ACUSYST-XCELLERATOR
Transcription
ACUSYST-XCELLERATOR
ACUSYST-XCELLERATOR™ ACUSYST-XCELLERATOR™ Flexible, pilot-scale bioreactor: - 500L fed-batch bioreactor equivalent… up to … - 1650L fed-batch bioreactor equivalent - Various sizes™of disposables provide flexibility Linear scale-up from Biovest’s benchtop systems Used to produce an FDA-licensed injectable Process-development, pilot-scale bioreactor Diagnostic and therapeutic uses 80L fed-batch bioreactor equivalent Produce MAbs, recombinant proteins or virus Diagnostic and therapeutic uses Culture suspension or adherent cell lines Produce MAbs, recombinant proteins or virus Simultaneously produce 1 or 2 products ACUSYST-miniMAX ACUSYST- miniMAX ™ Culture suspension or adherent cell lines Cell Culture System Single-use disposable: Single-use disposables: • Supplied sterile and ready-to-use validation - Supplied sterile and • No cleaning or expense • Fast turnaround time ready-to-use - No cleaning validation or expense In use worldwide for many years producing - Fast time regulated biologics with turnaround very high reliability! 2 gm/day from routine cell Produces upFast to ~1/acquisition cycle… <4 lines months from PO to completion of IQ/OQ and operator training 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-XCELLERATOR™ Project1_Layout 1 1/23/14 19:07 Page 1 Additional Features Save Time & Money XCELLERATOR automatically controls: XCELLERATOR uses two feed media: • • • • • • e.g., DMEM:F12 (no supplement) • e.g., DMEM:F12 with 5% FBS or ~125 to ~2 to Various commercial serum-free 250L / 4L / media month Use very littlemonth growth supplement! pH Incubator temperature ~125L / ~2L / Refrigerator temperature month month EC Cycling (tissue perfusion rate) Continuous or batch harvesting ~750 to 2500L / month ~12 to 40L / month XCELLERATOR produces concentrated and optionally clarified supernatant. Go directly from bioreactor to purification! Oxygenator ~ 5L / week Inside CO2 Incubator Hollow Fiber Means High Cell Density! Oxygenator ~4x1012 viable cells uniformly distributed throughout the bioreactor. Specifications & Requirements 418 kg 18–26°C ambient 100% CO2, 14–16 psi 134 cm W x 85 cm D x 203 cm H ~ 100–230 VAC, Hz, ~3000 watts, 30L50/60 / week Single-phase XCELLERATOR Product 1650L Fed-Batch Reactor FACILITY Compact & Rolls! 100% CO2, Standard electricity Large skid, multiple gases, CIP, SIP, etc. Complexity! SEED TRAIN 4L Inoculum week Simple static culture methods 80L Inoculum Complex, Expensive, Time-consuming MEDIA COSTS EXAMPLE $66/gm MAb produced $300/gm MAb produced DOWNSTREAM PROCESS 260L of Supernatant Supernatant is ready for purification! 1600L of Supernatant Concentration, Clarification… Expense and time TURNAROUND EXPENSE Runs last months Maximizes uptime Disposable = Rapid turnaround 10-Day Runs. Frequent cleaning and startup costs. Lower productivity ~ 0.15 L / Fresh Product Support 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. ~0.15 Our technical support assists customers withL achieving their success. Fresh / week / bioreactor Operates inside CO2 incubator Biovest provides training, IQ/OQ, field service, and preventive maintenance for its bioeactors. Curt Gleiter, Client Service - Instruments 8500 Evergreen Blvd. | Minneapolis, Minnesota 55433 USA (763) 786-0302 ext. 215 | cgleiter@biovest.com