About Us
Purpose and Mission
Bionique® Testing Laboratories LLC will provide the best possible mycoplasma testing products and services to all clients to meet their individual quality standards. We will continue to be recognized as a global leader in mycoplasmal testing services.
Core Values
Bionique® Testing Laboratories LLC supports the following set of core values by commiting ourselves to:
- Excellence in quality mycoplasma products and services.
- Meeting our customer's needs for mycoplasma testing, quality assurance and regulatory compliance.
- Continually improve and research in emerging methods and technology for mycoplasma detection.
- Maintain highest professional and ethical standards.
- Preserve a climate of trust and respect with all clients, suppliers, and regulatory authorities.
- Sustainable and profitable growth.
- Operate responsibly within the Adirondack Park.
Audits
Bionique® Testing Laboratories welcomes client audits. We recognize the role we serve as an extension of your manufacturing processes and quality control programs. We welcome the opportunity to demonstrate to you the expertise and experience of our staff, facilities and quality systems.
Confidentiality
All client information including sample receipt, raw data and final reports are treated in strict confidential manner. When requested, Bionique® Testing Laboratories will cooperate with individual clients to generate contractual service, confidentiality or quality agreements.
Quality Assurance
All clients can be assured that we comply to the highest standards for Quality Assurance and Quality Control activities. We are a cGMP (Current Good Manufacturing Practices) facility operating in accordance with the Code of Federal Regulations (CFR) 21 parts 210 and 211.
Reporting
Bionique® Testing Laboratories has the fastest possible turn around time for reporting in the industry. Clients receive written hard copies of all test results via first class mail provided by the United States Postal Service. If requested, final reports can also be provided by fax. Overnight courier service can also be arranged at the client's request and expense.
A Final Report package is prepared and compiled on the testing completion day. A Quality Assurance Report accompanies the Final Reports for the following GMP services: Cat. #: M-250, M-300, M-350, M-700, & M-800, M-1400, M-1500. Raw data and reports are archived and maintained by the Quality Assurance Department for a minimum of fifteen (15) years.
