Request for information on TaqMan Real Time Polymerase Chain Reaction (PCR) assays and associated reagents for a broad range of disease pathogens for diagnostic purposes.

THIS IS A REQUEST FOR INFORMATION ONLY for market research and planning purposes only, as defined in FAR 15.201(e). This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this Notice. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted, and the Government will not reimburse respondents for preparation of the response. Response to this Notice is strictly voluntary and will not affect future ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The North American Industry Classification System (NAICS) for this notice is 325413, In-Vitro Diagnostic Substance Manufacturing with a size standard of 500 employees. Program Description: The Joint Project Manager for Medical Countermeasure Systems (JPM MCS), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is issuing a Request for Information (RFI) to obtain information on the commercial sector's ability to accommodate a low rate manufacturing of various forms of TaqMan Real Time Polymerase Chain Reaction (PCR) assays and associated reagents for a broad range of disease pathogens for diagnostic purposes. The U.S. Department of Defense (DoD) and other federal agencies possess a large catalog of Real Time TaqMan PCR assays that were developed by both the federal government and private sector. The assays are used on a wide range of commercial diagnostic systems compatible with TaqMan Real Time PCR assays (e.g., ABI 7500 Fast DX, Roche Lightcycler, etc.). The vast majority of assays are of the liquid/frozen single-plex form with emerging needs for multiplex and/or lyophilized PCR assays to support future open architecture PCR platforms. The Government intent is for the Contractor to provide routine low volume manufacturing of pre-Emergency Use Authorization (EUA) and 510(k) cleared in vitro diagnostic assays and high-volume/short duration manufacturing of EUA assays, under the appropriate quality systems, based on Government Furnished Information (GFI). Additionally, the Government is interested in "value added" capabilities such as assay re-optimization to support various analytical formats and storage, kitting and distribution support for in vitro diagnostic products. The Government would be the FDA sponsor for all regulated products. It is envisioned that each manufacturing run of assays will be ordered explicitly by the Government. The Contractor will not be expected to manufacture assays on a speculative basis in order to sell finished assays to the Government. Manufacturing is expected to be located in the continental United States and Contractors must be eligible for facilities and personnel security clearances. ? Specific Products: Assay (primers and probes) and associated reagents manufacturing requirements - Target Master Mix (primers and probe mixture), Taq Polymerase (with Superscript Reverse Transcriptase if applicable), and a Positive Template Control. Most assays require an additional Internal Positive Control (IPC) and the corresponding master mix (e.g. RNase P Template Control and RNase P Master Mix for targets that are intended for detection in a human sample). - Assays will need to be produced in two configurations: wet/frozen (-20 minimum/-80 C preferred storage) and room temperature stable / lyophilized. - Correct licenses/fees will be applied as appropriate to the intended use: RUO, pre-EUA, EUA, 510(k) - Regulatory requirements specific to each product o Quality Systems appropriate to product regulation status (510(k): cGMP, pre-EUA: ISO9001 minimum, ISO17025 preferred) o Auditing as required (compliance/readiness audit, ISO audit, FDA audit etc.) - Post manufacture functional QC testing traceable to performance claims. Functional QC protocols may include but are not limited to linearity testing, LOD confirmation testing and negative control testing. - Production of lab qualification and proficiency test materials (e.g. blinded positive and negative samples) - Kitting, Documentation and Product/Package labeling to support needed configurations: o 96-well, 32-well, 3-well analyzers; 12-, 16-, 48-, 96- sample Automated sample preparation robots o U.S. diagnostic applications (pre-positioning of pre-EUA assays, Emergency Use Authorization assays or products with 510(k) licensure). Manufacturing Transition / Qualification o Pilot lot manufacturing to support activities including but not limited to product reformulation, quality control SOP development, prospective product stability testing. Work other than manufacturing: - Configuration management (SOPs, product formulations and work instructions, kits and documentation) - SOP development o Quality Control SOP development o Stability Study SOP development - Execution of prospective shelf-life studies including real-time stability studies as well as accelerated stability studies - Assay Development o Single Plex to Multiplex (3 plex) o Liquid Frozen to Lyophilized (Room Temp Stable) - New Sample Type / inactivation protocol development / qualification o Clinical sample types (whole blood, trizol inactivated blood, AVL+Ethanol inactivated blood, serum, plasma, sputum, NP Swabs) - Storage o Storage of fully kitted products o Storage of unkitted component reagents (e.g. when shelf lives are different, or when buying materials in different ratios to allow some kits to be built quickly as needed) - Distribution (CONUS and International) maintaining appropriate IVD handling and temperature requirements Non-Assay Consumable Supply: System specific non-assay consumables (e.g. tubes, plates, etc.) if they are needed to develop or run assays and are generally not available at end user labs. Manufacturing, Kitting, Labeling, Storage and Distribution Scenarios: The following scenarios are provided to help in determining the best contracting approaches and sources. An assay kit is a pre-packaged set of all reagent materials needed to run a sample. 