Quality Control ofMonoclonal Antibody
Production Process

Upstream
Upstream Process
Process

Sartorius QC Solutions

1 Octet/mAb Quantification
4 Bioburden Testing
5 Mycoplasma Testing
7 Microbial Air Monitoring
9 	Cell Line, Media and Testing Services

5 	Mycoplasma testing
7 Microbial Air Monitoring
9 	Cell Line, Media and Testing Services

Cell Banka

Unprocessed
Bulk Harvest

bed

Seed Expansion

Production

1 Octet/mAb Quantification
2 Viability and Cell Count
3 Metabolites Measurement

Cell Removal

Bulk Harvest

1 Octet/mAb Quantification
2 Viability and Cell Count
3 Metabolites Measurement
4 Bioburden Testing7 Microbial Air MonitoringcMedia Preparation

Media, Feeds

4 Bioburden Testing
5 Mycoplasma Testing
9 Cell Line, Media and Testing Services

Sartorius Solutions

Your Application

Typically performed by the vendor

1
OCTET GxP Solutions

2Viability and Cell Count

3
Metabolite Measurement

GxP compliant solution for stability indicating and product lot
release testing through ligand binding and potency assays
as well as in-process testing including host cell protein (HCP)
and residual protein A (RPA) detection.

Gives information about viable celldensity in your cell culture. Allows
automated cell bleed for perfusion
processes or inoculation of seedtrains.

Gives information about theproductivity, biochemical status,and lifecycle of your cells. Allows
automated feed control based on
glucose measurements.

Process Steps:

bdeg

hk

Process Steps:

bd

Process Steps:

GxP compliant Octet Systems; includes 21 CFR part 11­software, IQ | OQ and PQ kits. For mAb quantitation, potency
and specificity to target analysis

In-line monitoring and controlof viable biomass in cell culture
processes with BioPAT® ViaMass

Increase your analytical testing capacity

Fully automated control of the cultivation processbd

On-line monitoring and control ofglucose and lactate with BioPAT®
Trace

Downstream
Downstream Process
Process
1 Octet GxP Applications
4 Bioburden Testing
7 Microbial Air Monitoring
9 	Cell Line, Media and Testing Servicesg

Downstream

Concen­trationClarifi­cation

CaptureVirus
Inactivation

Polishing

Virus
Clearance

BufferExchangef
Buffer Preparation

Buffer

4 Bioburden Testing
9 Cell Line, Media and Testing Services
Typically performed by the vendor

4Microbial Contamination Control
Bioburden Testing | Rapid Testing

5Mycoplasma Detection

6Sterility Testing

Detect mycoplasma within hours.

Confirm that your products
are sterile and free of any microbial
contamination using the closedsystem membrane filtration method.

Count the number of microbes in your sample using
touchfree membrane transfer to agar or alternatively a rapid­PCR-based total ­bacteria and fungi test.

Process Steps:

cde

fg

hij

Process Steps:

ace

Process Steps:

kMicrosart @filter and @media
membrane filtration method forforceps-free and effortless
membrane transfer

Rapid microbial contamination
control based on qPCRMicrosart® Mycoplasma AMP
qPCR kit – a rapid, reliable, andeasy-to-use solution in compliancewith ­international guidelines

Batch release sterility testing withthe Sterisart® NF canisters andUniversal pump in compliance withinternational pharmacopeia

Minimize risk of cross-contamination

Know results in just 3 hours

Reduce time-to-result significantly

Easy handling and reliable test resultsFillandandFinish
FinishFill
4 Bioburden Testing*9	Cell Line, Media and Testing ServicesiBuffer Preparation

hDrug Substance

Formulation

BufferkSterile
Filtration

FillingDrug Productj

1 Octet GxP Applications
4 Bioburden Testing
7 Microbial Air Monitoring9 	Cell Line, Media andTesting Services

Excipient Preparation

Product and process related
impurities, product purity
Potency, identity, quantity
Advanced physico-chemical
characterization and pre-­developed biological assays
for mAbs.

