Repligen Corporation · NASDAQ:RGEN
Repligen — Cytovance Biologics — Technical Presentation (March 2017)
14 slides from Repligen's technical presentation, Mar 14, 2017
Slide 1: Economic Impact of Adopting Single-use TFF Flat Sheet Cassettes
Economic Impact of Adopting Single-use TFF Flat Sheet Cassettes Stephanie Wickham and Brent VanRite 14MAR17
Slide 2: Cytovance CDMO overview
• Biopharma Contract Development & Manufacturing Organization (CDMO) • Serving the pharmaceutical industry from drug development to vial filling • Clinical material supply for biological drug developers: antibodies, therapeutic proteins and enzymes • Mammalian, microbial, transgenic, and flex projec
Slide 3: Company history timeline 2005-2015
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Process Development, Continued growth in Introduced 1,000 L 200 L Microbial Automated Fill 3500 Facility cGMP Cell Banking, • Process & Microbial Bioreactor Manufacturing Finish Service Online Analytical Lab Services. Analytical Manufacturing br
Slide 4: Cytovance service offerings
Drug Substance and GMP GMP Clinical GMP Microbial GMP Flex Suite Drug Product R&D Services Mammalian Drug Product Manufacturing Manufacturing Release and Manufacturing Vial Filling Stability Testing
Slide 5: Biologics developed across disease areas
• Our scientists have developed processes for a wide variety of biologics using both microbial and mammalian platforms Biosimilar Clotting Orphan Drug • >50 Biologics and >14 Disease Areas Commodities Autoimmune Allergies Diabetes Cancer • Biosimilars Infectious Diseases • Transgenic Radiation Bone
Slide 6: Scalability, efficiency, production time, cost comparison
1. Scalability 2. Efficiency 3. Decreased production time 4. Cost Comparison
Slide 7: Traditional vs Repligen vs competitor TFF cassettes
Traditional TFF Cassettes: Repligen TFF Cassettes: Competitors Single-Use TFF 1. 0.01-2.5m2 bricks 1. 0.01-2.5m2 bricks Cassettes: 2. CRC and PES 2. PES membranes 1. 0.01-2.5m2 bricks Membranes A. Prostrem A. Not always B. Hystream stackable 2. PES membranes Image from millipore.com Image from tange
Slide 8: Single-use TFF cassettes increase efficiency by eliminating cleaning and storage
Traditional TFF Cassettes Operations Single-Use TFF Cassettes Operations 1. Installation and Pressure hold 1. Installation and Pressure hold 2. WFI Flush 2. WFI Flush 2-3hours 3. Equilibration 3. Sanitization 4. WFI Flush and NWP Testing 4. Concentration 5. Equilibration 5. Diafiltration 6. Concentr
Slide 9: Repligen TFF insert eliminates cleaning and testing of holder
• Use of Repligen’s TFF insert has eliminated the need for cleaning and testing of the TFF holder. • No Cleaning Validation required for membranes or holder.
Slide 10: TangenX holder with filter plate insert flexibility
• Usage of TangenX holder with filter plate insert allows flexibility in configuration customized per project.
Slide 11: Converting traditional CRC TFF process to TangenX PES TFF
Converting an existing traditional CRC TFF process to TangenX PES TFF. Traditional Cassettes 6x2.5m2 bricks = ~$11.2k each = TangenX Cassettes 6x2.5m2 bricks = ~$2.5k each =
Slide 12: Cassette cost and capacity comparison
Converting an existing traditional CRC TFF process to TangenX PES TFF. Traditional CRC Cassettes had a capacity of 65L/m2 with 3 uses before NWP dropped below 70%. 6x2.5m2 bricks = ~$11.2k each = ~$67k TangenX PES Cassettes had a capacity of 72L/m2 5x2.5m2 bricks = ~$2.5k each = ~$12.5k x 3 = ~$37.5
Slide 13: Raw materials cost cut by almost half
Converting an existing traditional CRC TFF process to TangenX PES TFF dropped raw materials cost by almost ½ and removed days of suite time for cleaning results.
Slide 14: Conclusions on single-use TFF cassettes
• Repligen’s Single-Use TFF cassettes exhibit the same scalability as traditional TFF cassettes • Repligen’s Single-Use TFF cassettes exhibited the same if not slightly better capacity for processes transferred with the traditional CRC membranes. • Single-Use TFF cassettes and Filter Plate Inserts o
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