National Institute of Immunology, New Delhi

Transcription

1 National Institute of Immunology, New Delhi QUOTATION INVITATION NOTICE For Website Ref: NII/AKS/GPL/2013 Date: 25/12/2013 Quotations are invited from technical firms specializing in either both or one of the following: (A) Expression, Purification and Production of Endotoxin Free Recombinant SPAG9 protein using bacterial system in GMP Facility (B) conducting GLP compliant preclinical regulatory toxicological studies so as to reach the undersigned within three weeks of the advertisement appearing in the news paper. The proposal is to be submitted in two parts, viz., technical and financial bids in separate sealed envelopes with respective marking. For further details, refer Dr. Anil K. Suri Cancer Microarray, Gene and protein Laboratory, National Institute of Immunology (NII), Aruna Asaf Ali Marg New delhi General Information a. The gene construct of SPAG9 (Sperm Associated Antigen 9) of human origin without tag in Bacterial expression vector pet-28 b (+) is with Dr. Anil K Suri and will be provided after signing Material Transfer Agreement with NII. b. Minimum of 300 mg of purified protein [(Endotoxin free, 98% purity, 100 mg of two Non-GMP (Total of 200 mg) and one GMP batch (100mg)] is required for validation and clinical efficacy studies. Non GMP batch protein will be used for regulatory toxicological studies and GMP batch will be used for Dendritic cell based Human clinical cervical cancer trials. 2. Scope of Work A. Expression, Purification and Production 2.1 Expression of the target gene in the bacterial (E.coli) expression system. Manufacture master cell bank (MCB) and Characterise MCB as per ICH and FDA guidelines 2.2 Optimization of SPAG9 expression conditions and development of the purification process. 2.3 Analysis and characterization of the purified protein

2 2.4 Perform characterization, in-process and release testing 2.5 Seeking appropriate regulatory approvals for initiating transfer of plasmid and production of SPAG9 (drug) 2.6 Production of 100 milligrams of purified protein per batch (recombinant SPAG9) 2.7 Batch production data from two Non-GMP and Batch Manufacturing data of one GMP batch (100 mg pure protein per batch) 2.8 Prepare SOPs for in-process and release methods 2.9 Perform real-time and accelerated stability studies of bulk drug according to ICH guidelines Demonstration of process consistency and cgmp production 2.11 Formulate, fill and lyophilize 2.12 QA release of cgmp batch 2.13 Perform real-time and accelerated stability testing on final drug as per ICH guidelines 2.14 Storage of materials including cell banks, drug substance, final drug product and documentation for up to five years. Dossier submission and presentation of data to RCGM and any additional regulatory authorities if required B Preclinical regulatory studies of the recombinant SPAG9 protein Protocol and dossier submission to regulatory authorities for the following studies: 2.15 Single-dose Toxicity Studies: These studies should be carried out in 2 rodent species (mice and rats) using the same route as intended for humans. Animals should be observed for 14 days after the drug administration 2.16 Repeated-dose Systemic Toxicity Studies: (14-28 Day repeated-dose toxicity studies): These studies (should be carried out in at least two mammalian species, of which one should be a non-rodent. 3. Instructions to the Organizations/ Applicants The applicants are requested to keep the following points in mind while submitting proposals as a response to this tender. 3.1 General All the information must be submitted in English References, information and certificates from the applicants certifying suitability, technical know-how or capability of the applicant shall be signed by the respective applicant The applicant is advised to attach any additional information that he/she thinks would be necessary in regard to his/her capabilities. No further information will be entertained after submission of applications unless the same is called for by the Institute. National Institute of Immunology reserves the right to call for additional information and clarification of information submitted from the applicants.

3 3.1.4 The right to refuse any or all applications without assigning any reasons is reserved with National Institute of Immunology The company who eventually will take the construct from National Institute of immunology for protein production will sign a Material Transfer Agreement with National Institute of immunology to use this construct exclusively for this purpose only. Neither the part of the protein nor the gene encoding should be handed over to any other party. NII retains all ownership of the construct, protein and production data. 3.2 Eligibility and Minimum Qualification Criteria For the purpose of this particular work, applicant should meet the following qualifying criteria as a minimum: The applicant must have a well equipped laboratory for the efficient conduct of the project The applicant must have a technical staff having experience in expression, fermentation, purification and protein characterization, capable of proper execution of the project The applicant must have prior experience in successfully conducting similar type of work The Manufacturer applicant organization must be cgmp compliant for GMP material production. The applicant organization for conducting preclinical regulatory toxicology studies must be GLP compliant and audited by the National GLP Compliance Monitoring Authority 3.3. Even though applicants satisfy the above requirements, they are subject to be disqualified if they have: Made untrue or false representation in the bid, statements and attachments Records of poor performance such as abandoning work or delayed completion. 3.4 For pre-qualification, the applicant should score not less than 75% of the marks in the technical bid in aggregate as per the system of evaluation enumerated hereafter in Section Scheduled Time Six months from the date of sanction. 5. Submission of Bids Sealed quotations are invited from the applicants for the above mentioned project containing technical bid and financial bid in two separate envelopes with respective marking in bold letter.

