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Inspiring Advances in Bioprocessing

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Presentation on theme: "Inspiring Advances in Bioprocessing"— Presentation transcript:

1 Inspiring Advances in Bioprocessing

2

3 Inspiring advances in bioprocessing since 1985
AN INDUSTRY LEADER IN Hollow Fiber and Flat Sheet Filtration Technologies Pre-packed Chromatography Columns Protein A Affinity Ligands Manufacturing Most of the world’s monoclonal antibodies are purified on Repligen’s Protein A Upstream and Downstream Applications Chromatography 25-30% Proteins ~40% Filtration 30-35% Repligen Corporation: one of the fastest-growing companies in North America Multiple global manufacturing sites 20 of the Top 25 Pharma companies use Repligen products

4 Rapid growth through innovative launches and strategic acquisitions
1985 1988 2010 2011 2012 2014 2015 2016 2017 Protein A ligands commercial manufacturing Launched Immobilized Protein A resins Acquired BioFlash technology: Pre-packed columns Acquired Novozymes Biopharma: Native Protein A, growth factors Launched OPUS® pre-packed columns Acquired Refine ATF technology: XCell™ ATF Launched OPUS® 60 Acquired Atoll: OPUS™ PD Acquired Spectrum® HF TFF Systems Repligen is one of the fastest growing companies in North America Launched XCell™ Single-use, OPUS® R Launched XCell™ 10 Single-use Launched OPUS® 45 Acquired TangenX™ TFF Cassettes

5 Repligen products in biologics
process development

6 Repligen products in biologics commercial manufacturing
mAb and Vaccine based Production

7 Repligen products in continuous processing

8 Setting new standards in bioprocessing
XCell™ ATF Systems Award-winning perfusion cell separation device Stainless steel and single-use formats Enables continuous processing In 50+ Phase 1-3 processes and 4 commercial processes Spectrum Filters and Systems KrosFlo® Hollow Fiber Filters and Perfusion Systems ProConnex™ modules, bags and tubing sets Used in biologics development & manufacturing, gene therapy, vaccine production TangenX™ TFF Filters First purpose-built single-use TFF cassettes Single-use and reusable formats 80% cost reduction, 50% labor reduction, 75% less buffer use In 200+ Phase 1-3 processes and 5 commercial processes LONG® Cell Culture Supplements Up to 200 times more potent than insulin Manufactured to ISO standards in Sweden In 6+ commercial processes OPUS® Pre-packed Columns Leader of the pack in resin choice and size From process development to large-scale commercial applications In 100+ Phase 1-3 processes, 1 commercial process Experts in column packing ELISA Quantitation Kits Fast, reliable, and re-producible quantitation of leached Protein A, MabSelect SuRe™ ligand and LONG®R³ IGF-I Less text, better way to get pictures in Optimizing process efficiency, process economics, and risk mitigation

9 Scaling to meet customer demands
Waltham, MA Shrewsbury, MA Lund, Sweden Ravensburg, Germany Los Angeles, CA Las Vegas, NV Houston, TX Dallas, TX Breda, Netherlands Growing global presence, Scaling to meet customer demands As of October 2017 Direct Sales (34) Field Applications Specialists (3) Field Service Specialists (7) Key Distributors (5)

10 Focus on business continuity, quality systems, and risk mitigation
Waltham, MA - Headquarters Lund, Sweden Ravensburg, Germany Shrewsbury, MA Los Angeles, CA Las Vegas, NV Dallas, TX Houston, TX Breda, NL, EU Multi-Site Manufacturing Safety Stock Program Stringent Inventory Management Program Animal-free Robust supply chain Secure Raw Material Supply Chains Supports customer filings Technical support Complete Regulatory Support Packages Global technical support Field applications team Hands-On Service and Support Focus on business continuity, quality systems, and risk mitigation

11 Redefining modern bioprocessing: 2017 and
beyond Single-use Systems for flexible bioprocessing Global expansion and outreach Continuous Processing tools and systems Europe manufacturing and center of excellence

