BalanCD CHO Media Platform...BALANCD CHO MEDIA PLATFORM | 11 Platform Media & Feeds for Bioproduction Providing seamless workflow and scalability Microliter / Milliliter > 10,000 L

BalanCD CHO Media PlatformACCELERATE YOUR DEVELOPMENT OF THERAPEUTICS FROM DISCOVERY TO COMMERCIALIZATION

A Foundation for Life

BalanCD CHO Media Platform

Delivering reliable, consistent results The BalanCD CHO Media Platform is an extended portfolio of chemically-defined, animal component-free growth and feed media formulated using Rational Culture Media Design. This multidimensional approach uses sequential, complementary media development methods to leverage our scientists’ knowledge of the effects of components and process parameters. The result is a media platform that delivers the precise combination of nutrient to maximize productivity, growth, and viability of CHO cell lines.

2 | FUJIFILM IRVINE SCIENTIFIC

DISCOVERY

CELL LINEDEVELOPMENT

PROCESSDEVELOPMENT

& SCALE-UP GMPMANUFACTURING

Media solutions for early stage to commercial production… and everything in between

• All BalanCD CHO Growth Media and Feeds are formulated for industrial applications and transition smoothly into commercial production

• Purpose-built formulations for fed batch bioprocesses

• Rational Culture Media Design approach ensures scalability to commercial production

• Manufacturing facilities in California and Japan utilize

the same global raw material sources to ensure an uninterrupted, reliable supply

• cGMP Compliant Manufacturing, FDA-regulated ISO 13485:2016 certified, EN 13485:2016 certified

• No extraneous components to complicate bioproduction or introduce unnecessary risks and costs

• Document packets (ie, Certificates of Analysis, Certificates of Origin, Drug Master Files) help fast-track the regulatory approval process

Reliable Supply and Support

FUJIFILM Irvine Scientific has become our trusted commercial manufacturer. We have established a good working relationship throughout all departments. They are responsive, willing to work with our constraints, and ready to adapt to our changing needs.

Satish Chandran CEO, Somahlution Inc., USA

BALANCD CHO MEDIA PLATFORM | 3

The BalanCD CHO Media Platform fosters growth and production at all phases, from discovery to production.

The platform includes:

BalanCD Transfectory CHO

BalanCD CHO Growth A

BalanCD CHO Feed 4

BalanCD CHO Feeds 1 through 3

All BalanCD CHO products can be tailored to suit your unique requirements; everything from formula, batch size, and packaging can be customized to your needs and preferences.


Maximize your protein yieldwith Transfectory Supplement

Adding this concentrated hydrolysate supplement increases cell growth and protein expression level while maintaining viability and efficiency.

BalanCD Transfectory CHO SystemA vital first step toward commercialization

Medium and supplements for rapid, scalable, high-yield protein production

• Produces milligram to gram-scale yield of recombinant proteins using a simplified and affordable protocol

• Supports small- and large-scale transient transfection in CHO cells

• Minimizes risk of critical quality attributes changing when progressing from transient host to stable host

BalanCD Transfectory CHO transient expression medium is a great product for cost-conscious researchers. It enabled us to produce protein at a cost of less than 40% of the cost incurred using other vendors’ products. We’ve been able to pass those savings onto our customers, giving us an advantage in a competitive marketplace.

Lake Pharma

The BalanCD Transfectory CHO Advantage

Choice Speed Efficiency

• Customizable protocols to fit individual needs

• Chemically-defined formulas to achieve high yields

• Transfectory Supplement for maximized yields

• Scalable protocol eliminates need to exchange medium before or after transfection

• Quickly achieves high protein yields

• Saves time and reduces development costs vs conventional stable cell line development

• Compatible with most commercially available transfection reagents (e.g. polyethyleneimine [PEI])

• Produces high yields of transiently expressed proteins

• Avoids need to switch from HEK293 to CHO cells for a seamless transition between early phase development to scale-up


Enhance Productivity and Growth

Figure 1. CHO-3E7 Cells were cultured in duplicate 125 mL Erlenmeyer flasks with a 30 mL working volume. PEI-mediated transfection was performed on day 3 to produce a biosimilar antibody. Transfectory Supplement was added to one of the BalanCD Transfectory CHO test conditions one day after transfection. Cultures in Medium B were terminated on day 7 due to poor transfection. Cultures in Medium C were terminated on day 9 due to poor viability. All data shown are the average of duplicate cultures.

