Personalized Medicine is a young but rapidly advancing field of health care that is guided by each person's unique clinical condition. Because every person is different, the nature of each patient's diseases may respond to drugs in different ways, good or bad.
Personalized medicine is about making the treatment as individualized as the disease. In order for personalized medicine to be used effectively by health care providers and their patients, the ability to manufacture innovative research discoveries to produce a consistent and safe product for patient use is crucial.
The Food and Drug Administration (FDA) has set stringent regulations for the production of therapeutic products, such as specialized “clean-room” facilities, validated equipments, a quality program, specially trained personnel, rigorous documentation, etc. While these FDA Good Manufacturing Practice (GMP) regulations ensure that quality is built into these targeted therapeutic products for patient safety, these same rules also make it difficult to introduce innovative therapies to the clinic due to the high cost of following these government standards.
Roswell Park: Bringing Personalized Medicine to the Clinic
Roswell Park Comprehensive Cancer Center is committed to developing new cancer therapies. With the addition of the Center for Immunotherapy, a streamlined, collaborative process of bringing innovative therapies to the clinic has been put in place. This new center includes talented scientists to develop novel therapies, a team of regulatory experts who work with the FDA to ensure adherence to all government standards and a state-of-the-art FDA compliant GMP facility to manufacture these targeted therapies for patient treatment.
New Cell Manufacturing Technology
The Roswell Park GMP Facility has a new, one-of-a-kind, barrier isolator incubation technology that provides:
- An improved Class 100 aseptic environment, separating the manufacturing personnel from the product through a physical barrier.
- A controlled atmospheric environment, temperature and humidity allowing cellular manufacture under near physiologic conditions, enabling cells to thrive.
- Continuous real-time monitoring of potential particulate contaminants, temperature, humidity, O2, CO2 and pressure differentials for a well controlled production process.
- ClO2 sterilization technology to eliminate contamination and prevent cross-contamination of products.
This new technology will promote quality production of cellular products and enhance patient safety.
From the Laboratory Bench to the Patient’s Bedside
From its inception, Roswell Park Comprehensive Cancer Center has identified cancer research as the core element of its mission. Groundbreaking research by Roswell Park scientists has led to greater understanding of cancer and to major advances in diagnosis and treatment. The Center for Immunotherapy’s GMP facility will enable Roswell Park researchers to bring their innovative ideas developed in the lab to the patient’s bedside.