4 5.1 Technical Bid The Technical Bid shall comprise the following: a) Name, address and contact details of the organization b) Name and address of the officer to whom all references shall be made regarding this tender c) Technical specifications of the organization including details of equipments/facilities available, scientific strength, expert personnel specialized in fermentation, protein expression, purification and characterization with their experiences and CVs of the professionals who would be engaged in this project. d) Accreditation status of the organization/facilities for biosafety assessment number and description of the similar type of work successfully undertaken in the past. f) The proposal should demonstrate the bidder s knowledge of the project requirement and bidder s understanding of the requisite tasks as set forth in the Scope of Work. g) Approach and methodology of the project including, the bacterial expression system to be used, fermentation process and conditions, protein purification process, analysis of the endotoxin free purified protein. h) Milestones and timelines for the project. i) Comments, if any, regarding the scope of work, designed to improve the performance in carrying out the assignment. 5.2 Financial Bid The Financial bid must contain objective wise quotations, terms and conditions, mode of payment and delivery schedule. Financial bid may also include service tax charges, as per Government rules. The rate shall be quoted in Indian Rupees in figures and words. In case of discrepancy between the rate quoted in figures and words, the rate quoted in words will be taken as final and shall be binding on the agency. 6. Evaluation Process A two step selection process would be followed. In step 1, the technical proposals will be evaluated. In step 2, the financial proposals of the applicants, whose technical bids qualify as per the evaluation criterion, would be evaluated. Proposed marking system for prequalification: Total marks = 100 Parameters for evaluating the applicant organization: Parameter for Evaluation Maximum marks A Accreditation status and GMP compliance for recombinant protein production 25 B Scientific strength and understanding of the 25 project C Track record of carrying out similar type of work 25 D Scientific approach and methodology 25

5 7. Clarification of Bidding Documents The bidder requiring any clarification of the bidding documents may notify the National Institute of Immunology in writing by letter or . The following personnel may be contacted for the purpose. Name and Designation of the officer Contact Details Dr. Anil K. Suri Cancer Microarray, Genes and Proteins Laboratory National Institute of Immunology Aruna Asaf Ali Marg New Delhi Tel: National Institute of Immunology will respond in writing to any request for clarification of the bidding documents, which it receives no later than 15:00 hours on Award of Contract Notification on Award of Contract will be made in writing to the successful bidder by the Institute. 9. Payment Terms A. Expression, Purification and Production of Endotoxin Free Recombinant SPAG9 protein using bacterial system in GMP Facility 1. First instalment: 25 % of the fees on signing of the agreement 2. Second instalment: 25% After completion of two Non GMP batches 3. Third Instalment: 25% After production of GMP batch 4. Fourth Instalment: 25% After presentation of data to RCGM and securing approval for preclinical regulatory toxicological studies B. Conducting GLP compliant preclinical regulatory toxicological studies 1. First instalment: 25 % of the fees on signing of the agreement 2. Second instalment: 25 % of the fees on completion of repeat dose toxicology study 3. Third Payment: 25% After submission of daft report for both toxicology studies 4. Fourth Instalment: 25% After presentation of data to RCGM 10. Validity Periods The bids shall remain valid for 60 days after the date of bid opening prescribed by National Institute of immunology. On completion of the validity period, unless the

6 bidder withdraws his proposal in writing, it will be deemed to be valid until such time that the bidder formally (in writing) withdraws his proposal. 11. Corrections in the Bid Corrections, if any, in the bid documents submitted by the agency should be attested properly by the authorized signatory failing which the bid is liable to be rejected. Bidders are advised to exercise adequate care in quoting the prices. No excuse for corrections in the quoted rate will be entertained after the financial bids are opened. 12. Deadline for Submission for bids 12.1 Last Date for Submission Both the technical and financial bids shall be submitted in two separate envelopes with respective markings in bold letters to Dr. Anil K. Suri, Cancer Microarray, Genes and Protein laboratory, National Institute of immunology, Aruna Asaf Ali Marg, New Delhi The sealed envelopes shall be superscripted as Proposal for (A) Expression, Purification and Production of Endotoxin Free Recombinant SPAG9 protein using bacterial system in GMP Facility (B) conducting GLP compliant preclinical regulatory toxicological studies and shall be dropped in the Tender Box kept at the Reception of National Institute Immunology up to 15:00 hours on Extension of Last Date for Submission The National Institute Immunology may, at it own discretion, extend the deadline for submission of bids and notify the same through the National Institute Immunology website, in which case all rights and obligations of National Institute Immunology and bidders subject to the previous deadline will thereafter be subject to the deadline as extended Acknowledgement of the understanding of terms By submitting a bid, each agency shall be deemed to have acknowledged that it has carefully read all the information and has fully informed itself as to all existing conditions and limitations.