(1 each) High Resolution Ion Mobility (HRIM) - High Resolution Mass Spectrometer (HRMS) System

75F40123Q00210_A00003

The purpose of this amendment is for:

1.  Extend the response date for quote till May 23, 2023 at 4:00 pm ET.

2.  All other terms and conditions remain the same. 

***************************************************************************************

75F40123Q00210_A00002

The purpose of this amendment is for:

1.  Change the status the text in the Attachment "Combined Synopsis Solicitation" to match the SAM.gov entry.  The Request for quote is for a small set-aside. not a full and open competition.  

2.  All other terms and conditions remain the same. 

*********************************************************************************************************************************************

75F40123Q00210_A00001

1. Posting Question and Answers.

2. No Other changes. 

3. See attachment Amendment A00001 

This is a combined synopsis/solicitation for commercial services prepared in accordance with the
format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-02.
THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00210 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard for NAICS 334516 is 1000 employees. The requirement will be awarded as Firm-Fixed Price and be competed as a small business set-aside. . Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.
The Government intends to issue a Purchase Order.
The U. S. Food and Drug Administration (FDA), has a need to procure one (1 each) High Resolution Ion Mobility (HRIM) - High Resolution Mass Spectrometer (HRMS) System
**************************BRAND NAME OR EQUAL ***************************
Description: Statement of Work
1. Scope of Work
To purchase and install a high-resolution ion mobility (HRIM) – high resolution mass spectrometer (HRMS) system to expand and augment the capacity and capability of Food and Drug Administration (FDA) to ensure pharmaceutical safety, efficacy, and high quality. In particular, this system will offer a wealth of multi-attribute information that can enable comprehensive analysis of complex biologics, peptide and oligonucleotide therapeutics and other complex drug products, thus promoting an in-depth understanding of the advanced manufacturing methods employed in the production of these complex therapeutic drug products.
2. Background:
High resolution mass spectrometer (HRMS) is essential in the characterization of emerging complex and biological drugs including peptides, proteins, oligonucleotides, and other complex mixtures. The
2
accurate mass provided by HRMS needs to be obtained to confidently identify active ingredients, isoforms, and impurities. The high resolution and high sensitivity by HRMS are needed to differentiate all the components including structurally-similar ones and to detect low-level species such as modifications and impurities, which are commonly present and are critical quality attributes in these highly complex and heterogeneous systems. Additionally, physical separation of highly heterogeneous complex drug products including impurities is needed prior to HRMS analysis and is often achieved with high performance liquid chromatography (HPLC). However, advanced separation techniques such as ion mobility (IM) technology can allow separation of chromatographically coeluting ions such as by their molecular shape and mobility. This additional dimension of separation in addition to HPLC enables a higher resolving power and can thus address the analytical challenges posed by the complexities of those drug products. The high-resolution ion mobility (HRIM) can further enhance the resolving power to separate structurally similar components that are not separated by LC, MS or low-resolution IM. The LC-HRIM-HRMS system permits the analysis of multiple critical quality attributes on a single analytical platform, enables complete process and product characterization, and offers the potential for drug manufacturers to gain deep understanding of their manufacturing processes, particularly the biopharmaceutical and complex product manufacturing.  See full Combined Synopsis/Solicitation in attachment.

75F40123Q00210_A00002

The purpose of this amendment is for:

1.  Change the status the text in the Attachment "Combined Synopsis Solicitation" to match the SAM.gov entry.  The Request for quote is for a small set-aside. not a full and open competition.  

2.  All other terms and conditions remain the same. 

*********************************************************************************************************************************************

75F40123Q00210_A00001

1. Posting Question and Answers.

2. No Other changes. 

3. See attachment Amendment A00001 

This is a combined synopsis/solicitation for commercial services prepared in accordance with the
format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-02.
THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00210 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard for NAICS 334516 is 1000 employees. The requirement will be awarded as Firm-Fixed Price and be competed as a small business set-aside. . Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.
The Government intends to issue a Purchase Order.
The U. S. Food and Drug Administration (FDA), has a need to procure one (1 each) High Resolution Ion Mobility (HRIM) - High Resolution Mass Spectrometer (HRMS) System
**************************BRAND NAME OR EQUAL ***************************
Description: Statement of Work
1. Scope of Work
To purchase and install a high-resolution ion mobility (HRIM) – high resolution mass spectrometer (HRMS) system to expand and augment the capacity and capability of Food and Drug Administration (FDA) to ensure pharmaceutical safety, efficacy, and high quality. In particular, this system will offer a wealth of multi-attribute information that can enable comprehensive analysis of complex biologics, peptide and oligonucleotide therapeutics and other complex drug products, thus promoting an in-depth understanding of the advanced manufacturing methods employed in the production of these complex therapeutic drug products.
2. Background:
High resolution mass spectrometer (HRMS) is essential in the characterization of emerging complex and biological drugs including peptides, proteins, oligonucleotides, and other complex mixtures. The
2
accurate mass provided by HRMS needs to be obtained to confidently identify active ingredients, isoforms, and impurities. The high resolution and high sensitivity by HRMS are needed to differentiate all the components including structurally-similar ones and to detect low-level species such as modifications and impurities, which are commonly present and are critical quality attributes in these highly complex and heterogeneous systems. Additionally, physical separation of highly heterogeneous complex drug products including impurities is needed prior to HRMS analysis and is often achieved with high performance liquid chromatography (HPLC). However, advanced separation techniques such as ion mobility (IM) technology can allow separation of chromatographically coeluting ions such as by their molecular shape and mobility. This additional dimension of separation in addition to HPLC enables a higher resolving power and can thus address the analytical challenges posed by the complexities of those drug products. The high-resolution ion mobility (HRIM) can further enhance the resolving power to separate structurally similar components that are not separated by LC, MS or low-resolution IM. The LC-HRIM-HRMS system permits the analysis of multiple critical quality attributes on a single analytical platform, enables complete process and product characterization, and offers the potential for drug manufacturers to gain deep understanding of their manufacturing processes, particularly the biopharmaceutical and complex product manufacturing.  See full Combined Synopsis/Solicitation in attachment.

