Inactive

PRE-SOLICITATION NOTICE – NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2229009 NAICS – 513210 (Software Publishers) This is a Notice of Intent, not a request for proposal. The National Institute of Al... PRE-SOLICITATION NOTICE – NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2229009 NAICS – 513210 (Software Publishers) This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with ProAnalytics LLC, a direct subsidiary of SecureCell, the manufacturer/manager of Lucullus software, to procure an annual renewal and support agreement that will reestablish the network and increase functionality of the software to its full capability within the Vaccine Research Center/Vaccine Production Program (VPP). The National Institutes of Health (NIH), National Institute of Allergy and Infectious Disease (NIAID), Vaccine Research Center (VRC) Vaccine Production Program (VPP) is dedicated to efficiently advancing research vaccine candidates into materials prepared for proof-of-concept clinical trials and subsequent development and approval in collaboration with partners. The VPP's primary objective is the swift and dependable development of investigational vaccine candidates and therapeutic biologics suitable for clinical trials. The Cell Culture Development (CCD) team contributes to the VPP's mission by researching and refining cell culture methods, ultimately scaling up successful production techniques for vaccines and therapeutic candidates. Effective process development is then transferred to a GMP facility for the manufacture of materials for phase 1 clinical trials. One of the primary goals shared by CCD and the broader biotech industry is to improve the production of vaccines and therapeutic proteins with the aim of reducing the cost of goods and improving robustness of bioreactor methodologies. Of critical requirement to this effort is a controlled and centralized data repository for information generated during bioreactor operation. The industry standard option for this concern is Laboratory Information Management System (LIMS) and/or Supervisory Control And Data Acquisition (SCADA) software. The CCD team currently relies on Lucullus software to fulfill this requirement. The purpose driving this Purchase Request (PR) is not to update VPP’s technological support to include an alternative SCADA software, but to leverage effective support for a tool already in use. Lucullus is encoded and managed by SecureCell. Over the past few years, the Lucullus support that has been provided under contractual relationships has provided notable ineffective support for the CCD team, and by extension the VPP’s programmatic needs. SME’s were very difficult to get on schedule for troubleshooting, requiring weeks to months of notice for a 1 hr meeting, and provided minimal assistance in generating effective solutions to problems. Coordinated technological review provided a wealth of unnecessary information and failed to target the CCD teams needs for effective understanding of software integration and use, while also demonstrating the visiting onsite SME lacked a significant depth of process understanding and software interfacing. Additionally, the Lucullus license provided by the former contractor was insufficient to VPP’s requirements: it offered only data storage and onsite monitoring, no remote monitoring capacity, no alarm notifications, and no capacity to integrate new and/or alternative technologies as the VPP expands operations in the future. While the CCD team was researching alternatives, SecureCell demonstrated the ability to solve many of these technical issues alluded to above, many persistent for months, in a single meeting. The proposed contractor for this current renewal, Pro Analytics, is a direct subsidiary of SecureCell and by using them specifically will ensure the VPP receives the best possible support for its in-house LIMS SCADA system. Transference to alternative LIMS / SCADA systems is not recommended. Many lack the features the CCD team defines as valuable, such as remote monitoring, live information display, alarm notifications, and variable control. Alternatively, some contain all the critical features but rely on alternative IT infrastructure than the currently established Oracle Database, while others are also highly likely to charge an additional fee per instrument licensure for all non-their brand equipment. Additionally, any alternative would need to be screened and approved by IT, fully configured to navigate NIH’s tight security protocols, and taught how to connect to all VPP capital assets needed. After that the CCD team would require training from the ground up, new SOP’s, new spreadsheet infrastructure to process data, and updates to numerous other documents (e.g., batch records, guidance documents, operation templates, etc.). Continuing with Lucullus as the VPP’s SCADA software saves significant time and money compared to other options; no alternatives were identified capable of providing the full breadth of required features, interfacing with established database structure, approved by NIH IT standards, and ready for use without significant training and internal paperwork/regulation delay by the CCD team. For all the reasons listed herein, for this FY renewal the best course of action for the government is to leverage effective support for a tool already in use by entering into the upcoming annual agreement with the subsidiary of the software’s management to reestablish the network and increase functionality of the software to its full capability before making any other changes. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement. All required documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov by August 19, 2024 at 5:00 pm ET. All vendors must register in the eSASS system to submit their documentation. Instructions on how to register /submit documents are included on the website. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.