GMP Manufacturing

The TRANSFERRA cleanroom facility includes ISO  7 compounding areas and an ISO 5 filling suite in an ISO 6 background.  The cleanroom space and supporting utilities were designed specifically for the manufacture of nanoparticles and more specifically, liposomes.  GMP batch manufacture services include formulations containing oligonucleotides, siRNA, mRNA, peptides, proteins, sparingly soluble compounds, and highly potent Active Pharmaceutical Ingredients (APIs).  Custom-designed isolators employed in the cleanroom provide protection for operators and manufacturing areas from highly potent APIs.  The manufacture of clinical trial material complies with U.S. and  European regulations.  TRANSFERRA provides full service GMP manufacturing including acquisition of raw materials, identity testing, drafting the master batch record, compounding, filling, inspection, labeling, release testing, and shipping to clinical distribution sites.  Analytical support for GMP manufacturing includes in-process testing, release testing, and stability studies.  TRANSFERRA’s formulation, analytical, and GMP manufacturing services in combination with established expertise in lipid nanoparticle technology, offers our clients an advantage in bringing first in class formulations from bench to bedside.

Request More Information