Amendment 2.pdf
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- Attached to
- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
- Solicitation number
- 75N95024R00094
About this file
This document is Amendment No. 2 to Request for Proposal (RFP) 75N95024R00094 for Chemistry, Manufacturing and Controls (CMC) services for drug substance development. The amendment provides responses to several questions related to the chemistry synthesis, including that no special equipment or high temperature/pressure steps are required, and that the current small-scale yield is 15% with an expectation for the offeror to improve it to over 30% yield. The starting materials for the synthesis are common and cost an average of $1,200-$1,300 per kilogram. The overall objective of the RFP is to obtain CMC services to ensure receipt of drug substances of sufficient quality and quantity to support preclinical and IND-enabling studies. The solicitation is issued by the Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse.
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Text version
Amendment No. 2 RFP 75N95024R00094
The purpose of this Amendment is to :
1. Answer the following questions that were received:
Q: Is there any unique equipment required for the synthesis?
A: No special equipment is required.
Q: Are high pressures or temperatures required in any of the steps?
A: No high pressure/high temperature (>140 C) reactions are involved in the synthesis.
Q: Are any of the intermediates purified by column chromatography?
A: No column chromatography will be used in the synthesis.
Q: What are the yields for each step or at least the overall yield?
A: The small-scale reactions give the final product (free base) in 15% yield (in 11 steps). We are expecting that the offeror can perform the process development and improve the yield to >30% yield.
Q: What is the starting material or the per Kg cost of the starting material?
A: The starting materials for this synthesis are quite common with the cost averaging $1200- $1300/Kg for all starting materials.
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