VENDOR_PRODUCTION_CAPACITY-Amd_0001-Attachment_3.pdf
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- Solicitation number
- 15-100-SOL-00003
About this file
This notice describes a solicitation for a medical countermeasures contract opportunity. The Department of Health and Human Services seeks proposals for the supply of influenza vaccine master seeds, investigational vaccine lots, commercial scale bulk vaccine lots, adjuvant bulk lots, formulation and filling services, storage and stability services, shipping services, candidate vaccine viruses, potency reagents, analytical testing, non-clinical studies, clinical studies, disposal services, and additional reporting. Proposals are due February 20, 2015 with contract awards anticipated in July 2015. Eligible offerors must demonstrate experience manufacturing influenza vaccines through a U.S. license or completed Phase 3 clinical trials and a Biologics License Application in preparation. The base period of performance is three years with two optional one-year extensions.
Attachment 3 - Amd 0001 - Vendor Production Capacity
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Amendment 0001-Attachment 3 Page 1
B.3. Vendor Production Capacity
Identify lead time from date of order to completion/delivery required by contractor for U/I and to reach maximum manufacturing production that vendor would be able to provide U.S.
Government in event of a pandemic (identify maximum production capacity). For purposes of the below table, assume duration of six (6) months for column “Maximum Quantity vendor could produce in event of pandemic.”
CLIN Item Name Unit of Issue Number of
Days/Lead
Time from date of Order to Delivery per U/I
Maximum
Quantity vendor could produce in event of pandemic
Number of
Days Needed from date of
Order to
Delivery per
Maximum
Quantity
0001 cGMP Influenza
Vaccine Master and
Working Seed Lot
Lot
0002 Influenza Vaccine
Research Lot(s)
0003 cGMP Influenza
Vaccine Investigational
Lot(s)
0004 cGMP Influenza
Vaccine Commercial
Scale Bulk Lot(s)
0005 cGMP Adjuvant:
Clinical or Commercial
Scale Bulk Lot(s)
0006A
Formulation and Filling:
Antigen--Single-dose vials
Each
0006B Formulation and Filling:
Antigen--Syringes or
Sprayers
0006C Formulation and Filling:
Antigen--Multi-dose
Amendment 0001-Attachment 3 Page 2
0006D Formulation and Filling:
Adjuvant--Single dose
0006E Formulation and Filling:
Adjuvant--Multi-dose
0006F Formulation and Filling:
Co-formulated antigen and adjuvant--Single dose vials
0006G Formulation and Filling:
Co-formulated antigen and adjuvant--Syringes
0006H Formulation and Filling:
Co-formulated antigen and adjuvant--Multi-dose vials
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