Custom Ligand Design
CaptureSelect® technology enables selective purification of biopharmaceuticals from any type of feedstock with high yield and purity. BAC’s ligand discovery program has proven itself for a wide variety of biotherapeutic compounds, ranging from antibodies and antibody fragments, recombinant and plasma proteins to even viral particles. Click here to review some of our case studies.
Besides selectivity and affinity, which enables single step purification with high purity and yield, the screening process also allows for incorporation of important attributes that relate to the final purification process. Specific mild elution conditions can be screened for, which enables the recovery of pH sensitive therapeutics.
Final products have been demonstrated to provide unparalleled HCP and HcDNA removal whilst in addition providing efficient viral clearance (4-5 Log reduction). Read Biogen's publication on HCP removal.
Our ligand discovery process has led to the successful development of purification products for specific clients, resulting in:· decreased clean-room time and increased yield through significantly reducing the amount of purification steps
· increased purity by highly specific capturing and removal of host cell proteins
· the ability to elute at pHs that leave the target biotherapeutic completely intact and active
· selective purification of compounds which only deviate by 1 point mutation
A standard custom ligand project can be divided into four phases and typically takes 6-10 months to complete, depending upon the availability of a target library or prototypes. The structuring of these projects allows for intermediary review and decision points:
R&D Media are then available for preclinical and first phase of clinical productions, while upscaling programs can deliver cGMP compatible resins at any scale, including a Regulatory Support File. BAC has successfully completed this for more than 10 affinity products, which are being used in late stage clinical manufacturing.