Viable Cell Density Post-transfection Cell Viability

Days post transfection

1 2 3 7 9 11 14Via

ble

cel

l den

sity

(x10

6 cel

ls/m

L)

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Transfectory CHO + SupplementTransfectory CHO

1 2 3 4 7 9 11 14


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Medium AMedium B

Antibody Production

1000

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0 4 7 9 14


Medium C


Ideal for diverse applications, BalanCD CHO Growth A delivers scalable, reliable, and exceptional productivity at every step of development.

BalanCD CHO Growth AProviding exceptional productivity & flexibility

A chemically-defined, animal component-free growth medium for optimized cell line development.

• Designed to maximize CHO cell growth, viability, and productivity at every development step and at any scale

• Thoughtfully balances key nutrients with an emphasis on maintaining protein quality

• Flexibly supports a range of CHO cell lines

• Pair with BalanCD CHO Feed 4 for maximum productivity of high producing cell lines

The BalanCD CHO Growth A Advantage

Flexibility Foundation Consistency

• Allows nutrient density control with a slightly leaner growth medium

• Fosters synergistic interaction between growth and feed media in fed-batch culture

• Provides tailoring of media to specific cell line and desired antibody product quality

• Supports limiting dilution cloning

• Formulated to support early-phase development activities

• Ensures predictable scale-up and seamless transition through all development stages

• Reliably achieves superior growth, sustained high-production capabilities

• Delivers superior growth across a spectrum of CHO cell lines


Protein Attributes Achieved

Figure 2. Comparison of ADCC activity of a biosimilar harvested from fed-batch cultures of BalanCD CHO Feed 4 and Supplier B Feed. Activity of the purified antibody was measured by ADCC reporter bioassay, triplicate per concentration.

Example Glycan Profile

Figure 3. Comparison of glycan profiles of biosimilar harvested from fed-batch cultures of BalanCD CHO Feed 4 and Supplier B Feed. Relative abundance of each glycoform was determined.

0 %

18 %

35 %

53 %

70 %

Man5 G0 G0f G1 G1f G2 G2f

Rel

ativ

e G

lyca

n D

istr

ibu

tio

n Batch

BalanCD CHO Feed 4

Supplier B Feed

Correlation Of Glycan Analysis To ADCC Activity

FEED EC50 (ng/mL) % AFUCOSYLATED

BalanCD Feed 4 44 18.5 %

Supplier B Feed 64 15.3 %

%Afucosylated = (%G0+%G1+%G2)/(%G0+%G0f+%G1+%G1f+%G2+%G2f)

0

10000

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-4 -2 0

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Supplier B Feed

BalanCD CHO Feed 4

log [Concentration (μg/ml)]

An advanced combination of industry- leading formulations.

• Delivers higher protein titer

• Provides product quality and consistency

• Formulated and designed to support full-scale commercial production

• BalanCD Gal Supplement for enhanced galactosylation and desired glycosylation profiles

BalanCD CHO Growth A plus BalanCD CHO Feed 4The perfect pair to boost performance


Figure 4. CHO cells were grown in 125 mL shaker flasks with 30 mL working volume. Cells were seeded at 3×105 cells/mL in BalanCD CHO Growth A medium in duplicate. The cells were fed daily on days 5 through 9 at equal volumes per event (total volume for each feed determined in prior experiment). Temperature shift was performed from 37°C to 33°C on day 7. Glucose was monitored every other day and supplemented to 8 g/L when levels dropped below 3 g/L. Final titer (A) and cumulative cell density (B) were measured. Supplier B Feed was progressed for additional comparative studies.

0

33

65

98

130

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lati

ve C

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ensi

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106 c

ell -

day

s/m

L)

Fed-batch culturesBatch culture

BalanCD CHO Feed 4B

Other available feeds

A1A2

A3 A4

A5A6

C

Boost manufacturing outcomes with the growth and performance benefits of our most advanced, high-nutrient feed medium.

BalanCD CHO Feed 4:Optimizing full production potential

A nutrient-rich feed medium designed to unlock the possibilities of high-performing CHO cell lines.

