Many modern medicines rely on biologic and genetic materials, such as proteins, viral vectors, and DNA/mRNA, rather than pharmaceutical compounds. Products in this class can be subject to unique regulation and require special handling. As a USDA-approved BSL-2 laboratory, CS Analytical can assist clients commercializing traditional attenuated virus, cutting-edge viral vector vaccines, and other novel products in a safe and effective manner.
CLIFTON, N.J., Jan. 15, 2025 -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services for drug product and medical device package systems, is pleased to announce that its New Jersey based laboratory has been granted Bio-Safety Level – 2 (BSL-2) certification by the United Stated Department of Agriculture. In preparation for the required inspection, CS Analytical implemented a number of physical and quality system improvements for proper handling of potentially biohazardous materials and products. With USDA approval, CS Analytical is authorized to receive Organisms and Vectors (OV) Permits, expanding service offerings to live attenuated virus vaccines and cutting-edge viral vector platforms.
"Many modern medicines rely on a biologic and genetic materials, such as proteins, viral vectors, and DNA/mRNA, rather than pharmaceutical compounds. Products in this class can be subject to unique regulation and require special handling." noted Brandon Zurawlow, Chief Scientific Officer. "As a USDA-approved BSL-2 laboratory, the CS Analytical Team can expand to assist clients commercializing traditional attenuated virus, cutting-edge viral vector vaccines, and other novel products in a safe and effective manner."
Although acquired for CS Analytical's use case as a container and package testing laboratory, the procedural and safety standards of BSL-2 laboratories prepares for safe handling infectious agents such as HIV, equine encephalitis viruses, and Staphylococcus aureus (staph infections). As such, a number of safety precautions must be in place inclusive of specialized equipment. Key requirements include:
- Specialized training for all CS Analytical Personnel in the handling of potentially biohazardous agents.
- Laboratory access restriction when BSL-2 work is conducted
- Appropriate PPE, such as lab coats, gloves, eye protection, and face shields.
- Installation and certification of a Class A2 biosafety cabinet for isolation of biohazardous materials and filtration of potential aerosols.
- Access to and qualification of an autoclave for decontamination of waste.
- Hand washing sinks, eye washing stations, and doors that close automatically and lock.
- Biohazard warning signs placed throughout the facility.
Executive Management has continued to implement service programs and processes to ensure the CS Analytical Team's capabilities expand to meet or exceed client expectations, especially when it comes to critical test needs for unique products and package systems. The team is committed to working with all clients to ensure that the regulatory requirements for their container and package systems continue to meet the strict requirements set forth and expected by FDA and regulatory bodies worldwide.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP <1207> services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
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