The Keck Institutional Vector Core (KIVC), Section for Retrovirus Vectors & Other Virus Vectors, offers Custom Services to M. D. Anderson investigators for the preparation and characterization of viral based vectors for research. The purpose of this service is to offer investigators and their laboratory staff access to facilities and staff of the KIVC to accomplish research objectives requiring expertise in virology and facilities and procedures for handling viral vectors and live virus controls under appropriate containment. Consultations are available for the production of GMP grade vector for clinical trials and for the preparation of INDs and NIH RAC submissions for trials involving viral vectors. GMP grade vectors are not produced by the KIVC. All users must comply with SOPs for the containment laboratory maintained by Dr. Giles (T6.3970 areas).

Types of Services

Level I Services

• Complete services provided by the KIVC staff including performance of cell culture and virology procedures.
• Development & characterization of retrovirus producer cell lines.
• Some procedures performed on a collaborative basis.
• Depending on the Project specific work-scope, user participation, laboratory training of users, collaborative development of vectors & assays.

Supplies

Complete supplies, including

• Growth media with serum;
• Cell culture reagents & solutions;
• Pipettes; tips;
• Standard culture flasks & multi-well trays;
• Tubes;
• Hood use;
• Basic facilities supplies;
• Decontamination & disposal.

Cost Rate $46/hour

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Level II Services

• Supervision,
• Partial personnel support and facilities support
• Work performed by users under limited direct supervision of KIVC staff. 25%/hour labor charge.

Supplies

Complete Supplies, including

• Growth Media with serum;
• Cell culture reagents & solutions;
• Pipettes; tips;
• Standard culture flasks & multi-well trays;
• Tubes;
• Hood use;
• Basic facilities supplies;
• Decontamination & disposal.

Cost Rate $26/hour

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Level III Services

• General supervision and facilities support.
• Work performed by users in the facility supervised by KIVC staff. 10%/hour labor charge.

Supplies

• Pipettes,
• Hood & facility use,
• Decontamination & disposal.

Cost Rate $7/hour + $3/day setup fee

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Meetings

• Scheduled meetings for planning & progress review

Supplies

• None

Cost Rate $65/hour

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Consulting Services & Training ($65/hour)

Dr. Giles will provide technical consulting services upon request. Support may be requested in any of the following areas:

• retrovirus vector production & testing;
• QC testing procedures;
• virus titration procedures;
• general virology methods;
• FDA requirements for gene therapy clinical trials;
• NIH RAC requirements for gene therapy clinical trials;
• preparation of FDA INDs for the utilization of virus based gene vectors in clinical trials;
• preparation of NIH RAC Appendix M submissions for the utilization of viral base gene vectors in clinical trials;
• pre-IND interactions with the FDA;
• project planning & management;
• interactions with external contractors for virus vector production and testing.

Gene Therapy Clinical Trial Development & Execution

• FDA requirements for gene therapy clinical trials.
• Preparation of Pre-IND documentation & participation (as desired) in Pre-IND interactions with the FDA (through the ORA) and participation (as desired) in interactions with institutional regulatory committees.
• Participation in preparation of the IND, participation of Section 7, Chemistry, Manufacturing & Controls. Overall organization of the IND in compliance with FDA required formats.
• NIH RAC requirements for gene therapy clinical trials & preparation of NIH RAC Appendix M 5. Project planning & management; interactions with external contractors for virus vector production, testing and final qualification of cGMP vector. Preparation & review of proposals for external contractor provision of MCB production & characterization; MWCB production & characterization; QC tests; bulk & final product tests and qualification of transduced patient's cells as a final product.
• Monitoring progress of outside contractors.
• Vector production & utilization records.

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Training

• Development & use of retrovirus vectors.
• Biosafety levels 2 & 3 procedures.
• Laboratory records for cell culture & virology.
• GLPs.
• GMPs & GCPs for gene vectors & biological products.
• Trouble-shooting problems in mammalian cell culture & virology

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Document Preparation

• USDA & CDC permit applications & submissions.
• IBC registration preparation.
• Others upon request

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Requesting Services

Investigators interested in obtaining Custom Services should contact Dr. Giles (tel: 713-792-2900; fax: 713-792-5948; e-mail: rgiles@notes.mdacc.tmc.edu) and arrange a meeting to discuss the scope of services to be provided. After an initial discussion of the scope of services, the investigator and Dr. Giles will draft a Memorandum outlining the proposed scope of services. An estimated statement of charges for a three-month period will be prepared by Dr. Giles and the KIVC administrative staff and reviewed by the investigator. Upon approval of the work scope and estimated statement of charges by the investigator and Dr. Giles, the Custom Services will be initiated by payment of one month's charges in advance by IDT. Subsequent monthly invoices will reflect the actual charges credited against the initial payment.

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