SPECIAL NOTICE
A -- Request for Information: Manufacturing of Cryopreserved Platelets - Table 1 - CPP Product Specifications
- Notice Date
- 8/15/2017
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- RFI-DM-CPP-FY17
- Archive Date
- 11/4/2017
- Point of Contact
- Douglas A. Medcalf,
- E-Mail Address
-
douglas.a.medcalf.civ@mail.mil
(douglas.a.medcalf.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Table 1 - CPP Product Specifications REQUEST FOR INFORMATION - MANUFACTURING OF CRYOPRESERVED PLATELETS 1.0 SUBJECT: In direct support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) product development efforts to support the battlefield management of severe hemorrhage due to combat trauma, the Government is seeking to manufacture and validate a current good manufacturing practice (cGMP) compliant process for the manufacture, storage, and transportation of a Cryopreserved Platelets (CPP) biologic product. All manufacturing and testing will be conducted in accordance with all applicable portions of the US Code of Federal Regulations (CFR) and the US Food and Drug Administration (FDA) guidance related to the manufacture of biological products. In addition, USAMMDA is seeking a regulatory sponsor of the CPP product for FDA licensing in the United States. 2.0 DISCLAIMER: This Request for Information (RFI) is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 BACKGROUND: The USAMMDA's mission is to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active duty personnel in the operational environment. As part of the U.S. Combat Casualty Care Research Program, USAMMDA has been developing a biologic product: Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen, biologic-platelet product. DMSO CPP are formulated to provide a platelet-derived product with a longer shelf life (2 years and potentially longer) than liquid stored platelets (LSP), which are currently licensed for storage up to 5 days at room temperature (20ºC to 24ºC) under gentle agitation. In vitro studies demonstrate that compared to LSP, CPP is potentially more hemostatically active. Such characteristic is defined by irreversible changes to platelets activation, microparticle release, loss of in vitro functions including a reduced response to agonists and hypotonic stress, decrease in shape change ability, increase in thrombin generation, and a conversion to a procoagulant phenotype (PS expression) and increased numbers of microparticles. DMSO CPP are prepared from γ-irradiated [2500 centi-gray (cGy)] leukocyte-reduced apheresis platelets, stored in plasma and anticoagulant citrate dextrose solution A for up to 57 hours at room temperature (20°C to 24°C) after apheresis. The apheresis platelets are then concentrated and cryopreserved in approximately 6% DMSO at -80°C and stored at ≤-65°C. Key CPP product specifications are contained in Table 1, attached. USAMMDA's past and current industry and academic partners have manufactured clinical-grade lots of CPP and performed Phase 1 and Phase 2 clinical studies (proof-of-concept studies) under a US Investigational New Drug (IND) application. Several Phase 1 in vivo recovery and survival studies demonstrated in vivo viability of CPP product as required by FDA's standards. In a Phase 1/2a dose-escalation study, no thromboembolic complications resulted from the transfusion of up to 3 units of CPP into actively bleeding thrombocytopenic patients. Moreover, in no case did bleeding worsen despite patients being largely refractory to platelet transfusions. A Phase 2 randomized controlled hemostatic efficacy trial comparing DMSO CPP to LSP in cardiopulmonary bypass surgery patients is currently ongoing. 4.0 DESCRIPTION OF NEED: An additional Phase 3 study (and/or post-marketing analysis studies) may be necessary to bring the CPP product to FDA licensure. To accomplish this goal USAMMDA is seeking a commercial partner who is willing and able to perform all aspects of manufacturing, including (but not limited to) the following: • continue efforts in accordance with established production methods and all applicable regulatory guidelines • manufacture, warehouse, and supply a CPP biologic product that is capable of meeting cGMP and related regulatory requirements in support of FDA approval and is suitable for the ultimate transfer of the manufacturing and storage process to military or commercial blood banks • produce and supply clinical-grade, cGMP lots of CPP in support of necessary clinical trials utilizing the previously established Master Production Records for the cGMP manufacturing process • ensure cold chain management and accountability of all investigational products used in relation to the study • purchase suitable shipping materials in adequate quantities to ensure successful product/record shipment • create and/or validate, or oversee the validation of, shipping procedures and methods to clinical sites • conduct assessment visits/audits of product/record storage repositories to ensure proper storage of investigational materials/records over the course of the study and produce assessment/audit reports resulting from aforementioned visits • provide technical/scientific, administrative, and logistical support to provide investigational product(s) to each clinical site to include, but are not limited to: ship/manage, store, and coordinate the shipment of investigational product(s) and study-related records in accordance with applicable regulations • conduct biocompatibility (extractables and leachables) and long-term storage/stability studies • continue to evaluate and characterize the re-suspension of CPP for shorter time periods than those being currently utilized for clinical trials • conduct manufacturing validation activities to achieve a cGMP-compliant manufacturing process and support for submission of a Biologics License Application (BLA) • characterize the CPP physical structure and function relevant to FDA requirements • assume regulatory sponsorship of the CPP product for FDA licensing in the U.S. OR provide USAMMDA IND amendments, IND annual reports, and submission of a BLA to the FDA (if USAMMDA remains the regulatory sponsor) • prepare and maintain a Technical Data Package (TDP) that includes all necessary documentation and technical data and reports collected and prepared during the development effort funded by the Government for transfer to the Government, or its designee, and allow the Government, or its designee, to continue the development and/or manufacture of the product candidate • produce and ship a predetermined amount of CPP to selected Department of Defense blood storage and processing centers (Continental Unites States) Establishment of regulatory sponsorship for future CPP studies is envisioned to occur through provision of a Letter of Authorization (LOA) from the US Army Medical Research and Materiel Command. It is anticipated that the successful Offeror(s) will subsequently establish regulatory sponsorship through subsequent submission of the LOA and protocol package, including protocol package,(but not limited to): Clinical Trial Agreement (CTA), Informed Consent Form (ICF), Investigator's Brochure (IB), FDA forms 1571 and 1572, and other documents (as necessary) to conduct the necessary clinical trials. The Government is seeking to formalize an agreement with qualified and interested industry/academia sources that have an interest in continuing and completing the manufacturing of CPP. Subsequent to discussions with a qualified partner, the Government intends to formalize the collaboration with a formal Contract or Cooperative Research and Development Agreement (CRADA). Under a CRADA, the Government can contribute (in-kind) personnel, services, intellectual property, the data package, or other resources. The partner, in turn, can reciprocate and also may provide funding to the Government. Teaming arrangement approaches will be considered for manufacturing activities and/or FDA sponsorship. 4.0 SUBMISSION CONTACT INFORMATION: Any commercial partner who has interest in collaborating with USAMMDA on the CPP program is encouraged to contact Mr. Doug Medcalf at douglas.a.medcalf.civ@mail.mil no later than the close of business 20 October 2017. Meetings and/or teleconferences may be requested. USAMMDA's technical point(s) of contract will be glad to answer any questions and provide more details, as appropriate. Contracting Office Address: Attn: MCMR-AAA 820 Chandler Street Frederick, MD 21702-5014, Maryland 21702-5014 United States Place of Performance: To Be Determined United States Primary Point of Contact: Doug Medcalf Contract Specialist douglas.a.medcalf.civ@mail.mil
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