Sartorius Solutions for Cell & Gene based Therapies

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Sartorius is a well respected global solution provider within the biologics industry, especially for antibody and vaccine production. Our proven products and services are being diversified for upstream and downstream processing of cells and viruses for allogeneic and autologous advanced therapies. Sartorius provides the cellular immunotherapy industry with a range of scalable single-use production technologies. Our portfolio supports viral vector transduction, cell expansion, and downstream processing steps including harvest, wash, and concentration of cells
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  • 1. Cell and Gene Therapy Manufacturing Solutions
  • 2. Cell and gene based therapies present a new treatment paradigm that have the potential to address clinical needs that are unmet by current small molecule and biotherapeutic approaches. Developers and manufacturers of these new therapies are looking for technology and service solutions that provide process integrity, robust supply chain support, standardization and automation. Sartorius is a well respected global solution provider within the biologics industry, especially for antibody and vaccine production. Our proven products and services are being diversified for upstream and downstream processing of cells and viruses for allogeneic and autologous advanced therapies. Therapy development can benefit from our single use systems, intelligent equipment and analytics. Combined, these help speed up your process development and support your manufacturing goals. Please ask our specialists for more information about our portfolio for any stage of your individual process. l Cellular Immunotherapy l Gene Therapy and Viral Vectors l Cell Therapy Sartorius Strengthens its Expertise and Technologies to Support the Growing Cell and Gene Therapy Industry
  • 3. Flexsafe® 2D2 Viral Vector Production Media Preparation Cell ExpansionProcess Development ambr® 250 modular1 BIOSTAT® B with RM 20 | 503 Cellular Immunotherapy Process Sartorius provides the cellular immuno- therapy industry with a range of scalable single-use production technologies. Our portfolio supports viral vector trans- duction, cell expansion, and downstream processing steps including harvest, wash, and concentration of cells. Application examples: Use of Sartorius Bioreactors to grow NK cells for immunotherapy: Reference: (2011) Spanholtz et al. PloS one 6 (6), e20740. DOI: 10.1371/ journal.pone.0020740. Application Note: Use of ambr 15 to optimize processes for NK cells in stirred bioreactors. Our solution for process development1 ambr™ 250 modular – Benchtop mini bioreactor system with automated, modular stirred tank format and working volume of 100 – 250 mL – Enables optimization of cell process that can be relevant for scale-up for stirred tank manufacturing Our solution for media preparation2 Flexsafe® 2D Bags – Single use Flexsafe® bags for media storage coupled with Flexsafe® Pre-Designed Solutions for sterile filtration, storage and transfer of media and buffers – Proven integrity to enhance process and product safety by reducing risks of contamination of valuable cell products Our solution for cell expansion3 BIOSTAT® B – Multifunctional bioreactor control tower with perfusion capability – Automatic feeding and waste removal and gentle rocking motion provides right environment for T-cells – Ability to support single or twin rocking bases enables optimal use of valuable manufacturing space BIOSTAT® RM – GM-compliant, single-use, rocking motion bioreactor platform. RM 20 | 50 accommodates 1 L – 50 L bioreactor bags – Suitable for autologous and allogeneic immune cell expansion
  • 4. Cell Expansion Cell Wash and Harvest Flexsafe® RM Bags4 kSep® 4006BioPAT® MFCS BioPAT® ViaMass 5 Biowelder TC – Automated welder for sterile connection of dry or liquid filled thermoplastic tubing, up to OD 1” (25.4mm) – Easy way to connect unit operations in either non classified or classified environment, to support a functionally closed process Our solution for safe cells4 Flexsafe® RM – Sterile single-use bioreactor bag made using Flexsafe® film – The Flexsafe® film provides outstanding quality, reliability, robustness and freedom from cytotoxic leachables to give peace of mind for cell expansion Our solution for automated in-line process control 5 BioPAT® MFCS – World standard for supervisory process control with GAMP category 4 software package – Provides reliable data acquisition, monitoring and control for a more efficient cell production process BioPAT® ViaMass – Flexsafe® RM bags can have integrated single use sensors for pH, DO and ViaMass for biomass measurement – These vital tools for in-line monitoring and control help you define and automate feeding and harvest regimes (including perfusion) for optimal cell growth. This can help minimize process risk. Our solution for gentle cell wash and harvest 6 kSep® 400 – Closed seal-less single-use fluidized bed centrifugation platform. – The 50 mL rotor option can process 5 L in less than 1 h (5 billion cells per cycle) – The opposing centrifugal and fluid flow mechanism provides low shear force which is ideal for sensitive cells – Used for wash and harvest of cell therapy products Analytics
