STATEMENT_OF_WORK_AiO_FDOPA__Syn__SETS(V2).pdf

Building 10, ACRF Rm 1C-498

10 Center Drive

Bethesda, MD 20892 Phone: 301-435-8499

E-mail: mchanning@mail.cc.nih.gov

STATEMENT OF WORK

Procurement of TRASIS All-in-One (AiO) FDOPA Synthesis Sets

PET Department Clinical Center

National Institutes of Health Bethesda, MD 20892

A. Background

The PET Drug 6-[18F]FluoroDOPA (FDP; IND # 35513) is routinely prepared by the PET Department for use in human imaging protocols 3 to 4 times a week. The TRASIS AiO Radiosynthesis Module uses TRASIS sterile disposable cassettes and Reagent kit-AiO-FDOPA specifically designed and developed for the preparation of no-carrier-added [18F]FDP via a nucleophilic method using the TRASIS AiO automated synthesizer.

B. Purpose

The purpose of this acquisition is to procure the necessary supplies for the TRASIS AiO Radiosynthesis Module for the production and manufacture of the PET Drug [18F]FDP (IND # 35513). Establishing a steady supply of materials and reagents required for the manufacture of these PET Drugs is vital to the PET Department mission. These supplies will be used to qualify the synthesis for amending the IND and once qualified serve as a stable supply stream.

C. Statement of Work

The cassette (PN: S4000-7557) and Reagent Kit (PN: S4000-7585) contain all the necessary supplies for the preparation of 6-[18F]FDP via a nucleophilic method using the AiO automated synthesizer. Each Cassette and Reagent Kit comes labeled and coded (Color and Letter) in accordance with TRASIS AiO synthesis program setup instructions. All components are manufactured according to GMP requirements and tested for bioburden. All components are released according to TRASIS specifications and TRASIS manufacturing documents. Each shipment includes a Certificate of Conformity (CoC) and batch specific information.

mailto:mchanning@mail.cc.nih.gov

D. Justification for additional Options to Procure 3 More Synthesis Sets of 10 each

The PET Department will be qualifying this new method to the NIH. In order to maintain current production of [18F]FDOPA synthesis the PET Department may require up to and no more than 160 FDOPA Synthesis Sets per year. The FDOPA Synthesis Sets will be procured approximately 8 times a year so as to maintain a fresh supply of material. The contract will have the option of 4 additional years and a total of 5 years including the base year.

2018 2019 2020 2021 2022

SUPPLIES

Price per

Set Items per

Year Base

Year

Year

Year

Year

TOTAL

FDOPA Synthesis Set - 160 - - - - - -

Shipping Cost - 8 - - - - - -

E. Place of Performance

The supplies shall be delivered on-site to PET Department, Building 10, Room 1C-498 at the National Institutes of Health Clinical Center in Bethesda, MD.

F. Government Furnished Property and Material

NA

G. Packaging, Packing, and Shipping Instructions

All deliverable materials will be delivered to:

National Institutes of Health Clinical Center 10 Center Drive

BLDG 10, ROOM 1C-498

Bethesda MD 20892

H. Acceptance Criteria

Reagents and Materials delivered with proper paperwork (see example Appendix 3 and 4)

I. Instructions to Offerors

Mandatory Requirements

1. The materials and supplies must be compatible with the TRASIS All-in-One automated synthesizer. The FDOPA Cassette and FDOPA Reagent Kit be specifically for the preparation of [18F]FDOPA via a nucleophilic method.

2. The cassettes shall be manufactured according to ISO13485 standards and tested for bioburden and endotoxins.

3. Reagent Kits shall be manufactured according to cGMP requirements and tested for bioburden.

4. All components are released according to TRASIS specifications and TRASIS manufacturing documents.

5. Each shipment shall include a Certificate of Conformity that contains batch specific information.

6. FDOPA (HF) Sets need to be delivered to the NIH within 2 weeks of receipt of order.

7. Expiry Date of all set materials must be at least 6 months from receipt of sets.

Appendix 1

List of TRASIS Supplies and Materials

Supplies and Reagents – AiO – FDOPA (Nucleophilic) Introduction

[18F]FDOPA is an IND PET diagnostic radiotracer used for imaging studies here at the NIH Clinical Center.

