CELL & GENE THERAPYMANUFACTURING SOLUTIONSIMMUNE CELL THERAPYREGENERATIVE MEDICINETABLE OF CONTENTS
Transitioning From Research to GMP .....................................................................................3
Characterization of Isolated Cells ...........................................................................................4
Cell Culture ................................................................................................................................5
Gene Engineering Services......................................................................................................7
Product Release Testing............................................................................................................82

Revolutionary cell and gene therapies offer exciting promise to treat life threatening diseases. Bio-Techne is in this journey with you.
As a full-solution ancillary reagent, services, and instrument provider, we will stand by you, providing flexible and pioneering tools tosimplify your workflow at every step of the manufacturing process. From CAR T cells in immune cell therapy to pluripotent stem cells
for regenerative medicine, let us help you get your therapy to market.
You can count on Bio-Techne to provide solutions focused on:• Innovation• Scalability• Flexibility and Customization• Consistency and Reproducibility• Reducing Manufacturing Risk

TRANSITIONING FROM RESEARCH TO GMP
As you develop new therapies and advance from preclinical studies to clinical manufacturing, we are here to support you.
We make the transition as efficient and seamless as possible. Incorporation of GMP or Ancillary Material-grade raw materials
early in your program will simplify your transition. If GMP-grade raw materials are not available, we will work with you to convert
RUO materials for manufacturing use.

FITTING THE PRODUCT TO THE PROCESS WITH CUSTOMIZED SERVICES
We will work with you to develop and deliver GMP raw materials and services that meet your unique process requirements. We
can provide customized vialing by mass and activity, construct design, formulation, and quality control analysis. If particular GMP
products are not available, we can develop them specifically for you. With a dedicated project manager, our expert scientists, quality
assurance team, and world-class technical support, we will provide solutions exactly tailored to lower the burden of comparability
proof during later stages.

GMP Capabilities
Each of our GMP manufacturing facilities is ISO certified. We ensure quality compliance with a team of quality and regulatory experts. Learn About Our GMP Capabilities

Visit | bio-techne.com/services/custom-cell-and-gene-therapy-services
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CHARACTERIZATION OF ISOLATED CELLS
Qualifying a robust starting cell population is essential for immune cell and stem cell manufacturing processes. The quality of the cells
at the beginning of your manufacturing pipeline will directly impact the efficiency of your cell expansion and differentiation protocols.

In addition to our vast portfolio of premium flow cytometry and IHC/ICC antibodies, we offer custom antibody services that cover:• Custom antibody development• Custom monoclonal antibody panels• Custom fluorophore conjugations• Recombinant antibody conversion

105

105

105

104

104

104103CD94

NKG2C/CD159c

NKG2A/CD159a• Custom GMP Antibodies

1030000103

104

NCAM-1/CD56

105

1030103

104

NCAM-1/CD56

1050103

104

105

NCAM-1/CD56

Analysis of distinct natural killer cell populations by flow cytometry. The detection of multiple NK cell receptors allows rigorous qualification of starting cell
preparations. Human PBMC were stained with conjugates of NCAM-1/CD56 antibody and either NKG2A/CD159a (left), NKG2C/CD195c (center), or CD94 (right).

CUSTOM ANTIBODY SERVICES
Leverage the experience and expertise of our Custom Antibody Services for your project. Our consultative, stage-gated approach
mitigates process risk, saves time, and eliminates obstacles to advancing your program.

Visit | bio-techne.com/services/custom-cell-and-gene-therapy-services

When your work demands unique reagents orscientific support, turn to the decades of productdevelopment legacy behind Bio-Techne’s trustedbrands. Together with a dedicated project manager,
our expert scientists, quality assurance team, andworld-class technical support, we will deliver
solutions exactly tailored to bring you success fasterand more economically.

4CELL CULTURE
Ensure the most robust cell expansion possible for your cell andgene therapies. We can help you achieve rapid cell proliferationand high viability to quickly generate the large cell numbers youneed for therapeutic doses.

