Biologics Translation Roadmap
UCL and partner NHS Trusts are globally leading innovators in the discovery, design, development, bioprocessing, formulation and clinical delivery of biologics including proteins, peptides, oligonucleotides and vaccines.
This roadmap provides a simplified workflow summarising key activities and considerations for development, evaluation and commercialisation of biologics, to facilitate their effective translation into the clinic.
The Therapeutic Design & Development phase of Biologics translation should involve an understanding of the patients needs in order to identify opportunities for clinical benefit. Additional considerations include the Target Product Profile (TPP) and Intellectual Property (IP).
In the Laboratory Evaluation stage of Biologics translation, it is important to address the question: Does your research grade product match the Target Product Profile (TPP) and meet all the essential requirements?
Process Development can be done ‘In-house’ or outsourced via CMO contracted development. This section includes important considerations of Process Development & Manufacturing for GLP Pre-Clinical Studies.
This section includes considerations for GMP Manufacturing and GMP Biologic.
Drug developers are required to conduct First-in-Man clinical trials to establish the safety of a new therapeutic in human subjects. Clinical evaluation must include Phase I and II clinical trials, and regulatory approvals.
The section includes manufacturers regulatory requirements for commercial adoption after completing the primary clinical safety and efficacy evaluation.