Amendment 2 - Final.pdf
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- Attached to
- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
- Solicitation number
- 75N95025R00005
About this file
This is Amendment #2 to RFP 75N95025R00005, posted on 1/14/2025, which provides responses to questions received as of 1/3/2025 regarding drug product development.
The Q&A clarifies several technical requirements, including: 1) The plasmid master cell banks refer to E.coli strains used for preparing cGMP grade plasmids; 2) Stability studies must be performed on both drug product and drug substance for up to 36 months under ICH procedures at specified temperatures; 3) For the Sample Task Order, formulation buffer should be developed for cryogenically stored liquid formulation stable up to 60 months, with lyophilization capability described but not required; 4) The certificate of analysis timeline is extended to 90 days after receiving all test results, accounting for the 28-day In Vitro Adventitious Agent assay. All other terms and conditions remain unchanged.
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AMENDMENT #2: RFP 75N95025R00005
The purpose of this Amendment is to:
1) Provide responses to Questions received as of 1/3/2025.
ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED
AMENDMENT 2 – POSTED 1/14/2025
Drug Product: Questions and Answers
1. The Sample Task Order for Technical Area 3, Task 1in Section E, includes the following subtask: Generate and release plasmid master cell banks for the gene of interest plasmid, Rep-Cap and AAV Helper plasmids. Plasmid master cell banks is an unfamiliar term. Does this refer to the master cell bank that will be transfected during cell culture, or is this something different?
A. The pMCB that we are referring here is for the E.coli strains that you use for preparing the cGMP grade plasmids
2. The Sample Task Order for Technical Area 3, Task 1 in Section E, includes the following subtask: Develop and qualify payload-specific analytical methods for product release specifications and stability indication. Is this the same assay as in Task 2 (Bulk Drug Substance, subtask 1)?
A. Yes.
3. The Sample Task Order for Technical Area 3, Task 1 in Section E, includes the following subtask: Perform standard stability studies on the cGMP material up to 36 M under ICH procedures at 2-8°C, negative 20°C and negative 70°C. Does this apply to drug substance and drug product, or just drug product?
A. Both for Drug Product and Drug Substance
4. The Statement of Work indicates formulation studies should include: excipient screening, optimize, and develop final formulation buffer for liquid formulation and lyophilization protocol for lyophilized DP. The Sample Task Order for Technical Area 3 does not mention lyophilization. We interpret this to mean that the proposal budget (based on the sample task order) should be developed for a cryogenically stored liquid formulation, but the proposal should highlight capability to produce a lyophilized product. Is this an accurate interpretation of the intent of the Statement of Work and Sample Task Order?
A. Yes, for the purposes of responding to the Sample Task Order, the formulation buffer should be developed for a cryogenically stored liquid formulation that will keep the drug product stable up to 60 M. Capability to lyophilize drug products is important to describe in the overall RFP response but is not a specific requirement of the Sample Task Order in this case.
5. The Sample Task Order for Technical Area 3, subtask 3 in Section G, requires that the certificate of analysis be provided within 30 calendar days; but Task 2, requires the use of a 28-day In Vitro Adventitious Agent assay. Considering test scheduling, testing, and report generation, is 90 days acceptable?
A. Within 90 days is acceptable. We mean 30 days after you get the results for all the relevant measures (process/quality attributes) on the DS and DP.
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