GMP CYTOKINES AND GROWTH FACTORS
We test the bioactivity of every production lot in side-by-side
comparisons to a master lot to ensure consistency over time andfacilitate lot bridging.
•IL-2, -3, -4, -6, -7, -15, -21•Activin A, FGF basic, Noggin, SCF•And many more
Lot #1

3000

Lot #2•IL-2, IL-7, IL-15 plus IL-21 coming soon

Lot #32500

Mean RFU

GMP ProDots™ Proteins are formulated as pre-aliquoted, dissolvablespheres, packaged in single-use bags for easy welding into closed systems
for media preparation.

2000
1500
1000

Bioactivity comparison of threeproduction lots of GMP ProDots IL-2 ina proliferation assay with CTLL-2
cytotoxic T cells.

500
10-3

10-2

10-1

100

101

Recombinant Human IL-2 GMP (ng/mL)

Visit | bio-techne.com/gmp-proteins
GMP SMALL MOLECULES
We follow relevant sections of ICH Q7 guidelines to ensure
consistency, traceability from start to finish, and animal-freeproduction.
• Y-27632 (ROCK inhibitor)• SB 431542 (TGF-β RI inhibitor)• CHIR 99021 (GSK-3 inhibitor)• XAV 939 (Tankyrase inhibitor)
Our Ancillary Material (AM) grade of small molecules provides
increased manufacturing control compared to research-grade.
• DAPT (g-Secretase inhibitor)• WIKI4 (Tankyrase inhibitor)• RepSox (ALK5 inhibitor)

STANDARD
CATALOGANCILLARYMATERIAL
GRADE

GMP

ISO 9001

333

QC Testing333

Controlled
ManufacturingZone

33

ISO-7 Cleanroom

33

Endotoxin/Bioburden Testing

33TSE and BSECertification

33

Risk-based
Approach toManufacturing

3

ICH Q7

3Visit | bio-techne.com/gmp-small-molecules
5GMP CLOUDZ™ CELL ACTIVATION KITS
Cloudz is a unique and customizable cell activation platform based on an alginatehydrogel. Cloudz reagents are conjugated with cell-activating antibodies or ligands
and rapidly dissolve with the addition of release buffer.
• Human T Cell Activation Kits, GMP and RUO available• Human Treg Expansion Kit, GMP and RUO available• Human NK Cell Expansion Kit, RUO available

A

B

350

100%300

CD3 CD56+(NK Cells)
CD3+80%

Other% of Total

Fold Change

250
20015010094.4%

40%20%

50060%

679Days in Culture

0%1016.3%010Days in Culture

Human PBMCs were expanded with the Cloudz Human NK Cell Expansion Kit. Following 10 days of culture NK cells showedapproximately 300-fold expansion (A) and a purity of 94.4% of CD3-CD56+ cells (B).

Visit | rndsystems.com/products/cloudz-cell-activation-kits

GMP AND XENO-FREE CELL CULTURE MEDIAPartner with us for the optimum media and supplements for your process. Our expertise covers GMP media production, media formula
optimization, and specialty testing assays.
• StemXVivo™ GMP Mesenchymal Cell Media• GMP N-2 MAX Media Supplement• ExCellerate™ Human T Cell Expansion Media, Xeno-Free• GMP-grade coming soon
• ExCellerate NK Expansion Media, Xeno-Free• ExCellerate B Cell Media, Xeno-Free

Visit | bio-techne.com/services/custom-cell-and-gene-therapy-services
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GENE ENGINEERING SERVICES
Let us solve your challenging gene engineering needs so you canfocus on groundbreaking research and manufacturing. Our geneengineering services team specializes in complex projects andhard-to-transfect cell lines.
• Cell modification using TcBuster™, our non-viral gene deliverysystem• Custom gene editing services to deliver simple and complex
engineering solutions in a realistic timeframe• iPSC engineering services (RUO and GMP capabilities) for
regenerative medicine therapies• GMP process development for your CAR-T, TCR, or iPSC
therapies• CDMO services for large scale isolation, cell engineering &activation, final fill & finish

Monitor the identity and purity of your viral vectors with automated, multi-attribute immunoassays. Our iCE Maurice™ andSimple Western™ systems deliver precise and sensitive analysis for vector and viral protein characterization.

