SOLICITATION NOTICE
Q -- Synthesis of DITPA
- Notice Date
- 10/21/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Attn: Department of Veterans Affairs New Mexico Health Care System, (501/90C), 1501 San Pedro Drive SE, Albuquerque, New Mexico 87108
- ZIP Code
- 87108
- Solicitation Number
- 501-07-03
- Archive Date
- 1/3/2003
- Point of Contact
- Point of Contact - Pamela Bayburt, Contract Specialist, (520) 629-4617, Contracting Officer - Pam Hayes, Chief, Acquisition, (505) 256-2711
- E-Mail Address
-
Email your questions to Pam Hayes
(pam.hayes@med.va.gov)
- Description
- The Department of Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico has a requirement for the contracted synthesis of 3, 5-Diiodothyropropionic acid (DITPA) for use in a controlled clinical trial. Synthesis and testing must be performed in accordance with current good manufacturing process (cGMP) as defined in the US 21 CFR part 211, as it applies to this project. The synthesis outline will be provided by the VA. The synthesis company will be responsible for purchasing and testing of appropriate raw materials. Synthesis will require process development and process validation with certificate of analysis for quality control (QC)/quality assurance (QA) release. The contractor will be required to provide (1) synthesis of an initial 200-gram quantity of the drug (which may or may not be GMP) by March 30, 2003; (2) Scale-up of the process in compliance with cGMP to provide a total of 10 kilograms of active material, with 6 kilograms to be delivered by June 15, 2003 and the remaining 4 kilograms to be delivered as soon as possible; (3) submission of a Drug Master File to the FDA; (4) a written Chemistry and Manufacturing Controls (CMC) section for an IND/NDA submission per CFR 21 Section 312.23(7); (5) Analytical method development and validation, including analytical work to define the chromatographic conditions, documentation of the validation and transfer of the method to the VA; (6) Preparation of a reference standard suitable for use in analytical testing procedures; (7) Synthesis and characterization of relevant impurities in the 3, 5-Diiodothyropropionic acid powder, including development of a stability indicating assay. Validation of the assay and transfer of the assay method shall be provided to the VA for future testing. The contract synthesis contractor must have demonstrated expertise and fast responsive service in contract process development and manufacture of active pharmaceutical ingredients. Previous experience in the synthesis of 3, 5-Diiodothyropropionic acid is desired. Expertise in project management, analytical testing services and regulatory support service is required. Full details of the plant cleaning, processing and decontamination must be documented as part of the batch record. The VA requires a summary of the development and manufacturing work, including a detailed description of the scope and extent of work, and copies of all batch records and certificates of analysis. Product specifications are to be determined through discussion with the VA sponsor after completion of the initial batch and development work. Project management responsibilities should include frequent communication, an outline of objectives and milestones, and clarification and sharing of additional data. NAICS code is 4222. The solicitation will be released on or about November 5, 2002 and will close 30 days thereafter. The solicitation will be available electronically at: http://www.bos.oamm.va.gov/cgi-bin/WebObjects/BosPublic.woa Electronic offers will not be accepted. All responsible sources may submit an offer which will be considered. All questions must be provided in writing. POC for this requirement is Pamela Bayburt at phone 520-629-4617, fax 520-629-1817, and e-mail at pamela.bayburt@med.va.gov. Contracting Officer is Pam Hayes at e-mail pam.hayes@med.va.gov or fax at 505-256-2894.
- Web Link
-
RFP 501-07-03
(http://www.bos.oamm.va.gov/solicitation?number=501-07-03)
- Record
- SN00191103-W 20021023/021021213234 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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