The Cassette and Reagent kit are components needed for its preparation. The synthetic method involving the Cassette and Reagents realizes high radiochemical yield, remains effective at high levels of radioactivity and provides stable, injectable and high specific activity [18F]FDOPA.

Application

The FDOPA nucleophilic process allows the production of [18F]FDOPA on the “AllinOne” automated synthesizer using a “Cassette” a “Reagent kit”

Features

FDOPA cassette.

The cassettes are assembled and packaged in clean room. The cassettes are provided ready to use. No laboratory bench work is required prior to the connection of the cassette with the AllinOne synthesizer.

FDOPA reagent kit.

The reagents are prepared and packaged under GMP conditions into ready-for-use containers. No laboratory bench work is required prior to the connection of these containers with the AllinOne synthesizer and its dedicated [18F]FDOPA cassette.

Description

The cassette includes

1 top row of 18 three way valves and 1 bottom row of 12 three way valves

1 small glass reactor and 1 large glass reactor

9 spikes with colored rings for the safe connection of the reagent vials

1 water bag spike

2 syringes (3 mL and 20 mL)

1 reservoir for up to 20 mL of incoming activity

1 SepPak QMA carbonate cartridge

1 SepPak tC18 cartridge

2 SepPak K2CO3 cartridges

HPLC system connections (load and collect)

1 line for the transfer of the final product – male luer lock end

3 Air/Nitrogen filters

The reagent kit includes

Pack 1 Storage in Fridge [2 to 8°C]

A – QMA eluent 4 mL clear glass vial, 13 mm stopper with silver crimp cap

B – Precursor 4 mL amber glass vial, 13 mm stopper with silver crimp cap

C – KOH 1 mL syringe, syringe cap

D – Alkylation 4 mL amber glass vial, 13 mm stopper with silver crimp cap

E – Dichloromethane 20 mL clear glass vial, 20 mm liner with blue crimp cap

G – Ethanol 13 mL clear glass vial, 20 mm stopper with gold crimp cap

H - HI

13 mL clear glass vial, 20 mm stopper with red crimp cap. Vial protected with additional package

K – Citrate buffer 30 mL amber glass vial, 20 mm stopper with green crimp cap

HPLC eluent Acetate buffer

5 mL syringe, syringe cap

HPLC eluent Excipients

5 mL syringe, syringe cap

HPLC eluent dissolution spike

Sterile water bag spike

Pack 2 Storage at Room Temperature

F – NaBH4 13 mL clear glass vial, 20 mm stopper with silver crimp cap

J – Ascorbic acid 13 mL amber glass vial, 20 mm stopper with silver crimp cap

The capital letters A, B, C etc. on the vials refer to the position of the reagents on the FDOPA cassette and help the operator at time of use.

Specifications

Each cassette, with a unique ID, is wrapped in a sealed and labeled bag. The 10 cassettes are packaged in a carton containing an anti-moisture plastic bag with a label.

Size of box (10 cassettes) 66 x 49 x 28 cm Weigh of box (10 cassettes) 5 kg

Reagent Kits

Pack 1 20 × 15 × 6 cm Pack 2 8 × 8 × 4 cm Size of box (10 packs 1) 38 × 38 × 40 cm Size of box (10 packs 2) 20 × 20 × 30 cm Weigh of box (10 packs 1) 3.5 kg Weigh of box (10 packs 2) 1.5 kg

Storage and Stability

Cassette Storage: Temperature from 2 to 30°C, protected from direct exposure to sunlight, in clean and dry environment. Stability: 18 months from date of manufacturing.

Reagent Kit Storage:

Pack 1: 5 ± 3°C, protected from light.

Pack 2: Room temperature, protected from light.

Short exposure preferably not exceeding 7 days at a temperature not exceeding 30°C doesn’t impact the outcome of the process.

Quality

The cassettes are manufactured according to ISO13485 standards and tested for bioburden and endotoxins. Similarly the Reagent Kits are manufactured according to cGMP requirements and tested for bioburden. All components are released according to Trasis specifications and Trasis manufacturing documents. Each shipment includes a Certificate of Conformity, which contains batch specific information.

Appendix 2

TRASIS FDP Cassette

Appendix 3

TRASIS FDP Certificates of Conformity