Cleanrooms
This area is broken up into 4000 square feet of liquid processing and 1500 square feet of powder processing.
What is the cleanroom?
This describes the requirements for our quality management system.
What is the quality manual?
The company was founded in this year.
What is 2016?
This service allows for the following pathway:
Order RUO Sample -> Test RUO Sample -> Customize your Media.
What is QuickStart Media?
This equipment is commonly referred to as "Big Bertha" by manufacturing technicians.
What is the 2000L tank?
The cleanroom contains 4 of these.
What are liquid processing rooms?
ISO 13485 is typically applicable in this industry.
What is medical devices?
NB expanded into 10929 in this year.
What is 2017?
This serum is specially designed for use with T cells. It significantly boosts transduction efficiency while maintaining proliferation and preserving relevant phenotypes to support the development of CAR-T cell therapies.
What is NB-ROC?
This technique is used when performing activities in the BSC.
What is aseptic?
This continuously records environmental parameters in the cleanroom.
What is the Xiltrix monitoring system?
This certification allows for the manufacturing, QC testing, and distribution of cell culture media, HSA, media supplements, buffers, and saline as pharmaceutical excipients and pharmaceutical auxiliary materials (PAMs).
What is EXCiPACT?
This innovative, first-to-market media maker was announced in 2022.
What is the Krakatoa?
This product is a chemically-defined, serum-free, xeno-free, DMSO-free cryopreservation media.
What is NB-KUL DF Cryomedia?
This type of equipment comes in 200L, 500L, or 2000L variations.
What is a tank?
This ISO 8 area is where raw material transfer occurs.
What is the raw material pass-through?
This system ensures the quality of manufactured products.
What is Good Manufacturing Practices?
This online configuration and ordering platform was made available in 2020.
What is NB-Lux?
This product improves the therapeutic potential and in-vivo efficacy of CAR T-cell therapy by promoting a more potent antitumor response.
What is Physiologix XF SR?
The smallest volume GMP product ever produced at 10908.
What is 50 uL FGF-2 TOP?
There are 80 of these in the cleanroom.
What are motorized HEPA filters?
This approach is used to identify, investigate, and address deviations, discrepancies, or non-conformances in a process, product, or system.
What is CAPA?
CEO Dave Sheehan said the following quote about this NB milestone:
"...demonstrates our commitment to quality and leadership in the industry to meet the highest regulatory standards...for our media, buffers, and supplements. "
What is EXCiPACT certification?
This product is a thermostabilized recombinant human growth factor manufactured in a novel plant-based expression system.
What is recombinant human FGF-2 TOP?
This must be signed before MFG can be initiated.
What is line clearance?