Cell Therapy Development & Commercialization
BioTechLogic’s team of experts has deep expertise and experience working on the front lines of cell therapy development.
While much progress has been made within the cell therapy development arena, many challenges remain, including using and managing unconventional raw materials, delivery specificity, control of activity, detection of potential off-target mutations, and their inherent immunogenicity.
Complete Cell Therapy Product Lifecycle Support Services
BioTechLogic has extensive experience with all cell therapy development and commercialization aspects from preclinical to market.
Cell Therapy Development
Globally, several thousand cell therapy candidates are in development, many of them in early phases of development. Progressing these therapies to commercialization is challenged by manual processes, lack of product characterization, reproducibility difficulties, precise control over cell therapy activity, and immunogenicity management.
How BioTechLogic Can Help
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- Cell colony development
- Product characterization
- Analytical method development
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- Critical Quality Attributes understanding
- Cell processing approach decision-making
- Purification processes
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- Reproducibility
- Process development and scale-up
- Regulatory filing support
- CDMO selection
Cell 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
Cell Therapy Resources
How the Industry’s Pandemic Response Opened the Door to Therapeutic Opportunities
The biopharma industry was certainly not immune to the turbulence brought about by the COVID-19 pandemic. The pandemic disrupted — and in some cases, stopped completely — clinical trials around the globe. In fact, as of January 2021, more than 2,000 clinical trials...
Gene and Cell Therapy Developers Are Getting Creative to Keep Programs on Track During the Pandemic
Jeanette Young, senior consultant for analytical services at BioTechLogic talks with Tonia Becker, Life Sciences Editor, Macon Raine As it became clear that the COVID-19 pandemic would not be a short-lived disruption, gene and cell therapy companies adjusted their...
Lessons and Insights into the Korean Biopharmaceutical Market During the COVID-19 Pandemic
Tonia Becker, Life Sciences Editor, Macon Raine talks with BioTechLogic's Dr. Eileen Choi How is the COVID-19 pandemic affecting the global biopharmaceutical market? To get at least some perspective on this question, there is no better place to turn to than...
FDA Seeking to Enhance Manufacturing of Cell Therapy and Gene Therapy Products
More consistent and reliable production cell therapy and gene therapy processes are critical for advancing innovative treatments. While cell therapy and gene therapy products hold the promise of transforming the treatment of many diseases, difficulties in achieving...
Comprehensive Regenerative Medicine Policy Framework Announced by FDA
On November 16, 2017 the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The framework – outlined in a suite of four guidance...
Therapeutic Gene Editing: An American Society of Gene & Cell Therapy White Paper
Interested in learning more about gene editing and its therapeutic applications? Download a new white paper from the American Society of Gene & Cell Therapy (ASGCT). The document, titled “Therapeutic Gene Editing: An ASGCT White Paper” is intended as background...
