Generating And Stockpiling
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Generating and Stockpiling Hyperimmune Plasma Against Botulinum Neurotoxin Solicitation Number: RFI-BARDA-09-38 Agency: Department of Health and Human Services Office: Office of the Secretary Location: Assistant Secretary for Preparedness and Response
Notice Type: Sources Sought
Posted Date: June 4, 2009
Response Date: Jun 19, 2009 11:59 pm Eastern
Archiving Policy: Manual Archive
Archive Date: -
Original Set Aside: N/A
Set Aside: N/A Classification Code: 65 -- Medical, dental & veterinary equipment & supplies NAICS Code: 325 -- Chemical Manufacturing/325412 -- Pharmaceutical Preparation Manufacturing
Synopsis: Added: Jun 04, 2009 3:10 pm The Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) is tasked with ensuring the availability of medical countermeasures for public health emergencies. This includes ensuring that the manufacturing infrastructure is sufficient to support the production of required products in a manner that is timely, reliable and cost effective. The BARDA ensures that existing manufacturing facilities and warm-base capabilities are met for the emergency production of medical countermeasures.
Currently, BARDA is seeking sources with the capability to produce and store equine monovalent hyperimmune plasma against the following seven serotypes of botulinum neurotoxin: BoNT/A, BoNT/B, BoNT/C, BoNT/D, BoNT/E, BoNT/F, and BoNT/G. Interested parties must be able to:
• Maintain a herd to generate, package, store and ship sufficient plasma for subsequent manufacture into a multivalent human product. The estimated titers and volumes are defined below;
• Maintain an equine herd in compliance with the Institutional Animal Care and Use Committee (IACUC), Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), and the HHS Office of Laboratory Animal Welfare (OLAW) and pertinent USDA and state regulations and guidelines;
• Work with select agents, specifically Botulinum Toxins serotypes A,B,C,D,E,F and G ;
• Determine equine antitoxin neutralization levels by use of a validated mouse neutralization assay (in-house or sub-contracted);
• Immunize horses and rapidly achieve the following minimum titers;
o anti-BoNT/A 2,200 IU/ml o anti-BoNT/B 475 IU/ml o anti-BoNT/C 425 IU/ml o anti-BoNT/D 754 IU/ml o anti-BoNT/E 3,500 IU/ml o anti-BoNT/F 700 IU/ml o anti-BoNT/G 175 IU/ml
• Collect the following minimum volumes of plasma per serotype with the defined minimum titer:
o anti-BoNT/A 7,000 Liters o anti-BoNT/B 10,500 Liters o anti-BoNT/C 11,600 Liters o anti-BoNT/D 3,500 Liters o anti-BoNT/E 4,750 Liters o anti-BoNT/F 7,000 Liters o anti-BoNT/G 12,000 Liters
3 of 5
• Perform plasmaperesis operations on horses under GMP conditions; and
• Package and store hyperimmune plasma under GMP conditions until September 2014 with an option to extend the storage contract and at two separate storage sites to reduce risk associated with long-term storage.
Responses to this Request for Information (RFI) must specifically detail how each of the key requirements specified above will be met and document performance in these areas from past experience. Capability statements must also include the following information:
1) A brief description of your organization (limited to one page).
2) A brief description of the key capabilities, technologies, and facilities that will be used to fulfill the requirement.
3) A brief description of the organization’s existing resources and any new resources that will be needed to fulfill the requirement (i.e. human resources, space, physical facilities, land, equipment, etc.).
4) A brief description of any collaboration with other organizations that will be needed to fulfill the requirement.
5) A description of previous experience/work conducted in this area of endeavor and a discussion on how it equips your organization with the skills necessary to fulfill this requirement. Please list the previous work or interactions of any proposed primary and secondary investigators or researchers with the US Government and BARDA.
6) A description of any potential conflicts of interest that may arise in addressing this requirement (i.e. currently funded research, collaboration with other companies, etc.).
7) Identification of any existing proprietary information or intellectual property needed to fulfill the requirement.
