D.CSS_Attach1-Purchase_Description.pdf

Purchase Description

Statement of Need and Purpose:

Cytiva AKTA Pure or brand-equal large scale system, Cytiva AKTA OLIGOPILOT 100 or brand-equal system, and Cytiva AKTAcrossflow or brand-equal system for NCATS Therapeutic Development Branch (TDB) ASO program.

Background Information and Objective:

The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions.

The Therapeutic Development Branch (TDB) ASO lab program’s mission is to encourage and speed the development of new antisense oligonucleotides (ASOs) treatments for viral and rare diseases with high unmet medical needs. To this end, TDB needs a DNA/RNA purification system, that allows for large scale purification. TDB also needs a DNA/RNA synthesizer, that allows for a range of scale 100 μmol – 8 mmol to speed up workflow and optimize cell culture work. TDB also needs an ultrafiltration and microfiltration system that allows for minimum working volume of 25 ml. All three systems will support the ASO lab work for ASO treatment assay development and toxicity studies generally required in humans. This equipment will allow the manufacturing of antisense oligonucleotides targeting COVID-19 and other viruses as a means of treatment.

Generic Name of Product:

DNA/RNA purification system, DNA/RNA filtration system, DNA/RNA synthesizer

Purchase Description:

This is anticipated to be a COVID-19 related contract action for the following three (3) Cytiva brand-name or equal systems:

1. AKTA pure 150 M or brand-equal system including:

- Instrument Control Package 110V, part no. 29251144

- AKTA pure 150 M, part no. 29046694

- UNICORN 7 WrkStn pure-BP-exp, part no. 29128116 -Sample pump S9H, part no. 29050593

- Column Valve (V9H-Cs, 1-column), part no. 29090693 -Air sensor L9-a.5mm, part no. 28956500 -Outlet Valve Kit (V9H-Os, 1-outlet), part no. 29090694 -Fraction collector F9-C, part no. 29027743 -Bottleholder, part no. 28956327 -Adapter for air sensor, part no. 28956342 -Fineline Pilot 35, part no. 18110202 -Source 15Q, 50ml, part no. 17094701 -Source 15Q, 500ml, part no. 17094702

ATTACHMENT 1

-Resource Q, 1 ml, part no. 17117701 -Source 15Q, Tricorn 10/200 GL, part no. 28921032

-INSIDE DELIVERY

-SHIPPING AND HANDLING

2. AKTA Oligopilot 100 or brand-equal system including:

- AKTA OLIGOPILOT 100, part no. 18113679 -CU-950 MEMORY KIT, part no. 11000322 -SYNTHESIS SUPPORT AND TRAINING, part no. 28998481 -Instrument Control Package 110V, part no. 29251144 -COLUMN REACTOR COMPLETE 6.3 ML, part no. 18110113 -COLUMN REACTOR COMPLETE 12 ML, part no. 18110116 -COLUMN REACTOR COMPLETE 24 ML, part no. 18110119 -COLUMN REACTOR COMPLETE 48 ML, part no. 18110122 -COLUMN HOLDER AKTA OLIGOPILOT, part no. 18113845 -FineLINE 35 oligo Column, part no. 28946841 -Adjustable oligo column, part no. 18110760 -Binder IQOQ OligoPilot 10/100, part no. 29425861 -Commissioning and Qualification Performance 3 days, part no. 28992656 -Commissioning and Qualification Performance 1 day, part no. 28992654 -BOTTLE CAP 4 X 5/16, part no. 18113701 -UNION 1/16in FEMALE/M6 MALE, part no. 18111257 -M6 CONNECTOR (P960, XPRESS), part no. 18117264 -SHORT COLUMN HOLDER, part no. 18111317 -LONG COLUMN HOLDER, part no. 18112632 -FERRULES FOR 1/16in O.D.TUBING, part no. 18112706 -CONNECTOR FOR 1/16in OD TUBING, part no. 18112707 -FERRULE FOR 1/8in TUBING, part no. 18112118 -TUBING CONNECTOR 1/8in, part no. 18112117 -FERRULE FOR 3/16 0.D. TUBING, part no. 18111248 -TUBING CONNECTOR 3/16in, part no. 18111249 -PEEK TUBING ID 1,0MM (1/16), part no. 18111583 -ETFE TUBING, ID1.0MM OD1/16in, part no. 18114238 -FEP TUBING, 3M/ID1/16/OD1/8, part no. 18112116 -FEP TUBING, ID1/8IN, part no. 18114236 -DISTRIBUTION UNIT 60 MM TI 1 FILTER 20um, part no. 29042220