12 Pre-packed Chromatography Columns
OPUS® Pre-packed Chromatography Columns Pre-packed chromatography columns with unparalleled flexibility in resin choice and size Experts in packing manufacturing scale columns Winner of multiple awards for design excellence First production- scale pre-packed columns In 100+ Phase 1-3 processes and 1 commercial process since its launch in 2012 Open platform, user-specified

13 OPUS® PD Pre-packed Columns
Designed for process development and process validation, including viral clearance, scale-up, and sample preparation Over resins packed OPUS® RoboColumn® for automated parallel chromatography OPUS® MiniChrom for process development and sample preparation OPUS® ValiChrom for process validation Pre-packed columns for process development (formerly Atoll Columns)

14 XCell™ ATF Systems Award-winning perfusion cell separation device for high cell concentration and process intensification Leading cell separation device in perfusion mAb and rProtein production Single-use and stainless steel formats Applications beyond perfusion; cell banking, seed train optimization In 50+ Phase 1–3 processes and 4 commercial processes Add in ATF products For high density cell culture and process intensification

15 TangenX™ TFF Cassettes
Featuring the first purpose-built single-use cassettes for tangential flow filtration Reliable, consistent performance since 2007 80% reduction in filter cost 50% reduction in labor use 75% reduction in buffer use Interchangeable, single-use, and reusable formats Scalable from bench to production Reliable, scalable, cost-effective solutions for tangential flow filtration

16 Spectrum® KrosFlo hollow fiber filters for tangential flow filtration
KrosFlo TFF Hollow Fiber Filters Scale-up made easy: Spectrum® KrosFlo hollow fiber filters for tangential flow filtration Scalable, from process development to commercial manufacturing Fast processing, with high flux rates High yield, low protein binding Manufactured in compliance with ISO guidelines Used in over Spectrum® Krosflo TFF Systems and over 2000 XCell™ ATF Systems worldwide Compatible with other industry hollow fiber TFF systems Pore size range: 1kD – 0.65µm Filter module Surface area Volume MicroKros 13 cm2 – 60 cm2 1-100 ml MidiKros 75 cm2 – 370 cm2 100 ml - 3 L MidiKros TC MiniKros Sampler 490 cm2 – 2600 cm2 3 L -15 L MiniKros 1550 cm2 – 8500 cm2 5 L - 50 L KrosFlo 7850 cm2 – 4.1 m2 10 – 100L KrosFlo MAX 4.3 m2 – 12.8 m2 100L – 1000+L KrosFlo MAX mPES (Modified Polyethersulfone) hollow fiber filters

17 Turnkey hollow fiber systems for tangential flow filtration
Spectrum® Standard KrosFlo TFF Systems Turnkey hollow fiber systems for tangential flow filtration Scalable from process development to commercial manufacturing Volumes from milliliters to thousands of liters Automated process control Proprietary data collection software Worldwide adoption, with over systems in use today Custom systems available, including KTF, KrosFlo Pilot Plus, and KPS Systems KMPi TFF System: L KR2i TFF System: 1ml to 10L KML 100 System: L

18 Protein A resins from the leading manufacturer of rProtein A ligands
CaptivA® Protein A Resin Protein A resins from the leading manufacturer of rProtein A ligands Industry-standard results at a fraction of the cost of traditional resins In 3 commercial processes, expanding pipeline of Phase 1–3 processes The value choice in Protein A resins

19 LONG®R³ IGF-I Cell Culture Supplement
Cell culture supplement 200 times more potent and two times more stable in cell culture than insulin Recombinant, animal origin-free, cGMP compliant Used extensively in mAb and rProtein production Secure global supply In 6 commercial processes Increasing adoption in biosimilar development, cell therapy, and vaccine applications Potent, safe, flexible cell culture growth factor

20 ELISA Quantitation Kits
Quantitation of leached Protein A, MabSelect SuRe™ ligand, and LONG®R³ IGF-I Most accurate matched standard for MabSelect SuRe™ resin High specificity and high sensitivity detection and quantitation Reproducible and consistent inter- and intra-kit consistency Fast, reliable, reproducible analytics