1 Octet GxP Applications
6 Sterility Testing
7 Microbial Air Monitoring
9	Cell Line, Media andTesting Services

Excipients

Product and process related
impurities, product purity
Potency, identity, quantity
Advanced physico-chemical
characterization and pre-­developed biological assays
for mAbs.

4 Bioburden Testing*
9 Cell Line, Media and Testing Services* depending on the nature of the excipient

7Microbial Air Monitoring

8
Data Analytics

9Cell Line, Media, and Testing Service

Quantitative detection of airborne
microorganism.

Analysis and interpretation ofcomplex data.

Sartorius Cell Line and Media Testing Solutions (CMTS)
combines Cell Line Development with Media provision,
Cell Bank Manufacture and Testing, and Biosafety Testing
and Characterisation of your mAb product. Our testingteam specialise in ready to use solutions in biosafety, biological activity, physico-chemical and structural analysesof mAbs.

Process Steps:

adeghkspecified rooms, clean roomsand filling lines

Process Steps:
throughout the manufacturing process

Active air monitoring with MD8Airscan® – agar-free, continuous air
monitoring with gelatine membranefilterAnalyze and interpret complex data to efficiently develop new products, and control
quality and costs

Process Steps:

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hijk

Endotoxin: Chromogenic LAL test, compliant to USP andEP ­requirements
Virus testing: Endogenous viral particles, adventitious
virus, retrovirus assays,virus and vector shedding
Product Impurities: UPLC assays, SEC for aggregatesstability studies
Process Impurities: Residual Host Cell Proteins by ELISA,
Residual DNA by qPCR
Product Characterization: PhysChem, ADCC, CDC,ADCP, Binding kinetics, cell based potency assays.

Ensure the most accurate data over an
8 hour period

Identify efficiently criticalprocess parameters

Release your final product safer and more cost-effectively

Growing inImportanceAs the significance of biopharmaceuticals continues torise, so does the need for analytical testing. Due to theircomplexity, QC testing of biopharmaceuticals is often
even more challenging than for classical pharmaceuticaldrugs. Within the biopharmaceutical market, monoclonal
antibodies have been widely adopted due to their ability
to offer specifically targeted treatment and fewer side
effects.

Quality Control Testing in
the Production of Mono­clonal Antibodies (mAbs)
Ensuring That Your Product Is Safe,
Effective and Pure.

Are you looking for more confidence in your quality testing?
Compliance is the basis for this. To support your daily
routine work we offer you		 simplified workflows		 accelerated time to results		 reduced risk of contaminations
The following figure shows a generic workflow for­monoclonal antibody (mAb) production with analysis
points for quality control applications.
Take a look at the workflow-application map and see
where our products and services can help you overcome
your quality control challenges.

Raw material testing

In-process control

Final release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.

Buffer and Standard Preparation
Semi-automatic preparation and documentation of highly reproducible HPLC calibration
standards with the Cubis® MSA high capacity
micro balance.

Arium® Type 1 Ultrapure Water Systems
The Arium® UV and Arium® Pro ultrapure labwater systems provide high quality Type 1 water
for analytic and life science application.

Clarification and Sterile Filtration with Sartoclear­Dynamics® Lab V50 kits: harvesting in one step.
Kits combine a vacuum filtration unit, Sartolab®
RF 50 with either a 0.2 µm or a 0.45 µm PES
membrane, and a filter aid for clarification.

Clarification or Sterile Filtration of media andaqueous solution up to 5 Liters with pressurefiltration units
Sartolab® P20 & Sartolab® P20 Plus units.
Pharma Compliant WeighingCubis® II Premium Lab Balances. Sartorius’s Cubis® II is­designed to follow US FDA data integrity principles that­require 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 compliance with common regulations.

See more Sample Preparation Solutions!
www.sartorius.com

Germany
Sartorius Lab Instruments GmbH & Co. KG
Otto-Brenner-Strasse 2037079 Goettingen
Phone +49 551 308 0

 or further contacts, visitFwww.sartorius.com

Specifications subject to change without notice.
Copyright Sartorius Lab Instruments GmbH & Co. KG.
Status: 10 | 2020

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ensuring high-quality results and optimal operation.

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Phone +1 631 254 4249
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