B6 PD_3D BioX6 printer.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: This requisition is to purchase a 3-D bioprinter and accessories for the Formulation Laboratory within the Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI) at NCATS.

2. Background Information and Objective: The National Center for Advancing

Translational Sciences (NCATS), a component of the National Institutes of Health, aims to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the Division of Preclinical Innovation (DPI), Therapeutic Development Branch (TDB), is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand new formulation laboratory dedicated to preclinical research will be opened in the fall of 2023.

In the new laboratory, scientists will research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized Instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials.

3-D printing is a rapidly emerging technology that has the potential to revolutionize many industries, including the pharmaceutical industry. Here are some reasons why 3-D bioprinting is important in pharmaceutical formulation development:

• Customization: One of the main advantages of 3-D printing is the ability to produce customized products on demand. In the case of pharmaceuticals, this means that medications can be tailored to the specific needs of individual patients, such as their dosage requirements, allergies, or other medical conditions.

• Reduced waste: With 3-D printing, medications can be produced in precise quantities, which can reduce waste and save money. Traditional manufacturing methods often require the production of large quantities of medication, which can result in unused or expired drugs.

• Novel drug delivery systems: 3-D printing allows for the creation of complex structures and shapes that are difficult or impossible to achieve with traditional manufacturing methods. This makes it possible to develop novel drug delivery systems, such as implants or personalized pills, that can improve the efficacy and safety of medications.

• Accelerated drug development: 3-D printing can speed up the drug development process by enabling researchers to quickly produce prototypes of new formulations and test them in preclinical studies. This can save time and resources, and ultimately bring new drugs to market faster.

3. Generic Name of Product: 3-D Printer and accessories

Purchase Description: Sole Source

(1) Specify name; Cellink

(2) Specify product’s brand name; BioX 6 Gen 3

(3) Specify manufacturer's name; (3) Specify model, type, catalog, and/or part number(s)> Bio X Gen 3 3-D printer and accessories

4. Salient characteristics

This order will be pursued using Sole Source Option Item number Salient characterics

CL-BP-BIOX6-G3-

PB

Bio X6 Gen 3 Printer 6 pneumatic Printheads 1 Thermoplastic Printhead Temerature controlled Printhead 4 Built in Photocuring modules for general crosslinking 12 months warranty

CL-BP-BIOX6-G3-

PF

Bio X6 3 D Bioprinter Platform 4 Built in Photocuring Modules for general crosslinking

D16110026762 DNA Studio 4 sofware for use with BioX/X6 bioprinter.

Full access to future 1.x versions of DNA studio 4.

D16110024229 Remote installation and training INK/BIO D16110024824 Shipping and handling Bio X6

5. Quantity: One (1) each per product in salient characteristics

6. Delivery Date: July 2024

7. Period of Performance: N/A

8. Option(s): N/A