Aseptic Manufacturing Makes Cincinnati Children’s a Leader in Viral Vector Technology
It looks like something out of a space-age movie in the cleanroom of the Vector Production Lab at Cincinnati Children’s.
Here, in one of the Translational Core Laboratories set up to help investigators take their innovative ideas from the bench to the bedside, scientists suit up from head to toe in white suits made to keep even a speck of dust out of their clinical manufacturing processes.
This is, by design, one of the most nearly sterile parts of the medical center. Here, scientists work in a state-of-the-art laboratory with strict standards of cleanliness in design and practices that limit the amount of dust, microbes, and other aerosol particles allowed in the air.
When employees prepare to work in the cleanrooms, they change into scrubs and step onto tacky mats to remove dust and dirt from their shoes. They don’t wear jewelry, makeup or scents. They suit up in sterile coveralls, high-top boots, masks, hoods, eye protection and gloves to work in a HEPA-filtered environment where the air pressure, temperature, humidity and filtration are all tightly controlled.
They do it because this is part of what makes Cincinnati Children’s a leader in viral vector technology. It’s where they develop modified viruses to use as vectors for genetic material for delivery into human cells.
When academic investigators are ready to take their vector processes out of the lab and into a clinical trial, this is where that happens. Work in the vector lab supports early-phase clinical trials by producing the clinical-grade viral vectors used for delivering genetic material into cells. This allows researchers to use the vectors in gene-therapy trials to accelerate the discovery of new therapeutic approaches for conditions such as sickle cell anemia, other inherited diseases, or cancers.
“Since the retroviral and lentiviral vectors that the Vector Production Facility manufacture need to be sterile for use in humans but cannot be terminally sterilized after manufacture, they must be specially produced by a process called aseptic manufacturing,” Vector Core Director Bill Swaney says.
“Aseptic manufacturing is performed in a specialized cleanroom by gowned personnel under strict control to ensure the product’s safety.”
The vector lab at Cincinnati Children’s has provided viral vector preps to institutions locally, nationally and around the globe. Since November 2016, the facility has produced 17 GMP products with several of them currently in clinical use.
“We are most proud of the internal projects we are supporting, such as the sickle cell gene therapy clinical trial being run by Dr. Punam Malik,” Swaney says, “and the novel cell and gene therapy for a rare lung disease, pulmonary alveolar proteinosis (hPAP), being led by Dr. Bruce Trapnell.”
Doctors are increasingly finding approaches to treat diseases by inserting a gene into patient’s cells instead of using conventional drugs or surgery. Engineering those viral vectors to deliver therapeutic genes all starts in this space-age looking lab right out of a movie.