-INSIDE DELIVERY

-SHIPPING AND HANDLING

3. AKTAcrossflow or brand-equal system (new or repurposed) including:

-ATKAcrossflow RePurposed, part no. 29409303 -RESERVOIR 1200 CPL AKTA CROSSF, part no. 11003116 -Commissioning and Qualification Performance 0.5 day, part no. 28992659 -Commissioning and Qualification Performance 4 days, part no. 28992657 -Binder IQ/OQ AKTA CROSSFLOW, part no. 44810077 -HP LAPTOP COMPUTER, part no. 18116852 -UNICORN 7 WrkStn pure-BP-exp, part no. 29128116 -UNICORN 7 Evaluation Classic, part no. 29115456 -KVICK LAB PACKET HOLDER, part no. KLPH001SS

-KVICKLAB HOLDER TORQUE WRENCH, part no. 56411284 -KVICK UNF ACCESSORY KIT, part no. KSP001AKT

-INSIDE DELIVERY

-SHIPPING AND HANDLING

Salient Characteristics:

AKTA Pure or brand-equal large scale system salient characteristics -Titanium pump heads to stop the buildup of Hydrophobic products within the pump head.Denatured or misfolded Proteins can be hydrophobic.

-UV modules -xenon flash lamp for the multi wavelength detectors and fiber optics.

-ability to pair with Analog and digital signals needed for Wyatt and many other detectors.

-onsite and remote support capabilities -Modular system design with a large range of options to allow flexibility in purification of proteins and peptides -Software that allows for intuitive and flexible method creation, system control, and evaluation

- Practical size, for easy placement on laboratory bench or in cold cabinet

- verify gradients with a conductivity monitor

- round fraction collector

- column valve V9-Cs with built in bypass and reverse flow functionality -UV monitor U9-L for detection at 280 nm and for triple wavelength detection

- high performance system pumps

- sample pump for automated sample loading of multiple samples

- flexible fraction collector for collection in deep-well plates and tubes -automation capabilities and resin screening for up to 10 columns.

-pH valve for in-line pH monitoring, calibration, and storage

- inlet automation valves to enable condition screening and air sensors to protect columns

AKTA Oligopilot 100 or brand-equal system salient characteristics:

• HPLC pumps to deliver synthesis reagents to the synthesis reactor, which allows for a range of scale 100 μmol – 8 mmol.

• UV-900 Monitor (variable wave length) to monitor Detritylation peaks and reagents during the synthesis.

• Conductivity Monitor to monitor reagents during the synthesis.

• UNICORN Control Software specifically developed to – control the system – enable programming & execution of methods,- collect data & allow post synthesis evaluation of data.

AKTAcrossflow (new or repurposed) or brand-equal system salient characteristics:

• Broad range of applications that cover ultrafiltration and microfiltration

• Flexible operation of either hollow fiber cartridges or cross flow cassettes

• Thorough and efficient process development with full TMP and flux scouting

• Single familiar UNICORN interface for both chromatography and membrane separations

• No disruption to proteins or cells with low shear force pumps that require no cooling

• Minimum working volume of 25 ml to ensure operation of complete processes using filters between 40 cm2 and 1200 cm2

Quantity:

One (1) Cytiva AKTA Pure or brand-equal large scale system and accessories, One (1) Cytiva AKTA OLIGOPILOT 100 or brand-equal system and accessories, and One (1) Cytiva AKTAcrossflow (new or repurposed) or brand-equal system and accessories.

Delivery Date:

Delivery within 60 days after receipt of order (ARO)

Period of Performance:

Instruments will be under 12-month original factory warranty beginning at the time of delivery/ installation at NCATS.

Option(s):

N/A.