viability and Cell Count Metabolite Measurement Mycoplasma Detection
Gives information about viable cell Gives information about the pro- Detect mycoplasma within three hours.
density in your cell culture; Allows ductivity, biochemical status, and
automated cell bleed for perfusion lifecycle of your cells; Allows auto- Process Steps: k l m n o p q
processes or inoculation of seed mated feed control based on glu-
trains. cose measurements.
Process Steps: a b Process Steps: a b
Sartorius Solutions
In-line monitoring and control of On-line monitoring and control Microsart® Mycoplasma AMP qPCR kit —
viable biomass in cell culture pro- of glucose and lactate with a rapid, reliable, and easy-to-use solution in
cesses with BioPAT® ViaMass BioPAT® Trace compliance with international guidelines
Fully automated control of the cultivation process Reduce time-to-result significantly
Downstream Process
5 Virus Analytics
4 Bioburden
d e Inactivation f g h
(optional Buffer
Clarification Concentration by vaccine Capture Polishing
Exchange
production)
o
Buffer Preparation Buffer
9 Biosafety and Characterization
3 Mycoplasma Testing
4 Bioburden
Typically performed by the vendor
4 5 6
Microbial Contamination Virus Analytics Sterility Testing
Control | Bioburden Testing Real-time tracking of virus titer Proof of sterility by membrane filtration method
Count the number of microbes in during growth, harvest, purifica- or rapid testing.
your sample using touch-free tion, and release allows process
membrane transfer to agar. optimization and early detection Process Steps: j
of problems.
Process Steps: b d e f
Process Steps: b c d e
g h i k n o p q
f g h i j n p q
Microsart @filter and @media Virus Counter® 3100 Platform Batch release sterility testing with Rapid sterility testing
membrane filtration method for rapidly and precisely quantifies the Sterisart® NF canisters and based on qPCR
forceps-free and effortless total virus particles, providing Universal pump in compliance
membrane transfer results in minutes with international pharmacopeia
Minimize risk of Quantify a wide range Easy handling and reliable Know results in just 3
hours
cross-contamination of viruses and VLPs test results
Fill and Finish
9 Biosafety
3 Mycoplasma Testing
4 Bioburden
p
Buffer Preparation Buffer
i j
Sterile
Drug Substance Formulation Filling Drug Product
Filtration
4 Bioburden q 6 Sterility
5 Virus Analytics 5 Virus Analytics
9 Biosafety and Excipient Preparation Excipients 9 Biosafety and
Characterization Characterization
Product and process related Product and process related
impurities, product purity impurities, product purity
Potency, identity, quantity 9 Biosafety and Characterization Potency, identity, quantity
Advanced physico-chemical 3 Mycoplasma Testing Advanced physico-chemical
characterization 4 Bioburden* characterization
* depending on the nature of the excipient
7 8 9
Microbial Air Monitoring Data Analytics Biosafety and Characterization Testing Service
Quantitative detection of airborne Analysis and interpretation of Sartorius Cell Line and Media Testing Solutions (CL&MTS) is a
microorganism. complex data. leading Contract Testing and Research Organization specializing
in biosafety, biological activity, physico-chemical and structural
Process Steps: specified rooms, Process Steps: throughout the analyses.
clean rooms and filling lines manufacturing process
Process Steps: i j k l m n o p q
Active air monitoring with MD8 Analyze and interpret complex Endotoxin:
Airscan®—agar-free, continuous data to efficiently develop new Chromogenic LAL test, compliant to USP and EP requirements
air monitoring products, and control quality and
Virus testing:
costs
Endogenous viral particles, adventitious virus, retrovirus assays,
virus and vector shedding
Product Impurities:
UPLC assays, SEC for aggregates stability studies
Process Impurities:
Residual Host Cell Proteins by ELISA, Residual DNA by qPCR
Ensure the most accurate Identify efficiently critical Release your final product safer and more
data over an 8 hour period process parameters cost-effectively
Planning for Quality Control Testing: Sample and Buffer Preparation
Contamination costs time and money. Improve the reliability of your analytical results and ensure speed-to-market
by investing in appropriate contamination prevention products.
Sampling and Aseptic Fluid Transfer Clarification and Filtration Concentration and Purification of
TAKEONE® Aseptic Sampling System, Sartoclear Dynamics® Lab V50 kits: Viruses
MYCAP® Bottle Closures, and QUICK- Virus harvesting in one step. Kits com- Vivapure® Virus Purification and Con-
SEAL® Aseptic Disconnect bine a vacuum filtration unit, Sartolab® centration Kits. Adenovirus Purification
RF 50 with a 0.45 µm PES membrane, with AdenoPACK kits and Lentivirus
and a filter aid for clarification. Purification with LentiSELECT kits
Pharma Compliant Weighing
Cubis® II Premium Lab Balances. Sartorius’s Cubis® II is designed to follow
US FDA data integrity principles that require data to be accurate, legible,
contemporaneous, original, and attributable (ALCOA). The Cubis® II balance,
with pharma package, contains all the technical controls to support full compli-
ance with common regulations.
See more Sample Preparation Solutions!
sartorius.com/en/applications/quality-control-testing/sample-preparation-qc
Service and Training
A comprehensive offering that includes qualified personnel, ensuring high-quality results and optimal operation.
Sales and Service Germany USA
Sartorius Lab Instruments Sartorius Corporation
Contacts GmbH & Co. KG 565 Johnson Avenue
Otto-Brenner-Strasse 20 Bohemia, NY 11716
For further contacts, visit 37079 Goettingen Phone +1 631 254 4249
sartorius.com Phone +49 551 308 0 Toll-free +1 800 635 2906
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Printed in the EU or US on paper bleached without chlorine.
Version 1 | 2020 | 02
