6.5389217_Purchase_Description.pdf

Purchase Description

Title: 96-Well Plate Assemblies with a Biodegradable Membrane

I. Statement of Need

The National Center for Advancing Translational Sciences (NCATS) BioPrinting Lab has a need for 96-well insert plate assemblies fabricated with a biodegradable membrane.

Complex cellular and tissue models, such as those created using 3D tissue biofabrication, provide physiologically relevant platforms to enhance the 1) development of therapeutics,

2) uses in regenerative medicine applications, and 3) testing environmental and man-made substances.

A challenge of these models has been the production of inserts with permeable membranes that promote initial structural support and cellular health which eventually biodegrade over time as the tissue matures. This is similar to the use of biodegradable sutures used in surgical procedures which are made of Polyglycolic Acid (PGA), such as NEOVEIL, that promote healing but eventually dissolve within the body.

Commercial well plates traditionally use non-biodegradable membrane materials (primarily Polyester (PET), Polycarbonate, or PTFE). There are no commercially available well plates offering biodegradable alternatives to these materials.

NCATS regularly fabricates plates with biodegradable membranes by hand on an as-needed basis, using a process it developed to affix custom membranes to plates in the laboratory, but this has been a rate limiting step in providing better tissue construct production. In addition, it is a laborious manual process that is not suited to mass production of plates utilizing these membranes. As NCATS has previously developed such well plates, the Government considers this to be a non-developmental item of supply.

The objective of this purchase is for the Contractor to deliver 25 prototype 96-well or higher plate assemblies that utilize Poly lactic-co-Glycolic Acid (PLGA) as the well-bottom membrane that can be sold as COTS items to the general public.

II. Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements listed herein.

a. The Contractor shall deliver 25 prototype high density (96+) well plates with biodegradable membranes with the following characteristics:

i. Biodegradable membrane requirements:

1. The biodegradable material must be manufactured using GMP-compliant equipment to the maximum extent practical.

2. Biocompatible with tissue culture environments

3. Biodegradable within 2-6 weeks

4. Suitable for cellular health and function for long-term experiments (1+ month)

5. Thickness 2-10 µm

6. Mean pore size 1-2 µm

7. Able to increase cell attachment with the need for additional coatings

8. The biodegradable polymer must have two intrinsic viscosities (e.g. 0.6 and 1.0 I.V.).

ii. Plate assembly must conform to the ANSI/SLAS standard microplate footprint dimensions and tolerances:

1. ANSI/SLAS 1-2004 (R2012) Microplates – Footprint Dimensions (formerly ANSI/SBS 1-2004)

2. ANSI/SLAS 2-2004 (R2012) Microplates – Height Dimensions (formerly

ANSI/SBS 2-2004)

3. ANSI/SLAS 3-2004 (R2012) Microplates – Bottom Outside Flange Dimensions (formerly ANSI/SBS 3-2004)

4. ANSI/SLAS 4-2004 (R2012) Microplates – Well Positions (formerly

ANSI/SBS 4-2004)

iii. Plate design must include the following component pieces:

1. 96-well base plate to hold culture medium beneath each individual membrane of the 96-well insert plate.

2. Alternate single-well base plate to hold culture medium beneath the 96-well insert plate. This well is to provide a common medium exposure to all membranes on the 96-well membrane plate and contain baffles to control medium movement within the plate.

3. 96-well insert plate that the biodegradable membranes will be attached.

This insert plate must fit into the base plate described in this section and contain an access port for each individual membrane insert to allow access to the medium well beneath the insert.

4. Lid to cover the 96-well insert plate and base plate assembly. The lid must maintain sterility and allow air access to the apical surface of the insert plate and the culture medium contained in the base plate.

iv. Plates must be manufactured from a high-quality polystyrene or copolyester (such as Eastar™ Copolyseter DN004) that meets FDA/ISO 10993 and USP Class VI Biological Evaluation testing after Gamma and EtO sterilization.

v. Surface morphology of the materials pre and post-cutting must be evaluated to confirm that the cutting process does not alter the thickness, average pore size or surface morphology (i.e. tearing, deformation) of the resulting material (specifically the inner surface of the resulting cut material. A microscopy system must be used to compare surface properties pre and post-cutting to confirm that there are no significant changes to these key parameters. The Government’s preferred system for this process is a Keyence VK-X1100 Profile Measurement Microscope. If purchased in direct support of this contract, the Government will reimburse the contractor for the cost of the Keyence microscope, and it will be transferred to the Government upon competition of the contract. If an alternative microscopy system is used, the system must be described with reference to its ability to determine that a prototype plate meets these technical requirements.

vi. Biodegradable membranes must be attached to the plates as one sheet per plate. Excess materials between the plates must be cut away after adhesion.

vii. Finished plates must be sterilized prior to packaging.

b. The Contractor shall deliver QC metrics to be applied to the plates.

c. The Contractor shall deliver 25 prototype plates to NCATS. Prototypes will be evaluated by NCAS for compatibility and integrity.

III. Reporting Requirements

a. Progress Reports

During the development of the manufacturing technique the Contractor shall provide progress reports every other month. This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period.

The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of two calendar months.

b. Final Report

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved.