JOFOC_1978426.pdf
PDF 135 KB Posted
- Attached to
- LyoStar 3 Laboratory Scale Federal contract opportunity
- Solicitation number
- RFQ-NIAID-1978426
About this file
Brand-Name Justification
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Billof_Materials_1978426.xlsx | XLSX spreadsheet | |
| FAR_52.204-24_Provision_(Aug_2019).docx | DOCX document | |
| P_52.212-5_(August_2019).docx | DOCX document |
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
ROCKY MOUNTAIN LABORATORIES National Institutes of Health National Institute of Allergy And Infectious Diseases Bethesda, MD 20892
BRAND-NAME JUSTIFICATION
Background The Vaccine Production Program (VPP) is the development arm of the Vaccine Research Center (VRC). The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, Malaria and other known pathogens and get these potentially lifesaving products into the clinic. These products are often deployed in clinical trials in locations where refrigeration and temperature control may be unreliable or nonexistent. Lyophilization (freeze-drying) of vaccines products is an alternate product development approach that will lessen the risk of clinical trial failure. Successful lyophilization process development requires knowledge of the collapse temperature (Tc) of each formulation being tested, which dictates the temperature range for primary drying. The standard method for determination of the collapse temperature is sample analysis by Freeze-Dry Microscopy.
The key piece of equipment needed to develop a freeze-dried product is a development scale lyophilizer that will enable lyophilization cycle development (this is an absolute requirement for production of the clinical product). The VRC requests purchase of the FTS Systems LyoStar 3 Laboratory Scale Lyophilizer (SP Scientific) to meet this critical mission objective.
Justification for Other than Full and Open Competition
• ☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Brand-Name
• The instrumentation being requested is a FTS Systems LyoStar 3 Laboratory Scale Turn-Key
R&D Lyophilizer, manufactured by SP Scientific. This brand is requested because only the FTS LyoStar 3 is compatible with the FTS Pilot Scale GMP lyophilizer currently installed at the Vaccine Clinical Materials Program (VCMP), enabling transfer of methods between the sites.
• Manufacturer:
• SP Scientific
• 935 Mearns Road
• Warminster, PA 18974-281
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