Take the Rational Approach of the BalanCD CHO Media Platform

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1 Accelerate your development of therapeutics from discovery to commercialization Take the Rational Approach of the BalanCD CHO Media Platform It takes ambition, dedication, and fortitude to translate a lab bench discovery into a full-fledged therapeutic. With over 45 years of cell culture media expertise, Irvine Scientific is uniquely positioned to help you navigate every step of the journey. Trust our industry-leading cell culture media solutions and commitment to excellence to deliver a strong foundation that combines the development of life with unparalled customer service.

2 A Foundation for Life: The 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, 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 nutrients to maximize productivity, growth, and viability of CHO cell lines. Discovery Cell Line Process & Scale-up GMP Manufacturing Media solutions for early stage to commercial production and everything in between The BalanCD CHO Media Platform fosters growth and production at all phases, from discovery to production. The BalanCD platform includes: BalanCD Transfectory CHO BalanCD CHO Growth A BalanCD CHO Feeds 1 through 3 All BalanCD CHO products can be tailored to suit your unique requirements: customize formulas, batch sizes, and packaging based on your preferences 2

3 Reliable supply and support All BalanCD CHO 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 batch size 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 13485:2012 certified, EN 13485:2012 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 «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., U.S.A «3

4 TM BalanCD Transfectory CHO System: A Vital First Step Toward Commercialization Discovery BalanCD Transfectory CHO 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 Maximize your protein yield with Transfectory TM Supplement Adding this concentrated hydrolysate supplement increases cell growth and protein expression level while maintaining viability and efficiency «Transfectory CHO transient expression media 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 «

5 The BalanCD Transfectory CHO system advantage Choice Speed Efficiency Customizable protocols to fit individual needs Completely 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 (eg, 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 Enhanced productivity and growth Viable cell density Post-transfection cell viability Antibody production 10 Viable cell density (x10 6 cells/ml) Percent viability Protein production (mg/l) Days post transfection Days post transfection Days post transfection Transfectory CHO + Supplement Transfectory CHO Medium A Medium B Medium C Figure 1 CHO-3E7 Cells were cultured in duplicate 125mL Erlenmeyer flasks with a 30mL 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. 5

6 BalanCD CHO Growth A: Providing Exceptional Productivity & Flexibility Cell Line BalanCD CHO Growth A A chemically-defined, animal componentfree 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 Pairs perfectly with any BalanCD CHO feed medium The BalanCD CHO Growth A advantage Ideal for diverse applications, BalanCD CHO Growth A delivers scalable, reliable, and exceptional productivity at every step of development. 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 6

7 BalanCD CHO Growth A + : The Perfect Pair to Boost Performance Process & Scale-up BalanCD CHO Growth A 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 Protein attributes achieved Correlation Of Glycan Analysis To ADCC Activity Example Glycan Profile % Supplier B Feed Batch Luminescence Supplier B Feed Relative Glycan Distribution 53 % 35 % 18 % % Man5 G0 G0f G1 G1f G2 G2f log [Concentration (μg/ml)] Figure 3 Comparison of glycan profiles of biosimilar harvested from fed-batch cultures of and Supplier B Feed. Relative abundance of each glycoform was determined. FEED EC 50 (ng/ml) % AFUCOSYLATED BalanCD Feed % Supplier B Feed % %Afucosylated = (%G0+%G1+%G2)/(%G0+%G0f+%G1+%G1f+%G2+%G2f) Figure 2 Comparison of ADCC activity of a biosimilar harvested from fed-batch cultures of and Supplier B Feed. Activity of the purified antibody was measured by ADCC reporter bioassay, triplicate per concentration. 7

8 : Optimizing Full Production Potential GMP Manufacturing BalanCD CHO Growth A 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 Boost manufacturing outcomes with the growth and performance benefits of our most advanced, high-nutrient feed medium Day 14 Protein Titer (g/l) 6,0 4,5 3,0 1,5 Other available feeds A3 A4 A1 A5 A2 A6 B C Cumulative Cell Density (x10 6 cell -days/ml) Other available feeds A3 A4 A1 A2 A5 A6 B C 0 Batch culture Fed-batch cultures 0 Batch culture Fed-batch cultures Figure 4 CHO cells were grown in 125 ml shaker flasks with 30 ml working volume. Cells were seeded at 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. 8

9 The advantage 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 «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 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 Simple feed preparation: easily dissolved, no ph adjustments required 9

10 The BalanCD CHO Media Platform: Your Partner At Every Phase of A comprehensive line of products to support your development needs Discovery Cell Line Process & Scale-up GMP Manufacturing BalanCD Transfectory CHO BalanCD CHO Growth A BalanCD CHO Growth A BalanCD CHO Growth A All BalanCD CHO products can be tailored to suit your unique requirements: customize formulas, batch sizes, and packaging based on your preferences 10

11 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 PRODUCTS CATALOG # SIZE * BalanCD CHO Growth A BalanCD CHO Growth A (Liquid) L BalanCD CHO Growth A (Powder) L, 100 L L L BalanCD CHO Feed 3 BalanCD CHO Feed 3 (Liquid) L BalanCD CHO Feed 3 (Powder) L BalanCD CHO Feed 2 BalanCD CHO Feed 2 (Liquid) L BalanCD CHO Feed 2 (Powder) L BalanCD CHO Feed 1 BalanCD CHO Feed 1 (Liquid) L BalanCD CHO Feed 1 (Powder) L BalanCD Transfectory CHO BalanCD Transfectory CHO (Liquid) L BalanCD Transfectory CHO (Powder) Transfectory Supplement (Liquid) ml Anti-Clumping Supplement (Liquid) ml * Custom sizes and packaging available on request. 11

12 The BalanCD CHO Media Platform: Delivering Reliable, Consistent Results from Discovery to Commercialization Flexible, scalable, and expertly formulated to maximize productivity, growth, and viability of CHO cell lines Designed to nurture and advance every step of development Discovery Cell Line Process & Scale-up GMP Manufacturing BalanCD Transfectory CHO BalanCD CHO Growth A BalanCD CHO Growth A BalanCD CHO Growth A A flexible medium and supplements for rapid, scalable, high-yield protein production A chemically-defined, animal component-free growth medium to support cell line development An advanced combination of industry leading formulations Formulations purposebuilt for large-scale manufacturing Customizable to fit unique parameters, including feed requirements, batch sizes, and packaging Contact your Irvine Scientific sales representative or visit us at today to learn more about our company and our products. With over 45 years of industry experience, 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, Irvine Scientific has defined the industry standard in support, innovation, and best-in-class turnaround time. Irvine Scientific, the Irvine Scientific logo, Life.Support, BalanCD, Transfectory, and Rational Culture Media Design are trademarks of Irvine Scientific Sales Company, Inc Irvine Scientific P/N 10769ICC Rev.0