SOLICITATION NOTICE
A -- Production of a Chimeric Monoclonal Antibody IgG1κ in a Hollow Fiber Bioreactor - S10-072 - Chimeric Monoclonal Antibody lgG1k Production
- Notice Date
- 11/6/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S10-072
- Archive Date
- 12/31/2009
- Point of Contact
- Howard R. Souder, Jr., Phone: 301-846-5096
- E-Mail Address
-
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Please download the attachment for further instructions, and for additional information. This document will be required to be apart of all submissions, and potential offerors are advised to closely scrutinize the instructions contained within. Project: Production of a Chimeric Monoclonal Antibody IgG1κ in a Hollow Fiber Bioreactor 1. INTRODUCTION A monoclonal antibody has been developed as an immunotherapy treatment of primary amyloidosis in humans. This antibody is directed against the fibrillar deposits formed from the disease in vital tissues as the disease progresses. This antibody is a chimeric IgG1κ. The requirement for the antibody is development and production to support toxicology studies and Phase I clinical trials. The specified production technology for clinical grade material would be at a GMP biopharmaceutical production facility that can produce this antibody in a hollow fiber bioreactor. 2. PROJECT SUMMARY An adherent dhfr- CHO cell line from a MCB supplied by the BDP will be scaled up in cell culture vessels to obtain enough cells to inoculate 1 or more cultureware sets for a hollow fiber bioreactor. More then 1 bioreactor may be needed to produce a required 140 grams of bulk bioreactor harvest. The crude harvest will be packaged in bottles and frozen for storage until delivered to SAIC-F. An End of Production cell bank will be required. 3. STATEMENT OF WORK A. Project Management Plan The Subcontractor will be required to submit a Project Management Plan (PMP) describing the means of accomplishing the project tasks. The PMP will include milestones to meet the project deliverables and timelines. Milestones will include but are not limited to 1) acceptable cell growth with respect to cell number and viability during scale up, 2) successful bioreactor start up and inoculation, 3) harvesting with sufficient antibody titer and 4) recovery of viable cells to make an End of Production cell bank. B. Risk Management Plan The PMP will include a risk management plan (RMP) to identify potential technical problems that might arise during the course of work. The Subcontractor shall suggest solutions or alternative back up plans to address these potential problems. C. Reports and Meetings 1. Project meetings will occur bi-weekly or as required by the Project Scientist 2. Monthly technical and financial status reports 3. Reports will include assay profiles, technology transfer report, certificates of analysis and a manufacturing report. D. Production Tasks A technology transfer package and vials of the MCB will be supplied to the Subcontractor. An Assay Profile of acceptance criteria for the harvest and End of Production bank will be supplied. 1. The cells are scaled up in cell factories or roller bottles until ample cells are obtained to inoculate a hollow fiber bioreactor. The cells have a doubling time of between 50 and 66 hours using CHO-S-SFM II serum free medium (contains glutamine, Invitrogen catalog number 31033), 10% dialyzed Fetal Bovine Serum and 1µM methotrexate. The peak cell density range at 3 days is 8 X104 to 1 X105 per cm2 and the viability remains in the mid 90% range. 2. The bioreactor is run for 60 calendar days. Approximately ten 850cm2 roller bottles are required to inoculate a single 2.1m2 hollow fiber cartridge at 1X109 cells. A bioreactor feasibility run performed at SAIC-F located at the NCI-Frederick at this scale produced 11 grams of unprocessed crude antibody in 10 liters. The bioreactor ran for 53 days. The medium for the bioreactor is: Intracapillary Side - Modified DMEM/F12 without phenol red, HEPES, Glutamine, 4.5grams glucose/liter L-Glutamine, 4mM final Methotrexate, 1µM final Extracapillary Side - CHO-S-SFM II (Invitrogen catalog number 31033) 10% dialyzed Fetal Bovine Serum Day 0 to day 23 5% dialyzed Fetal Bovine Serum Day 24 to day 60 3. Harvest is collected at +20C to +80C in volumes up to 2 liters or no longer then every 4 days and frozen in aliquots at ≤ -70C. 4. A 60 vial End of Production Cell Bank will be required from the longest run (if more then one bioreactor run is needed). Each vial will contain at least 4 X 106 cells 4. Deliverables and Acceptance Criteria a) 140 ± 10 grams of bulk sterile harvest frozen at ≤ -70C b) 60 vial EOP bank c) Batch Production Records for all bioreactor runs and the EOP bank d) Monthly technical and financial status reports and a comprehensive final report due within 60 days of completion of the project. Final inspection and acceptance of all work performed, reports and other deliverables will be approved by the SAIC-F Contracting Officer's Technical Representative. All deliverables are also subject to the final review of documentation and release by the SAIC-F Quality Assurance department. 5. Period of Performance The period of performance is 10 months beginning upon the award of the Subcontract. 6. Other Requirements 1. Facility audit for Subcontractor's technical capability and cGMP compliance 2. Execution of a Quality Agreement prior to or at subcontract award.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S10-072/listing.html)
- Place of Performance
- Address: Awarded Vendor's location - TBD, United States
- Record
- SN02000266-W 20091108/091107000649-ec9adbcee6bc69cd3f9752e234240244 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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