SOURCES SOUGHT
A -- Mammalian Cell Culture
- Notice Date
- 8/28/2009
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-09-1062622-SS
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774, Doreen Williams, Phone: 301-827-3366
- E-Mail Address
-
karen.petty@fda.hhs.gov, doreen.williams@fda.hhs.gov
(karen.petty@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential certified 8(a) and/or HUB Zone businesses. Project Title Mammalian Cell Culture: Application of Concepts of Process Analytical Technology (PAT) and Quality by Design (QbD) for Mammalian Cell Culture Production Bioreactor Unit Operation utilized for production of human therapeutics. Background The objective of achieving a desired state for pharmaceutical manufacturing, “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” These expectations have been outlined in the guidance PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance as well as the International Conference on Harmonization (ICH) guidelines: ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality System. Quality by Design. As per the ICH Q10 guideline, “Quality by design means designing and developing manufacturing processes during the product development stage to consistently ensure a predefined quality at the end of the manufacturing process”. The QbD approach involves identification of the product attributes that are of significant importance to product’s safety and/or efficacy (TPP and CQA), design of the process to deliver these attributes; a robust control strategy to ensure consistent process performance; validation and filing of the process demonstrating the effectiveness of the control strategy; and finally, ongoing monitoring to ensure robust process performance over lifecycle of the product. Further, risk assessment and management, raw material management, and use of statistical approaches provide a foundation to these activities. The concept of “design space” is gaining popularity as a tool for implementation of QbD for pharmaceutical products. ICH Q8 defines design space as “The multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.” Process Analytical Technology. PAT has been defined as "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality." As such, the goal of PAT is to "enhance understanding and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design". The concept of PAT is complementary to that of QbD as it facilitates utilization of “real time” or “near real time” process monitoring and “adaptive controls” to mitigate variability that is routinely seen in quality of feed materials and/or raw materials in biotech processes so as to deliver consistent product quality. Statement of Objective (SOO) In this project, we wish to elucidate implementation of the concepts of PAT and QbD for the mammalian cell culture unit operation in a step by step manner. It will involve a transparent presentation of data for all the steps involved in the implementation of PAT and QbD. It will present approaches for process modeling of the mammalian cell culture unit operation. This case study will propose control schemes that are more adaptive in nature and that would allow for altering the operating conditions in view of the variability in quality of the feed material and/or raw materials such that the product has consistent quality. Statement of Work (SOW) The contractor shall minimize the need for training by demonstrating previous work in the FDA regulated topic area. The contractor shall maximize the potential for consensus by demonstrating previous collaborations involving multiple universities involved in this topic area. The contractor shall maximize the ease of creating training materials by demonstrating previous efforts in training 50 to 100 people at a time. The contractor shall pick a biotech molecule, a cell line and a manufacturing process such that there is no intellectual property (IP) concerns in publishing the process and the data. The choice will need to adequately reflect the complexities associated with commercial mammalian cell culture processes. The contractor shall identify the critical quality attributes (CQA) for the product. Utilize literature and industrial experience in doing this. Appropriate risk analysis methodologies will be utilized to perform this step. Once the CQAs have been identified, risk analysis tools will be utilized to identify the critical process parameters (CPP). Literature and prior experience with the mammalian cell culture processes will be utilized. This should be done within five months. The contractor shall perform mechanistic modeling based on the fundamental mass and momentum transfer principles and our knowledge of cell metabolism. Experiments will be performed to provide key input to the model and the revised model will be validated by experiments performed under defined conditions (such as worst case conditions). The contractor shall utilize process understanding gained from the modeling and experimental studies to create adaptive process control strategies and test them via experiments. Perform data analysis to propose a design space for the step, process model and optimal adaptive control strategy for the production bioreactor unit operation. Prepare training materials and provide a single training session to FDA reviewers on the results of this study. Contractors shall satisfy the following requirements. Provide a detailed description of your company’s (including its teammates, if applicable) experience and demonstrated abilities to deliver each and every one (address each separately) of the following requirements: A fixed price contract is anticipated. This is a new requirement. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses to this notice shall be limited to [15] pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS _______ (size standard $ or number of employees) and status, if qualified as an 8 (a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted shall be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA, may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is for Government market research only, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. RESPONSES DUE: All capability statements must be received by email to: karen.petty@fda.hhs.gov, on or before September 2, 2009 no later than 4:30pm, EST. Telephone calls will not be accepted.
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