The contract research organization (CRO) this week announced a three-fold expansion of its translational medicine division located at the company’s headquarters at the Delaware Technology Park.
With many of its gene therapy clients conducting trials in the US, John Kolman, PhD, vice president and global head of translational medicine, QPS, said it made sense to match capabilities and regulatory compliance levels with sponsors’ needs.
The Newark, DE site also provides both custom and client assays to CLIA (Clinical Laboratory Improvement Amendments), adapting from GLP as needed, said Kolman.
“We are completing CLIA accreditation in all 50 States within the next few months. We see this as a nice add-on capability for many clients in both the gene therapy and immunotherapy spaces,” he added.
QPS has been “aggressively” adding additional lab and office space at its Delaware campus over the last 14 months, said Kolman. As he explained, vacated space is retained, refurbished, and prepped for the next expansion “on a rolling basis.”
The company’s laboratory that uses mass spectroscopy of immunocaptured biologics was moved and expanded three-fold in parallel with the gene therapy lab expansion, explained Kolman.
Additionally, the laboratory providing cell-based neutralizing antibody assays was rebuilt at a new location – still on the Delware campus – doubling in size. Staff is set to move as the new lab goes live in the next two weeks.
QPS also will gut its pharmacokinetics (PK) and immunogenicity labs, which Kolman said will be expanded and rebuilt “on the fly” over the next few months.
“Large molecule therapies continue to fill our clients’ pipelines,” added Kolman. “This leads directly to increasing demand for high quality, timely bioanalytical service.”
Two trends are driving demand for gene therapy, Kolman said. This includes “a mini renaissance” in nucleic acid drug delivery technologies, conceived years ago, but having matured recently. Examples include mRNA encapsulation and siRNA targeting.
Also increasing demand it “the halo of excitement that surrounds new uses of nucleic acids as therapies,” Kolman said.
“These include CRISPR, which directly modifies the genome of targeted cells in patients with genetic disorders, and CAR-T in which exogenous nucleic acid is added to a patients T-cells to illicit an anti-cancer physiologic response,” he added.