6 samples per kit (min 6 max ~30) are assumed when determining the number of patient samples per kit. Approximately 5 - 70 separate analytical locations are expected to be supported so smaller, separable kits that would provide capability to each location are desired. - Pre-positioned liquid/frozen pre-EUA IVD Assay Kits to test 2,500 samples for each of up to 30 different analytical targets (plus controls) needed on a routine, rolling basis over the contract period of performance (assuming a 1 year shelf life). At the beginning of the contract, approximately 8 different assays will be needed with more being added to the manufacturing rotation over the life of the contract as they become available as GFI. Orders are placed ahead of need such that optimal manufacturing practices and efficiencies can be achieved, when applicable. (expected 5-10 times during period of performance based on shelf life expiration of assay materials) - Pre-positioned lyophilized, single plex or multiplex, pre-EUA IVD Assay Kits to test for 500 samples for each of 10 different analytical targets (plus controls) needed on a routine basis (at least 3 months lead time for delivery). Orders are placed ahead of need such that optimal manufacturing practices and efficiencies can be achieved, when applicable. (expected 3 - 5 times during period of performance based on shelf life expiration) - Liquid frozen or lyophilized single plex EUA IVD Assays kits to test 100-400 samples for 1-4 analytical targets (plus controls) needed on an emergency basis over a period of 15-30 calendar days. (anticipated once per year during contract period of performance) - Liquid/Frozen EUA or 510(k) approved IVD Assay Kits to test 10,000 samples per month for 1 analytical target (plus controls) needed on an emergency basis for a period of 6 months. Assays would be used to fulfil the requirements of a U.S. Government sponsored EUA for diagnostic testing of U.S. Citizens. (anticipated once during contract period of performance) Assay Development Scenarios: - On a routine basis, GFI assay designs are transitioned to a reliable, quality controlled manufacturing process, such that, when needed, assays can be manufactured in small or large quantities - On a routine basis, GFI wet frozen assay designs are optimized and transitioned into lyophilized room temperature stable assay design for future manufacturing - On a routine basis, GFI single-plex assay designs are optimized and transitioned into a multiplex assay design for future manufacturing - On a routine or urgent basis, modify analytical protocols to add additional clinical or environmental sample types. Subsequently the Govt will perform testing using this protocol to generate the data set needed to expand the pre-EUA or EUA or 510(k) submission to the FDA. Submission Instructions: Information gathered in response to this RFI will be used to support the development of an acquisition strategy to enhance the capabilities of JPM MCS Diagnostic Program. The DoD is particularly interested in determining if small businesses can support this requirement. The DoD is also considering if multiple awards or an omnibus approach would best meet this requirement and welcomes industry comment. Interested parties are requested to submit discussion of minimum order quantities that would comprise a viable "warm base" for contingency response, how risks and costs of potential idle time of the manufacturing capability can be mitigated, and how the range of manufacturing described in the scenarios below could be spanned. Interested Parties shall submit a short summary (no more than 15 pages total) describing the following: - Ability to manufacture wet frozen PCR assays for diseases, Biological Warfare Agents (BWA) and pathogens for both detection and diagnostic purposes under a quality management system (ISO and/or cGMP) with the appropriate licensures - Ability to re-optimize and manufacture lyophilized PCR assays based on the same design packages as the wet frozen PCR assays previously mentioned - Ability to assemble assays in multiple configurations dependent on the intended platform and end user requirements - Ability to develop appropriate conformance test plans assure product performance and shelf life stability - The ability to warranty assay performance and shelf life when stored in accordance with labeled temperature storage conditions. - Ability to meet surge capacity production requirements; please elaborate on facility's weekly and monthly capacity for production - Ability to distribute products to CONUS and OCONUS locations - Utilizing the Manufacturing, Kitting, Labeling, Storage and Distribution scenarios described above, please describe the ability of the facility to meet these needs and include examples of current assays produced at the facility - Utilizing the Assay Development scenarios listed above, please describe the ability of the facility to meet these need and include current examples of products that have been undergone successful development - Respondents are encouraged to comment on the feasibility of incorporating assay production into their current processes even if the capabilities would not meet all, but some, of the above outlined requirements. Responses shall be submitted and received via Email to sandra.j.oconnell.civ@mail.mil no later than 2:00PM EST November 13, 2015. Documents shall be electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. Technical Questions concerning this RFI may be addressed by contacting: adam.j.becker3.civ@mail.mil. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. ? Please provide information on your organization (not counted towards page limitations shown above): 1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address. 2. DUNS Number and Cage Code 3. Confirmation of Current Active Registration in System for Award Management (SAM), SAM registration information may be found at the following website: https://www.sam.gov/portal/public/SAM 4. Primary NAICS Code(s) and Business Size (i.e., small/large) 5. GSA Schedule, If Available 6. Commercial Price List, if GSA schedule is Not Available 7. Product Specific Brochures Literature