Liposome Preparation for Experimental Rheumatoid Arthritis treatment

PRE SOLICITATION NOTICE Department of Veterans Affairs Network Contracting Office 05 (NCO 05) Joint Targeted Drug Delivery Approach for Arthritis Therapy Liposome Preparation NAICS:

325412 Pharmaceutical Preparation Manufacturing PSC: AJ13 R&D Biomedical, Advanced Development 1. Announcement The Department of Veterans Affairs, Network Contracting Office (NCO) 05, intends to issue a solicitation for the preparation and characterization of specialized liposomal formulations incorporating patented joint targeting technologies. This notice serves as a Pre Solicitation Notice only and is issued in accordance with FAR 5.204.

This notice is not a request for quotes or proposals, and no responses are required at this time.

2. Summary of Requirement The forthcoming solicitation will seek a qualified contractor capable of producing research grade liposomes utilizing: A patented lipid composition A patented joint targeting peptide (ART2) Encapsulation of an anti arthritis drug Standard physicochemical characterization of nanoparticle/liposome systems This work supports VA owned intellectual property associated with an experimental drug delivery system intended for arthritis therapy.

Full technical details, including lipid composition, ratios, and ART2 functionalization methods will be released only after completion of a Confidential Disclosure Agreement (CDA) with the VA Technology Transfer Program.

3. Anticipated Contractor Capabilities The forthcoming solicitation will require vendors with demonstrated capability in: Custom nanoparticle or liposome formulation using sponsor specified lipid systems Peptide or ligand functionalization of nanoparticle surfaces Drug encapsulation and documentation of encapsulation efficiency Analytical nanoparticle characterization (particle size, zeta potential, PDI, drug loading) LC MS/MS or HPLC drug quantification Delivery of research grade formulations for non GLP exploratory studies Production of Certificates of Analysis (COA) for liposomal drug systems 4. Security and Intellectual Property Restrictions The lipid composition and ART2 peptide functionalization process are proprietary and patented by the VA.

Distribution of proprietary information will require: Execution of a Confidential Disclosure Agreement (CDA) with the VA Technology Transfer Program prior to release of any technical specifications. 5. Solicitation Release Information The formal solicitation (Request for Quote or Request for Proposal) is expected to be posted on SAM.gov. The solicitation will include:

Detailed performance requirements Instructions to offerors Evaluation criteria CDA instructions for accessing proprietary specifications Vendors are responsible for monitoring SAM.gov for updates.

6. Point of Contact Contracting Officer: Robert O Keefe Jr.

Email: robert.okeefejr@va.gov No phone inquiries will be accepted. All questions will be addressed after formal solicitation issuance. 7. Disclaimer This Pre Solicitation Notice does not constitute a solicitation. It does not request proposals or quotes and does not obligate the Government to award a contract. The VA will not reimburse any costs associated with preparation or submission of information in response to this notice. Upon completion of market research and release of the solicitation, selected vendors will be required to sign a Confidential Disclosure Agreement (CDA) prior to receiving proprietary materials and full technical specifications.