AN42--Notice of Intent to Sole Source - Anti-Osteopontin (OPN) Antibody

This Notice of Intent to Sole Source is provided to advise that the Government intends to solicit and negotiate a Sole Source, Firm-Fixed-Priced, Purchase Order, with only one (1) source, Celltheon Corporation. The procurement is to procure 1 gram of Protein for the VA Palo Alto Health Care System Research Division. This contract action is for supplies for which the Government intends to solicit and negotiate with only one (1) source under the authority of FAR 13.106-1(b) and 41 USC §1901, only one (1) will meet the Government s needs. Only one (1) source is capable of responding due to the unique or specialized nature of the supplies and/or services. Interested persons may identify their interest and capability to respond to the requirement. The applicable NAICS Code is 541714 and the size standard is 1,000 employees. 1. SCHEDULE OF PROPOSED CLIN. *All line-items are considered Brand Name or provide your Equal substitute for the purpose of market research.* Item Information ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 2.00 EA __________________ __________________ PLASMID PREP Contract Period: Base POP Begin: POP End: LOCAL STOCK NUMBER: 2023-STFD-014 0002 1.00 EA __________________ __________________ TRANSIENT PRODUCTION Contract Period: Base POP Begin: POP End: 0003 1.00 EA __________________ __________________ PROTEIN A PURIFICATION Contract Period: Base POP Begin: POP End: 0004 1.00 EA __________________ __________________ Analytics: SDS-PAGE, SE-HPLC, LAL Endotoxin Contract Period: Base POP Begin: POP End: 0005 1.00 EA __________________ __________________ SUPPLIES - These supplies are use to scale-up to product the appropriate amount of plasmid required to transiently product 1g of purified antibody. Contract Period: Base POP Begin: POP End: GRAND TOTAL __________________ Salient Characteristics & Scope of Work Phase I: Molecular Biology The HC and LC plasmids encoding mAb A6 version 3 were previously cloned by Celltheon for pilot transient expression. These plasmids will be scaled-up to produce an appropriate amount of plasmid required transiently produce 1g of purified antibody. Phase II: Transient Transfection Celltheon will scale up and transfect transient CHO cells an appropriate volume to produce 1g of mAb A6 version 3. The transient CHO cultures will be harvested by centrifugation and sterile filtration followed by purification via Protein A chromatography. The purified antibody will be buffer exchanged, concentrated, and aliquoted per the client s requirements and shipped accordingly. In addition, Celltheon will also perform Size Exclusion HPLC (determine %monomer), SDS-PAGE Reduced and Non-reduced (visual purity) and LAL endotoxin (specs TBD). Plasmid Prep Transient Production Protein A purification Analytics: SDS-PAGE, SE-HPLC, LAL Endotixin Supplies Other 2. DELIVERY OF ITEMS The address is with FOB Destination shipping: VA Palo Alto Healthcare System 3801 Miranda Ave. Palo Alto, CA 94304 This Notice of Intent to Sole Source is not a request for competitive quotes and no solicitation will be made available. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition. Your response should include: Statement of Capability GSA or other Schedule Information specifically the Contract Number System for Awards Management (SAM) UEI#, Business Size and Socio-Economic Status for the NAICS code listed above. The Government will not pay for information submitted. All quotations/responses should be emailed to Dennis Salmonsen at dennis.salmonsen@va.gov by 08/07/2023 at 1300 Pacific. No telephone requests will be accepted.