  • 5. Media PreparationResearch Development ambr® 15 cell culture1 Gene Therapy and Viral Vectors Viral vectors such as adenoviruses, adenoassociated viruses, lentiviruses and retroviruses are effective delivery systems for genetic material used in cell and gene therapies. Sartorius technologies are ideally suited for development and manufacturing processes for viral vectors. They allow end-to-end, single-use processing of virus batches at scales required for process development through to commercial manufacturing at the 2000 L scale. Vivapure® LentiSELECT Vivapure® AdenoPACK™ Flexel®  | Flexsafe®  | Flexboy® Bags Single-use mixing systems Palletank for Storage Sartorius Filter Range Seed Expansion Virus Propagation BIOSTAT STR® 2BIOSTAT® B with RM or UniVessel® Application examples: Use of ambr 15 bioreactor mimic in scale up of lentiviral vectors: Reference: (2016) Miskin, J. BioProcess UK Conference Our solution for media and cell screening 1 ambr® 15 – Industry standard automated multiple microbioreactor system, used as a reliable microscale (10-15 mL) stirred-tank model for upstream processes – The ability to perform a large number of parallel bioreactor experiments, in combination with our BioPAT® MODDE Design of Experiment software, enables rapid development and optimization of your cell production process – Early optimization of process parameters such as suspension adaptation of viral vector production cell lines, media devel- opment and viral vector screening to identify best producer cell clones, can lead to substantial time savings and reduction of development efforts Our solution for cell expansion and virus production 2 BIOSTAT STR® – Scalable, single-use bioreactor family based on stirred-tank design which can easily connect to our BioPAT® MFCS or third party supervisory software like DeltaV™ – Wide range of sizes (50L to 2000L) and process regimes (such as fed-batch and continuous) is an ideal platform for a flexible manufacturing facility which can reflect your evolving needs – BioPAT® process control portfolio, especially ViaMass, are a valuable tool to determine optimal timing for intro- duction of genetic material. Automated control loops for cell density, glucose and perfusion can help improve cell productivity and viral vector quality.
  • 6. Our solution for concentration and diafiltration of viruses 4 Clarification Sterile FiltrationBuffer ExchangeCapture | PolishingConcentration Virus Analytics Sartorius Pre- | Final Filters Sartobind® 3 Sartocon® 4 Sartorius Pre- | Final Filters Virus Counter® 31005 Our solution for effective virus purification 3 Sartobind® membrane chromatography – Membrane adsorbers display a macropo- rous structure with huge capacity for large molecules. Sartobind membranes are available in a contained capsule format or a flexible modular cassette format. – High binding capacity for viruses combined with high flow-rates make Sartobind® ideal for for purification and contaminant removal (DAN, HCP) of viral vectors used in cell and gene therapies Sartocon® Self Contained Bag Loop Assembly – Fully disposable and pre-sterilized loop assembly for cross-flow filtration. Facilitates efficient, contained, concen- tration diafiltration of viral vectors. – Ensures total containment and efficient, safe, down-stream processing of viral vectors for use in cell and gene therapies Our solution for rapid virus quantification 5 Virus Counter® 3100 – Automated technology to rapidly quantify intact virus particles, providing results in minutes. – Multiple reagents allow specific detection of a wide range of viruses and VLPs – Enables real-time monitoring and optimization of cell and gene therapy processes Sartocon® 4
  • 7. Sterile Filters Our solution for contamination control1 Media Preparation Microsart® ATMP Mycoplasma and Bacteria Kits – PCR-based, easy and fast detection of either mycoplasma or bacteria. – Results in 3 hours (rather than days) means better ability to keep your cell- based therapeutics contamination-free Sterile Filters Sartorius vast range of products for air and liquid filtration in a cell processing environment include: – Midisart® filters. Available with PTFE (autoclavable) or PES (gamma-irradiat- able | autoclavable) membrane. Ready-to-use, 100% integrity tested and fully validated, these are an ideal choice for small scale sterile air | gas filtration. – Sartopore® 2 XLG MidiCaps® , MaxiCaps® and Capsules. Self contained filter units especially designed for sterilizing