ESBD_394760_1739199867521_RFP 25-23 Large Scale Bioreactors.pdf

RFP 25-23 Large Scale Bioreactors 1

REQUEST FOR PROPOSALS (RFP) #25-23

Large Scale Bioreactors

PROPOSED SOLICITATION SCHEDULE

This schedule may be modified or changed at the sole discretion of SJCCD.

DATE ACTION

February 10, 2025 RFP issued.

February 19, 2025

Questions and/or Clarifications Deadline

Requests for questions and clarifications regarding RFP documents shall be submitted through the Questions tab in IonWave by 5:00 p.m. Central Time to be considered.

February 21, 2025 Issuance of final addendum, if necessary.

February 28, 2025

Proposal Submission Deadline

All proposal documents shall be submitted before 2:00 p.m. Central Time in IonWave.

The RFP opening will take place digitally through IonWave immediately following time due. A list of vendors who submitted will be made available upon written request to the Procurement Contact.

March / April 2025 Recommendation of award and approval to enter into contract.

Award will be announced after approval received.

E-Bidding Website: IonWave https://sanjac.ionwave.net

PROCUREMENT CONTACT

Kimberly Adams, Buyer 281-998-2614 kimberly.adams@sjcd.edu https://sanjac.ionwave.net/ mailto:kimberly.adams@sjcd.edu

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SCOPE OF WORK AND SPECIFICATIONS

1. General

San Jacinto Community College District (“SJCCD” or “College”) is soliciting sealed proposals from qualified firms to provide large scale single-use or stainless-steel bioreactor/fermenters and associated components.

SJCCD reserves the right to select one or more companies based on the best value, as determined by SJCCD, overall response(s) submitted to the College, with consideration given to proposals that best meet the desired scope of work and specifications set forth in this request for proposals.

All work performed must be in compliance with existing federal, state and local codes, statutes and requirements.

SJCCD is a public community college district organized under Chapter 130 of the Texas Education Code and is tax exempt in the State of Texas.

2. Scope of Work

This scope of work covers the requirements to provide SJCCD with new or used single-use bioreactor system(s) with a working volume range between 50L and 200L. System(s) will support biopharmaceutical production training. The College is looking for established basic function models (as opposed to top-of-the-line, state-of-the-art designs) for operational reliability, flexibility, and regulatory compliance. All components are to be compatible with US power supply:

60Hz, 120/240 VAC.

A. Bioreactor System

1. Volume: Working volume range of 50L up to 200L.

2. Material: Fully single-use reactor chamber/bag with gamma-sterilized and disposable bags or multi-use stainless steel.

3. Pressure Specifications:

o Maximum operating pressure: 0.5 PSI or as appropriate for biopharmaceutical processes.

o Minimum working pressure: 0 bar (ambient pressure).

4. Agitation: Magnetically driven or equivalent agitation system to ensure homogenous mixing, with variable speed and impeller options.

B. Gassing System

1. Gas Inputs: Dedicated lines for Oxygen (O₂), and Carbon Dioxide (CO₂)

2. Flow Control: Gas mixing via a mass flow controller for precise control of dissolved oxygen (DO) and pH levels.

3. Sparging: Integrated sparger system suitable for cell culture and microbial applications

(e.g., microbubbles and macro bubbles).

C. Temperature Control

1. Integrated temperature control system with adjustable ranges between 4°C to 40°C.

2. Uniform heating/cooling system compatible with the reactor design (e.g., heating blankets or water jacket systems).

RFP 25-23 Large Scale Bioreactors 3

D. Control Tower

1. User Interface: Modern touchscreen interface with configurable settings for DO, pH, temperature, agitation, and gas flow.

2. Data Logging: Data export capabilities via SCADA Ethernet or USB.

3. Software: FDA 21 CFR Part 11 compliance for electronic records and signatures.

E. Accessories

a. Hoses: Supply all tubing and connectors to integrate gas, liquid, waste and sensor systems (extra tubing preferred).

b. Connectors: Supply additional tubing clamps, and probe connectors appropriate to unit and bags

c. Stand-alone Peristaltic pump: appropriate for size of unit to transfer fluid from line sets

d. Temperature Control Unit (TCU): Appropriate for size of unit

e. Sensors: Temperature and pressure.

f. Probes: Autoclavable DO and pH proves (single use not an option)

g. Filters: Include sterile filters for gas and liquid inputs/outputs.

h. Bags: Include purchase of 2 bags for system (if applicable).

