National Center for Therapeutics Manufacturing
The National Center for Therapeutics Manufacturing (NCTM) is an interdisciplinary workforce education and research center serving the global biopharmaceutical and vaccine manufacturing industries. A member of the Texas A&M Engineering Experiment Station, the NCTM develops and delivers customizable instructor-led, computer-based, and hands-on learning to expose the student to various aspects of cell culture and basic molecular biology, aseptic processes and microbiology, upstream and downstream processing of biological materials including viruses, monoclonal antibodies and other recombinant proteins, as well as industrial bioanalytical methods.
NCTM also provides enabling technologies to academic or medical researchers and start-ups through its blended infrastructure of academic, scientific and industrial expertise and complete range of bench-to-pilot and Phase I scale bioprocess and analytical equipment. Our capabilities include:
- LNP encapsulation, mRNA production, formulation and QC analysis
- Media screening to improve cell line productivity
- Expression systems including bacteria/yeast/mammalian/algae/insect lines
- Protein expression and purification
- Process development/optimization support
- Analytical methods development and characterization
Process Development and Upstream Production
This 2,000 square foot cGMP BSL2 suite is subdivided to accommodate to multiplatform processes from bacteria (E. coli, etc.) to various mammalian cell (CHO, VERO, BHK, etc.) expression systems. Activities in this suite include upstream process development and manufacturing up to pre-clinical and Phase I scale. We have bioreactors from 1L to 100L working volumes, including single use, stainless steel and wave-type systems that will also accommodate perfusion.
Equipment:
- New Brunswick BioFlo® 610 Stainless steel 125L bioreactor
- New Brunswick BioFlo® 310 fermentors with 5 and 14L vessels
- Sanimatic UltraFlo 45 CIP skid
- Microfluidics M-110P homogenizer
- GEA Lab Homogenizer Panther 3006
- Beckman Coulter Avanti high speed floor centrifuges
- GEA Westfalia Separator disc stack centrifuge
- GEA WhisperFuge® Solid Bowl Clarifier
- YSI 2900D biochemistry analyzer
- Sartorius BioSealer®
- Sartorius BioWelder®
- New Brunswick Scientific I 24 Incubator Shaker Series
- QSonica Q500 Sonicator
- Panasonic MLS Series top-loading portable autoclave
- STERIS® AMSCO® 250LS Autoclave
- STERIS® AMSCO® 430LS Autoclave
Process Development and Downstream Production
This 2,700 square foot suite enables our downstream purification process development and manufacturing activities (see this lab’s equipment listed in the yellow side bar). The processes supported in this area include clarification, normal flow filtration, tangential flow filtration and chromatography methods from benchtop to pilot scale production appropriate for pre-clinical to Phase I. Additionally, early formulation studies can be conducted as well as liquid vial filling from a few hundred to several thousand vials. Early stage lyophilization studies can also be conducted in this suite.
Equipment:
- Cytiva ÄKTA process™ chromatography system
- GE ÄKTA Pilot chromatography system
- GE ÄKTA Avant 150 chromatography system
- GE ÄKTA Avant 25 chromatography system
- GE ÄKTA Pilot chromatography system
- GE AxiChrom™ and BPG column housings
- Precision Nanosystems NanoAssemblr® Ignite™ LNP encapsulation device
- Millipore TF2S Mobius® FlexReady Solution for TFF
- Spectrum Labs KrosFlo® Research IIi TFF systems
- Spectrum Labs KrosFlo® MiniKros Pilot TFF system
- Repligen KrosFlo® KR2i TFF System
- Millipore Pellicon® TFF cassette and mini cassette assemblies
- Watson Marlow 720UN (66 LPM) peristaltic pump
- Millipore Millistak+® Pod depth filter holder
- Millipore Integritest® 4 filter integrity tester
- Millipore Mobius® Power MIX 100 single-use mixer (10-100L)
- Liquidyne Stainless Steel power mixer (100L)
- Mettler Toledo PUA579 1000 lb. floor scale with ramp
- Labconco Freeze Zone 2.5L lyophilizer
- M&O Perry Industries P-1540 vial filler
Analytical Methods Development and Product Testing
This 2,700 square foot suite houses instrumentation to support various analytical assays used in both quantifying and analyzing biomolecules and potential contaminants (see this lab’s equipment listed in the yellow side bar). As a Texas A&M Center, we also have access to vast resources throughout Texas A&M University including centers containing extensive mass spectrometry and flow cytometry systems to analyze cells and biomaterials.
