Preclinical

Expression offers Research, Feasibility, Pilot, and Engineering scale viral vector production for LV, RV, and AAV. These materials are made, purified, and concentrated using the exact same manufacturing processes as used in GMP, but at reduced scale. Critical Raw Materials used in manufacturing, such as cell substrates, plasmids, buffers, and media may be GMP grade or not depending upon sponsor’s needs. Pre-clinical materials are usually made in the Process Development Laboratory but may be produced inside a cleanroom.  Research analytical testing, sterility, endotoxin, mycoplasma, infectious titer, and pH of these products is available. Turnaround time from construct submission to shipment of vector typically ranges between 2–8 weeks depending upon scale and specifics. 

Clinical

Expression currently offers the following clinical grade services:

  • LV manufacture at 60L or 120L scale which is purified and concentrated to approximately 200–400 mL of highly concentrated vector (1E8 to 1E9 IU/mL).

  • RV manufacture from either a Transient Transfection or stable Producer Line platform at up to 30L scale.

  • AAV manufacture at up to 10 x 10^13 total vg.

  • GMP γδ T cell manufacturing.

  • Hematopoietic Stem Cell or T-cell transduction.

  • Master Cell Banks & Working Cell Banks (> 150 vials with 1E7 cells/vial)

All clinical grade manufacturing is performed compliant with FDA cGMP regulations by a highly trained and experienced staff using QA issued Batch Records. All open manipulations occur inside ISO Class 5 BSCs located inside ISO Class 7 modular cleanrooms built by G-CON. Only properly released single use disposable raw materials are used. All production equipment is validated, calibrated, maintained, and cleaned accordingly. Quality is maintained through the use of an electronic Quality Management System.

Bioanalytics

Expression also brings significant experience in the development and execution of unique class-specific bioanalytical assays required to support cell and gene therapy clinical programs. Expression has dedicated GLP laboratory space, equipment, QA/QC systems, as well as qualified personnel, to support a range of cell and gene therapy bioanalytical needs, including vector copy number, enzyme-linked immunoassays, flow cytometry, as well as protein and cell based functional assays.