Common use of Production Facility Clause in Contracts

Production Facility. Cytovance is a full-service Contract Development and Manufacturing organization (CDMO) in Oklahoma City, OK employing 220 people. Microbial host services include strain development and process development for cGMP production at the 10 L, 200 L, and 1,000 L scales, with 300 L SUF technology being added in 2018. Mammalian services include cell line development and process development for cGMP production at the 100 L, 250 L, 500 L, and 1,000 L scales with a planned expansion into 2,000 L production for early 2019. With full Analytical Development and Quality Control testing groups, Cytovance provides method transfer, development, qualification, and validation, and in-process, release, and stability testing. Cytovance also has clinical-grade, liquid vial fill/finish capabilities, Master, Working, and End-of-Production cell banking, viral validation, and Process Characterization and Validation services. Cytovance operates out of four (4) facilities - three (3) located within the Oklahoma University Research Park, close to the city’s central business district encompassing over 100,000 square feet of laboratories, cGMP Drug Product and mammalian manufacturing, and administration space. Just north of the main campus is a 30,000 ft2 microbial cGMP manufacturing building, and a 100,000 ft2 cGMP warehouse. Cytovance welcomes appropriate Synthorx representatives to tour the facilities and perform a detailed review of Cytovance’s facility design, equipment, validation, process flow, and quality systems. pH ▇▇▇▇▇▇▇ 350 pH meter ▇▇▇▇▇▇▇ Toledo Conductivity Mettler Mettler Osmolality Advanced Instruments Micro-Osmometer 3300 N/A % Purity/Aggregates Waters 2695 HPLC Agilent 1100/1200 HPLC/Waters 2695 HPLC/Acquity H-Class Bio UPLC Bioburden Millipore Milliflex single head pump system Certified biological safety cabinet Precision Incubator N/A Endotoxin Molecular Devices Spectra Max 384 plus UV/Vis plate reader/ Endosafe PTS Molecular Devices Spectra Max M2e/ Endosafe PTS Protein content ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ DU 730 spectrophotometer Molecular Devices Spectra Max 384 Plus Molecular Devices Spectra Max M2e ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ DU 730 spectrophotometer Eppendorf Biophotometer Molecular Devices Spectra Max M2e ELISA Lab Line Instruments Titer Plate Shaker ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ MW96/384 plate washer Molecular Devices Spectra Max 384 plus Molecular Devices Spectra Max M2e BioTek Synergy / neo2 Multimode Reader Lab Line Instruments and VWR Titer Plate Shakers ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ MW96/384 plate washer Molecular Devices Spectra Max M2e Forte Bio Octet Red BLI SDS-PAGE Bio Rad Power Pac Bio Rad & Invitrogen electrophoresis cells SYNGENE G:BOX F3 Gel Documentation System Un-Scan-It Gel Analysis Software Bio Rad Power Pacs Bio Rad & Invitrogen Electrophoresis cells Un-Scan-It Gel Analysis Software CGE or CE-SDS ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ProteomeLab PA 800/PA 800plus ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ProteomeLab PA 800plus IEF/cIEF/icIEF Bio Rad Power Pac GE Amersham Biosciences multiphor II VWR Model 1160S Chiller SYNGENE G:BOX F3 Gel Documentation System/ Un-Scan-It Gel Analysis Software ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ProteomeLab PA 800/PA 800plus Protein Simple iCE280 System Bio Rad Power Pac GE Amersham Biosciences multiphor II VWR Model 1160S Chiller Protein Simple iCE280 System ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ProteomeLab PA 800 Plus Immunoblotting Bio Rad Power Pac Bio Rad & Invitrogen electrophoresis cells Bio Rad Trans Blot Semi-dry Transfer Cell SYNGENE G:BOX F3 Gel Documentation System Bio Rad Power Pac Bio Rad & Invitrogen Electrophoresis/Transfer cells Bio Rad Trans Blot Semi-dry Transfer Cell Residual DNA Applied Biosystems Quant Studio 6 RT PCR System Applied Biosystems Step One RT PCR System Sialic Acids/ Glycoprofile Dionex BioLC System – HPAED Acquity H-Class Bio UPLC- FLD Detector Fermenter Systems • 10 L Bio-Flo 320 • 200 L Biostat D200 Sartorius Fermenter • 300 L ThermoFisher HyPerforma SUF • 1,000 L Biostat D1000 Sartorius Fermenter • 5 L Sartorius Biostat Aplus (8) • 14 L New Brunswick BioFlo 310 (1) and 320 (1) Cell Processing • Alfa Laval LAPX 404 Disk Stack Centrifuge • Alfa Laval High MBPX 810 Disk Stack Centrifuge • Pneumatic Scale Angelus P12 Centrifuge • GEA Homogenizer GEA Niro Soavi Ariete NS3015H • GEA Homogenizer Niro Soavi Panther NS3006L • GEA homogenizer Niro Soavi Panda 2000 • ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ J-26XP • ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ 367160 • GEA Homogenizer Niro Soavi Panda 1000+ • ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ J-25 • VWR Clinical 200 • Angelus Powerfuge Pilot Continuous Centrifuge Purification Systems • Mixing and depth filtration capabilities up to 1,000 L • Refolding and PEGylation capabilities up to 1,000 L • ASI Impulse Single Use Mixer (two (2) x 5,000 L) • 1 in AKTA Process (up to 2000 LPH, gradient capability) • 10 mm AKTA Process (27 to 400 LPH, gradient capability) • AKTA Ready, single-use (3 to 510 LPH, gradient capability) • Large inventory of columns up to 80 cm • Millipore membrane holder (0.1 to 5.0 m2 capacity) • TangenX membrane holder (1.0 to 30.0 m2 capacity) • Refolding with imPULSE 30L SUM • Mixing and Depth filtration capabilities up to 30L • AKTA Pure (2), AKTA Explorer (2) • AKTA Avant (2), AKTA Pilot • GE 10 mm Bioprocess Skid • Chromatography columns 0.6 to 30.0 cm • Scilog TFF systems with holders to 0.5 m2 (5)