8) A general estimate of the cost to fulfill the requirement. Please include:
12/01/09 11:32 PM
a. The price/liter (with the minimum titer identified above); and b. The price for the storage of plasma for one year at the following amounts: 5,000 L, 10,000 L, 20,000 L, 40,000 L and 60,000 L.
The estimate should also include the cost for the acquisition and care of the horses, and the costs for plasmaphresis, immunization, and toxin/toxoid procurement.
9) An estimate of the number of horses your organization can maintain, including seasonal considerations, shelter, land, etc.
10) Submitter’s Name, Street Address, City, State, Zip code, Point of Contact (POC), POC Telephone and facsimile numbers.
11) Business size status (large, small business, 8(a), HUBZone, Small Disabled Veteran owned Business, Women-owned Small Business, etc.) and North American Industry Classification System (NAICS) Code.
Organizations capable of fulfilling this requirement are invited to submit a capability statement to the address shown above no later than 4:30 PM Eastern Standard Time (EST) on Friday, June 19, 2009. Attn: Paquetta N. MyrickHancock, Contracting Officer, RFI-BARDA-09-38. Your response must be submitted in one (1) hard copy and two (2) CDs (word or PDF).
All information submitted will be reviewed; however, BARDA will not acknowledge or respond to any submissions.
Information obtained under this RFI will be used solely for information and planning purposes. This request is not a Request for Proposals (RFP) or Request for Quotations (RFQ) or a promise to issue a solicitation in the future. It does not commit the Government to contract for any supply or service.
Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. All costs associated with responding to this RFI will be the responsibility of the respondent. All information received in response to this RFI that is clearly identified as proprietary or trade secret information will be handled and safeguarded in accordance with Government regulations.
Contracting Office Address: Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640 Washington, District of Columbia 20201 United States Primary Point of Contact.: Paquetta N Myrick-Hancock, Contracting Officer [email protected] Phone: (202) 260-0534 Fax: (202) 205-0613 Secondary Point of Contact: Tasha A. McMillian, Contract Specialist [email protected] Phone: 202-205-1502 Fax: 202-205-0613
Opportunity History Original Synopsis Jun 04, 2009 3:10 pm
Notice Type: Sources Sought
Posted Date: June 4, 2009
Response Date: Jun 19, 2009 11:59 pm Eastern
Archiving Policy: Manual Archive
Archive Date: -
Original Set Aside: N/A
Set Aside: N/A Classification Code: 65 -- Medical, dental & veterinary equipment & supplies NAICS Code: 325 -- Chemical Manufacturing/325412 -- Pharmaceutical Preparation Manufacturing
Synopsis: Added: Jun 04, 2009 3:10 pm The Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) is tasked with ensuring the availability of medical countermeasures for public health emergencies. This includes ensuring that the manufacturing infrastructure is sufficient to support the production of required products in a manner that is timely, reliable and cost effective. The BARDA ensures that existing manufacturing facilities and warm-base capabilities are met for the emergency production of medical countermeasures.
Currently, BARDA is seeking sources with the capability to produce and store equine monovalent hyperimmune plasma against the following seven serotypes of botulinum neurotoxin: BoNT/A, BoNT/B, BoNT/C, BoNT/D, BoNT/E, BoNT/F, and BoNT/G. Interested parties must be able to:
• Maintain a herd to generate, package, store and ship sufficient plasma for subsequent manufacture into a multivalent human product. The estimated titers and volumes are defined below;
• Maintain an equine herd in compliance with the Institutional Animal Care and Use Committee (IACUC), Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), and the HHS Office of Laboratory Animal Welfare (OLAW) and pertinent USDA and state regulations and guidelines;
• Work with select agents, specifically Botulinum Toxins serotypes A,B,C,D,E,F and G ;
• Determine equine antitoxin neutralization levels by use of a validated mouse neutralization assay (in-house or sub-contracted);
• Immunize horses and rapidly achieve the following minimum titers;
o anti-BoNT/A 2,200 IU/ml o anti-BoNT/B 475 IU/ml o anti-BoNT/C 425 IU/ml o anti-BoNT/D 754 IU/ml o anti-BoNT/E 3,500 IU/ml o anti-BoNT/F 700 IU/ml o anti-BoNT/G 175 IU/ml
• Collect the following minimum volumes of plasma per serotype with the defined minimum titer:
o anti-BoNT/A 7,000 Liters o anti-BoNT/B 10,500 Liters o anti-BoNT/C 11,600 Liters o anti-BoNT/D 3,500 Liters o anti-BoNT/E 4,750 Liters o anti-BoNT/F 7,000 Liters o anti-BoNT/G 12,000 Liters
3 of 5
• Perform plasmaperesis operations on horses under GMP conditions; and
• Package and store hyperimmune plasma under GMP conditions until September 2014 with an option to extend the storage contract and at two separate storage sites to reduce risk associated with long-term storage.