3. Specifications

For its current purposes, the College considers the following to be instructionally equivalent.

The large-scale training bioreactor(s) appropriate to this RFP include, but are not limited to equipment meeting the specifications found in the following attachments:

Attachment A: Cytiva Xcellerex XDR 50L to 200L (or equivalent) Attachment B: Cytiva Xcellerex X-platform 50L to 200L (or equivalent) Attachment C: Thermofisher HyPerforma DynaDrive S.U.B 50L to 250L (or equivalent) Attachment D: Eppendorf BioFlow 610 (or equivalent) Attachment E: Sartorius Biostat STR Generation 3 50L to 200L (or equivalent)

4. Delivery and Installation

a. Promised date of equipment delivery, installation, and operational readiness will be a consideration in the determination of best value.

b. Location does not have a loading dock; delivery truck must include a liftgate or use of the College’s forklift. Delivery and installation must be coordinated with the SJCCD contact person.

c. Delivery shall be made FOB destination, inside delivery, to San Jacinto College, 13455 Lockwood Rd, Houston, TX 77044

d. Proposer shall provide all accessories necessary for complete installation and operation of the large-scale bioreactor equipment and accessories.

e. All equipment shall be set in place, assembled, and ready for College use upon delivery.

f. Awarded vendor shall clean up all debris and is responsible for haul-away of shipping and packaging debris.

RFP 25-23 Large Scale Bioreactors 4

5. Supplier Diversity Reporting

SJCCD does not give preference to historically underutilized or small business in the awarding of contracts. However, if the awarded contractor utilizes a subcontractor(s) to fulfill the proposed requirements, the contractor will be required to track and report the amount paid to each subcontractor along with the subcontractor’s supplier diversity classification. This information will only be used for the purpose of statistical tracking. The reportable classifications include:

• African American

• Asian Pacific American

• Caucasian

• Hispanic American

• Native American

• Small Business

• Veteran Owned

• Minority Owned

• Woman Owned

• LGBTQ

• Other / Non-disclosed

6. Special Requirements

All contractors, subcontractors or company representatives working at any college property or college facility shall wear a clearly visible name tag, badge, embroidered or labelled uniform shirt, or other personal or company identification at all times. Failure to comply with this requirement could result in removal from the campus until corrected.

RFP 25-23 Large Scale Bioreactors 5

EVALUATION CRITERIA

An Evaluation Committee will review all proposals according to the criteria stated herein. The committee’s evaluations will be based on all available information, including qualification statements, subsequent interviews/presentations, reports, discussions, reference checks, and other appropriate review.

Proposals will be evaluated using the following criteria:

Factor Points

Section 1: Qualifications and Experience of Firm 10

Section 2: Equipment (Attachment A-E) 40

Section 3: References 5

Section 4: Exceptions to Terms and Conditions 5

Section 5: Price Proposal* 40

Total 100

* The price proposal for each firm will be evaluated in comparison with the other firms’ price proposals;

however, the number of points possible may be evaluated in proportion to each respondent’s evaluation score received for Section 2: Equipment (Attachment A-E) in determining “best value”. The College may purchase more than one system. In such case, the best value for the College’s intended use will be selected, and the next best value will be selected based on available funds and the instructional benefit to be obtained through the supplemental system.

RFP 25-23 Large Scale Bioreactors 6

PROPOSAL RESPONSE REQUIREMENTS

All proposal response requirements must be submitted through IonWave. The system does not allow a proposal submission unless all requirements have been met, including Attributes and Response Attachments. The College understands the requirements may seem onerous to firms that have primarily been servicing the commercial market, but they are required for penetrating the academic market. These requirements include, but are not limited to, the following:

Written Proposal

Written Proposal shall be submitted as a Response Attachment in IonWave and shall include responses to Section 1 – 2. Written Proposals shall be a single PDF document with a maximum of twenty (20) pages (numbered 1-20). Sections must be in order and clearly labeled as outlined below.

Include a coversheet that includes your firm’s name, representative, and contact information.

Coversheet does not count towards the 20-page limit.

