July 12th, 2018
Saint-Gobain opens test lab for life sciences unit
By CATHERINE KAVANAUGH
100 Cie de Saint-Gobain United States Medical
For original article visit Plastics News
Solon, Ohio-based Saint-Gobain Performance Plastics has opened a life sciences lab in Worcester, Mass., for testing products in the fast-growing market for cell and gene therapies.
Living cells are essentially a new class of drugs thanks to recent advances like CAR-T cell therapy, which allows scientists to modify a patient's immune cells and send them back into the person to detect and destroy cancer. Targeting the immune system instead of the disease represents a paradigm shift in treating cancer and other life-threatening diseases.
Saint-Gobain's Performance Plastics business unit produces a variety of disposable products for these promising new therapies, including cell culture and processing bags branded as VueLife® and cryopreservation products branded as KryoSure® that are made mostly from flourinated ethylene propylene (FEP). The company is also developing new products for this field.
The Worcester lab is dedicated to learning more about cell and material interactions for designing single-use systems for cell and gene therapies, Benjamin Le Quere, manager of Saint-Gobain's Bioprocess Solutions, said in a phone interview.
"Saint-Gobain has a long history around high-performance materials, including fluoropolymers," Le Quere said. "Now we're adding this layer of biology to better relate what our materials do to the application of the customer, which in this case is biotech drug manufacturers."
This emerging field of medicine has specific needs when it comes to ensuring patient safety through validated processes and materials in drug manufacturing, Le Quere said.
"In cases where a biotech company takes the cells of a patient, and in a way, trains the cells to fight diseases, such as cancer, and puts them back into the same patient, you have manufacturing concerns," he added.
The best practices for manufacturing and distributing personalized medicines, which are developed with genetic material in gene therapy or whole cells in cell therapy and sometimes overlap, are still unfolding. Any problems or challenges could affect the commercial and clinical viability of these precious products.
"Logistics for these therapies is an open problem," Le Quere said.
Consider all the steps and people involved with a cell-based gene therapy branded as Kymriah, which last August became the first CAR-T cell therapy approved by the Federal Drug Administration. Unlike other medicines, Kymriah has been likened to your body using your own strength to fight your cancer. The therapy is given to patients under the age of 25 who relapsed or aren't responding to initial treatments for B-cell acute lymphoblastic leukemia, an aggressive deadly type of cancer for some.
Kymriah requires a lengthy process with various settings, handlers and containers, including dedicated containers for storage and transport as well as disposable containers, like culture bags, for the manufacturing process. The therapy takes about a month, starting with the patient going to a medical center for a blood draw to collect T cells, the natural defender of the immune system. The cells are then frozen and shipped to the drug manufacturer — in this case Novartis Pharmaceutical Corp. in New Jersey, for reprogramming and multiplying. Then the cells, which have been altered to attack cancer, are frozen again and sent back to the medical center to be placed back into the patient through an IV infusion.
In a trial involving 63 severely ill children and young adults, 83 percent went into remission from their customized treatments, which are given once at a cost of about $475,000. (For comparison, bone marrow transplants, which can cure some kinds of leukemia, generally range from $540,000 to $800,000.)
To help advance these kinds of therapies at its new 1,400-square-foot Biosafety Level 2 lab, Saint-Gobain staff will isolate, process and culture both primary and so-called immortalized cells then evaluate material, cell and protein interactions. They will study the effects of materials on cell attributes and yields using high-end analytical equipment. The facility also devotes space to develop applications for new products and has capabilities for sterile welding, pumping and low temperature testing.
The lab is located on the campus of the University of Massachusetts Medical School, but Saint-Gobain and the university aren't research partners. The site was chosen because the company has a research and development facility in nearby Northboro.
"This lab is an annex of that," Le Quere said. "The purpose is to understand what our products do to the end-use application. We're trying to bridge that gap of understanding between materials and biology."
A critical component
Saint-Gobain officials call the Worcester lab a "critical component" to leveraging the company's material science expertise into scalable solutions for bioprocessing.
Some of the company's prior research compared FEP cell culture bags to rigid polystyrene multiwell plates or T-flasks, which are the traditional products used since the 1960s. The research found fluoropolymer bags offer the benefits of transparency, flexibility and permeability for gas exchange in cell culture incubators. The bags also resist chemicals and biologics and remain flexible and thermally stable across a wide range of temperatures. FEP is also extruded as a virgin resin and doesn't contain additives or plasticizers.
"The work on polystyrene vs. FEP cell culture containers is representative of the studies that we will conduct in the sense that we will be looking at the impact of different plastic disposables on cell attributes and cell culture yield, and with commercial cell therapy manufacturing in mind, meaning at scale and following good manufacturing practices," Le Quere said.
Some of the work done at the lab will focus on protecting the microenvironment inside the culture container. To make an effective drug, cells need to properly grow and multiply in sufficient numbers, and keep expressing their traits without losing or altering the end drug product during storage at cryogenic temperatures, Le Quere explained.
Strategically designed cell culture, processing and preservation systems will pave the way for the next generation of potent cell-based cancer therapies and vaccines, according to Saint-Gobain's Performance Plastic officials.
The growing need
The World Health Organization says there are about 14 million new cases of cancer a year and the disease was responsible for 8.8 million deaths in 2015. The grim numbers and promising treatments have companies sharpening their focus on developing and launching novel therapies and products to meet growing demand for individualized drugs for patients facing poor outcomes, according to Coherent Market Insights.
The firm with a U.S. office in Seattle, Wash., estimates that the global CAR-T Cell therapy market, which is only a subset of cell therapy, is valued at $167.9 million in 2018 and will increase to $8 billion in the next 10 years. In addition to Novartis, major players are Kite Pharma Inc., Juno Therapeutics, Pfizer Inc., Bellicum Pharmaceuticals Inc., Celgene Corp. and others.
Zion Market Research of New York says the regenerative medicines market, which includes tissue engineering and immunotherapy in addition to gene and cell therapies, was valued at about $7.9 billion in 2017 and will grow at an annual rate of about 18.6 percent to $26.3 billion by the end of 2024 with the cell segment dominating.
Saint-Gobain Performance Plastics' Life Sciences division opened a manufacturing facility for specialty disposables for both the cell therapy and biotechnology markets in 2016. The company renovated a 37,000-square-foot building in Gaithersburg, Md., and installed injection molding and over-molding machines with automated part retrieval and conveyance to an ISO 7 cleanroom. Bags are manufactured with a proprietary laser welding process.
With more than 6,000 employees in 22 countries, Saint-Gobain Performance Plastics also manufactures flexible tubing, seals, coated fabrics, foams, window film, barrier/release films and tapes in addition to medical components.
The business unit is part of Saint-Gobain Corp., which is the North American holding company of the France-based parent company, Cie de Saint-Gobain. Founded in 1665, the parent company, which also serves the building products, infrastructure, transportation and industrial markets, posted sales of $47.5 billion in 2017. The company has a manufacturing or retail presence in 67 countries and a total of 179,000 employees.