Responses to this Request for Information (RFI) must specifically detail how each of the key requirements specified above will be met and document performance in these areas from past experience. Capability statements must also include the following information:
1) A brief description of your organization (limited to one page).
2) A brief description of the key capabilities, technologies, and facilities that will be used to fulfill the requirement.
3) A brief description of the organization’s existing resources and any new resources that will be needed to fulfill the requirement (i.e. human resources, space, physical facilities, land, equipment, etc.).
4) A brief description of any collaboration with other organizations that will be needed to fulfill the requirement.
5) A description of previous experience/work conducted in this area of endeavor and a discussion on how it equips your organization with the skills necessary to fulfill this requirement. Please list the previous work or interactions of any proposed primary and secondary investigators or researchers with the US Government and BARDA.
6) A description of any potential conflicts of interest that may arise in addressing this requirement (i.e. currently funded research, collaboration with other companies, etc.).
7) Identification of any existing proprietary information or intellectual property needed to fulfill the requirement.
8) A general estimate of the cost to fulfill the requirement. Please include:
12/01/09 11:32 PM
a. The price/liter (with the minimum titer identified above); and b. The price for the storage of plasma for one year at the following amounts: 5,000 L, 10,000 L, 20,000 L, 40,000 L and 60,000 L.
The estimate should also include the cost for the acquisition and care of the horses, and the costs for plasmaphresis, immunization, and toxin/toxoid procurement.
9) An estimate of the number of horses your organization can maintain, including seasonal considerations, shelter, land, etc.
10) Submitter’s Name, Street Address, City, State, Zip code, Point of Contact (POC), POC Telephone and facsimile numbers.
11) Business size status (large, small business, 8(a), HUBZone, Small Disabled Veteran owned Business, Women-owned Small Business, etc.) and North American Industry Classification System (NAICS) Code.
Organizations capable of fulfilling this requirement are invited to submit a capability statement to the address shown above no later than 4:30 PM Eastern Standard Time (EST) on Friday, June 19, 2009. Attn: Paquetta N. MyrickHancock, Contracting Officer, RFI-BARDA-09-38. Your response must be submitted in one (1) hard copy and two (2) CDs (word or PDF).
All information submitted will be reviewed; however, BARDA will not acknowledge or respond to any submissions.
Information obtained under this RFI will be used solely for information and planning purposes. This request is not a Request for Proposals (RFP) or Request for Quotations (RFQ) or a promise to issue a solicitation in the future. It does not commit the Government to contract for any supply or service.
Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. All costs associated with responding to this RFI will be the responsibility of the respondent. All information received in response to this RFI that is clearly identified as proprietary or trade secret information will be handled and safeguarded in accordance with Government regulations.
Contracting Office Address: Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640 Washington, District of Columbia 20201 United States Primary Point of Contact.: Paquetta N Myrick-Hancock, Contracting Officer [email protected] Phone: (202) 260-0534 Fax: (202) 205-0613 Secondary Point of Contact: Tasha A. McMillian, Contract Specialist [email protected] Phone: 202-205-1502 Fax: 202-205-0613
Opportunity History Original Synopsis Jun 04, 2009 3:10 pm
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