There are times when training alone is not sufficient. Gain guidance from experienced experts, who were pionneers in antibody discovery and on the field of process development and validation for decades to launch new biological entities, including biosimilars. Talabardon Consulting will assist you in your CMC projects, from mammalian cells, yeasts or bacteria cultures, for gene & cell therapy, ATMP, antibody or any other large molecules. The following are our main specific areas of deep expertise.
large molecule biologics
glycosylated molecules
process design
fed-batch, perfusion upstream process
continuous upstream & downstream process
technical transfer & scale-up
risk assessments
scale-down model qualification
process troubleshooting
stage 1 process characterisation
stats & design space
stage 2 Process qualification
stage 3 Continued Process Verification
Quality by Design (QbD)
Prior knowledge
LCM, process optimisation
selection of critical quality attributes
specifications
mammalian cell culture , microbial fermentation
cell & gene therapy
Analytical methods
formulation development
process characterisation
process qualification
CPV - Life Cycle Management
product characterisation
product release
shelf life
specs at release and end of shelf life
product stability
process optimisation
process troubleshooting
product sterility
prior knowledge
analytical methods
CMC regulatory Strategy & guidance (Module 3)
early-stage, late-stage and marketing approval
FDA, EMA & other agencies
submission management & publishing
IND/IMPD, BLA/MAA
post-approval supplements
CMC package for accelerated programs for breakthrough therapies
cell line development
monoclonality
establishment of RCB, MCB, WCB, EoPCB, LIVCA
cell bank system qualification
cell banks for Bioassays
process design
testing requirements
biosimilarity with originator
process development
differences in CMC activities compared to NBE
specifications set-up
specific regulatory requirements
statistical analysis for biosimilars only
Raw materials testings
Cell banking testings
risk assessments
toxicity assessment
viral clearance studies
analyticals
control strategy
testing plan
DP sterility