CUSTOM SOLUTIONS FOR GENE ENGINEERING
We offer dedicated project management supported by our Custom Services team. Regardless of the project, we can customize alldeliverables including the number of cells/vial, validation testing, datasheet preparation, and batch record documentation.

Visit | bio-techne.com/services/gene-engineering-services7

PRODUCT RELEASE TESTINGCell therapies are classified as Advanced Therapy Medicinal
Products (ATMPs) and require rigorous phenotypic and purity
characterization before final release. Our pioneering technologies
allow you to generate reliable and accurate data for release testing
to ensure that your cell therapy gets to the clinic as fast and assafely as possible.

Watch our webinar, Challenges of Analyzing ATMPs, to learn about the complexities
of analyzing cell products as you scale up and scale out.

FLOW CYTOMETRY
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We offer thousands of conjugated primary antibodies forflow cytometry as well as custom antibody conjugation withnearly 20 fluorophores.

A105• Custom Antibody Services – development, conversion torecombinants, antibody engineering, and GMP-grade

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rhCD19rhCD19104

103

0• Fluorescent-Labeled Recombinant Proteins - direct-labeled
receptor ligands to verify CAR expression and antigen specificity

B103

0-103

0103

104

CD4105

-103

0103

104

CD4105

Analysis of CD19 CAR expression on human T cells before (A) or after (B)transduction with a human CD19 CAR. Cells were stained with human CD19 Atto647N-conjugated protein.

Visit | bio-techne.com/methods/flow-cytometry

IMMUNOASSAYS FOR CELL PHENOTYPE TESTING
Confirm the secretory profile and surface marker expression ofyour cell product. At the core of each our immunoassays are R&D
Systems™ antibodies and proteins, backed by over 30 years ofexperience designing, testing and optimizing immunoassay kits.
• Luminex® Assays – quantitative multianalyte detection• Quantikine™ ELISA Kits – exhaustively tested for superior
performance and reproducibility• Simple Plex™ Automated ELISAs – quantitation of cytokine
secretion profiles in <1 hour with 4+ logs dynamic range• Simple Western™ - automated, capillary-based immunoassays
and size assays• Custom Assay Services – assay development, optimization, andtranslation to automated platforms

Visit | bio-techne.com/methods/immunoassays
8PRODUCT PURITY TESTING
Ensure that your final product meets purity specifications bymonitoring contamination and heterogeneity.
Micro-Flow Imaging™ (MFI) provides image-based analysis ofsubvisible particle counts and morphology. MFI discriminates
between protein aggregates, oil droplets, bubbles, andother contaminants.
• Up to 150 µL/minute at 900,000 particles/mL• Bot1 Autosampler for up to 90 samples per run• High-resolution images with 85% sampling efficiency
Single-Cell Western quantitates protein expression forprofiling cell heterogeneity. Milo™ enables thoroughmonitoring of key molecules in cell therapy products to meetyour purity requirements.
• Analysis of ~1000 single cells in a single run• Up to 12 protein analytes per cell

Bio-Techne believes in the power of partnerships. We have joined with Fresenius Kabi andWilson Wolf to bring you ScaleReady™ for powerful and versatile immune cell manufacturing.
ScaleReady brings cell and gene therapies to life by streamlining manufacturing processes
across cell culture, cell activation and expansion, gene editing, and cell processing.

Learn more at ScaleReady.com

9

NOTES:

10WHEN YOUR WORK DEMANDSUNIQUE SOLUTIONS,TURN TO BIO-TECHNE’SDECADESOFPRODUCTD E V E LO P M E N T

LEGACY
View our updated guide for
Custom Reagents and Contract Services
rndsystems.com/custom-services

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