Newsletter | December 13, 2022

12.13.22 -- Predicting Issues And Mitigating Obstacles In Early Phase Drug Development

Drug Development
De-Risking Drug Development At The Earliest Stages

To start the de-risking process, the team can predict development issues very early, based on the candidate’s sequence and structure, and apply in vitro tools to look at product characteristics and potential immunogenicity challenges allowing for the mitigation of potential efficacy, safety, or manufacturability risks.

CDMO Partnerships
Going From DNA To IND In 11 Months*

In a recent webinar, experts from Lonza convened to explore how the company is able to guarantee customers five months from DNA to tox drug substance, and 11 months to Investigational New Drug designation (IND) filling for antibodies, using its Ibex®️ Design 2.0 Program.

Biotherapeutics Product Development
Integrated Drug Substance And Drug Product Offering From One Site

Using cloning and expression technologies and running workstream activities in parallel through an integrated services approach enables reduced timelines without increased development risks.

CDMO Selection
mAbs Biotech Recognizes Value In Expertise, Track Record

See how reputation for quality and experience with antibodies were driving forces in the CDMO selection for a CPI-006 antibody program, which is currently under development as an oncology drug and investigation as a therapeutic for immune disorders and infectious diseases.

Risk Mitigation
Overcome Manufacturability, Expression, Early Material Generation Challenges

Learn how in silico and in vitro design and optimization tools can help assess and mitigate risks and how to optimize early expression and material supply processes to enable optimal developability.

Early Phase Development
Early Assessments And Manufacturing Strategies To Maximize Success

In silico and in vitro design and optimization serve as valuable tools in these assessments by not only identifying but also mitigating risks, ultimately optimizing early expression and material supply processes to improve developability of the candidate molecule.