Technique Matters
Separates biomolecules based on highly specific biological interactions
What is Affinity Chromatography?
Prepacked chromatography columns that come in 1ml and 5ml formats.
What are HiTrap Columns?
These are the three general phases used to take an antibody from harvested cell culture fluid to a highly purified product.
What are capture, intermediate purification, and polishing?
Cytiva provides a detailed documentation package for BioProcess resins that helps customers prove its safety, quality, and compliance when used in the manufacture of abiotherapeutic agent.
What is an RSF (Regulatory Support File)?
A resin base matrix that can be described as being used for SEParation, originally manufactured by PHArmacia, primarily made of agaROSE.
What is Sepharose?
A technique that uses a positively charge resin to separate molecules based on charge.
What is Anion Exchange Chromatography?
A GMP compatiable chromatography column that packs resin using axial compression.
What is an AxiChrom Column?
The step in a chromatography run where the target molecule comes off the column.
What is Elution?
Using the Swedish word for genuine or real, this product line contains systems for both bioprocess and research labs.
What is AKTA?
Antibodies with two binding sites directed at two different antigens. The clinical therapeutic effects of these antibodies are superior to those of monoclonal antibodies
What is a bispecific antibody (BsAbs)?
Used for antibody polishing or separation of empty versus full capsids, this unit can be plug and play and avoids the need to pack a column.
What is Mustang Q Membrane Chromatography?
Prepacked columns that can help customers save time and an money at both clinical and full scale manufacturing.
What are ReadyToProcess Columns?
Abbreviated CIP, this phase often uses sodium hydroxide to remove residual material bound to a chromatography column.
What is Cleaning In Place?
Part of the IQ/OQ/PQ system and operating qualification test, it is the one test a vendor cannot do.
What is PQ (Performance Qualification)?
This Cytiva Protein A chromatography resin on a 60um bead combines high antibody binding capacity with enhanced alkaline stability for monoclonal antibody capture.
What is MabSelect PrismA?
A technique that used high salt to promote binding on ligands such as phenyl, octyl and butyl.
What is Hydrophobic Interaction Chromatography?
Systems that use disposable flow paths in filtration and chromatography unit operations.
What are the AKTA ready and AKTA readyflux systems?
During this final purification phase, chromatography is used to remove remaining impurities such as aggregates, host cell proteins, DNA, and other contaminants.
What is the polishing phase?
Two measurements used to describe how well a column is packed describing the bead orientation and peak shape
What are HETP (Height Equivalent to Theoretical Plate) and As (Asymmetry)?
It is used for aggregate/dimer, DNA, host cell proteins and endotoxin removal in biological purification schemes.
What is Capto adhere?
This acidic treatment, typically performed after Protein A capture, is the most common viral inactivation step in monoclonal antibody purification.
What is low-pH viral inactivation?
Used in screening studies, these 96 well plates hold 2-50ul of chromatography resin.
What are PreDictor Plates?
Comprised of 20-100 healthy volunteers, this study determines safety and dosage.
What is a Phase I Clinical Trial?
A physical, chemical, biological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
What is a Critical Quality Attribute (CQA) ?
One out of 5000.
What is the number of molecules approved by the FDA compared to the number of molecules entering drug discovery per year?