FDA_20-223-SOL-1226392 SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER)/Facility for Biotechnology Resources (FBR) in order to determine if there are existing small business sources capable of providing a Fermentor system.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees, and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all the minimum performance requirements.

Background: The FDA/CBER/FBR has a need for a Fermentor system. CBER has a requirement to expedite potency measurement of pandemic influenza vaccines. CBER/FBR provides services on protein expression and characterization using the E. coli expression system. To expand the services for supporting large-scale protein expression in eukaryotic cells (e.g., cultured mammalian cells or insect cells), a fermentor with necessary accessories will be suitable for using either an autoclavable vessel or a single-use vessel under controlled environment. Scientists at CBER and Center for Drug Evaluation and Research (CDER) conduct cutting-edge biological research and review products related to pathogen identification, disease mechanisms, vaccine development (e.g., influenza and other viruses), etc. Often their studies require analysis and characterization of proteins, either naturally expressed or expressed from bioengineered cells harboring recombinant deoxyribonucleic acid (DNA) encoding the protein. One of the limiting factors in obtaining sufficient protein for analysis is the number of harvested cells available for protein extraction. Most traditional small-scale culture in the lab uses petri dishes or small flasks (10-75 ml) to grow eukaryotic cells.

To achieve a desired cell number, a general practice is to use multiple containers for the same culture. Such practices require a large number of flasks or petri dishes and adequate incubator space providing controlled environment. The practice is laborious that doesn’t guarantee consistent cell growth and/or level of protein expression in different containers. A bioreactor or fermentor could use various sizes of containers for cell culturing (0.3-5 liter, and up to 40 liter for laboratory scale experiments), depending on the number of cells needed. It allows cells to grow under strictly controlled conditions (e.g., stirring rate, temperature, pH, dissolved oxygen, etc.) by use of monitoring probes. Using a fermentor, it is easy to obtain large number of cells under controlled environment, thus achieving reproducible protein expression. While most eukaryotic proteins could be expressed in E. coli transformed with an appropriate recombinant gene, there are situations in which the function of a eukaryotic protein relies on post-translational modifications (e.g., phosphorylation or glycosylation). However, protein glycosylation is a process not carried out by E. coli, necessitating the production of functional glycosylated proteins in eukaryotic cells. For this reason and for meeting increasing interests of FDA scientists in expressing proteins in eukaryotic cells, FDA is expanding our services to include eukaryotic protein expression. Therefore, a fermentor (or bioreactor) system suitable for eukaryotic protein expression needs to be purchased. The fermentor is for cultivating various types of cultured eukaryotic or prokaryotic cells and therefore needs a wide range of flexibility to meet our needs.

Minimum Technical Requirements for a Fermentor system:

• Shall be a compact system so vessel and controller will fit into lab space, not to exceed a footprint of 25” x 25”.

• Shall be able to accommodate both glass autoclavable vessels and single-use cell culture vessels of various overlapping volume ranges:

Glass autoclavable: e.g., from <1 liter to ~10 liters, with overlapping range. Single Use:

from <0.5 to ~20 L, with overlapping ranges.

• Shall be able to accommodate cell culture-packed bed single use vessel for adherent cells and secreted product.

• Controller shall be capable of also converting for both mammalian cell culture and microbial cell culture.

• Shall be capable of using both direct drive and magnetic drive agitation motors to meet the demands of both eukaryotic cell culture and microbial culture.

• Shall have automatic gas mixing and control of 4 gases with 3 or more flow controllers for easy culture control, along with automatic control of carbon dioxide for pH control.

• Shall be able to interchange gas controllers when using larger vessels which requires higher gas flow.

• Shall be capable of using pH and DO (dissolved oxygen) digital sensors.

• Preferably a domestic instrument supplier with local service engineers so that repairing will be prompt without severely affecting operation.

• Contractor shall install the system and provide one-day on-site training

Installation, Training and Warranty Requirements

• The instrument and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall conduct an onsite training session to provide a thorough demonstration of all system/solution functions, maintenance, data acquisition and analysis, basic troubleshooting and hardware/software operation.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Estimated Delivery Date: 4-6 weeks after award

Delivery Location:

Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Ave Building 52, Room 1152 Silver Spring, MD 20993

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• 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.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, 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 the manufacturer (to include DUNS number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities exist for small business concerns.

• The Government is not responsible for locating or securing any information, not identified in the response.

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before April 10, 2020 by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, at email yolanda.rankin@fda.hhs.gov. Reference: FDA_20-223-SOL- 1226392.

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 FedBizOpps. 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.