21 Pre-packed Chromatography Columns
OPUS® Pre-packed Chromatography Columns Pre-packed chromatography columns with unparalleled flexibility in media choice, application, and size Expert in packing manufacturing-scale columns >100 45s and 60s shipped since 2015 > cm columns shipped since 2013 1000s of pre-packed columns shipped globally each year (>0.5cm ID) >100 Phase 1-3 campaigns and 1 commercial process since launch in 2012 >100 different resins packed (8-60cm IDs) Any resin, any application, any size Leader in pre-packed columns Increase process efficiency Most flexible in resin choice, application, and size (0.5-60cm IDs) Ready-to-use and disposable—no cleaning validation process Faster campaign turnarounds Optimize process economics Up to 35% cost savings over self- packed columns Up to 150 FTE hours savings per campaign No upfront capital expense Quality and risk mitigation No column packing failures ISO 9001 quality manufacturing Complete documentation package for GMP use

22 XCell™ ATF Systems Award-winning filtration device that delivers high cell concentration and process intensification Single-use and stainless steel formats Leading cell separation device in perfusion mAb and rProtein production Applications beyond perfusion—process intensification, cell banking, seed train optimization In 6 of the Top 10 Pharma companies In 4 commercial and 50+ Phase 1-3 processes For high density cell culture and process intensification Finalist 2012 Bioprocess International Technology of the Decade Increase process efficiency Consistently high cell retention, concentration, and viability Easy to use, fewer process steps Reduced batch size—development scale is commercial-use Optimize process economics Reduced capital investment—fewer smaller bioreactors, smaller facilities Up to 40% reduction in COGs Quality and risk mitigation Enables multiple smaller facilities in different regions

23 TangenX™ TFF Cassettes
Proven TFF cassettes in single-use and reusable formats Reliable, consistent performance since 2007 Used in 200 Phase 1-3 processes and 5 commercial processes Scalable from bench to production Interchangeable single-use and reusable formats TangenX™ SIUS™ and SIUS™ PD Single-use TFF Cassettes TangenX™ PRO and PRO PD Reusable TFF Cassettes Two membrane chemistries: ProStream and HyStream Reliable, scalable, cost-effective solutions for tangential flow filtration (TFF) First single-use TFF cassettes Increase process efficiency Pre-sanitized, ready-to-use Scalable from bench to production Faster campaign turnarounds Optimize process economics 80% reduction in filter costs 75% reduction in buffer use 50% reduction in labor use Quality and risk mitigation Complete documentation package for GMP use Compliant with USP Class VI BSE / TSE Free

24 CaptivA® Protein A Resin
Most cost-effective Protein A affinity resin available today Industry-standard results at a fraction of the cost of traditional resins Secure global supply In 3 commercial processes, expanding pipeline of Phase 1-3 processes The value choice in Protein A resins Protein A resins from the leading manufacturer of Protein A ligands Increase process efficiency High dynamic binding capacity, low Protein A leaching Fastest Protein A quantitation—reliable, robust, reproducible Optimize process economics Up to 50% lower than the price of leading resins Increased savings when pre-packed into OPUS® columns Quality and risk mitigation Fully documented, certified ISO 9001 quality system Animal origin-free, manufactured to USP purity standards Secure supply chain

25 LONG®R³ IGF-I cell culture growth supplement
Potent and safe cell growth supplement for serum-free or low-serum cell culture Recombinant, animal-free, cGMP compliant Used extensively in mAb and rProtein production Secure global supply In 6 commercial processes Increasing adoption in biosimilar development, cell therapy, and vaccine applications Related products: LONG®EGF growth factor and LONG®R³ IGF-I ELISA Quantitation Kit Potent, safe, flexible cell culture growth factor Up to 200 times more potent than insulin Increase process efficiency Increased cell density Increased viability Increased cell-specific productivity Optimize process economics Reduced frequency of growth factor feeds Improved performance of chemically-defined protein-free media Reduced processing time Quality and risk mitigation Recombinant, animal-free, cGMP compliant Global safety stock program Secure supply chain


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