Notice_of_Intent_to_SS__1214272.pdf

September 7, 2019

Notice of Intent to Sole Source for the

Equine Ebola Antibody Production

FDA_SS_1214272

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to UNAM-USA, located at 600 Hemisfair Plaza Way, San Antonio, TX, 78205.

In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required services as no other source has been identified who can provide the requirements listed below.

The purpose of this notice is to inform the public that FDA anticipates issuing an award for the continuation of service for a Base Year:

1. Technical Requirements:

A. Vendor shall have a properly resourced facility for equine vaccination, blood collection, and plasmapheresis.

B. Vendor shall assure that prior to vaccination, horse(s) are in good health.

C. Vendor shall have demonstrated prior experience in equine hyperimmune vaccination protocols, with or without adjuvants.

D. Vendor shall up to 3 horses that have been previously immunized with the EboV GP-1 + GPl-2 preparation that resulted in neutralizing antibody production.

E. Vendor shall produce needed amounts of GP-1 + GP-2 for equine immunization F. Vendor shall have access to BSL-2 laboratory for processing equine serum and plasma G. Vendor shall collect and process blood samples during the boosting series of vaccinations, for

FDA to evaluate binding and neutralizing activity. Blood will be processed into serum, and at 4oC -20o C for shipment to FDA. Vendor shall provide, along with samples, horse identification number, time of last immunization, amount of immunogen and amount/type of adjuvant used, immunization number, and time of collection.

H. Vendor shall have expertise in equine plasmapheresis, to obtain large volumes of Immune Plasma (not more than 20 mL/kg per horse).

I. Vendor shall have experience and ability to purify immunoglobulin from the collected pooled hyperimmune plasma.

J. Vendor shall also collect an equal volume of plasma from an unimmunized horse and purify into immunoglobulin as for vaccinated horses. This material will serve as a negative control reference preparation.

K. Vendor shall have experience in lyophilization of immune globulins or similar proteins at high concentration (5-20% IgG).

L. For 2nd year Option: Vendor shall have experience in enzymatic digestion of equine IgG to produce F(ab’)2 antibody preparations.

M. Shall possess experience with equine hyperimmunization protocols, equine husbandry, serum and plasma collection, ideally for production of Ebola antibodies.

N. Shall access BSL-2 laboratory for processing of equine serum and plasma.

O. Vendor shall be able to manufacture EB1 + EB2 immunogens.

P. Shall possess ownership of previously vaccinated horses that received EB-1 + EB-2 antigens.

2. Deliverables:

A. Vaccine boosting of 1-3 horses that have previously received a series of vaccinations with GP1 + GP2 recombinant proteins B. Provision of equine health records pre- and post-vaccination Q. Provision of post vaccination serum (10 mL) to PDB laboratory, with related information to include horse identification number, date of last immunization, amount of immunogen and amount/type of adjuvant used, immunization number, and date of collection. This will aid in monitoring the boosting protocol and selecting one or more horses for manufacturing of Ebola Immune Globulin reference material.

C. Purification of Ebola Immune Globulin from high-titer donor horse plasma D. Provision of at least 250 vials of lyophilized equine Ebola Immune Globulin and 250 vials of negative control equine Immune Globulin to FDA E. Shipping of equine Ebola Immune Globulin to FDA for testing F. Provision of one control equine Immune Globulin preparation

3. Security:

A. Vendor shall ship equine serum and Immune Globulin that is stable (frozen or lyophilized) to arrive within 24-48 hours at FDA’s secure facility at White Oak: Building 52/Room 4124, 10903 New Hampshire Avenue, Silver Spring MD 20993.

The associated North American Industrial Classification System (NAICS) Code is 611310: Colleges, Universities, and Professional Schools

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.

Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to UNAM-USA, within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: Friday, September 13, 2019 by 7:00AM Eastern Time. Please email responses to Janae Hughes at janae.hughes@fda.hhs.gov. No phone calls will be accepted.

mailto:janae.hughes@fda.hhs.gov