AP_Attachment_8_Pre-Sol_Notice_N02CM57002_05.pdf

SYNOPSIS

N02-CM-57002-05

MANUFACTURE OF ORAL AND TOPICAL DOSAGE FORMS

Background

The Developmental Therapeutic Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) is involved in discovery and development of new therapeutic agents for treatment of cancer. Molecules for development enter the system under various mechanisms such as NCI Experimental Therapeutics Program (NExT) and Chemical Biology Consortium (CBC).

Current contract provides the NCI with pharmaceutical development and production of oral and topical dosage forms for use in clinical trials.

Project Requirements:

A Statement of Work (SOW) is attached to this notice

The Contractor shall furnish services, qualified personnel, material, and a complete, ongoing, and fully operational facility including all necessary equipment for all aspects of the production and analytical testing of the final product. The active pharmaceutical ingredient (API) will in most cases be supplied by the NCI. The dosage forms will include but not be limited to tablets, enteric-coated tablets, capsules, soft gelatin capsules, liquid filled hard gelatin capsule, oral powders, oral solutions, gel, cream and ointment. The facility and equipment shall conform to current Good Manufacturing Practices (cGMP) set forth by the FDA. Manufacturing activities could be sub-contracted if the Offeror does not have manufacturing capability of the soft gelatin capsules and topical dosage forms.

In addition, the Contractor shall provide adequate analytical instrumentation and pharmaceutical equipment to perform complete quality control evaluation of the formulated drug products.

1. Formulation Studies All new assignments may require pre-production evaluation such as preparation of formulation, adoption of stability-indicating assay or development of such assay, accelerated stability studies, process optimization and compatibility studies with excipients commonly used in the manufacture of oral and topical products. Information on chemical purity, analytical methods and some preliminary solubility data of the API will be provided if available at the time of the new assignments.

2. Production of Oral and Topical Dosage Forms The Contractor shall manufacture batches of drug products intended for the use in clinical trials. Validated Standard Operating Procedures (SOP) for all phases of production and compendial testing should be available to the Offeror at time of application. In case of capsules or tablets, batch sizes will range from several hundred units to as many as 50,000. In case of topical dosage forms, the batch size may be in the range of 50-1,000 units. Each written assignment will specify a dosage form, strength, batch size, and packaging size unless work is needed during the course of preparation of the formulation.

3. Quality Assurance The Contractor shall perform quality control testing of all components used in the formulation as well as the finished products. The testing shall include an identity of the API. Other tests such as purity of the API may be required to assure conformance with the previously obtained independent analytical results. All applicable compendial and other pharmaceutical testing for excipients shall be required.

Quality control evaluation of the finished drug products shall be required to assure conformance to the NCI specifications. In addition to the testing required for oral and topical dosage forms in the current United State Pharmacopoeia (USP), the testing for the specifications may consist of the following as determined by the Contracting Officer’s Representative (COR):

Oral Dosage Forms Topical Dosage Forms

1) Identity 1) Identity

2) Assay and Impurities 2) Assay and Impurities

3) Content Uniformity 3) Content Uniformity

4) Dissolution

The Contractor shall be responsible for Quality Assurance of products manufactured by the Sub-Contractors and shall provide detailed plans for monitoring sub-contract work.

4. Packaging, Labeling, Storage and Shipment of Finished Products All finished products shall be labeled and packaged according to specifications supplied by the COR. Label preparation may be subcontracted, but labeling shall be performed on the contract site. All products shall be sent directly to the NCI’s designated storage facility upon release and to arrive within two (2) days under appropriate storage conditions.

Solicitation Date:

The solicitation is scheduled for electronic release on or about January 30, 2015. The RFP may be accessed through the NCI Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/index.jsp; or through FedBizOpps.gov https://www.fbo.gov/. It is the offeror’s responsibility to monitor the above internet sites for the release of this solicitation and amendments if any. ALL OFFERORS WILL BE

RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND

AMENDMENTS. IN ADDITION, ALL QUESTIONS MUST BE SUBMITTED

ELECTRONICALLY. NO FAX SUBMISSIONS WILL BE ACCEPTED. NO COLLECT

CALLS WILL BE ACCEPTED.

Other Important Considerations:

The contract type is single award, five (5) year, Indefinite Delivery Indefinite Quantity (IDIQ) (FAR 16.5) type contracts. Task Orders will be either cost reimbursement completion, fixed price completion, or a combination of both. Offerors will be invited to submit a sample task order with their proposal. The sample task will be detailed in the solicitation. This acquisition will be full and open due to the responses that were received from a small business sources sought notice that was posted on Oct 20, 2014.

NAICS Code and Size Standard: The North American Industry Classification System (NAICS) code that will be used is 325412 with a size standard of 750 employees.

DISCLAIMER AND IMPORANT NOTES: This notice does not obligate the Government to award a contract. Interested parties are advised that the Government is under no obligation to acknowledge receipt of any information received or provide feedback to interested parties with respect to any information submitted.

Point of Contact: Heidi A Crawley, Contracting Officer crawleyha@mail.nih.gov Riverside Five, Suite 400 8490 Progress Drive Frederick, MD 21701 Phone: 301-624-8764