1. Qualifications and Experience of Firm

a. Include a description of the firm including firm’s history and size. Provide information regarding how long the proposer has provided the services requested in this RFP.

b. Describe previous experience with SJCCD or other public entities and/or colleges. Include how many public entities and/or college accounts are in your current client base. Did your company perform satisfactorily to the terms and conditions of the last award given to your company? Were there any discrepancies, issues or complaints reported concerning your organization’s performance?

c. Address customer service strategies for delivering a high level of customer service and handling customer complaints. Describe how your organization handles complaints, comments, or suggestions received.

2. Equipment (Attachment A-E) If your firm is submitting more than one system listed in Attachments A-E, please submit a separate response to this section for each proposed system and clearly indicate the Attachment letter (A-E) or “Other.”

a. List the Equipment/System that your proposal includes (as described in Attachments A through E) and describe how your product meets the specifications listed in this RFP.

b. Include a complete description of the specific equipment and accessories being offered, the date of anticipated installation and operation, and any warranty terms. State whether your product(s) are new or certified pre-owned. If certified pre-owned, disclose the age of the product(s). Address any variances between your proposal and the specifications.

c. List your lead time to deliver and install the equipment, and address any additional services provided, such as training, maintenance, warranty, etc. If these services are not included in the price proposal, clearly indicate the respective fees for these additional services.

RFP 25-23 Large Scale Bioreactors 7

3. References

Include references in the Attributes tab in IonWave for the following:

a. The proposer shall provide at least five (5) references on recent projects for which the proposer's company is currently providing or has provided the same type and level of service required in this RFP within the past three years. Include the name, telephone number, and valid email address of a reference person who may be contacted for further information. It is highly preferable that these references are other colleges or public sector accounts comparable in size or larger.

b. All references will be contacted by email. Evaluations will be based on responses received from references. It is advisable to notify your references ahead of time that a reference will be requested by email.

4. Exceptions to Terms and Conditions

An exception includes any addition, deletion, or other modification. Submit exceptions to terms and conditions as an attachment in the Response Attachment tab in IonWave as follows:

a. If you select Yes to “EXCEPTIONS TO TERMS AND CONDITIONS” under the Attributes tab, you must submit a written summary of each exception to this RFP, including the scope, specifications, and/or sample contract, as applicable. The summary shall include supporting justification that clearly identifies the specific reference, page, section, and sub-section of the change, relevance of the change, the vendor’s rationale for the change, and benefit to the College for accepting the change for the submitted exceptions to be considered in the evaluation.

b. The College’s evaluation of submitted exceptions will address the quantity of exceptions, type of exceptions, and justification(s) for exceptions. Fewer exceptions and/or exceptions with a lower risk to the College, if accepted, will equate to a higher score.

c. Any exceptions not explicitly stated may not be considered during contract negotiations, if any. The submittal of exceptions to terms and conditions does not guarantee the College’s acceptance of exceptions. The College reserves the right to accept or reject any exceptions as necessary to negotiate a mutually beneficial contract.

5. Price Proposal

Include total required pricing for each system proposed (Attachments A-E) on the Line Items tab in IonWave. Do not include optional pricing in Line Items tab:

Attachment A: Cytiva Xcellerex XDR 50L to 200L (or equivalent) Attachment B: Cytiva Xcellerex X-platform 50L to 200L (or equivalent) Attachment C: Thermofisher HyPerforma DynaDrive S.U.B 50L to 250L (or equivalent) Attachment D: Eppendorf BioFlow 610 (or equivalent) Attachment E: Sartorius Biostat STR Generation 3 50L to 200L (or equivalent)

RFP 25-23 Large Scale Bioreactors 8

Upload a Pricing Attachment document outlining pricing details for each system proposed (Attachments A-E). Pricing details shall address inclusions, exclusions, and quantities in accordance with each specification number listed with the corresponding Attachments A-E (i.e., A.1, A.2, A.3, A.4, etc.). Provide a total for all required features and list the total required pricing in the Line Item Tab. Optional pricing should not be included in the Line Items tab.

Any costs not explicitly stated in a proposal response shall not be charged to the College. The College reserves the right to consider pricing submitted through Line Items, Line Notes, and Response Attachments.

List of Response Attachments:

Include the following documents in the Response Attachments tab in IonWave.

All forms are available to download under the Attachments tab in IonWave. Except when listed as Optional, all Response Attachment documents are required and failure to provide a required document may deem the proposer non-responsive and disqualify the response from consideration for award.

1. Written Proposal

2. Pricing Attachment(s)

3. Conflict of Interest form

4. Proof of Insurance Requirements

5. Exceptions to Terms and Conditions (optional)