Gene Therapy Development & Commercialization
BioTechLogic’s team of experts has deep expertise and experience working on the front lines of gene therapy development.
The path to gene therapy commercialization is often uncharted, fraught with product characterization, viral vector development, process development, and manufacturing challenges.
Complete Gene Therapy Product Lifecycle Support Services
BioTechLogic has extensive experience with all aspects of gene therapy development and commercialization from preclinical to market.
Viral Vector Development & Production
Viral vectors, including retrovirus, adenovirus, adeno-associated virus (AAV), and herpes simplex virus, have evolved to become highly efficient nucleic acid delivery vehicles. However, there are often challenges at every stage of a viral vector’s life cycle.
How BioTechLogic Can Help
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- Production system selection
- Product characterization
- Analytical method development
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- Purification processes
- Reproducibility
- Critical Quality Attributes understanding
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- Process development and scale-up
- Regulatory filing support
- Vector CMO partner selection and management
Gene Therapy CMC Services
CMC Strategy
Quality Assurance
Analytical Services
Regulatory Consulting & Submissions Support
Process Development & Validation
Contract Services & Tech Transfer Support
Supply Chain Management
Inspection Readiness
Project Management
Years
Consultants
Clients
projects
E B O O K
Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle
Process Development & Contract Services Decision Making
This guide gives gene therapy innovators a high-level perspective on the process development and contract services selection decisions to be made throughout the phases of development.
Gene Therapy Resources
Top 25 Biotech Companies of 2024
Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow the rates of cognitive and functional decline in adults with Alzheimer’s disease, to the first CRISPR-based gene editing...
Strengthening Your Gene Therapy Process Control Strategy
WEBINAR ON-DEMAND Strengthening Your Gene Therapy Process Control StrategyGiven the incredible diversity of gene therapy product characteristics, there is no “one solution fits all” process control toolbox to assure consistent, quality product. Manufacturers of some...
Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle
eBook Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle This guide gives gene therapy innovators a high-level perspective on the process development and contract services selection decisions to be made throughout the phases of...
AAV Viral Vector Production at Scale—Improving the Current State
The gene therapy sector is continuing to come into its own, and many developers are shifting their attention from nearly exclusively treating rare diseases to developing therapeutics for prevalent indications. An interesting dynamic of the gene therapy market is that...
A Guide to Integrating QbD in Gene Therapy CMC Programs
Cell and gene therapies have a potential, unlike anything we've ever seen before in medicine. With the power to deliver curative relief to patients suffering from debilitating conditions — many of which have no treatment options — the cell and gene therapy field is...
The High Bar for Gene Therapy CMC
WHITE PAPER The High Bar for Gene Therapy CMCHow drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After well publicized stumbling blocks in the late-90s, vigor was restored to the gene therapy field in...