• Enriched formulation is rich in amino acids and vitamins

• Maintains protein quality and functionality in large-scale, fed-batch cultures

• Optimized for use with BalanCD CHO Growth A

• Maximizes yields of high-quality recombinant proteins

0

1.5

3.0

4.5

6.0

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14

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/L)

Fed-batch culturesBatch culture

BalanCD CHO Feed 4

BOther available feeds

A1A2

A3 A4

A5

A6

C

Productivity and Cell Growth

Quality and Control

Efficiency and Ease of Use

• Advanced, concentrated formula designed to meet the needs of high performing cell lines

• Optimized for pairing with BalanCD CHO Growth A

• Achieves consistent protein quality

• Low glucose concentration offers more control over protein quality attributes

• Three simple steps for feed preparation avoid complicated and time-consuming preparation protocols

• Easily dissolves with no pH adjustments needed

• pH remains stable in culture


The BalanCD CHO Feed 4 Advantage

Simple feed preparation: easily dissolved, no pH adjustments required

Feed 4 must be made from ground up unicorn horns. It improved the performance of my cultures with every growth media I paired it with.

Heather Brett, Senior Researcher, OncoResponse Inc.

BalanCD Transfectory CHO BalanCD CHO Growth ABalanCD CHO Feed 4

BalanCD CHO Growth A BalanCD CHO Growth ABalanCD CHO Feed 4

Additional feeds to meet different process requirements

BalanCD CHO Feed 1

• Formulated to pair with BalanCD CHO Growth A

• Supports CHO-S, CHO-M, and CHO-DHFR cell lines

BalanCD CHO Feed 2

• Designed as a lean formula

• Synergistically supports CHO cell lines when paired with a richer growth medium

BalanCD CHO Feed 3

• Intended to support a variety of CHO cell lines, including high-producing cell lines

• Created as a rich feed to pair with a lean growth medium

All BalanCD CHO products can be tailored to suit your unique requirements; everything from formula, batch size, and packaging can be customized to your needs and preferences.

DISCOVERY CELL LINEDEVELOPMENT

PROCESSDEVELOPMENT

& SCALE-UP

GMPMANUFACTURING


The BalanCD CHO Media PlatformDelivering reliable, consistent results from discovery to commercialization

A comprehensive line of products to support your needs at every phase of development.

• Flexible, scalable, and expertly formulated to maximize productivity, growth, and viability of CHO cell lines

• Designed to nurture and advance every step of development


Platform Media & Feeds for BioproductionProviding seamless workflow and scalability

> 10,000 LMicroliter / Milliliter

Discovery

100 - 1,000 L

ManufacturingCell Line

DevelopmentProcess

Development

Liter

Contact your FUJIFILM Irvine Scientific sales representative or visit us at www.irvinesci.com today to learn more about our company and our products.

With over 45 years of industry experience, FUJIFILM Irvine Scientific is focused on providing the highest quality cell culture media. We are dedicated to bringing life to products, and ultimately, to the patients who benefit from the resulting therapeutic advances. World-renowned for our unwavering commitment to full-spectrum partnership, FUJIFILM Irvine Scientific has defined the industry standard in support, innovation, and best-in-class turnaround time.

Ordering Information

©2019 FUJIFILM Irvine Scientific. FUJIFILM Irvine Scientific, its logo, and Express Media Service are trademarks of FUJIFILM Irvine Scientific, Inc. in various jurisdictions. P/N 004664 Rev.00 www.irvinesci.com

Item Catalog # Size*

BalanCD CHO Growth A (Liquid) 91128 1 L

BalanCD CHO Growth A (Powder) 94120 10 L, 100 L

BalanCD CHO Feed 4 94134 1 L, 10 L

BalanCD CHO Feed 3 (Liquid) 99471 1 L

BalanCD CHO Feed 3 (Powder) 94118 10 L

BalanCD CHO Feed 2 (Liquid) 91129 1L

BalanCD CHO Feed 2 (Powder) 94121 10L

BalanCD CHO Feed 1 (Liquid) 91127 1 L

BalanCD CHO Feed 1 (Powder) 94119 10 L

BalanCD Transfectory CHO (Liquid) 91147 1 L

BalanCD Transfectory CHO (Powder) 94129 10 L

BalanCD Gal Supplement 91175 100 mL, 1 L

Transfectory Supplement (Liquid) 91148 500 mL

Anti-Clumping Supplement (Liquid) 91150 50 mL

*Custom sizes and packaging available on request.

BalanCD CHO Media Platform...BALANCD CHO MEDIA PLATFORM | 11 Platform Media & Feeds for Bioproduction Providing seamless workflow and scalability Microliter / Milliliter > 10,000 L

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