grade filtration. For applications including media with or without serum. – Sartopore® 2 XLM 0.1 μm has industry specifically developed finer filter mem- branes for successful retention of Myco- plasma, to reduce risk of contamination of contamination of cell culture media. Cell Therapies Cell therapies applications encompass the use of a variety of cell types, including those derived from adult stem cells, embryonic stem cells (ESC) or induced pluripotent stem cells (iPSC). Mesenchymal stem cells (MSCs) are the most commonly used class of multipotent stem cells and are illustrative of production requirements of other cell therapies. Sartorius technologies are ideally suited for development and manufacturing processes for cell-based therapies. Cell Expansion Media Feeds ambr® 15 |  ambr® 250 | UniVessel®  | BIOSTAT STR® Mycoplasma Assay Application examples: CD34+ cord blood cells differentiated into erythrocytes in small stirred bioreactors: Reference: (2013) Glen, K., et al. Cytotherapy 15 (9), pp. 1106–1117 Expansion of human MSC on microcarriers: Reference: (2015) Chen, A., et al. Cytotherapy 17 (2), pp. 163–173 Human ADSC grown in FlexSafe single-use bags: Reference: (2016) Blaschczok, K., et al. Bioprocess International 14 (3)S, pp 26-35 FlexAct® Systems Microsart® ATMP Mycoplasma and Bacteria Kits 1 – Custom-configured single-use solutions to connect all your bio- manufacturing steps. Can include unit opera- tions such as FlexAct® BP (buffer preparation) and FlexAct® MP (media preparation) – Enables interconnection of unit operations for a closed cell manufac- turing process Sartorius has a long-standing reputation for expertise in microbiological quality control. Our premium products for microbial limit testing, sterility testing, air monitoring and Mycoplasma detection, help improve the safety of quality-critical processes such as cell-based therapies. Flexel®  | Flexsafe®  | Flexboy® Bags Single-use mixing systems Palletank for Storage Sartorius Filter Range
  • 8. Cell Wash and Harvest Cell Bank | Media Storage Our solution for cell banking3 fill-it – Filling system combining proven decap | recap modules with aseptic liquid handling, for use within a GMP environ- ment. Enables rapid creation of consistent stock tubes (dispense volume 250 μL to 5 mL) – Useful for creation of GMP cell banks or liquid aliquots Our solution for media | buffer freezing4 Celsius® – Fully integrated, purpose-designed logistics solutions (e.g. bags, tubing, connectors, containers) for safe, reliable frozen storage and shipping of cell culture liquids – Proven robustness throughout freeze- thaw lifecycle make Celsuis ideal for cell media and buffer handling Our solution for understanding your cells 5 iQue Screener PLUS Platform – An integrated flow cytometry-based instrument, software and reagent system. Enables high content, multiplexed analysis of cells and beads in suspension – Provides applications for immune cell assessment including immunopheno- typing, immune cell function and cytokine profiling – Rapid results mean that you can efficiently gain insight into your cell manufacturing process Our solution for cell expansion at any scale 2 BIOSTAT STR® – Fully scalable, single-use stirred tank design bioreactor family – Working volumes from 12.5 L to 2,000 L – Easily connect to SCADA systems like our BioPAT® MFCS – Monitor cell growth with BioPAT® Viamass probe Flexsafe® STR Bags – Single-use stirred tank bioreactor bags are manufactured with our full control of the production process - from resin to final sterilized bag. – The use of FlexSafe® film and a wide range of standard or custom tubing, stirrer and sparger options ensure you can get the right environment for growth of sensitive stem cells in suspension or on microcarriers Analytics kSep® Celsius® Platform4Flexsafe® STR Bags2 iQue Analytics Screener PLUS Platform 5 fill-it3
  • 9. Sartorius as your partner for cell and gene therapy manufacturing An integrated solution approach: l Our application and product specialists combine to add value with an integrated solution approach l At Sartorius, we help you develop a scalable, cost-effective manufacturing process and combine this with the security of our worldwide supply chain and manufacturing capabilities l The right process at the right scale enables regenerative medicine companies to enter the clinic with product as quickly as possible Creating the right solution Developing the right portfolio Sartorius is at the forefront of innovation: l Strong RD centres including our dedicated Regenerative Medicine Applications RD group l Product, technology experts and solution services l Recent acquisitions bring the ambr® platform, Umetrics automation solutions, analysis platforms such as iQue, InCucyte and Virus Counter and biosafety services, providing you with a growing range of solutions to assist the development of your cell and gene therapy