Partnering with ReflectionBio® in cutting-edge, translational gene therapy R&DReflectionBio® has been partnering with leading biomedical researchers, CROs and CMOs to translate the latest scientific breakthroughs to real-life treatments to benefit patients.
As a patient-driven gene therapy company, we at ReflectionBio® always welcome partners who share our key values – passion in science and compassion for patients.
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Reflection Biotechnologies (ReflectionBio®) is a patient-driven biotech company focused on developing gene and cell therapy for rare diseases. Our gene therapy program for treating Bietti’s Crystalline Dystrophy (BCD), has been granted Orphan Drug Designation by the U.S. FDA. As we prepare to advance the BCD gene therapy program into human clinical trial, we welcome interested parties in the following areas to submit quotations to us. Please submit your quotation by June 29, 2020 (Monday) via email to firstname.lastname@example.org Please also include your credentials and availability for new projects in the submission. We will consider pricing, availability, relevant experience, and overall suitability in our review.
AAV production services.
We are looking for a contract manufacturing organization (CMO) with a strong track record in AAV GMP manufacturing to manufacture AAV vector for use in IND-enabling toxicology study. The related services and quotation should include process development and yield assessment, helper plasmids for use in clinical grade production, production of plasmids at a grade suitable for producing AAV for use in Tox study, and AAV production for use in IND-enabling Tox study.
Assay development and validation services.
We are looking for a contract research organization (CRO) to develop assays for use in gene therapy IND-enabling toxicology study. The CRO should have a strong track record in developing similar assays for gene therapy programs.
- qPCR for AAV vector: Assay Development/Validation
- qPCR for transgene expression: Assay Development/Validation
- ELISA Method Development and Qualification CYP4V2
- ELISA Method Development and Qualification Anti-AAV
- ELISA Method Development and Qualification Anti-CYP4V2
- Quotation should include pass through cost such as non-human primate matrix.
Gene therapy toxicology consultant
Scope of services:
- Outline gaps in IND-enabling toxicology study design and ways to address them
- Outline questions and rationale for questions in FDA meeting package
- Experienced in retinal gene therapy toxicology study projects.
Gene therapy CMC consultant
Scope of service:
- CMC early-stage regulatory strategy
- Gap analysis
- Draft and review FDA meeting package (CMC only)
- Prepare and attend meeting with the FDA
- Experienced in advising on FDA CMC requirements for gene therapy programs. Past FDA work experience is a plus.