Custom Product Development and Services

ZeptoMetrix offers a variety of custom Virology, Bacteriology, Molecular and Immunology services.  All custom work is performed in our facilities, which have Quality Management Systems that are certified as being in compliance with ISO 13485. With an extensive collection of microorganisms and multiple biosafety level (BSL) 2 and 3 laboratories, we can efficiently adapt our products and services to meet the needs of our customers.

ZeptoMetrix provides BIOSTOR™ Specimen Repository that is safe and secure at our state of the art specimen archiving facility.

• Controlled Access to –190°C, –70°C, -20°C, 2-8°C Cold Storage
• All Cold Unit temperatures monitored with real time measurement, 24 hours a day
• Entire facility backed up with 360KVA Natural Gas Generator
• Product Storage documentation auditable per cGMP standards
• Full regulatory compliance with local, state, and federal requirements

Along with the broad scale of custom capabilities and sample storage services that are offered, ZeptoMetrix also provides:

• Custom Design and Development
• Validation of ELISA and Western Blot Kits
• OEM and commercial test validation and testing services
• Test development compliant with 21 CRF Part 820 design controls
• Testing validations for CLIA waived, RUO, and FDA cleared assay for clinical trial testing
• Vialing, aliquotting, labeling, & packaging
• Customized repackaging per client specifications, maintaining 'chain of custody'
• Customized labels, reports, and data maintenance
• Specimen disposal per OSHA, EDA, State, and Federal guidelines
• Comprehensive domestic & international shipping & tracking
• Etiologic 6.2 certified “infectious substance” shipping containers