8/22/2025:
Question: The statement on page 2, section 3, “1. The service provider shall provide complete system maintenance which encompasses maintenance of the mass spectrometer system (including the computer, plateloading/retrieval station, and other accessories) in a functional state…” is confusing as to what is actually to be covered. Can you provide the models of the plateloading station and any other “accessories” that will be needing service along with the MicroFlex?
Response: All parts described are associated with the Microflex MALDI-TOF (Microflex LRF, no externally added apparatus). The accessories include software programs loaded in the computer controlling the operation of the instrument, as well as the laser.
Scientists at FDA conduct cutting-edge molecular biological research and review products related to pathogen identification, disease mechanisms, vaccine development (e.g., influenza and covid 19 viruses), or protocols involving cellular, tissue and gene therapies. Often these studies require synthetic peptides for characterization or for antibody production. Frequently, one needs to identify proteins present in biological samples.
At FBR, we performed macromolecular synthesis to provide scientists with needed peptides. In addition, we offer proteomic services to help identification and characterization of proteins based on mass spectrometric analyses. We achieve these tasks using either a MALDI-TOF or LC-MS. Bruker Microflex MS is particularly useful for assessing the quality of synthetic peptides as data
of multiple samples could be acquired in very short time.
To ensure uninterrupted services, the Microflex MS needs professional preventive services or repairing. FBR uses this Bruker Microflex mass spectrometer (MS) to ensure high quality peptides are accurately synthesized. The MS is also used for proteomic services to support the research endeavors of FDA scientists. The MS is utilized daily, thus maintaining the system at a good
working condition is critical for our operation.
This requirement is for a service contract for maintenance and/or repairs of the MS and accessories.
