cGMP Manufacturing
High-end cGMP Manufacturing Facility Suites designed to meet FDA and EMA cGMP manufacturing standards. Passed European QP (EMA) and Israeli MoH audits for Phase 3 clinical trial product
Manufacturing Services
Fully equipped clean suites including 30L and single-use 300L fermentors, continuous centrifuge, AKTA process, columns, single-use mixers, and powder transfer systems
Upstream fermentation
up to 300L
Media and buffer preparation-
Clean rooms for buffer and media preparation. Fully segregated air system for each room.
Downstream purification
clean rooms for downstream. Sterile grade B clean room with separate access. Fully segregated air system for each room. Cleaning and sterilization suite with cGMP dish washer and autoclave; WFI, OFA, gases and CIP
Deep In-house Pharma Experience
Experienced team with decades of recombinant protein process development and cGMP manufacturing from bench through Phase 3
Tehila Sonnenfeld, Director of Production
-
Director of Production Extensive experience in aseptic production under GMP conditions
REQUEST MORE INFO
Get in touch to learn more about our comprehensive CDMO solutions and request a quote for your project