ACUSYST-MAXIMIZER® - Biovest Hollow Fiber
ACUSYST-MAXIMIZER® ACUSYST-MAXIMIZER® Flexible, pilot-scale bioreactor: 80L or 160L fed-batch bioreactor equivalent depending on disposable size in use ACUSYST-miniMAX ™ Diagnostic and therapeutic uses Produce MAbs, recombinant proteins or virus Culture suspension or adherent Process-development, pilot-scale bioreactor cell lines 80L fed-batch bioreactor equivalent Single-use disposable: - Supplied sterile and ready-to-use Produce MAbs, recombinant proteins or virus - No cleaning or expense Culture suspension or adherent cellvalidation lines - Fast turnaround time Single-use disposable: Diagnostic and therapeutic uses ACUSYST- miniMAX ™ Cell Culture System • Supplied sterile and ready-to-use In validation use worldwide • No cleaning or expensefor • Fast turnaround time many years producing regulated biologics with very high reliability! In use worldwide for many years producing regulated biologics with up veryto high reliability! Produces ~1gm/day from routine cell lines Produces up to ~1/2 gm/day from routine cell Runs routinely last for months—maximizing lines your production uptime Runs routinely last for months—maximizing your production uptime Hollow Fiber Advantages Protein Production and Concentration in the Bioreactor! Mother Nature knows this already! Capillaries efficiently perfuse dense tissues. Hollow fiber capillaries are Hollow Fiber Advantages semipermeable membranes (<60KDa MWCO). Nutrients Mother Nature knows already! and wastes freelythis exchange. Cells, growth supplements Capillaries efficiently perfuse dense tissues. andfiber products are retained. Products are simultaneously Hollow capillaries are semipermeable membranes (10KDa MWCO). Lactate cross CROSS section SECTION produced and concentrated! Growth supplements are Nutrients and wastes freely exchange. needed in very small amounts to save $$$ and create purer Glucose Glutamine O2 CO2 NH4 Cells, growth supplements and products are retained. supernatant than in other culture methods. Products are simultaneously produced and concentrated! Growth supplements are needed in very small amounts to save $$$ and create purer supernatant than in other culture methods. Creating the next generation of therapeutic and diagnostic products Protein Production and Concentration in the Bioreactor! Biovest.com ACUSYST-MAXIMIZER® Project1_Layout 1 1/23/14 19:07 Page 1 Additional Features Save Time & Money MAXIMIZER automatically controls: Automation = Less labor • • • • • e.g., DMEM:F12 (no supplement) • e.g., DMEM:F12 or/ ~125L / with 5% FBS ~2L month monthmedia Various commercial serum-free FACILITY ~ 5L / week Hollow Fiber Means High Cell Density! ~4x1011 viable cells uniformly distributed throughout the bioreactor. Specifications & Requirements 54.4 kg 18–26°C ambient 100% CO2, 14–16 psi 70 cm W x 66 cm D x 52 cm H 100–230 VAC, 50/60 Hz, 500 watts ~125 to 250L / month ~2 to 4L / month Use very little growth supplement! MAXIMIZER 160L Fed-Batch Reactor Simple, Bench-Top, 100% CO2, Standard electricity Large skid, multiple gases, CIP, SIP, etc. Complexity! Oxygenator Cascading pH controller. MAXIMIZER produces concentrated and optionally clarified supernatant. Go directly from bioreactor to purification! Maximizer uses two feed media: ~ 0.15 L week SEED TRAIN 0.4L Inoculum Simple static culture methods 8L Inoculum Complex, Expensive, Time-consuming MEDIA COSTS EXAMPLE $66/gm MAb produced $300/gm MAb produced DOWNSTREAM PROCESS 26L of Supernatant Supernatant is ready for purification! 160L of Supernatant Concentration, Clarification… Expense & time TURNAROUND EXPENSE Runs last months Maximizes uptime Disposable = Rapid turnaround 10-Day Runs Frequent cleaning and startup costs Lower productivity Inside CO2 Incubator Support Oxygenator pH Incubator temperature EC Cycling (tissue perfusion rate) Continuous or batch harvesting You focus on the science. We’ll focus on providing robust, easy-to-operate, and low-maintenance bioreactors. Our bioreactors are successfully operated by technicians with routine cell culture experience, not chemical engineers. Our technical support assists customers with achieving their success. Operates inside CO2 incubator Biovest provides training, IQ/OQ, field service, and preventive maintenance for its bioeactors. ~ 30L / week Curt Gleiter, Client Service - Instruments 8500 Evergreen Blvd. | Minneapolis, Minnesota 55433 USA (763) 786-0302 ext. 215 | cgleiter@biovest.com ~0.15
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