Advanced Cell Therapy Laboratory (ACTL) Cell Therapy Product Proposal
Advanced Cell Therapy Laboratory (ACTL) Cell Therapy Product Proposal
Please complete the sections below to request access to ACTL cGMP systems and facilities.
Date Prepared
Date Prepared
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Client Name
Client Name
First
Last
Organization Name
Client Email Address
Client Phone Number
Client Phone Number
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Additional project-related contacts (include name, title, & email).
1. Service(s) Requested
Select all that apply.
Select all that apply.
Service 1: Consultation
Service 2: Process Development
Service 3: Manufacturing
Service 4: Storage
Service 5: Final Dose & Fill
2. Project Overview
Therapeutic Goal & Clinical Impact: Briefly describe the treatment rationale and expected clinical benefits.
Cell Therapy Product Name & Description: Provide the product name, cell source, culture method, and any modifications (e.g., gene editing). Provide any key reference of pre-clinical or clinical development, methods used, etc.
Regulatory Status
Regulatory Status
IND Filed
Pre-IND Completed
Pre-IND planned
Other (please describe)
Other (please describe)
3. Manufacturing Details
Raw Materials & Key Components: List critical raw materials, their sources, and qualification status.
GMP Process Summary: Include manufacturing scale, process flow, estimated production timeline, and key QC tests/specifications
Facility/Equipment Needs
Facility/Equipment Needs
Class II Biosafety Cabinet (BSC)
CO₂ Incubator
Centrifuge
Controlled-Rate Freezer
-80°C Freezer
LN₂ Freezer
Sterile Tubing Welder/Sealer
Peristaltic Pump
Automated Cell Counter
Label Printer with Barcode Scanner
Other (please describe)
Other (please describe)
Provide a list of specialized equipment that would be need for this project (e.g. Clinicmacs or other cell isolation method, electroporation equipment, etc.)
4. Clinical & Timeline Information
Treatment site(s)
Treatment site(s)
UCSD
Other
Other
Trial start date
Trial start date
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YYYY
Production start
Production start
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MM
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DD
YYYY
Duration
Estimated number of patients
5. Funding Status
Funded
Funding source(s)
Funding source(s)
NIH
CIRM
Philanthoropy
Industry
Other
Other
Please provide the details of the source of funding for your project, including investor names, grant numbers or titles (if applicable), and evidence of funds (if available).
Please attach relevant funding source details (if available)
Attach Files