75F40123Q00210_A00001

1. Posting Question and Answers.

2. No Other changes. 

3. See attachment Amendment A00001 

This is a combined synopsis/solicitation for commercial services prepared in accordance with the
format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-02.
THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00210 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard for NAICS 334516 is 1000 employees. The requirement will be awarded as Firm-Fixed Price and Full and Open Competition. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.
The Government intends to issue a Purchase Order.
The U. S. Food and Drug Administration (FDA), has a need to procure one (1 each) High Resolution Ion Mobility (HRIM) - High Resolution Mass Spectrometer (HRMS) System
**************************BRAND NAME OR EQUAL ***************************
Description: Statement of Work
1. Scope of Work
To purchase and install a high-resolution ion mobility (HRIM) – high resolution mass spectrometer (HRMS) system to expand and augment the capacity and capability of Food and Drug Administration (FDA) to ensure pharmaceutical safety, efficacy, and high quality. In particular, this system will offer a wealth of multi-attribute information that can enable comprehensive analysis of complex biologics, peptide and oligonucleotide therapeutics and other complex drug products, thus promoting an in-depth understanding of the advanced manufacturing methods employed in the production of these complex therapeutic drug products.
2. Background:
High resolution mass spectrometer (HRMS) is essential in the characterization of emerging complex and biological drugs including peptides, proteins, oligonucleotides, and other complex mixtures. The
2
accurate mass provided by HRMS needs to be obtained to confidently identify active ingredients, isoforms, and impurities. The high resolution and high sensitivity by HRMS are needed to differentiate all the components including structurally-similar ones and to detect low-level species such as modifications and impurities, which are commonly present and are critical quality attributes in these highly complex and heterogeneous systems. Additionally, physical separation of highly heterogeneous complex drug products including impurities is needed prior to HRMS analysis and is often achieved with high performance liquid chromatography (HPLC). However, advanced separation techniques such as ion mobility (IM) technology can allow separation of chromatographically coeluting ions such as by their molecular shape and mobility. This additional dimension of separation in addition to HPLC enables a higher resolving power and can thus address the analytical challenges posed by the complexities of those drug products. The high-resolution ion mobility (HRIM) can further enhance the resolving power to separate structurally similar components that are not separated by LC, MS or low-resolution IM. The LC-HRIM-HRMS system permits the analysis of multiple critical quality attributes on a single analytical platform, enables complete process and product characterization, and offers the potential for drug manufacturers to gain deep understanding of their manufacturing processes, particularly the biopharmaceutical and complex product manufacturing.  See full Combined Synopsis/Solicitation in attachment.

This is a combined synopsis/solicitation for commercial services prepared in accordance with the
format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-02.
THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00210 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard for NAICS 334516 is 1000 employees. The requirement will be awarded as Firm-Fixed Price and Full and Open Competition. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.
The Government intends to issue a Purchase Order.
The U. S. Food and Drug Administration (FDA), has a need to procure one (1 each) High Resolution Ion Mobility (HRIM) - High Resolution Mass Spectrometer (HRMS) System
**************************BRAND NAME OR EQUAL ***************************
Description: Statement of Work
1. Scope of Work
To purchase and install a high-resolution ion mobility (HRIM) – high resolution mass spectrometer (HRMS) system to expand and augment the capacity and capability of Food and Drug Administration (FDA) to ensure pharmaceutical safety, efficacy, and high quality. In particular, this system will offer a wealth of multi-attribute information that can enable comprehensive analysis of complex biologics, peptide and oligonucleotide therapeutics and other complex drug products, thus promoting an in-depth understanding of the advanced manufacturing methods employed in the production of these complex therapeutic drug products.
2. Background:
High resolution mass spectrometer (HRMS) is essential in the characterization of emerging complex and biological drugs including peptides, proteins, oligonucleotides, and other complex mixtures. The
2
accurate mass provided by HRMS needs to be obtained to confidently identify active ingredients, isoforms, and impurities. The high resolution and high sensitivity by HRMS are needed to differentiate all the components including structurally-similar ones and to detect low-level species such as modifications and impurities, which are commonly present and are critical quality attributes in these highly complex and heterogeneous systems. Additionally, physical separation of highly heterogeneous complex drug products including impurities is needed prior to HRMS analysis and is often achieved with high performance liquid chromatography (HPLC). However, advanced separation techniques such as ion mobility (IM) technology can allow separation of chromatographically coeluting ions such as by their molecular shape and mobility. This additional dimension of separation in addition to HPLC enables a higher resolving power and can thus address the analytical challenges posed by the complexities of those drug products. The high-resolution ion mobility (HRIM) can further enhance the resolving power to separate structurally similar components that are not separated by LC, MS or low-resolution IM. The LC-HRIM-HRMS system permits the analysis of multiple critical quality attributes on a single analytical platform, enables complete process and product characterization, and offers the potential for drug manufacturers to gain deep understanding of their manufacturing processes, particularly the biopharmaceutical and complex product manufacturing.  See full Combined Synopsis/Solicitation in attachment.