SOURCES SOUGHT
R -- Manufacture of Drug Products and Matching Placebos in Capsule Form
- Notice Date
- 6/23/2016
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-16-450
- Archive Date
- 7/21/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information/Sources Sought Notice HHS-NIH-NIDA-SSSA-SBSS-16-450 Manufacture of Drug Products and Matching Placebos in Capsule Form Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, MD 20892, UNITED STATES. Introduction: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified large and small business sources, (2) whether they are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background: The NIH Clinical Center Pharmacy Development Section recently closed and alternative sourcing is now required to manufacture drug products and matching placebos needed for two clinical protocols at the National Institute of Mental Health (NIMH). These studies are being performed on a double blind basis. The first NIMH protocol is entitled "An endocrine model for postpartum mood disorders" and the second is entitled "The effects of an ER beta agonist (Lilly Compound LY500307) on estradiol-withdrawal-induced mood symptoms in women with premenopausal depression." Purpose and Objectives for the Procurement: The purpose of this acquisition is to provide the National Institute of Mental Health with Progesterone, Estradiol, and LY500307 capsules as well as matched placebo capsules. This requirement constitutes a request for complete drug product manufacturing and control services. This is a NON -research-and-development requirement. Project Requirements: The National Institute of Mental Health requires the following: 1.The contractor shall manufacture and provide twelve-thousand 200mg capsules of Progesterone with twelve-thousand matching placebos and twenty-thousand 2mg capsules of Estradiol with twenty-thousand matching placebos. a.The Contractor must provide reports on the following for this manufacturing process: i.Assay and Impurities/Related Substances Method Qualification of HPLC ready filter compatibility, system suitability, linearity (detection and quantification limits), accuracy and range (bracketing the intended strength), specificity from the diluent, mobile phase and placebo, as well as standard and sample solution stability over 7 days, detection limits and quantification limits. ii.Dissolution Method Quantification consisting of filter compatibility, system suitability, linearity, recovery, and standard/sample solution stability. iii.Confirmation of the identity of the active compound through Fourier Transform Infrared Spectroscopy identification. iv.Microbial Enumeration and Tests for Specific Organisms Suitability v.Finished Product Release Testing on Appearance, Identification, Assay and Degradants, Absence of Active, Moisture, Content Uniformity, Dissolution (4 point profile), Capsule Closure, Microbial Enumeration (USP <61>), and Testing for Specified Microorganisms (USP <62>). vi.Stability Assessment to ensure stability in the following storage conditions: Storage condition must include the following combination: 25°C/60% RH, 30°C/60% RH, and 40°C/75% RH. Storage duration will include the following number of months: 3, 6, 9, 12, 18, 24, 36, 48, and 60. vii.Verification of environment sterility via swab sample testing at regular intervals throughout the manufacturing process. 2.The contractor shall manufacture and provide five-thousand 25mg capsules of LY500307 and five-thousand matched placebo capsules. a.The Contractor must provide reports on the following for this manufacturing process: i.Assay and Impurities/Related Substances Method Qualification of HPLC ready filter compatibility, system suitability, linearity (detection and quantification limits), accuracy and range (bracketing the intended strength), specificity from the diluent, mobile phase and placebo, as well as standard and sample solution stability over 7 days, detection limits and quantification limits. ii.Dissolution Method Quantification consisting of filter compatibility, system suitability, linearity, recovery, and standard/sample solution stability. iii.Cleaning Assay Method Quantification. Swab interference, detergent interference, swab recovery, and recovery of API (Active Pharmaceutical Ingredient) for coupons representing the materials of construction used in the manufacturing of the drug product will be performed. iv.Microbial Enumeration and Tests for Specific Organisms Suitability v.Content uniformity analysis on blend samples vi.Finished Product Release Testing on Appearance, Identification, Assay and Degradants, Absence of Active, Moisture, Content Uniformity, Dissolution (4 point profile), Capsule Closure, Microbial Enumeration (USP <61>), and Testing for Specified Microorganisms (USP <62>). vii.Stability Assessment to ensure stability in the following storage conditions: Storage condition must include the following combination: 25°C/60% RH, 30°C/60% RH, and 40°C/75% RH. Storage duration will include the following number of months: 3, 6, 9, 12, 18, 24, 36, 48, and 60. viii.Verification of environment sterility via swab sample testing at regular intervals throughout the manufacturing process. 3.Capsule manufacturing will include preparation of complete formulation development, manufacturing records according to customer specifications, milling of tablets for the actives (for Estradiol), blending tablet powder with other excipients (Estradiol), blending API with other excipients (for LY500307 and Progesterone) as per manufacturing records, filling of the powder into capsules, capsule weight monitoring, cleaning the room and inspection of capsules. The contractor shall be responsible for procuring estradiol tablets and progesterone for the capsule manufacturing process. 4.All capsules shall be bulk packaged in High-Density Polyethylene (HDPE) containers. 5.All drug and placebo capsule manufacturing must be performed in a facility licensed by the US Food and Drug Administration as a Good Manufacturing Product (GMP) facility. 6.The Contractor shall ensure that all workers wear protective respirators and clothing if/as applicable for the type of compound being manufactured. 7.The Contractor will provide all Chemistry Manufacturing and Control information to the NIH Clinical Center Pharmacy Development Section (PDS) for Investigational New Drug (IND) filing. PDS will review the documents and send IND package to NIMH for IND filing with the Food and Drug Administration. Anticipated Contract Type: The Government anticipates award of one (1) fixed price purchase order within the Simplified Acquisition Threshold (< $150,000.00) in reference to this requirement. Anticipated Period of Performance/Delivery Requirements: Delivery of the manufactured drug products and associated documentation shall be made within twelve (12) weeks following contractor receipt of the drug formulas and capsules provided by the Government. Contractor delivery of the manufactured drug products and associated documentation shall be made on a FOB Destination basis and any cost associated with this must be included in any quotation submitted. Capability Statement: Contractors that believe they possess the ability to provide the required services or replacement should submit documentation of their ability to meet the project requirements to the Contract Specialist. The capability statement must include 1) confirmation of contractor certification as a Food and Drug Administration Approved Human Drug Compound Outsourcing Facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, 2 ) the total number of employees, 3) documentation of ability to provide the required support, 4) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 5) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Lauren Phelps, Contract Specialist, at Lauren.Phelps@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a fixed price purchase order.
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