QELS Dynamic Light Scattering Detector

OPQR has a requirement to obtain an advanced dynamic light scattering detector to enhance characterization capabilities for emerging pharmaceutical products and complex biologics. For a quoter's detector to be deemed acceptable, the following salient characteristics shall be met:

• QELS Dynamic Light Scattering Detector: Real-time hydrodynamic radius measurement capability that operates inline with Field-Flow Fractionation separation to provide simultaneous size characterization as samples elute from the FFF system.
• Compatibility with Existing FFF System: Must be fully compatible with and integrate seamlessly into the existing FFF system, including hardware connections, software integration with chromatography software, and synchronized data acquisition with existing MALS detectors.
• High-Sensitivity Detection: Capable of measuring hydrodynamic radii across a wide dynamic range from approximately 10 nm to 1000 nm to accommodate diverse sample types including proteins, protein aggregates, liposomes, and lipid nanoparticles.
• Orthogonal Size Validation: Provides diffusion-based size measurements that complement separation-based FFF analysis, enabling validation of particle size distributions and detection of sub-populations or aggregates that may not be fully resolved by separation alone.
• Data Correlation and Analysis: Integrated software functionality that enables direct correlation between molecular weight data from MALS detection and hydrodynamic size from DLS detection to provide comprehensive analysis of absolute molar mass, root-mean-square radius, and hydrodynamic radius.
• Data Output: Generates validated, audit-trail-compliant data files suitable for regulatory submissions and scientific publications, with full integration into existing software platform for unified data processing and reporting.
• Maintenance and Support: Technical support, software updates, preventive maintenance, and alignment with FDA's quality assurance requirements for analytical instrumentation.

• 3.4 Deliverables

  Ref

  Description

  Quantities Required

  Due Date

  3

  Quasi-Elastic Light Scattering Unit for FFF

  1

  120 days after award

  3

  Installation, instrument qualification and training

  1

  120 days after contract award.

  Detector hardware with all necessary cables, connectors, and mounting hardware for integration with existing FFF system. Software licensing and installation files compatible with current chromatography software version. User manuals, technical specifications, and standard operating procedure templates provided in digital format via download or physical media (CD/DVD). CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor. Deliverables are delivered to the following address:

  U.S Food and Drug Administration

  Center for Drug Evaluation and Research / Office of Pharmaceutical Quality / Office of Pharmaceutical Quality Research

  Attn: TBD

  645 S Newstead Avenue

  St. Louis, M0 63110

  3Schedule: Delivery shall be no later than 120 days after contract award.

  Vendor is responsible for coordination with FDA staff for installation and integration with existing FFF system. FDA staff will provide access to laboratory space and existing instrumentation for installation activities.

  3.6 Maintenance and Technical Support: At minimum the contractor must:

• Provide support via email, phone, and/or web conference for troubleshooting and technical assistance.
• Provide on-site installation, integration testing, and performance qualification of the detector with existing FFF-MALS system.
• Provide on-site training for FDA staff on detector operation, data analysis, method development, and routine maintenance procedures.
  1. Inspection and Acceptance Criteria

• Partial acceptance is made upon delivery of all the parts. Full acceptance is made after completion of Installation and Operational Qualification (IQ/OQ) by the contractor that the system meets all the specifications and requirements.

• 1. Terms of Use

• Fixed Term License: FDA shall the ability to purchase a new subscription after the original subscription expires to continue the use of the software and to gain access to technical support and product upgrades.

• 1. Period of Performance

• The period of performance is 12 months from the installation date of the system. The delivery of the entire system with accessories as outlined in the SOW should be completed within 120 days of award. Instrument installation and qualification should be completed within 120 days of award. Instrument familiarization and training should be completed on the day of installation.

• 1. Options

• None

• 1. Order Type

• The order type is firm-fixed-price.