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/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:
- 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
- Sartorius BIOSTAT® Cultibag rocking bioreactor with RM 20 and RM50 platforms
- Sartorius BIOSTAT® B Plus 10L bioreactor
- Cell Culture Company AutovaxID® perfusion bioreactors
- Sanimatic UltraFlo 45 CIP skid
- Microfluidics M-110P homogenizer
- CEPA® Z41 tubular bowl continuous centrifuge
- Beckman Coulter Avanti high speed floor centrifuges
- YSI 2900D biochemistry analyzer
- Sartorius BioSealer® and BioWelder®
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:
- GE ÄKTA Pilot chromatography system
- GE ÄKTA Avant 25 chromatography system
- GE AxiChrom™ and BPG column housings
- Spectrum Labs KrosFlo® Research IIi TFF systems
- Spectrum Labs MiniKros Pilot 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
- Hyclone™ SU process liquid mixer and containers (50, 100, 200L)
- Mettler Toledo PUA579 1000 lb. floor scale with ramp
- Labconco Freeze Zone 2.5L lyophilizer
- M&O Perry Industries P-1540 vial filler
- QSonica Q500 Sonicator
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
- Tecan Freedom EVO® liquid handling system
- FortéBio BLItz® system
- GE ÄKTA Micro chromatography system with analytical sizing columns
- GE SimpliNano systems
- GE Sievers 900 TOC analyzer with auto sampler
- Bio-Rad C1000 Touch™ thermal cycler
- Beckman Coulter DU730 UV-VIS spectrophotometer
- Lighthouse Worldwide Solutions Solair 3100 airborne particle counters
- Millipore MAS-100Eco® air samplers
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/thaw, cryopreservation, cell banking, cell expansion and seed train propagation.
Equipment:
- Labconco Class II, Type A2 biosafety cabinets
- New Brunswick Galaxy® 170S CO2 incubators
- Cell Culture Company Multi6™ and Primer™ perfusion bioreactors
- Nova Biomedical BioProfile® 400 chemistry analyzer
- Thermo Fisher CryoExtra™ 20 LN₂ storage vessel
- Thermo Fisher Neon® transfection system
- Eppendorf 5810R centrifuges
- Bio-Rad TC20™ automated cell counters
- Olympus IX53 inverted fluorescence microscope with camera
- Carl Zeiss Primovert inverted microscopes
- Leica DM750 upright microscopes
