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Cell and Gene Therapy, Industrial Impact

Benefit-Risk Considerations for Product Quality Assessments; Guidance for Industry; DRAFT GUIDANCE

May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

Spotlight

TRIANNI, Inc an AbCellera Company

Trianni, Inc. is a biotech company specializing in human antibody discovery platform technology. We offer the leading in vivo platform enabling efficient discovery of fully-human monoclonal antibodies. The Trianni Mouse offers biologic drug discoverers a best-in-class solution for the isolation of therapeutic antibody candidates. Benefits over older conventional mouse immunization + humanization approaches include superior lead panels with respect to potency and diversity along with speed to the clinic and lower operating costs. We aim to make Trianni’s premium technology available to any Pharma or Biotech company engaged in antibody discovery by offering flexible licenses and multiple access models including partnerships with preferred Contract Research Organizations.

OTHER WHITEPAPERS

Cell and Gene Therapy Hot Buttons Series

whitePaper | September 27, 2022

Cell and Gene Therapy (CAGT) activity has increased dramatically in recent decades, especially in Chimeric Antigen Receptor T-Cell (CAR-T) clinical trials and therapy registrations. The IQVIA CAGT Hot Buttons series covers basic concepts in CAGT for newcomers to this field.