processes Our dedicated Regenerative Medicine Applications team work with internal and external specialists to support you: l Building market, technology and application knowledge l Working with many leading organiza- tions to understand and validate methods, technologies and to support new product development for this evolving industry l Combine with product experts, Sartorius’ College, Training and Application Centres to help you develop your knowledge and expertise Providing the know-how Helping you improve your manufacturing efficiencies Our expertise and experience, acquired over many years supporting the biopharma industry, allows us to provide you with full support during early stage process development and the establishment of scalable processes. l Predefined single-use bioprocess platforms l Consulting expertise for rapid process development l Biosafety and validation services for confidence in your manufacturing regime Contact us Please ask our specialists for more information about which product will work best for any stage of your individual process. Email: regenmed@sartorius.com
  • 10. Sales and Service Contacts For further contacts, visit www.sartorius-stedim.com Europe Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen Phone +49.551.308.0 Sartorius Stedim Systems GmbH Robert-Bosch-Strasse 5–7 34302 Guxhagen Phone +49.5665.407.0 France Sartorius Stedim FMT S.A.S. ZI des Paluds Avenue de Jouques – CS 91051 13781 Aubagne Cedex Phone +33.442.845600 Sartorius Stedim France SAS ZI des Paluds Avenue de Jouques – CS 71058 13781 Aubagne Cedex Phone +33.442.845600 Austria Sartorius Stedim Austria GmbH Modecenterstrasse 22 1030 Vienna Phone +43.1.7965763.18 Belgium Sartorius Stedim Belgium N.V. Rue Colonel Bourg 105 1030 Bruxelles Phone +32.2.756.06.80 Hungary Sartorius Stedim Hungária Kft. Kagyló u. 5 2092 Budakeszi Phone +36.23.457.227 Italy Sartorius Stedim Italy S.r.l. Via dell’Antella, 76/A 50012 Antella-Bagno a Ripoli (FI) Phone +39.055.63.40.41 Netherlands Sartorius Stedim Netherlands B.V. Phone +31.30.60.25.080 filtratie.nederland@sartorius-stedim.com Poland Sartorius Stedim Poland Sp. z o.o. ul. Wrzesinska 70 62-025 Kostrzyn Phone +48.61.647.38.40 Russian Federation LLC “Sartorius Stedim RUS” Vasilyevsky Island 5th line 70, Lit. A 199178 St. Petersburg Phone +7.812.327.53.27 Spain Sartorius Stedim Spain, S.A.U. Avda. de la Industria, 32 Edificio PAYMA 28108 Alcobendas (Madrid) Phone +34.913.586.098 Switzerland Sartorius Stedim Switzerland AG Ringstrasse 24 a 8317 Tagelswangen Phone +41.52.354.36.36 U.K. Sartorius Stedim UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT19 9 QQ Phone +44.1372.737159 Ukraine LLC “Sartorius Stedim RUS” Post Box 440 “B” 01001 Kiev, Ukraine Phone +380.44.411.4918 Americas USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY 11716 Toll-Free +1.800.368.7178 Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone +54.11.4721.0505 Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil Phone +55.11.4362.8900 Mexico Sartorius de México, S.A. de C.V. Libramiento Norte de Tepotzotlan s/n, Colonia Barrio Tlacateco, Municipio de Tepotzotlan, Estado de México, C.P. 54605 Phone +52.55.5562.1102 leadsmex@sartorius.com Peru Sartorius Peru S.A.C. Avenue Alberto del Campo 411 Floor 12 – The Office 15076 – San Isidro, Lima Phone +51.1.441 0158 Asia|Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone +61.3.8762.1800 China Sartorius Stedim (Shanghai) Trading Co., Ltd. 3rd Floor, North Wing, Tower 1 No. 4560 Jinke Road Zhangjiang Hi-Tech Park Pudong District Shanghai 201210, P.R. China Phone +86.21.6878.2300 Sartorius Stedim (Shanghai) Trading Co., Ltd. Beijing Branch Office No. 33 Yu’an Road Airport Industrial Park Zone B Shunyi District, Beijing 101300 Phone +86.10.8042.6501 Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch Office Room 1105 Xing Guang Ying Jing Building No. 119, Shui Yin Road Yue Xiu District, Guangzhou 510075 Phone +86.20.3836.4193 India Sartorius Stedim India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra Nelamangala Tq 562 123 Bangalore, India Phone +91.80.4350.5250 Japan Sartorius Stedim Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-11, Kita-Shinagawa 1-chome Shinagawa-ku, Tokyo, 140-0001 Japan Phone +81.3.4331.4300 Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil 57000 Kuala Lumpur, Malaysia Phone +60.3.8996.0622 Singapore Sartorius Stedim Singapore Pte. Ltd. 10 Science Park Rd The Alpha #02-13/14 Singapore Science Park II Singapore 117684 Phone +65.6872.3966 South Korea Sartorius Korea Biotech Co., Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, 463-400 Phone +82.31.622.5700 www.sartorius-stedim.com Specificationssubjecttochangewithoutnotice.CopyrightSartoriusStedimBiotechGmbH.PrintedintheEUonpaperbleachedwithoutchlorine. PublicationNo.:S--1552-e180405·OrderNo.:85037-560-31·Ver.04 | 2018
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