Equipment:
- Dionex UltiMate® 3000 HPLC system with PDA and charged aerosol device detectors
- Biotek Synergy™ H1 multi-mode plate reader
- Biotek ELx50 ELISA plate washer
- Bio-Rad ChemiDoc™ MP gel and Western blot imaging system
- Forté BIO BLItz® Label-Free Protein Analysis System
- GE SimpliNano™ spectrophotometer
- GE Sievers 900 Laboratory TOC analyzer with auto sampler
- Promega Spectrum Compact CE (Capillary Electrophoresis) System
- Applied Biosystems 7500 Fast Real-time PCR system
- Bio-Rad QX200™ Droplet Generator and Droplet Reader (ddPCR)
- Bio-Rad PX1™ PCR Plate Sealer
- Bio-Rad C1000 Touch™ thermal cycler
- Bio-Rad T100™ thermal cycler
- Beckman Coulter DU730 UV-VIS spectrophotometer
- Lighthouse Worldwide Solutions Solair 3100 airborne particle counters
- Millipore MAS-100Eco® air samplers
- Thermo Scientific Genesys 10S UV-VIS
- spectrophotometers
- Mettler Toledo Seven Compact conductivity meters
- Thermo Scientific Orion Dual Star pH meters
- Elga PureLab Ultra pure water system
- New Brunswick Ultra-Low Temperature Freezer
- Bio-Rad Trans-Blot ® Turbo™ Transfer
- Systems (western blot)
- Bio-Rad Mini-PROTEAN ® Tetra Systems (SDS-PAGE)
- Bio-Rad Mini-Sub ® cell GT (nucleic acid gels)
Cell Culture Lab
This 600 square foot suite houses equipment and supplies to support aseptic handling of cell culture operations associated with cell line selection, maintenance, and scale-up activities (see this lab’s equipment listed in the yellow side bar). Some of the processes performed in this lab include cell freeze or thaw, cryopreservation, cell banking, cell expansion and seed train propagation.
Equipment:
- Cytiva Xcellerex XDR 50 single-use bioreactor (50L)
- Labconco Class II, Type A2 biosafety cabinets
- New Brunswick Galaxy® 170S CO2 incubators
- PBS Biotech PBS 3 MAG spinning wheel bioreactor
- PBS Biotech PBS MINI spinning wheel bioreactor
- Sartorius BIOSTAT ® RM 50 (rocking motion bioreactor)
- Sartorius BIOSTAT ® CultiBag RM rocking motion bioreactor (5-50L)
- Eppendorf BioFlo ® 320 bioreactor with 14L vessel
- Nova Biomedical FLEX2 biochemistry analyzer and automated cell counter
- Beckman Coulter ViCELL BLU automated cell counter
- Bio-Rad TC20™ automated cell counters
- Eppendorf epMotion 5073 automated liquid handler with HEPA filter
- Thermo Fisher CryoExtra™ 20 LN₂ storage vessel
- Thermo Fisher Neon® transfection system
- Eppendorf 5810R centrifuges
- Olympus IX53 inverted fluorescence microscope with camera
- Zeiss Primovert inverted microscopes
- Leica DM750 upright microscopes
- Thermo Scientific Reach-In CO 2 incubator
- VWR® symphony™ CO 2 incubators
