MEND Biotechnology Development

MEND's Biotechnology Development Center employs our expertise and infrastructure to apply advanced formulations and alternate route of administration technologies to vaccine candidates to improve their overall sustainability and "developability." We generate fully-integrated development plans to ensure a "clear line of site" from research to commercialization. We work with our own proprietary platform, as well as conduct feasibility and preclinical studies for others’ licensed intellectual property at our laboratories in Pretoria and Cambridge.

Areas of expertise:

• Research: in-vitro feasibility studies of biologicals and small molecules, and pre-clinical work through IND-enabling tox
• Manufacturing: GMP-quality drug/vaccine clinical trial supply
• Regulatory & QA: assurance that all programs are conducted in strict accordance to GLP and/or GMP regulations as appropriate.
• Business development: creating and sustaining healthy and productive partnerships that take into account the variety of sources of technology & intellectual property.
• Intellectual Property: constructing solid and strategic patent estates that allow for freedom to operate, establish royalty-free situations in developing countries, and allow for for-profit applications that can further MEND’s not-for-profit mission.

MEND Biotechnology Development’s two primary development programs include inhaled capreomycin powder in phase I clinical testing, and inhaled BCG vaccine in pre-clinical testing.