Körber Pharma Software, Inc PAS-X MES Manufacturing Execution System

Körber Pharma Software, Inc PAS-X MES Manufacturing Execution System

• NAICS Code: 541512-Computer Systems Design Services (Small Business Size Standards $34M Average Annual Receipts)
• Product Service Code: 7A20- IT and Telecom - Application Development Software (perpetual License Software)
• Place of Performance: Clinical Center, Bethesda, MD 20892

POTS:  24-007691

Description:
This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested.

The National Institutes of Health, Office of Purchasing and Contracts on behalf of the Center of Cellular Engineering intends to award a firm fixed priced contract issued on a sole source basis to Körber Pharma Software, Inc. for implementing, installing, and configurating a Manufacturing Execution System for a base year period and four option years.

The Center of Cellular Engineering intends to partner with Korber Pharma has extensive experience in Manufacturing Execution System for pharmaceuticals, biotechnology, and cell & gene therapy. 

Körber Pharma Software, Inc will configure a Manufacturing Execution System (MES) with the primary objective of enhancing the safety and effectiveness of cellular therapies provided to patients.  Körber Pharma Software, Inc has extensive experience in MES deployment for pharmaceuticals, biotechnology, and cell & gene therapy. Korber's proven track record includes successful implementations tailored to biotechnology companies and academic centers with comparable manufacturing schemas to the Center of Cellular Engineering. Korber Pharma software solution is called PAS-X MES, which has the following key features:

GMP-Ready Product:
The PAS-X MES integrates leading IT technologies to provide a product compliant with Good Manufacturing Practices (GMP).
This ensures that the system meets the rigorous quality and safety standards necessary for cellular therapies.
The system has many out of the box functions to facilitate implementation.

Tailored Procedures
Develop Manufacturing Execution System procedures that precisely match the unique requirements of CCE’s cell and gene therapies.

Korber’s experience with other biotechnology companies and academic centers will minimize the extent of customization required for implementation, thus streamlining the process.

Efficient Deployment:
Successfully install and configure a MES system within 12 months.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri.nih.gov by the due date May 27, 2024 and time 12:00 pm EST marked in this notice.