Sources Sought: Protien Purifier
Sources Sought Notice: Protein Purifier
MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Drug Evaluation and Research's (CDER).
This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.
Several companies are seeking to participate in Center for Drug Evaluation and Research (CDER)'s Emerging Technology Program, to manufacture biosimilars and New Molecular Entity (NME) biologics using continuous manufacturing and (CM) single use technologies. The limited knowledge on the risks of CM and single use technologies on the quality of biotech products necessitates expanded research in this area. The Division of Product Quality Research (DPQR) wants to establish a continuous process for a biologic produced by a Chinese Hamster Ovary (CHO) cell line. A bioreactor will be operated for extended durations of time (≥25 days) under perfusion mode and will generate hundreds of liters of the perfusate containing dilute amounts of the biologic. It is essential to integrate the upstream process with the downstream processes via a protein capture step. Therefore, a protein purifier that can handle loading and elution simultaneously on two (2) columns and switching the columns by preparing one for the other is essential to keep the protein capture step continuously going as long as the upstream processes are operated. AKTA Avant 25 with four (4) more versatile valves and other accessories meets this technical challenge to keep the capture step of the protein continuous and there is a need to acquire this instrument.
Capabilities Required:
The FDA is seeking sources capable of providing an AKTA Avant 25 purifier (or equivalent) with 4 additional versatile valves and other accessories for capturing the protein of interest from the upstream processed bioreactor perfusate in a continuous operation as required to support extended duration bioreactor production of biologics.
Capable sources shall be able to furnish an instrument capable of meeting or exceeding the following salient characteristics:
1. The purifier shall be one instrument with cooled (temperature controlled) fraction collector.
2. Shall provide all necessary pumps and valves to be able to handle two (2) columns simultaneously.
3. The purifier shall facilitate continuous loading on one (1) column up to saturation and switch the column to elution while replacing that with another column for loading without delay or loss of time.
4. The purifier shall perform both loading and elution, followed by cleaning of two (2) independent columns continuously by rotating them for either loading or elution and preparation.
5. The instrument shall provide standard operating software that facilitates continuous capture using two (2) columns alternating them between loading and elution-cleaning steps.
6. The purifier shall be easily operated through the included software, at a "turn-key" level, without requiring additional accessory software or computer coding knowledge.
7. The purifier shall provide all accessory columns and resins required to achieve continuous capture of the biologic in a scenario of continuous production of a biologic in bioreactors.
8. Shall provide full system software and peripheral installation (if applicable).
9. Shall provide on-site hardware and software training.
10. Shall provide Factory Acceptance Tests (FAT). The FAT protocols shall be discussed prior to the evaluation. Preferably, the test is performed at the installation site (DPQR lab).
Capability Statements:
Responses to this sources sought notice shall unequivocally demonstrate the respondent's capabilities to provide the instrument, accessories, and services described above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following:
1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.
2. Past Performance information shall include date of services, description, dollar value, client name,
3. Client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.
4. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.
5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.
Response Instructions:
Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on June 6th, 2019 to Christopher.mcgucken@fda.hhs.gov.
Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).
Christopher R. McGucken, Contract Specialist, Phone (240) 402-7566, Email christopher.mcgucken@fda.hhs.gov
